|
|
 |
 |
 |
|
White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers
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
Labels: analytical laboratory, analytical services, medical device, Microseq, Microtest, release testing, sterility validation
Microtest Labs Offers Free Microbial Identification Testing, Free Shipping on Other Tests, to MD&M West Attendees
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.
# # # Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/services/public-relations Labels: analytical laboratory, analytical services, medical device, medical device manufacturing, Microseq, Microtest, release testing, sterility validation
Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
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. 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. # # # Labels: Compliance, FDA regulations, medical device, Microtest, pharmaceutical manufacturing, pharmaceutical testing, sterilization, white paper, whitepaper
White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers
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. # # # Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/
 bookmark to del.icio.us
 Technorati tags: Microtest, FDA regulations, white paper, whitepaper, combo products, combination products Labels: combination products, combo products, FDA regulations, Microtest, white paper, whitepaper
Free Seminar for Medical Device Makers on Importance of Sterile Package Validation Set for Nov. 12th
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: 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.
# # # Labels: free seminar, ISO 11607, ISTA shipping testing, medical device, medical device manufacturers, Microtest, New England, physical package test
“Biosafety Testing of Cell Lines Used in Vaccine and Virus Vector Production” is Focus of Presentation at WilBio Viral Vectors and Vaccines Conference
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/.
# # #
Labels: biosafety testing, medical device, Microtest, pharmaceutical manufacturing, pharmaceutical testing, vaccine and virus vector, Viral Vectors and Vaccines, virology
Microtest Honored as Regional Example of Success; Receives Hampden Achievement Award, Induction into STCC Western Mass. Entrepreneurship Hall of Fame
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. # # # Labels: Agawam, analytical laboratory, analytical services, Aseptic Fill/Finish Contract Manufacturer, Contract Manufacturing Organization, medical device, Microtest, release testing, sterility validation
New USP 797 Regulations May Create New Hazards for Compounding Pharmacy Directors
 AGAWAM, MASS. – September 23, 2008 – Though the new USP 797 regulations, which become effective June 1st, ease testing requirements, the impact of following the new minimums has the potential of creating new hazards for compounding pharmacy directors, warns Steven Wieczorek, Supervisor, Environmental Sciences, Microtest, Inc.
Issued by the U.S. Pharmacopoeia, the new version of USP 797 establishes bi-annual environmental sampling and testing as a minimum requirement, in place of the former monthly frequency. The regulations continue to require that pharmacies preparing compounded sterile preparations must have an effective plan and program that incorporate best practices and provide a clean, sterile working environment free of contamination.
Potential Hazards from Hidden Impacts
But Wieczorek says that adopting a bi-annual environmental testing program may impact a facility’s capability to maintain compliance. “Compounding pharmacy directors need to recognize the series of potential hazards lurking for them within the ‘hidden impacts’ of the new regulations.” Those hazards, he said, include: Bi-annual testing will not capture seasonal blooms of yeast, fungi, and bacteria. Problem tracking, diagnosis, and resolution will be difficult if environmental testing is conducted at six month intervals. The development of trend data that shows important seasonal fluctuations will be impossible when conducting bi-annual environmental testing. If a failure occurs during a bi-annual testing program, investigating up to 6 months of compounding activities and justifying what may or may not have been affected will be nearly impossible and extremely time consuming. With a monthly testing program, a failure will require investigation of only 3 to 4 weeks of data and will be significantly easier -- saving large amounts of time and money. It will also help insure that the compounds prepared in your facility are sterile and will provide a safer final product for patients. Testing at a higher frequency will provide peace of mind. You will know that your controlled compounding environment(s), policies, and technicians are under control and in compliance. This will help reduce infections and save lives.
Wieczorek and Microtest (Agawam, Mass., www.microtestlabs.com/usp797) will continue to recommend a monthly testing regimen for all pharmacies compounding sterile preparations.
“A monthly testing regimen will continue to provide critical environmental and trend data of a pharmacy as the seasons change. Monthly testing will better reflect continued control of the compounding environment. It also will enable rapid problem resolution at a time when facilities are most vulnerable to non-compliance issues,” Wieczorek said.
“Under the regulations, the pharmacy director holds quality control responsibility and is accountable for the facility’s compliance performance. We believe that embracing best practices to create a plan that meets the pharmacy’s specific environment will achieve the greatest success,” he said.
Pharmacies failing to comply with USP 797 risk exposure to patient lawsuits as well as the potential loss of The Joint Commission’s (JCAHO) accreditation.
Free Facility-Gap-Analysis Audit
To help pharmacy directors set a benchmark, Microtest offers a free facility-gap-analysis audit to help compounding pharmacies determine their USP 797 compliance level and corresponding preparation. The audit includes an examination of the compounding pharmacy service’s physical facility footprint, drug compounding procedures, operational policies and training programs. Microtest experts will determine the level of compliance achieved, existing level of risk exposure, and recommendations to achieve compliance to USP 797.
“The audit will recommend the designated sterile compounding risk level of the pharmacy service as well as establish an accurate baseline for compliance program next-action development,” Wieczorek said “With the audit in-hand, pharmacy directors can then create a service plan.”
Microtest offers compounding pharmacy directors a single, one-stop resource of complete USP 797 compliance solutions – as advice, assistance, or complete implementation – available in an incremental approach or as a comprehensive, turnkey solution. Services include: program implementation, onsite training, custom SOP documentation, clean room design, environmental monitoring, and CSP product testing. To learn more, on the Web, visit http://www.microtestlabs.com/usp797 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 http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.
# # #
Labels: compounding pharmacy, Microtest, United States Pharmacopeia Chapter 797, USP 797, USP 797 compliance, USP797, USP797 compliance
White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
AGAWAM, MASS. – September 15, 2008 – 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. 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. 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 (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 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
# # # Labels: analytical laboratory, analytical services, medical device, Microseq, Microtest, release testing, sterility validation, white paper, whitepaper
Microtest Offers New Services, Free Facility Audit, for Compounding Pharmacies Seeking USP 797 Compliance
AGAWAM, MASS. – July 29, 2008 – Microtest Laboratories has launched a suite of services to assist the numerous compounding pharmacies in the U.S. that have yet failed to meet mandatory United States Pharmacopeia Chapter 797 (USP 797) regulations. Microtest also announced its offer of a free facility-gap-analysis audit to help compounding pharmacies determine their USP 797 compliance level and corresponding preparation. Pharmacies failing to comply with USP 797 risk exposure to patient lawsuits as well as the potential loss of The Joint Commission’s (JCAHO) accreditation. Microtest’s launch of the new services, and its free audit offer, are timed with moves by the FDA to prompt more pharmacies to achieve USP 797 compliance. “As the FDA relaxes some restrictions, we expect overall enforcement efforts to increase. We’re recommending that any pharmacy not now in full compliance move quickly to achieve full compliance,” said Steve Wieczorek, supervisor of environmental services at Microtest ( http://www.microtestlabs.com/usp797). One example of the FDA’s easing of regulations is that as of June 1st, in-house audits are no longer required monthly, but only twice a year, he noted. “But this could prove a double-edged sword, and pharmacies should look twice before loosening their internal controls -- despite the regulations.” “While the FDA may not require such audits monthly, reducing their frequency is contrary to what’s needed given the demands – and risks – of operating compounding pharmacies today – including the increasing intricacies of compounding prescriptions, and demands on pharmacy resources and personnel,” Wieczorek said. “Think of the risks involved – and the possible consequences that could result – from a situation that may not be discovered until the next audit – perhaps six months later,” he said. Complimentary AuditMicrotest’s free facility-gap-analysis audit includes an examination of the compounding pharmacy service’s physical facility footprint, drug compounding procedures, operational policies and training programs. Microtest experts will determine the level of compliance achieved, existing level of risk exposure, and recommendations to achieve compliance to USP 797. The audit will recommend the designated sterile compounding risk level of the pharmacy service as well as establish an accurate baseline for compliance program next-action development. With the audit in hand, pharmacy directors can then create a service plan. Complete USP 797 Compliance SolutionsMicrotest offers pharmacy directors a single source of complete USP 797 compliance solutions – as advice, assistance, or complete implementation – available in an incremental approach or as a comprehensive, turnkey solution. Microtest’s services include: Program Implementation Onsite Training Custom SOP Documentation Clean Room Design Environmental Monitoring CSP Product Testing
“Microtest delivers professional, compliance-specific experience and expertise, comprehensive in-house capabilities, and full follow-through,” Wieczorek said. “Our veteran team includes a full-range of expertise: microbiologists, chemists, clean room specialists, and project managers – many of whom have spent years working for the FDA.”
To learn more, on the Web, visit http://www.microtestlabs.com/usp797 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.
# # # Labels: compounding pharmacy, Microtest, United States Pharmacopeia Chapter 797, USP 797, USP 797 compliance, USP797, USP797 compliance
Microtest Labs Doubles Microbial Identification, Analytical Services
The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified. “With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” stated Dr. Steven Richter, Microtest President and Chief Scientific Officer. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.” Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time. “In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Richter. “Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.” The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in: · Contract Manufacturing
· Pharmaceutical Testing & Validation
· Medical Device Testing & Validation
· Environmental Control and Testing
· Water Validation
· Mold Identification
· Biologics/Virology The MicroSeq systems are 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today. 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. Labels: Aseptic, Contract Manufacturer, drug, Fill/Finish, laboratory, manufacturing, Microseq, Microtest, pharmaceutical, Sterility Testing, virology
White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes
AGAWAM, MASS. – For pharmaceutical manufacturers, the process of choosing a Contract Manufacturing Organization (CMO) can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue. The informative white paper, “ Selecting An Aseptic/Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake,” focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Product (FDP). Download it at: http://www.microtestlabs.com/asepticpaper. In addition to providing guidance on the selection process, the white paper also discusses common mistakes made by potential clients. These oversights – and their remedies – are sourced from a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product. “The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations for Microtest Laboratories. Dobiecki’s experience, which spans 25 years in the manufacturing and quality control of pharmaceuticals, medical devices, and biologic products, includes the preparation of INDs, NDA/ANDAs, CMC sections, and Pre-Approval Inspections (PAI), as well as multiple U.S. and European Regulatory Inspections. In the white paper, Dobiecki: Details the nine key components of the RFP – The First Step (in the selection process) Discusses the finer points of Evaluating the Contractor’s Proposal Explains the two types of Site Visits and what should be included on the agenda Provides cautionary tips for making The Selection itself Warns of stumbling into making The Biggest Mistake which can derail a successful selection at any step of the process.
To download the white paper, free of charge, visit: http://www.microtestlabs.com/asepticpaper. 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/
bookmark to del.icio.us
Technorati tags: Microtest, FDA regulations, white paper, whitepaper, combo products, combination products Labels: combination products, combo products, FDA regulations, Microtest, white paper, whitepaper
|
|
| |
|
|
|
|
