Microtest Labs

Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of New White Paper

2012-01-23T10:00:00.000-05:00

AGAWAM, Mass. — Jan. 23, 2012 — A new white paper outlining the six steps that pharmaceutical and medical device manufacturers must employ to qualify disinfectants used in their environmental cleaning processes is now available from Microtest Laboratories at http://www.microtestlabs.com/6stepspaper-disinfectant-qualification.

“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,” stated Deborah Ensign, supervisor, R&D of Microtest Laboratories, in the new white paper, “Six Steps to Qualifying Disinfectants.”

In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.

“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.

“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.

“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.

Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants” for pharmaceutical manufacturing companies from Microtest Laboratories website at http://www.microtestlabs.com/6stepspaper-disinfectant-qualification.

Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical manufacturing, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Microtest Laboratories Will Manufacture ImmusanT’s Nexvax2 Immunotherapeutic Vaccine for Expected Clinical Trial

2012-01-10T10:21:00.007-05:00

AGAWAM, MASS. – January 10, 2012 – Microtest Laboratories has announced that the company will manufacture and provide supporting pharmaceutical testing services for ImmusanT, Inc.’s Nexvax2^® immunotherapeutic vaccine for its expected upcoming clinical trial.

In addition to manufacturing Nexvax2, Microtest will provide a full range of testing services to ImmusanT supporting its drug product manufacture, including method transfer activities, complete final product release testing, storage and stability.

ImmusanT recently raised $20 million in financing to advance the development of their technology, Nexvax2, for the treatment of celiac disease. Celiac disease is an inherited autoimmune disorder that is triggered by the consumption of foods containing gluten causing an immune response resulting in inflammation of the small intestine. Safety, tolerability and bioactivity of Nexvax2 have been established in a Phase 1 clinical study.

“As a one-stop source of on-site pharmaceutical testing and manufacturing services, Microtest provides a fast, efficient, cost-effective — and risk-minimizing — alternative to subcontracting with a variety of providers at multiple locations,” said Alex Mello, Director of Project Management, Microtest Laboratories. “We deliver the flexibility, solutions, and problem-solving experience manufacturers must have to ensure the most expeditious release of their product.”

Microtest Laboratories provides flexible, customizable aseptic processing and fill/finish services – and a full-range of pharmaceutical testing services – for biotechnology and pharmaceutical companies of all sizes conducting Phase 1, 2, or 3 clinical trials. Microtest fill/finish operations comply with U.S. FDA and European EMA guidelines. Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.

For more information, visit the Microtest website at: http://www.microtestlabs.com/aseptic-processing/fill-finish/ or contact Alex Mello, Director of Project Management, at 1-800-631-1680, extension 121. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest Laboratories

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com

New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper

2011-11-02T10:41:00.001-04:00

AGAWAM, MASS. – Nov. 2, 2011 – A new white paper detailing the new scope of reusable medical device cleaning validations is available free from Microtest Laboratories on the Web at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

“Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead,” writes white paper author Patrick Kenny, Manager of Analytical Services, Microtest Laboratories.

In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny notes that “although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.”

“An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device’s submission,” he notes.

In the paper, Kenny also discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. His recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.

Kenny holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories. At Microtest, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide.

Downloada free copy of the white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

Microtest's broad portfolio of medical device and combination product testing services include sterilization validation, reusable device studies, endotoxin and sterility testing, and package validation.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm

2011-09-27T09:12:00.000-04:00

Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is detailed in a free white paper available at http://www.microtestlabs.com/dietarypaper.

The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

“Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

“In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on:

Developing the Necessary Quality System
Management “Buy In”
Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

“The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

“Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.”

For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Building, Validating & Maintaining Controlled Environment Facilities is Focus of Oct. 18th Seminar in Boston Hosted by Microtest Laboratories

2011-09-21T14:55:00.003-04:00

AGAWAM, Mass. — Building, validating, and maintaining a controlled environment facility is the subject of a daylong seminar on Oct. 18, 2011, hosted by Microtest Laboratories at the MIT Endicott House in Dedham, Massachusetts.

Titled “Keeping It Clean? The Building Blocks of Facility Control,” the seminar will focus on the clean room testing, disinfection validation, and related contamination testing issues that arise from manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

In each seminar program, industry experts will present practice advice and sound solutions in an interactive format that will encourage a high level of engagement by participants for questions, answers and discussion. The topics will include:

Killing The Bugs Without Killing Yourself: Disinfectant Qualifications
Feeling Like A Fish Out of WFI?: Water System Validation and Maintenance
Got A Lot On Your Plate: Clean-room Validations and Maintenance
The Old In & Out: Considerations On Insourcing vs. Outsourcing

“Keeping It Clean? The Building Blocks of Facility Control” will be presented 8:30 a.m. to 3:30 p.m. on Tuesday, Oct. 18, 2011, at the MIT Endicott House, 80 Haven Street in Dedham, Mass., just outside of Boston. Registration and a complimentary continental breakfast is at 8 a.m. Lunch will be served at Noon. The cost is $149 per person and includes meals, refreshments, and workshop handouts.

To register or for more information, visit the Microtest Laboratories website athttp://www.microtestlabs.com/seminar/index.asp. Or, contact Julie Adamski at 413-786-1680, toll-free at 1-800-631-1680, or at jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in controlled environment facility testing, laboratory testing, and contract manufacturing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Press contact: Don Goncalves, Tiziani Whitmyre, 1-781-793-9380, dgoncalves@tizinc.com

New White Paper Examines Clinical Trial Material Production & Testing: What Your Contract Manufacturing Organization is Not Telling You

2011-08-24T09:30:00.003-04:00

AGAWAM, MASS. – For pharmaceutical manufacturers, delays in starting a clinical trial program due to issues involving the manufacture of clinical trial material (CTM) and the associated fill/finish and release work can make even the most dogged project managers wince in pain. A new, free white paper recommends a proven process of evaluating a cGMP contract manufacturing organization (CMO) to deliver all the required processes needed to release CTM for clinical trial use.

The new white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” explores what pharmaceutical manufacturers must require from a CMO in terms of capabilities and expertise and the critical roles that the contractor must be able to assume in the clinical trial material manufacturing process.

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

“In order to keep clinical protocols on time and on budget in the CTM manufacturing process, it’s critical that the selected CMO has comprehensive capabilities that are both in-house and readily available,” notes Alexander Mello, author of the white paper and Director of Project Management, Manufacturing, for Microtest Laboratories, a leader in contract manufacturing, aseptic processing and full service pharmaceutical testing.

“Contracting with a CMO without complete in-house expertise will add unnecessary time to the CTM process. In these cases, performing a GMP audit of the CMO, plus all of the other companies (formulators, laboratories, labelers, etc.) that the CMO uses in the supply chain, will add significantly to the overall cost and time for the technical transfer of the product,” he explains.

The new white paper illustrates how the proper selection of a CMO can help meet product schedules and minimize potential restart activities. The paper reviews the roles that the CMO must be able to play in CTM process, from first steps through the completion, and details the key areas of Raw Materials, Formulation, and Final Drug Product (FDP).

The white paper also discusses how a fully-capable CMO will have the ability to perform all the required processes in CTM – including excipient and API release for GMP manufacture, formulation, in-process testing, environmental monitoring, filter integrity testing, and final release testing.

To download the new, free white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” visit http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

Mello, the author of the white paper, is Director of Project Management, Manufacturing, for Microtest Laboratories. Mello’s 15 years of experience span Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

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Environmental Monitoring and Certification in Controlled Environments - New White Paper

2011-08-10T12:38:00.004-04:00

AGAWAM, MASS. – August 10, 2011 – Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?

Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.

But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” available for free download at http://www.microtestlabs.com/environmentpaper, may help.

The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met with the assistance of an update-to-date testing laboratory.

The white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass.

Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at http://www.microtestlabs.com/environmentpaper.

About Microtest

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Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com

Microtest Laboratories Hosts Students During 2nd Annual Statewide Biotechnology Job Shadow Day

2011-07-08T09:00:00.002-04:00

AGAWAM, MASS. -- Microtest Laboratories opened its doors — and labs — to 12 high school students during the 2nd Annual Statewide Biotechnology Job Shadow Day on June 8.

Sponsored by MassBio and MassBioEd, the program allows local high school students "to explore life science career options by shadowing biotechnology professionals to experience the very real connection between classroom science and the science that drives the state's biotechnology industry."

At Microtest Laboratories, the students learned of the company's history, listened to stories from current employees regarding what brought them into the field, and toured and viewed the work underway in the company's testing labs. The day allowed the students to meet actual professionals at work in the field, ask questions, and network with individuals who will hopefully someday be their colleagues.

"At Microtest, we're big believers in the power and potential of education and science," said Steven Richter, Ph.D., Microtest Labs president and chief scientific officer. "We participated last year, in the inaugural Job Shadow Day, and are involved year-round in a number of local and regional workforce training partnerships with other companies, governments, schools, and colleges."

"Programs such as Job Shadow Day that support local science and technical education are critical to helping students turn their classroom curiosity in science into meaningful, fulfilling, lifelong careers," he said.

"Workforce development programs have a direct impact on the future — in terms of personal careers, new jobs and economic growth, and the discovery of breakthrough products and services that will better everyone's health and quality of life. Job Shadow Day is an all-around win for everyone," Richter said.

The 2nd Annual Statewide Biotechnology Job Shadow Day was sponsored by the Massachusetts Biotechnology Education Foundation (MassBioEd) and the Massachusetts Biotechnology Council (MassBio). Statewide, 650 students from 18 Massachusetts public high schools participated in the program at 18 biotechnology companies.

About Microtest Laboratories

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The company is based in Agawam, Massachusetts, U.S.A. Microtest's expertise and flexible processes enhance product safety and security, reduce time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Microtest Laboratories Announces New Fast-Track Toxicity Testing for Medical Devices Using Zebrafish Embryos

2011-07-06T10:00:00.003-04:00

AGAWAM, MASS. — July 6, 2011 — Microtest Laboratories has announced a new fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos (Danio rerio), a technique already widely utilized in drug development studies.

"Testing has revealed that Zebrafish embryos are highly susceptible to toxins. In fact, Zebrafish labs are ubiquitous in most universities and research hospitals," said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and former U.S. Food & Drug Administration (FDA) official.

"We've confirmed the application of Zebrafish embryos in the toxicity testing of materials used in medical devices," Dr. Richter said. "With our in-vitro test, manufacturers and bio materials researchers can screen thousands of polymers in less than a week — yielding significant economic savings in both the time and expense of medical device testing."

In its research, Microtest Laboratories found that the current "gold standard" USP Cytotoxicity Assay, which utilizes live mouse fibroblasts (L929) cells in culture, failed to detect the toxicity of a BPA extract during testing — while Microtest's new Zebrafish embryo screen succeeded.

BPA (bis-phenol A) is a suspected toxic polymer assumed as having both carcinogenic and teratogenic effects on humans. The U.S. Environmental Protection Agency (EPA) has indicated that BPA will be slated for screening soon.

"Microtest’s new Zebrafish embryo assay has better sensitivity and generates more scientific data than the small animal tests currently recommended by the FDA," Dr. Richter said.

"The use of Zebrafish embryos will reduce or eliminate the current animal testing required for all medical devices testing. This important vertebrate model has demonstrated similarities to mammalian models and humans in toxicity testing,” he noted.

Microtest Laboratories' new Zebrafish embryo assay for the toxicity testing of medical devices is immediately available. For more information, visit http://www.microtestlabs.com/zebrafish-embryos-testing or call 1-413-786-1680 or toll-free 1-800-631-1680

About Microtest Laboratories

Microtest Laboratories is a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Press Contact: Don Goncalves, Tiziani Whitmyre, 781-793-9380, dgoncalves@tizinc.com

Download high resolution image from: http://www.microtestlabs.com/photos

Microtest Laboratories Hosts Students During 2nd Annual Statewide Biotechnology Job Shadow Day

2011-06-28T15:35:00.002-04:00

Microtest Laboratories opened its doors — and labs — to 12 high school students during the 2nd Annual Statewide Biotechnology Job Shadow Day on June 8.

Sponsored by MassBio and MassBioEd, the program allows local high school students “to explore life science career options by shadowing biotechnology professionals to experience the very real connection between classroom science and the science that drives the state’s biotechnology industry.”

At Microtest Laboratories, the students learned of the company’s history, listened to stories from current employees regarding what brought them into the field, and toured and viewed the work underway in the company’s testing labs. The day allowed the students to meet actual professionals at work in the field, ask questions, and network with individuals who will hopefully someday be their colleagues.

“At Microtest, we’re big believers in the power and potential of education and science,” said Steven Richter, Ph.D., Microtest Labs president and chief scientific officer. “We participated last year, in the inaugural Job Shadow Day, and are involved year-round in a number of local and regional workforce training partnerships with other companies, governments, schools, and colleges.”

“Programs such as Job Shadow Day that support local science and technical education are critical to helping students turn their classroom curiosity in science into meaningful, fulfilling, lifelong careers,” he said.

“Workforce development programs have a direct impact on the future — in terms of personal careers, new jobs and economic growth, and the discovery of breakthrough products and services that will better everyone’s health and quality of life. Job Shadow Day is an all-around win for everyone,” Richter said.

The 2nd Annual Statewide Biotechnology Job Shadow Day was sponsored by the Massachusetts Biotechnology Education Foundation (MassBioEd) and the Massachusetts Biotechnology Council (MassBio). Statewide, 650 students from 18 Massachusetts public high schools participated in the program at 18 biotechnology companies.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The company is based in Agawam, Massachusetts, U.S.A. Microtest’s expertise and flexible processes enhance product safety and security, reduce time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

2011-06-06T14:16:00.003-04:00

A free white paper that guides manufacturers of medical devices in the validation of their cleaning processes is available from Microtest Laboratories.

As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.

In the white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation.

Several sections of Part 820 can be directly related to medical device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.

In the paper, Kenny presents a five-step process that provides a framework to assist manufacturers of medical devices in their cleaning validation efforts:

#1: Evaluate the Process, Determine the Potential Contaminants
#2: Determine the Limits
#3: Identify the Analytical Test
#4: Validate the Method for Use
#5: Validate the Cleaning Process

Download a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” at http://microtestlabs.com/cleaning-validation-paper.

At Microtest Labs, Kenny leads the services group performing medical device and pharmaceutical analytical testing. He holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories.

About Microtest Laboratories

Microtest Labs is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com

Seminar to Help Manufacturers Accelerate the Process of Bringing Reusable Medical Devices to Market

2011-04-06T14:33:00.005-04:00

Medical product manufacturers can learn how to accelerate the process of bringing their reusable devices to market in a day-long seminar on May 3, 2011, in Dedham, Massachusetts.

Titled “Bringing Your Reusable Device To Market: Just Because Your Device Lasts Forever Doesn't Mean The Process of Bringing It To Market Has To,” the seminar will provide an extensive look at the process of introducing such products and help manufacturers answer critical questions such as: “What is required?”; “How much will it cost?”; and “How long will it take?”

The seminar will cover the product introduction process from manufacture of the sterilization tray to the testing that’s required for regulator submittal. Presentations will include:

• Flushing It Out: New Analytical Methods of Testing on Protein, Hemoglobin, and Carbohydrate

• Don’t Get Stuck in a Groove: Cleaning Validations Using Microbial Methods

• What is the Good in Good Laboratory Practices (GLP): Understanding the Process

• Packaging Your Idea Into Reality: A Look at the Process of Tray Manufacturing

• One Cycle, Two Cycle, Three Cycle, More?: Sterilization of Your Reusable Devices

The event will run from 8:30 a.m. to 3:30 p.m., with registration and a complimentary continental breakfast starting at 8 a.m. The seminar will be held on Tuesday, May 3, 2011, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts. The cost is $149 per person and it includes breakfast, lunch, and workshop handouts.

The seminar is sponsored by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

To register, contact Julie Adamski at 413-786-1680, toll-free at 800-631-1680, or at jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

“Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab” – New White Paper from Microtest Laboratories

2011-03-22T11:49:00.000-04:00

Press Release – For Immediate Release

“Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab” – New White Paper from Microtest Laboratories

AGAWAM, MASS. – March 22, 2011 – A new, free white paper titled “Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab” is now available for download from Microtest Laboratories at http://www.microtestlabs.com/stability-program-paper.

Many virtual clinical manufacturers, as well as some nonvirtual companies, require a stability program but lack the brick-and-mortar facilities to operate a fully compliant and capable stability laboratory. Such firms will often outsource their programs to third-party laboratories.

The new white paper details the critical issues that a manufacturer must address in starting and setting up a stability program with an outside contract laboratory. Much more than regurgitating the ICH guidelines, the paper’s discussion centers on the following key issues:

Initial communication with the contract stability laboratory or organization
Transfer of methods
Required product knowledge and stability program management
Data presentation for important decision making on label claims

The white paper reviews the development of a parenteral stability program from the standpoint of effective stability program management, rather than from a regulatory or scientific requirements perspective.

The paper is authored by Alex Mello, Director of Project Management, Manufacturing, and Jessica Labrie, Project Manager/Stability Coordinator, both of Microtest Laboratories.

Download a free copy of the white paper “Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab” from http://www.microtestlabs.com/stability-program-paper.

About Microtest Laboratories

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Press contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com

Download high-resolution image from: http://microtestlabs.com/photos

White Paper Outlines Disinfection Testing, Cleaning Validation Studies Requirements for Reusable Medical Devices

2011-03-03T11:43:00.000-05:00

AGAWAM, MASS. – A new, free white paper outlining the application of disinfection and cleaning validation requirements for reusable medical devices in line with U.S. Food and Drug Administration (FDA) regulations is now available from Microtest Laboratories (http://www.microtestlabs.com/medical-disinfection-paper).

Titled “Reusable Medical Device Disinfection and Cleaning Validation Requirements,” the paper outlines the salient aspects of validating that a medical device can be safely reused; addresses disinfection studies and processes, rather than sterilization; and provides cleaning validation information germane to all reusable medical devices.

The author of the paper is Steven Richter, Ph.D., president and scientific director of Microtest Laboratories. Richter is himself a former FDA official.

“Reusable medical devices come in all shapes and sizes — from specula to colonoscopes. Generally, these devices have expensive components that require them to be cleaned and disinfected or sterilized,” Dr. Richter notes.

“Recently, the FDA began requiring additional information on 510(k) submissions, demanding clarity in the options afforded to practitioners. Microbiologists generally treat all medical devices equally, even though many devices require special treatment.

“Historically, manufacturers were not required to validate that cleaning and disinfection processes were effective in reducing microbial and protein loads to safe levels. The FDA may have asked manufacturers for data regarding disinfectant use during reprocessing, but manufacturers would often simply perform cursory simulated-use tests that might not pass muster with FDA reviewers today.

“Currently, the FDA requires validation studies for both disinfection and cleaning. Both disinfection testing validation and cleaning validation studies are important to the manufacturer because they will validate the safety and efficacy of the disinfection process. It is important to qualify both the cleaning and disinfecting processes prior to validation activities.

“This new white paper is aimed at helping practitioners determine the best practices for performing these critical disinfection testing and cleaning validation studies,” Dr. Richter states.

Download a free copy of the white paper “Reusable Medical Device Disinfection and Cleaning Validation Requirements” from http://www.microtestlabs.com/medical-disinfection-paper.

Dr. Richter founded Microtest Laboratories in 1984 after a distinguished career at the FDA. Under his leadership, Microtest Laboratories provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

About Microtest Laboratories

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Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com

Keywords: Cleaning validation studies, Disinfection testing, Reusable Medical Devices

New White Paper Examines Clinical Trial Material Production & Testing: What Your Contract Manufacturing Organization is Not Telling You

2010-12-07T12:29:00.002-05:00

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

# # #

Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com

New White Paper: Having a Solid Package Validation Program Can Prevent Failure of Combination Products

2010-11-16T11:33:00.002-05:00

AGAWAM, MASS. – November 16, 2010 – A new white paper urges medical device and combination product manufacturers to employ a solid package validation program as a means of preventing the failure of combination products.

“FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs,” said Steven Richter, Ph.D., founder, president and chief scientific officer of Microtest Laboratories in Agawam, Mass.

Richter is author of the new white paper that provides insight into the general requirements in a microbiological and physical testing program. In it, he discusses how combination products pose a unique set of challenges to package validation engineers.

Titled, “Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” the paper is available for download from: http://www.microtestlabs.com/packaging-validation-paper.

In the white paper, Richter discusses the challenges of packaging validation and some of the options for testing. He provides a summary of the standardized test methods commonly used in the U.S. for satisfying ANSI/AAMI/ISO 11607 requirements, and outlines the steps in the packaging validation process. He also focuses on the points to consider during packaging validation studies for cell therapy products.

“All device and combination product manufacturers are required to have a robust package validation program, and medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions,” Richter said. “The necessity to develop a robust packaging validation regimen cannot be overstated. A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

“This white paper is presented to give medical device and combination product manufacturers a starting point for package validation programs,” he said.

Download the new, free white paper, “Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” from: http://www.microtestlabs.com/packaging-validation-paper.

Steven Richter, Ph.D., is founder, president, and chief scientific officer of Microtest Laboratories, Inc., in Agawam, Mass. Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest has provided the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

# # #

USP Microbial Examination of Non-Sterile Products: New White Paper is Roadmap of Regulations for Manufacturers

2010-10-05T10:00:00.002-04:00

AGAWAM, MASS. – Manufacturers examining their microbial limits testing policies and assessing the impact of the recent harmonization of USP, EP, and JP requirements will find guidance in a new white paper titled “USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World.” It’s available for download from http://www.microtestlabs.com/microbial-examination-paper/default.asp.

Manufacturers required to evaluate the microbial content of their non-sterile products utilize the Microbial Limits Test used to determine the bioburden of the product and also if objectionable organisms are present. In 2009, the harmonized test method became effective, requiring manufacturers to meet the new guidelines set forth in it.

“The new white paper examines how the recent harmonization of USP, EP, and JP requirements affects the processing of raw materials and finished products by manufacturers. It also examines the considerations that manufacturers should examine when establishing a microbial limits testing policy,” said white paper authors James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services; and Kimberly Kitch, A.S., Laboratory Technician II – both of Microtest Laboratories.

In the paper, Gebo and Kitch examine:
• The Affects of Harmonization
• Sample Requirements
• Sample Processing
• Suitability Testing v. Validation
• Essential Product Information Required for Testing

Download a free copy of “USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World,” from http://www.microtestlabs.com/microbial-examination-paper/default.asp.

Both authors are members of the Laboratory Services group at Microtest Laboratories. Gebo has had hands-on experience in regulatory microbiology and virology testing since 2004. He holds a B.S. in Biology, a Masters in Public Administration, and is a Registered Microbiologist (NRCM). Kitch has been employed by Microtest Laboratories since January, 2006, and has worked in Microbial Limits, Genetic Identification of Bacteria and Fungi, LAL/Biocompatibility, Bioburden Testing, and other areas. She holds an A.S. in Biology.

Follow Microtest Labs on Twitter: @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products

2010-07-13T10:12:00.002-04:00

AGAWAM, MASS. – July 13, 2010 – A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/)

Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, “Combination Products 2.0: Applying the New FDA Regulations,” Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., addresses the implications for manufacturers. (Download from: http://www.microtestlabs.com/combination-products-20).

In the white paper, Dr. Richter discusses:
• The New Regulations
• Determining Principal Mode of Action — Device or Drug?
• Stem Cells & Human Tissue in Combination Products
• The Implications for Testing and Validation
• An Example: Drug-Eluting Stents

“The new FDA regulations governing combination products are a major step forward for the industry. They apply to parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part IV closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety. The ability of manufacturers to understand, establish, implement reliable testing procedures will be critical in complying with these new requirements,” Dr. Richter said.

Download a free copy of “Combination Products 2.0: Applying the New FDA Regulations” from http://www.microtestlabs.com/combination-products-20/.

Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

2010-06-09T14:38:00.001-04:00

AGAWAM, MASS. – June 9, 2010 – A new free, white paper that guides medical device manufacturers in the validation of their cleaning processes is now available from Microtest Laboratories.

As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.

In a new white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation. (Download from: http://www.microtestlabs.com/cleaning-validation-paper.)

Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.

In the paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts:
• #1: Evaluate the Process, Determine the Potential Contaminants
• #2: Determine the Limits
• #3: Identify the Analytical Test
• #4: Validate the Method for Use
• #5: Validate the Cleaning Process

For a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” visit Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Or, download a free copy from http://www.microtestlabs.com/cleaning-validation-paper.

At Microtest Labs, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide. He holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

New White Paper: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers

2010-06-09T14:26:00.003-04:00

AGAWAM, MASS. – June 8, 2010 – Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?

Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.

But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” available for free download at www.microtestlabs.com/environmentpaper, may help.

The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met with the assistance of an update-to-date testing laboratory.

The white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass.

Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at http:/www.microtestlabs.com/environmentpaper.

Or, obtain a free copy of the white paper from Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest Laboratories offers reliable, accurate programs for testing of product bioburdens; viable aerobic, anaerobic, or fungal microorganisms; and nonviable air particulates. The company’s expertise at characterizing, controlling, and understanding environmental bioburden levels and trends are the cornerstones to defining and implementing a solid Environmental monitoring program which fully supports sterilization validation and release activities. Microtest, a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries, is based in Agawam, Massachusetts, USA. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Microtest Labs Offers Expanded Clean Room, Contamination Testing Services for Medical Device Manufacturers

2010-06-09T14:22:00.001-04:00

AGAWAM, MASS. – June 8, 2010 – Microtest Laboratories (www.microtestlabs.com) features new technology and professional staffing as part of its expanded offering of proven, one-stop provider of contamination and clean room testing services for manufacturers of medical devices.

Microtest Labs will highlight its MLT testing services and expertise at the Medical Design & Manufacturing East / MD&M East Exposition, booth #1251, June 8-10, 2010 in New York City.

Microtest helps manufacturers maintain control of their controlled environment to ensure regulatory compliance as well as to achieve greater productivity. Microtest assists manufacturers to identify, assess and resolve a wide range of clean room and environmental contamination problems while ensuring little or no process disruption or downtime.

Microtest’s environmental services group is comprised of highly trained microbiologists with extensive experience applying modern testing technologies in all varieties of clean room and other controlled environments. Their work meets or exceeds applicable clean room testing requirements for regulatory regimes including the International Organization for Standardization (ISO), the European Union (EU) Annex, and the U.S. Food and Drug Administration (FDA).

Microtest offers the following testing and support services:

• ISO certification and clean room validation, to any ISO Class required, for all controlled environments, including clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and fume hoods.

• HEPA filter repair, replacement, and installation for all controlled environments including clean rooms, laminar flow hoods, biological safety cabinets , compounding aseptic isolators, and fume hoods.

• Viable sampling, including evaluating for contamination of aerobic and anaerobic microorganisms, surface testing and analysis, active air sampling, and collecting passive air samples. In-house MicroSeq® DNA-sequence-based analyzers provide results as fast as 24 hours to speed isolation and elimination of the source.

• Nonviable air particulate sampling and testing to ISO 14644 guidelines, the EU Annex, or both.

• Disinfection validation, including dilution testing, phenol coefficient testing, sporicidal testing, and germicidal testing.

• Gowning validation as well as assistance with developing and demonstrating proper gowning procedures.

• DNA-sequence-based microbial identification utilizing in-house MicroSeq® Microbial Identification Systems for fast, precise and reliable bacteria, mycoplasma, and mold identification.

• Compressed air/gas testing, including nonviable air particulate testing; compressed air testing for aerobic, anaerobic, and fungal organisms; and testing for hydrocarbons and water vapors.

For more information about Microtest Laboratories’ complete offering of contamination and clean room testing services for manufacturers of medical devices, visit Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Or, visit Microtest website at: http://www.microtestlabs.com/cleanroom-testing-services or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Microtest Labs Highlights 20 Years’ Experience as Leader in Cleaning Validation Studies for Medical Devices Designed for Reuse

2010-06-09T14:18:00.001-04:00

AGAWAM, MASS. – June 8, 2010 – Microtest Laboratories will highlight its 20 years of experience in providing cleaning validation studies of medical devices designed and labeled for reuse at the Medical Design & Manufacturing East /MD&M East Exposition, booth #1251, June 8-10, 2010 in New York City.

Microtest bases its cleaning validation studies on the recommendations of the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), and the American Society for Testing and Materials (ASTM).

In doing so, Microtest can document, with a high level of assurance, that a given cleaning process used on a given device will clean it effectively — to parameters predetermined by the manufacturer — after each use.

Services include AAMI TIR12 and AAMI TIR30 cleaning validation.

At Microtest, the studies are conducted according to a thorough, multi-step process. The device is first inoculated with a biological challenge organism — a spore strip or liquid spore inoculum — used as an indicator. Recommendations of the United States Pharmacopeia (USP) and Association for the Advancement of Medical Instrumentation (AAMI) suggest organisms with high resistance to the given sterilization process. The device is then cleaned, and tested for recovery of the indicator.

If the indicator hasn’t been reduced by at least a factor of 3 logs, the cleaning cycle fails the test. Valid devices must pass three consecutive cleaning cycles to be considered validated.

Testing uses spore strips with 106 spores per strip, or liquid suspensions. Inoculated devices are cultured under an ISO Class 5 (Class 100) laminar airflow hood, using aseptic technique, determination of recovery factors, and traditional culture/enrichment techniques to optimize indicator recovery.

Test controls include the following:
• All culture media undergo USP Growth Promotion Testing (GPT) and sterility assurance to ensure optimal recovery and sterility
• Incubators are calibrated and monitored 24/7 via an advanced SCADA system
• Bacterial spore populations used in biological challenges are controlled and verified per USP prior to use
• Each sample is tested with positive and negative controls

Microtest possesses the knowledge, experience, specialized equipment and techniques, and strict adherence to protocols required to provide the highest level assurance of required for cleaning validation studies of medical devices designed and labeled for reuse.

For more information, visit Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Or, visit the Microtest website at http://www.microtestlabs.com/medical-device-testing/reusable-device-testing/cleaning-validation.html or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

2010-06-02T09:00:00.000-04:00

AGAWAM, MASS. – June 2, 2010 – A new free, white paper that guides medical device manufacturers in the validation of their cleaning processes is now available from Microtest Laboratories.

As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.

In a new white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation. (Download from: http://www.microtestlabs.com/cleaning-validation-paper.)

Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.

In the paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts:
• #1: Evaluate the Process, Determine the Potential Contaminants
• #2: Determine the Limits
• #3: Identify the Analytical Test
• #4: Validate the Method for Use
• #5: Validate the Cleaning Process

Download a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” from http://www.microtestlabs.com/cleaning-validation-paper.

At Microtest Labs, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide. He holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact, Boston: Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations

Get with the Program: Having a solid package validation program can prevent failure of combination products

2010-05-24T11:25:00.007-04:00

FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs.

Read the new bylined article by Steven Richter, "Get with the Program: Having a solid package validation program can prevent failure of combination products," for insight into the general requirements in a microbiological and physical testing program. It also discusses how combination products pose a unique set of challenges to package validation engineers.

Published May 2010 in MD&DI, at http://ht.ly/1P7lO

White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

2010-04-22T09:34:00.001-04:00

AGAWAM, MASS. – April 20, 2010 – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed. The typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical are discussed in a new, free, white paper.

The new white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” will be available from Microtest Labs at Interphex 2010, booth #147, April 20-22, 2010, in New York City.

The new white paper is also available for free download at: http://www.microtestlabs.com/control-environment.

The white paper focuses on what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”).

Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

The white paper is authored by Alex Mello, Director of Project Management, Manufacturing, of Microtest Laboratories (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing services. In the white paper, he:

Warns to test only when necessary to reduce interventions.
Explains to test using methods that give data as quick as fittingly possible to condense processing times.
Discusses how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.

For a copy of the free white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit Microtest Laboratories at Interphex 2010, booth #147, April 20-22, 2010 in New York City.

Or, visit the Microtest website at: http://www.microtestlabs.com/control-environment. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest Labs is a Leader in Cleaning Validation Studies for Medical Devices Designed for Reuse

2010-04-22T09:27:00.000-04:00

AGAWAM, MASS. – April 21, 2010 – Microtest Laboratories is a leader with 20 years of industry experience in providing cleaning validation studies of medical devices designed and labeled for reuse.

Microtest Labs will highlight its expertise in providing cleaning validation studies at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Microtest bases its cleaning validation studies on the recommendations of the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), and the American Society for Testing and Materials (ASTM).

In doing so, Microtest can document, with a high level of assurance, that a given cleaning process used on a given device will clean it effectively — to parameters predetermined by the manufacturer — after each use.

Services include AAMI TIR12 and AAMI TIR30 cleaning validation.

At Microtest, the studies are conducted according to a thorough, multi-step process. The device is first inoculated with a biological challenge organism — a spore strip or liquid spore inoculum — used as an indicator. Recommendations of the United States Pharmacopeia (USP) and Association for the Advancement of Medical Instrumentation (AAMI) suggest organisms with high resistance to the given sterilization process. The device is then cleaned, and tested for recovery of the indicator.

If the indicator hasn’t been reduced by at least a factor of 3 logs, the cleaning cycle fails the test. Valid devices must pass three consecutive cleaning cycles to be considered validated.

Testing uses spore strips with 106 spores per strip, or liquid suspensions. Inoculated devices are cultured under an ISO Class 5 (Class 100) laminar airflow hood, using aseptic technique, determination of recovery factors, and traditional culture/enrichment techniques to optimize indicator recovery.

Test controls include the following:

All culture media undergo USP Growth Promotion Testing (GPT) and sterility assurance to ensure optimal recovery and sterility
Incubators are calibrated and monitored 24/7 via an advanced SCADA system
Bacterial spore populations used in biological challenges are controlled and verified per USP prior to use
Each sample is tested with positive and negative controls

Microtest possesses the knowledge, experience, specialized equipment and techniques, and strict adherence to protocols required to provide the highest level assurance of required for cleaning validation studies of medical devices designed and labeled for reuse.

For more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Or, visit the Microtest website at http://www.microtestlabs.com/medical-device-testing/reusable-device-testing/cleaning-validation.html or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Microtest Labs Offers Expanded Clean Room, Contamination Testing Services for Medical Device Manufacturers

2010-04-22T09:23:00.001-04:00

AGAWAM, MASS. – April 21, 2010 – Microtest Laboratories (www.microtestlabs.com) features new technology and professional staffing as part of its expanded offering of proven, one-stop provider of contamination and clean room testing services for manufacturers of medical devices.

Microtest Labs will highlight its MLT testing services and expertise at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Microtest helps manufacturers maintain control of their controlled environment to ensure regulatory compliance as well as to achieve greater productivity. Microtest assists manufacturers to identify, assess and resolve a wide range of clean room and environmental contamination problems while ensuring little or no process disruption or downtime.

Microtest’s environmental services group is comprised of highly trained microbiologists with extensive experience applying modern testing technologies in all varieties of clean room and other controlled environments. Their work meets or exceeds applicable clean room testing requirements for regulatory regimes including the International Organization for Standardization (ISO), the European Union (EU) Annex, and the U.S. Food and Drug Administration (FDA).

Microtest offers the following testing and support services:

ISO certification and clean room validation, to any ISO Class required, for all controlled environments, including clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and fume hoods.
HEPA filter repair, replacement, and installation for all controlled environments including clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and fume hoods.
Viable sampling, including evaluating for contamination of aerobic and anaerobic microorganisms, surface testing and analysis, active air sampling, and collecting passive air samples. In-house MicroSeq® DNA-sequence-based analyzers provide results as fast as 24 hours to speed isolation and elimination of the source.
Nonviable air particulate sampling and testing to ISO 14644 guidelines, the EU Annex, or both.
Disinfection validation, including dilution testing, phenol coefficient testing, sporicidal testing, and germicidal testing.
Gowning validation as well as assistance with developing and demonstrating proper gowning procedures.
DNA-sequence-based microbial identification utilizing in-house MicroSeq® Microbial Identification Systems for fast, precise and reliable bacteria, mycoplasma, and mold identification.
Compressed air/gas testing, including nonviable air particulate testing; compressed air testing for aerobic, anaerobic, and fungal organisms; and testing for hydrocarbons and water vapors.

For more information about Microtest Laboratories’ complete offering of contamination and clean room testing services for manufacturers of medical devices, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Or, visit Microtest website at: http://www.microtestlabs.com/cleanroom-testing-services or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest Labs Provides Experienced USP Microbial Limits Testing of Raw Materials, Other Nonsterile Products for Pharma Manufacturers

2010-04-22T09:22:00.000-04:00

GAWAM, MASS. – April 21, 2010 – Microtest Laboratories, a leader in pharmaceutical testing services, is an experienced resource of USP Microbial Limits Testing (MLT) of raw materials and other nonsterile products in pharmaceutical manufacturing.

Microtest Labs will highlight its MLT testing services and expertise at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

The quantitative phase of MLT testing determines the bioburden of given pharmaceutical manufacturing samples, determining the number of total aerobic organisms as well as the total number of yeasts, and molds. The qualitative phase of testing examines samples per U.S. FDA criteria for “objectionable organisms.”

For minimum coverage, these criteria require testing for the following:

The bacteria Escherichia coli (E. coli)
The bacteria Staphylococcus auseus (S. auseus)
The yeast Candida albicans (C. albicans)
The bacteria Pseudomonas aeruginosa (Ps. aeruginosa)
The fungus Aspergillus niger (A. niger)

The first step in microbial limits testing is the preparatory testing which validates the product with the method used. This ensures the product has no inhibitory effect on the recovery of organisms from the product. Once the product has passed the preparatory test, the product is validated for routine screening. The routine microbial limits screening test consists of the total aerobic and total yeast and mold counts as well as the test for objectionable microorganisms. If the total aerobic and total yeast and mold counts are acceptable and no objectionable organisms are found, then Microtest microbiologists okay the swift release of the product or raw material.

Full microbial limits testing then inoculates specific organisms into general nutrient media. After allowing time for any growth, Microtest microbiologists transfer the results to specific media that show differential reactions to the presence of a given organism.

While the preparatory and the routine microbial limits screening test can be particularly problematic for inexperienced laboratory personnel at other facilities, Microtest brings the industry’s highest levels of expertise to MTL testing.

This expertise enables Microtest to deliver its clients a competitive advantage – in the form of faster regulatory approvals and time to revenue, high-quality customized testing, the elimination of schedule disruptions and reduction of risks, accelerated reliable turnarounds, and enhanced costs savings.

For more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Or, visit Microtest website at: http://www.microtestlabs.com/pharmaceutical-testing-services/usp-assays/usp-microbial-limits.html or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

New, Free White Paper: “Environmental Monitoring and Certification in Controlled Environments

2010-04-22T09:19:00.002-04:00

AGAWAM, MASS. – April 21, 2010 – Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

Or, for more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest Laboratories offers reliable, accurate programs for testing of product bioburdens; viable aerobic, anaerobic, or fungal microorganisms; and nonviable air particulates. The company’s expertise at characterizing, controlling, and understanding environmental bioburden levels and trends are the cornerstones to defining and implementing a solid Environmental monitoring program which fully supports sterilization validation and release activities. Microtest, a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries, is based in Agawam, Massachusetts, USA. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

New White Paper for Dietary Supplement Manufacturers Provides How-to for New Compliance Paradigm

2010-04-05T10:55:00.002-04:00

AGAWAM, MASS. – April 5, 2010 -- Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is presented in a free white paper, available now for download from http://www.microtestlabs.com/dietarypaper.

The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

“Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

“In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on:
• Developing the Necessary Quality System
• Management “Buy In”
• Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
• Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

“The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

“Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.”

For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact, Boston: Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations

Free White Paper: Advanced Detection of Mycoplasmas

2010-02-11T09:40:00.002-05:00

Free White Paper: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers

Contamination by mycoplasmal organisms is an ever-present concern in biopharmaceutical manufacturing.

Learn how real-time PCR analysis is an effective alternative testing method for fast, preliminary mycoplasma detection.

Visit: http://www.microtestlabs.com/mycoplasmapaper/default.asp

New White Paper: “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control

2009-09-21T15:29:00.000-04:00

AGAWAM, MASS. – September 21, 2009 – Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

A new white paper, titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” and available for free download at www.microtestlabs.com/environmentpaper, may help.

The author of the white paper is Steven Wieczorek, Supervisor, Environmental Sciences. He leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services.

Download the white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” from www.microtestlabs.com/environmentpaper.

About Microtest

Microtest Laboratories offers reliable, accurate programs for testing of product bioburdens; viable aerobic, anaerobic, or fungal microorganisms; and nonviable air particulates. The company’s expertise at characterizing, controlling, and understanding environmental bioburden levels and trends are the cornerstones to defining and implementing a solid Environmental monitoring program which fully supports sterilization validation and release activities. Microtest is based in Agawam, Massachusetts, USA. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or 1-800-631-1680.

# # #

Public Relations contact, Boston: Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations

Microtest Offers Comprehensive Accelerated Aging Studies for Medical Device Manufacturers

2009-06-16T12:09:00.000-04:00

AGAWAM, MASS. – June 16, 2009 –Microtest Laboratories is an industry leader in providing validation studies is now offering accelerated aging studies as part of Microtest’s portfolio of package validation services.

Microtest uses accelerated aging studies to aid medical device manufacturers in predicting what will occur to the packaging or product during normal storage conditions. Studies are used to set preliminary shelf life dates, the period during which the product remains stable for its intended use.

Available accelerated aging studies from Microtest include:

Standard chamber temperature studies (-70C, -20C, 25C 60% RH), (30C 65%RH), (35C 75% RH), (40C 75%RH), (50C 10-50% RH),( 55C 10-50%RH), (60C 10-50%RH)
Post-stability/aging testing
Custom studies

Backup storage is guaranteed. All chambers are monitored by SCADA, a 24-hour temperature monitoring system that alerts Microtest personnel to out of tolerance conditions, and feature back-up power.

“Unlike some other labs, at Microtest advanced SCADA systems monitor test chambers 24 hours a day, 7 days a week. So customers and regulators can be sure humidity and temperature remain within prescribed ranges,” said Steven Richter, Ph. D., President and Scientific Founder of Microtest Laboratories (http://www.microtestlabs.com/). “And since we offer a full range of drug testing at a single source, products aren’t exposed to temperature or humidity hazards in transit between tests.”

Microtest is widely recognized for its problem-solving expertise in medical device contract manufacturing. Services include single-source production and testing, plus dedicated product management.

For more information on Microtest’s complete portfolio of services, visit Microtest Laboratories on the Web at www.microtestlabs.com/medical-device-testing/package-validation-testing.html, or call 1-800-631-1680.

Or, visit Microtest at the 2009 MD&M East, June 9th-11st, in Booth 1442 in the Jacob K. Javitz Convention Center New York, NY.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact: Tiziani Whitmyre Inc., www.tizinc.com

White Paper Explains Package Validation Requirements For Medical Devices & Combinatory Products

2009-06-09T10:00:00.000-04:00

AGAWAM, MASS. – June 9, 2009 – Validation requirements and combination products pose a unique set of challenges to the medical device engineer. A new whitepaper from Microtest Laboratories discusses how an engineer can best to utilize packaging validation programs and discusses options when testing medical device packaging.

The white paper, ““Package Validation Requirements For Medical Devices and Combinatory Products” provides an insight into the general requirements in microbiological and physical testing programs. It is available for download at: www.microtestlabs.com/package-validation-paper/

Specifically, the white paper discusses that medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions and that performing accelerated aging studies does little to address liability during shipment and storage.

The white paper discusses:
· The necessity to develop a robust packaging validation regimen
· That a packaging validation program should include transportation simulation testing with concomitant sterility testing.
· A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

The white paper is authored by Steven Richter, Ph.D, is President and Chief Scientific Officer of Microtest Laboratories, (www.microtestlabs.com/), a contract manufacturer and provider of contract manufacturing testing.

To download the white paper, “Package Validation Requirements For Medical Devices and Combinatory Products“ visit: www.microtestlabs.com/package-validation-paper/

Or, visit Microtest at the 2009 MD&M East, June 9th-11st, in Booth 1442 in the Jacob K. Javitz Convention Center New York, NY.

About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact: Tiziani Whitmyre Inc., www.tizinc.com

Microtest Laboratories Provides ICH Stability Testing to Pharmaceutical Product Manufacturers

2009-05-26T11:35:00.004-04:00

AGAWAM, MASS. – May 26, 2009 –Microtest Laboratories is an industry leader in providing ICH stability testing, compliant with International Conference of Harmonisation (ICH) guidelines, to manufacturers of pharmaceuticals products. The testing is offered as part of Microtest’s complete portfolio of contract manufacturing testing services.

Before a drug product is submitted for regulatory approval, ICH stability testing helps demonstrate that the product will continue to be safe and efficacious for its stated shelf life. Real-time ICH stability testing is conducted at room temperatures to reproduce actual storage conditions. Accelerated stability testing occurs at higher temperatures — up to 55°C — to simulate longer spans.

Microtest typically tests three conformance lots, to some target of 6, 9, 12, 18, or 24 months. Total elapsed time of all testing is usually 1 year or less. Microtest conducts tests for sterility, endotoxins, and particulates. Microtest also checks that the concentration of active ingredients is within specifications, and watch for evidence that real-time or accelerated aging has affected drug concentration or purity. Moreover, Microtest is one of a few labs that offer photostability testing to monitor the effect of prolonged light exposure.

“Unlike some other labs, at Microtest advanced SCADA systems monitor test chambers 24 hours a day, 7 days a week. So customers and regulators can be sure humidity and temperature remain within prescribed ranges,” said Steven Richter, Ph. D., President and Scientific Founder of Microtest Laboratories (http://www.microtestlabs.com/). “And since we offer a full range of drug testing at a single source, products aren’t exposed to temperature or humidity hazards in transit between tests.”

Microtest is widely recognized for its problem-solving expertise in pharmaceutical contract manufacturing, aseptic processing, and pharmaceutical packaging. Services include single-source production and testing, plus dedicated product management.

For more information, visit Microtest Laboratories on the Web at www.microtestlabs.com/aseptic-processing/stabilty, or call 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

Microtest Labs Adds Dissolution Testing to its Suite of Analytical and Stability Testing Services

2009-05-14T11:48:00.000-04:00

AGAWAM, MASS. – May 14, 2009 – Microtest Laboratories, a leading single source provider of contract analytical solutions, is adding dissolution testing to its current suite of analytical testing and stability services.

“The addition of dissolution testing is the perfect complement to our portfolio of services,” said Steven Richter, Ph. D., President and Scientific Founder of Microtest Laboratories (www.microtestlabs.com). “By offering an even more comprehensive array of assays, we’re increasing the convenience, efficiency, and value that we deliver as a single, preferred provider of contract laboratory services.”

Dissolution is a compendial method used to measure a drug’s rate of release from its dosage form. It is a complement to other analytical assays – potency and related substances (Microtest already offers both) – that characterize the dosage form.

Dissolution is typically used:

To optimize drug delivery rate during development studies
For use in routine QC analysis for lot release and to measure lot-to-lot variability
For use in stability studies to study the effects of time/temperature/humidity on the dosage form
To compare one dosage form to another (different formulations, different processes, analysis of competitor's samples)
To estimate release and absorption rates in humans after an in vitro - in vivo correlation is established
Dissolution is a sample preparation technique. Samples still need to be analyzed separately, usually by Microtest’s HPLC or UV Spectroscopy testing. Typical samples are oral dosage forms, although it can also be used on topicals and transdermal systems.

In addition to dissolution testing, Microtest provides a host of analytical assays, including HPLC Assays, GC Analysis, Protein Analysis, FTIR Analysis, and UV/VIS Analysis.

Microtest’s analytical testing processes follow guidelines from all major standards authorities, including the United States Pharmacopeia (USP), the Japanese and European Pharmacopoeias, the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and the Association for Advancement of Medical Instrumentation (AAMI).

For more information, visit the Microtest website at www.microtestlabs.com/analytical-chemistry-testing or call 1-800-631-1680.

Or, visit Microtest at the 2009 Bio International Convention in Atlanta, May 18th-21st, in Booth 2803 in the Massachusetts Pavilion.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact: Tiziani Whitmyre Inc. (www.tizinc.com/services/public-relations/index.html)

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Microtest Labs Expands Clean Room, Contamination Testing Services

2009-04-22T08:30:00.000-04:00

AGAWAM, MASS. – April 22, 2009 – Microtest Laboratories (www.microtestlabs.com) has added new technology and professional staffing to expand its position as a proven, one-stop provider of contamination and clean room testing services for manufacturers of medical devices or pharmaceuticals.

Microtest helps manufacturers maintain control of their controlled environment to ensure regulatory compliance as well as to achieve greater productivity. Microtest assists manufacturers to identify, assess and resolve a wide range of clean room and environmental contamination problems while ensuring little or no process disruption or downtime.

Microtest’s environmental services group is comprised of highly trained microbiologists with extensive experience applying modern testing technologies in all varieties of clean room and other controlled environments. Their work meets or exceeds applicable clean room testing requirements for regulatory regimes including the International Organization for Standardization (ISO), the European Union (EU) Annex, and the U.S. Food and Drug Administration (FDA).

Microtest offers the following testing and support services:

ISO certification and clean room validation, to any ISO Class required, for all controlled environments, including clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and fume hoods.
HEPA filter repair, replacement, and installation for all controlled environments including clean rooms, laminar flow hoods, biological safety cabinets , compounding aseptic isolators, and fume hoods.
Viable sampling, including evaluating for contamination of aerobic and anaerobic microorganisms, surface testing and analysis, active air sampling, and collecting passive air samples. In-house MicroSeq® DNA-sequence-based analyzers provide results as fast as 24 hours to speed isolation and elimination of the source.
Nonviable air particulate sampling and testing to ISO 14644 guidelines, the EU Annex, or both.
Disinfection validation, including dilution testing, phenol coefficient testing, sporicidal testing, and germicidal testing.
Gowning validation as well as assistance with developing and demonstrating proper gowning procedures.
DNA-sequence-based microbial identification utilizing in-house MicroSeq® Microbial Identification Systems for fast, precise and reliable bacteria, mycoplasma, and mold identification.
Compressed air/gas testing, including nonviable air particulate testing; compressed air testing for aerobic, anaerobic, and fungal organisms; and testing for hydrocarbons and water vapors.

For more information about Microtest Laboratories’ complete offering of contamination and clean room testing services for manufacturers of medical devices or pharmaceuticals, visit Microtest at BIOMEDevice in Boston, April 22-23, 2009 at booth no. 1023. Or, visit the Microtest website www.microtestlabs.com, or call 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com/services/public-relations/index.html)

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Technorati tags: clean room testing ISO certification clean room validation HEPA filter repair HEPA filter replacement Viable sampling Nonviable air particulate sampling Disinfection validation Gowning validation DNA-sequence-based microbial identification Compressed air testing Compressed gas testing

New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers

2009-04-03T15:40:00.000-04:00

AGAWAM, MASS. – Contamination by mycoplasmal organisms is an ever-present concern in biopharmaceutical manufacturing. Their properties make them ready sources of contamination, while rendering them difficult and time-consuming to detect. A new free white paper, examines how PCR mycoplasma tests and analysis, deployed by a cutting-edge laboratory, minimizes testing delays and enable safe, high-volume biopharmaceutical production.

The new white paper, “Advanced Detection of Mycoplasmas: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers,” explores relevant mycoplasma characteristics, established testing solutions, and the use of real-time PCR analysis as an alternative testing method for fast, preliminary mycoplasma detection.

It also available for download from: www.microtestlabs.com/mycoplasmapaper.

“Of all the threats that keep quality managers awake at night, mycoplasmas rank high. In a career performing quality control or quality assurance for biopharmaceutical manufacturing anywhere in the world, a QC or QA specialist will probably encounter mycoplasma contamination of a production facility at least once. The resulting devastation to the site’s output and schedules, as well as to its staff’s peace of mind, makes it urgent to avoid any repetition of the experience,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories, a leader in biopharmaceutical and mycoplasma tests and services.

“Whereas the traditional direct cultivation method takes 28 days to provide results, modern real-time PCR mycoplasma tests and analysis in an experienced testing laboratory may be accomplished in an actual testing duration of only 24 hours, plus the time needed for sample collection, shipment, preparation, and handling,” he said.

The white paper identifies the shortcomings of traditional identification methods, such as direct culture (for cultivable species), indirect culture (DNA fluorochrome staining — for noncultivable species), DNA probe, PCR, enzyme-linked immunosorbent assay (ELISA), autoradiography, and immunofluorescence.

The white paper explains how, as opposed to traditional methods, PCR mycoplasma analysis accurately quantifies DNA and/or RNA, furnishes increased sensitivity and specificity, detects all known mycoplasma species and works whether mycoplasmas in sample are living or dead.

Download the new white paper on PCR mycoplasma tests, “Advanced Detection of Mycoplasms: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers,” at http://www.microtestlabs.com/mycoplasmapaper.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com/services/public-relations/index.html)

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Technorati tags: Microtest, white paper, whitepaper, PCR mycoplasma tests, PCR mycoplasma analysis

White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers

2009-04-03T15:18:00.000-04:00

AGAWAM, MASS. – Contamination by an unknown organism often calls for total shutdown of a cleanroom’s operation until that organism can be identified and eliminated. Such shutdowns can have catastrophic effects on the schedules and productivity of medical device and pharmaceutical manufacturers alike.

A new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” outlines common sources of contamination, discusses problems and delays associated with traditional methods of identifying those contaminants and highlights breakthrough solutions to these difficulties.

The white paper is available, free, for download at: http://www.microtestlabs.com/microseq.

“Modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry in invasive organisms on themselves –as well as on the equipment and materials they bring into the environment,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories.

With more than 13 years' experience in regulatory microbiology and contract laboratory operations, Champagne leads Microtest's microbiology, contract analytical chemistry, laboratory support, and virology departments. He holds a B.S. degree in microbiology from Iowa State University, and is a nationally-registered microbiologist.

“Fast action is vital. To get the cleanroom back up and running as quickly as possible, the extent and location of areas affected must be determined, and the exact organism responsible identified,” Champagne said.

The white paper identifies the shortcomings of traditional identification methods, such as only identifying bacteria or yeast only; requiring live, isolated colonies; demanding colonies grown in specific media to match library; delivering subjective results; requiring matches against appropriate library for accurate ID; providing library IDs based on multiple strains/species for each entry; and long turnaround times.

As opposed to traditional methods, DNA sequencing for microbial identification has proven highly accurate and is ideal for testing applications, Champagne explains in the white paper. These include pharmaceutical quality assurance/quality control labs, finished product and in-process testing, media fill failure investigations, sterile medical products, opthalmics, medical devices, cosmetics, and nutritional supplements.

Once the organism is positively identified, managers can much more easily deduce the source or sources of contamination, and take swift corrective action to enable the resumption of manufacturing production.

Download the new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” at http://www.microtestlabs.com/microseq/

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/services/public-relations

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Technorati tags: Microtest, MicroSeq, medical device, analytical laboratory, sterility validation, release testing, analytical services

White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

2009-04-03T15:15:00.000-04:00

AGAWAM, MASS. – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.

The white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product” focuses what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). It is available for download at: http://www.microtestlabs.com/control-environment.

In the white paper, the authors:

Warn to test only when necessary to reduce interventions.
Explain to test using methods that give data as quick as fittingly possible to condense processing times.
Discuss how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories (http://www.microtestlabs.com/), a contract manufacturer and provider of contract manufacturing testing services.

To download the white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit: http://www.microtestlabs.com/control-environment.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Microtest Labs Offers Free Microbial Identification Testing, Free Shipping on Other Tests, to MD&M West Attendees

2009-01-29T10:39:00.008-05:00

AGAWAM, MASS. – January 29, 2009 – To highlight its 20 years of experience as a leader in medical device testing services, Microtest Laboratories (http://www.microtestlabs.com/) is offering free microbial identification testing, along with free shipping on other lab tests, to eligible attendees visiting the Microtest exhibit, #828, at MD&M West 2009 in February.

The free offers highlight Microtest’s wide range of laboratory testing and validation services – and problem solving approach – that combine to assist medical device manufacturers to gain a competitive marketplace advantage.

“We work with our clients throughout the testing and validation process to help reduce down-time, lower costs and risk, speed regulatory approvals and time to market, and minimize schedule disruptions,” said Dr. Steven Richter, Microtest President and Chief Scientific Officer.

The free microbial identification offer demonstrates the fast, precise and reliable bacteria, mycoplasma, and mold identification services that Microtest provides by utilizing its two in-house MicroSeq® Microbial Identification Systems.

With two MicroSeq systems, Microtest delivers precise and reliable test results in a 24-hour time period – rather than traditional testing that’s often less accurate and requires a week or more turn around. Microtest is one of only a few labs in its area with such technology.

Microtest is also offering one year of free standard ground shipping to spotlight the dozens of other medical device testing services it offers, including Gamma/ethylene oxide (EO) sterilization validation, and Reusables, Endotoxin, and Sterility testing and related services.

To receive any of the free offers, companies must register at the Microtest exhibit (booth #828) during the MD&M West 2009 Expo. Current Microtest clients are not eligible.

Microtest’s medical device testing facilities are ISO 9001 and ISO 17025:2005 certified, and U.S. FDA-regulated, meeting all GLP/GMP standards. For more information, visit Microtest at MD&M West 2009 in booth #828, on the Web at http://www.microtestlabs.com/medical-device-testing, or call 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers

2009-01-12T11:30:00.002-05:00

AGAWAM, MASS. – January 12, 2009 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest (http://www.microtestlabs.com/). The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies.

For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm.

For pharmaceutical manufacturers, sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue. Pharmaceutical manufacturers can download the white paper at: www.microtestlabs.com/sterilitypaper/pharma-paper.htm.

The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution.

For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue visit Microtest on the Web: http://www.microtestlabs.com/ or toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers

2008-12-01T14:33:00.001-05:00

AGAWAM, MASS. – December 1, 2008 – Even as the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics components is expected to become even more challenging and complex.

“Given the convergence of technologies, combination product manufacturers – often either medical device or pharmaceutical companies “crossing over to the new market” – must ensure their products meet cGMP practices as well as pass muster with the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and The United States Pharmacopeia (USP),” said Steven Richter, Ph.D., President & Chief Scientific Officer of Microtest Laboratories, and a former FDA official.

“The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Richter. “The process, already complex, is likely to become even more so,” he warned.

In fiscal 2007, the FDA received 333 original applications for combination products, a 42 percent increase over 2006. The FDA itself reports that combination product submissions “raise challenging regulatory, policy, and review management issues... (that) can impact the regulatory processes of all aspects of the product life cycle.”

In the free white paper, “Combination Products: Navigating Two FDA Quality Systems,” Richter provides a helpful overview of the challenges facing combination product manufacturers. Download the white paper at www.microtestlabs.com/combinationpaper.

“For manufacturers, the convergence of devices and drugs or biologics brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products – and generally outside their original core competence in achieving regulatory approvals as either a medical device or pharmaceutical manufacturer,” he said.

In the white paper, Richter discusses: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

According to the FDA, some estimate the total global value of the drug-device combination products market will grow to $11.5 billion in 2010, up more than double from $5.4 billion in 2004.

Download the free white paper at: www.microtestlabs.com/combinationpaper. For more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Free White Paper Discusses Complexity of Virus Testing for Biological Products, How Best to Partner with Contract Labs

2008-11-17T11:20:00.001-05:00

AGAWAM, MASSACHUSETTS – November 17, 2008 – As the number of biological drugs continues to increase, so does the complexity involved in the virus contamination testing of those products. A free white paper discussing the challenges of virus contamination testing – along with tips on how best to partner with a contract lab on such testing – is available for free download at: www.microtestlabs.com/biopaper.

“In the manufacture of biological products derived from living organisms, such as bacterial, yeast, or mammalian cells, animals, and humans, the potential for virus contamination can occur at many levels from raw materials through processing. Virus testing is required when there is any risk of contamination to ensure the safety of biologics prior to use in humans,” said Merribeth Morin, Ph.D, Director of Virology at Microtest, and author of the white paper, “Virus Testing for Biological Products: Partnering With a Contract Lab.”

In the white paper, Dr. Morin discusses the sources and opportunities of contamination of a biological product. She notes various virus testing considerations for mammalian cell culture based systems, such as the use of animal derived raw materials, cell bank characterization, virus concerns during the manufacturing process – and discusses the implications of other biologic products.

The white paper also offers tips on planning and initiating the testing process along with advice on how to select and work with a contract testing company to obtain the best possible benefits.

With a Ph.D. in Virology from Harvard University and having served as Director of Virology at the former Q-One Biotech, Dr. Morin has extensive experience in virology/biosafety testing services. Dr. Morin oversees Microtest’s complete range of pharmaceutical and virology test services which support full in-process and product release testing as well as product stability testing, raw material qualification and assay development/validation. The services help companies reduce costs and risk, support rapid regulatory approvals, and benefit from reliable, fast, turn-arounds.

Download the free white paper, “Virus Testing for Biological Products: Partnering With a Contract Lab,” at: www.microtestlabs.com/biopaper. Or, for more information, contact Microtest at http://www.microtestlabs.com/ or toll-free at: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers

2008-11-11T12:10:00.000-05:00

AGAWAM, MASS. – November 11, 2008– Contamination by an unknown organism often calls for total shutdown of a cleanroom’s operation until that organism can be identified and eliminated. Such shutdowns can have catastrophic effects on the schedules and productivity of medical device and pharmaceutical manufacturers alike.

A new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” outlines common sources of contamination, discusses problems and delays associated with traditional methods of identifying those contaminants and highlights breakthrough solutions to these difficulties.

The white paper is available, free, for download at: http://www.microtestlabs.com/microseq/

“Modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry in invasive organisms on themselves –as well as on the equipment and materials they bring into the environment,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories.

With more than 13 years' experience in regulatory microbiology and contract laboratory operations, Champagne leads Microtest's microbiology, contract analytical chemistry, laboratory support, and virology departments. He holds a B.S. degree in microbiology from Iowa State University, and is a nationally-registered microbiologist.

“Fast action is vital. To get the cleanroom back up and running as quickly as possible, the extent and location of areas affected must be determined, and the exact organism responsible identified,” Champagne said.

The white paper identifies the shortcomings of traditional identification methods, such as only identifying bacteria or yeast only; requiring live, isolated colonies; demanding colonies grown in specific media to match library; delivering subjective results; requiring matches against appropriate library for accurate ID; providing library IDs based on multiple strains/species for each entry; and long turnaround times.

As opposed to traditional methods, DNA sequencing for microbial identification has proven highly accurate and is ideal for testing applications, Champagne explains in the white paper. These include pharmaceutical quality assurance/quality control labs, finished product and in-process testing, media fill failure investigations, sterile medical products, opthalmics, medical devices, cosmetics, and nutritional supplements.

Once the organism is positively identified, managers can much more easily deduce the source or sources of contamination, and take swift corrective action to enable the resumption of manufacturing production.

Download the new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” at
http://www.microtestlabs.com/microseq/

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Free Seminar for Medical Device Makers on Importance of Sterile Package Validation Set for Nov. 12th

2008-11-11T12:08:00.001-05:00

A free morning-long seminar to help New England-based medical device manufacturers negotiate the increasing important – and complex – challenges of sterile package validation is scheduled for November 12th in Agawam, Mass.

“FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs,” says Steven Richter, Ph. D., president and CEO of Microtest, a leader in medical device testing services, including medical device package stability and validation testing.

The seminar will detail the necessary sterilization processes and test methods that should be part of any reliable validation program to avoid such failures, Richter said.

Titled "Package Validation Requirements for Medical Devices and Combinatory Products," the seminar will detail the general concepts and problems associated with medical device packaging testing as well as reviewing different testing methodologies.

Specific topics will include:

ISO 11607 Overview
Physical Package tests vs Microbial
Stability & Accelerated Aging
Combinatory Products
Flexible Packaging
ISTA Shipping Testing

The seminar will be held Nov. 12, 2008, from 10 a.m. through Lunch at Microtest Laboratories, Inc., 104 Gold St., Agawam, Mass. The seminar is free and lunch will be provided.

The seminar is free, but prior registration is required. To register, visit www.microtestlabs.com/packagingseminar or call toll-free 1-800-631-1680.

For directions to Microtest, visit http://www.microtestlabs.com/contact-us/index.html.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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“Biosafety Testing of Cell Lines Used in Vaccine and Virus Vector Production” is Focus of Presentation at WilBio Viral Vectors and Vaccines Conference

2008-10-28T09:57:00.000-04:00

Merribeth Morin, PhD, of Microtest Laboratories will present “Biosafety Testing of Cell Lines used in Vaccine and Virus Vector Production” at the WilBio Viral Vectors and Vaccines conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy, at 11:15 am-Noon, on Tuesday, Nov. 4, 2008 in Santa Barbara, Calif.

Dr. Morin’s presentation will discuss the safety concerns for the use of cell lines, in reference to their use in vaccine and vector production.

“The use of cell lines for the production of virus vectors and vaccines is widely applied. The ability to manipulate cells in culture and grow them to large scale is advantageous, and in the case of vaccines, presents a more attractive and consistent process than some more traditional methods for vaccine products. As for any type of biological product, using cell lines presents various safety considerations. There are a number of regulatory guidance documents that address the characterization of cells used for the production of biological products. The safety program for cell lines needs to be reasonable, but thorough, to address the safety concerns outlined in these documents,” said Dr. Morin.

Dr. Morin is Director of Virology for Microtest Laboratories, (http://www.microtestlabs.com/), a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. She received her PhD in Virology from Harvard University and has spent a number of years in both in vaccine research and in contract testing. Her research included developing DNA vaccines for the treatment of influenza virus infection and other infectious diseases, and the development of an attenuated vaccine for Herpes simplex virus infection.

Based in Agawam, Mass., Microtest's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

The Viral Vectors and Vaccines Conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy runs Nov. 3-5, 2008. For more information, visit http://www.wilbio.com/.

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Microtest Honored as Regional Example of Success; Receives Hampden Achievement Award, Induction into STCC Western Mass. Entrepreneurship Hall of Fame

2008-10-03T12:05:00.000-04:00

Agawam, Mass., October 3, 2008 – In recognition of the company’s growth, success, and importance to the region, Microtest Laboratories of Agawam has received the Hampden County Achievement Award and has been inducted to Springfield Technical Community College’s Western Massachusetts Entrepreneurship Hall of Fame.

“The achievements of Microtest Laboratories’ growth and success serve as a powerful model for the future of Massachusetts, and Microtest will serve as an inspiration to thousands of people who visit every year,” said Dr. Andrew M. Scibelli, President of Springfield Technical Community College (STCC).

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries and has made numerous multi-million capital investments and expansions of its facilities the past several years – along with growing its professional workforce to more than 100. The company works closely with Western Mass. economic and business organizations as well as the region’s educational institutions.

Microtest President and Scientific Founder Steven Richter, Ph. D., is an ardent supporter of regional technical training programs as a means to ready both current and future workers to contribute to – and reap the benefits of – the area’s burgeoning life science industry.

“It is an honor for all of us at Microtest to be recognized for our achievements,” said Richter. “If we can serve a role for others, then let it be as a example of the potential that’s available throughout Western Mass. when working partnerships among our entrepreneurs, education, residents, and government are permitted – and encouraged – for the benefit of all.”

The Andrew Scibelli Enterprise Center is committed to furthering regional economic development, entrepreneurship education and workforce development. It is home to the Western Massachusetts Entrepreneurship Hall of Fame. Established in 2000, it honors innovative entrepreneurial individuals and businesses in Western Massachusetts, in hope to inspire the next generation of business leaders.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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