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Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief
Bacterial
endotoxins cause fever, septic shock, and other disease symptoms — and thus
attract considerable regulatory scrutiny from such organizations as the U.S.
Food & Drug Administration (FDA) and the United States Pharmacopeial
Convention. Regulations require that devices that contact circulating blood or
cerebrospinal fluid, or are used with intraocular products or in vitro
fertilization procedures, are required to be endotoxin-free.
- Definition of endotoxins;
- Various tests used for their detection;
- Use of depyrogenation and other ways to remove
endotoxins;
- Types of devices that should be tested;
- Preparation and testing of samples;
- Options for sampling containers;
- Acceptance criteria for each of the assays; and
- Sources of official information, reference, and
guidance.
“The
Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D.,
said Steven Richter, Ph.D., president and scientific director of Microtest
Laboratories — and a former FDA official.
The
paper is one in a series about testing, manufacturing, and regulatory issues of
concern for medical device manufacturers from Microtest Laboratories, a leader
in testing services and contract manufacturing for medical devices,
pharmaceuticals, and biotechnology.
About Microtest Laboratories
Microtest Laboratories is a leader in testing
services and contract manufacturing for medical devices, pharmaceuticals, and
biotechnology. It was founded in 1984. The company’s expertise and flexible
processes enhance product safety and security, speed time to market, and
minimize supply chain disruption. Microtest’s unique single-source capability
to provide testing and manufacturing solutions allows the firm to support a
full pharmaceutical or medical device product release. The company’s facilities
in Agawam, Massachusetts, USA include state-of-the-art aseptic manufacturing
areas; analytical chemistry, microbiological, and virological laboratories;
Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus
depyrogenation capabilities; purified water systems; and voice/data systems. 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 on Facebook at http://goo.gl/TndoBg.
# # #
Labels: endotoxin testing, FDA, medical device, medical device manufacturing, medical device testing
“Combination Products: What You Need to Know” Seminar for Medical Device, Pharmaceutical Manufacturers is Scheduled for October 31st in Boston
A full-day technical seminar
designed to assist medical device and pharmaceuticals with what they need to
know about manufacturing combinations products, including best practices and applicable
FDA regulations, is scheduled for Thursday, October 31st, in
Waltham, Mass., just outside Boston.
Combination
products are a large and growing segment of the medical device market. Some
analysts estimate they represent more than 30% of all new FDA product
submissions. But for manufacturers, the convergence of drugs, biologics, and
devices presents a host of best practice and regulatory issues.
Titled “Combination Products: What You Need to Know,”
the seminar will outline a realistic approach for manufacturers
to navigate the testing, production, and regulatory standards related to the manufacture
of combination products. Topics will include:
- Combination Products —What You Need To
Know:
Overview of regulatory hurdles for combination products highlighting the
determination of PMOA.
- Applications of Lean to Combination
Product Manufacturing: Case studies specific to applying lean to
manufacturing of combo products for clinical use.
- In-Process and Release Testing PTC: Outline of
in-process and release testing points to consider during development and
specification determination.
- EM Monitoring of GMP Manufacturing
Space:
Current EM procedures for setting up GMP manufacturing.
- Choosing the Right CMO: Discussion of
best practices to determine a right fit CMO.
“Combination Products: What You Need to Know,”
will be presented by Microtest Laboratories, a leader in
testing services and contract manufacturing for the medical device,
pharmaceutical, and biotechnology industries. The seminar will be held at the Conference Center at Waltham Woods in Waltham, Mass., just
outside Boston, on Thursday, October 31, 2013, from 9:00 a.m. to 3:00 p.m. Registration
is at 9:00 a.m. Continental breakfast, break refreshments
and luncheon is included.
The seminar is one
in a continuing series of technical events presented by Microtest Laboratories for
medical device and pharmaceutical manufacturers. The seminars tend to fill up
quickly so please register early! Follow Microtest Laboratories on Facebook at http://goo.gl/pHNP63, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.
Labels: best practices, Boston, combinations products, FDA regulations, manufacturing, Mass, medical device, pharmaceuticals, seminar, technical seminar, Waltham
Medical Device Professionals to Learn “What They Need to Know” about Manufacturing Combinations Products & FDA Regulations at MD&M East Workshop
Medical device professionals will
learn what they need to know about manufacturing combinations products and FDA
Regulations at a workshop to be featured at MD&M East, the world's largest
medical OEM event, in Philadelphia on Tuesday, June 18, 2013.
Titled “Combination Products: What You Need to Know,”
the workshop will outline
a realistic approach for medical device professionals to use in navigating the
regulatory standards required for the approval, marketing, and manufacture of combination
products. Topics will include:
- Defining a Combination Product
- Current and pending FDA regulations re:
their approval, marketing, and manufacture
- Self-assessing the Primary Mode of
Action (PMOA)
- Integrating with the FDA through the
Request for Designation (RFD) Guidance from the Office of Combination
Products (OCP)
- GMP issues involving the manufacture
of a drug component with a medical device
- Differences between medical device
cGMPs and pharmaceutical cGMPs: Jargon, regulations, and general culture
- Real-world case studies
- Questions & answers
Microtest Laboratories Director of Project Management,
Manufacturing, Alex Mello will lead the workshop. Microtest Laboratories is a leader in testing services and
contract manufacturing for the medical device, pharmaceutical, and
biotechnology industries. Mello has more than 20 years of experience in Aseptic
Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical
Devices/Combo Products, and Sterilization Sciences. He holds a graduate degree
in Biological Sciences and is a Specialist Microbiologist (NRCM).
“Combination Products:
What You Need to Know” will be featured
at MD&M East as part of the event’s “Innovation Briefs” series. The
workshop will be held on Tuesday, June 18 at
1 p.m. in booth #957. Attendance is free for MD&M East guests and
participants. For more information, contact Microtest Laboratories by phone at 1-800-631-1680
or by email at amello@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.
Labels: combination products, combo products, MD&M, MD&M East, medical device, medical device manufacturers, medical device manufacturing
Microbiology Quality Control Seminar to Assist Medical Device Manufacturers Validate Sterilization, Cleaning Processes
A seminar on microbiology
quality control — designed to help medical device manufacturers validate sterilization and cleaning processes,
and maintain controlled environments — will be held on Thursday, May 16, in Boston.
“For today's medical device
manufacturers, the challenge is to validate their sterilization and cleaning
processes to ensure patient safety and product integrity. This seminar will
focus on a host of issues pertaining to the sterilization of medical devices
including sterilization validation, bioburden, sterility, and endotoxin
testing, as well as submitting samples to a contract testing laboratory,” said Steven Richter, Ph.D.,
president and scientific director of
Microtest Laboratories, which is hosting the event.
- MICRO 101
- Sterilization Validation
- Bioburden Testing
- Sterility Testing
- Endotoxin Testing
- Testing Sample Submissions
The event will be held at the MIT
Endicott House in Boston, Mass., on Thursday, May 16, 2013, from 9 a.m. to 3:30
p.m. Registration is 9 a.m. to 9:45 a.m. A networking reception and lunch are included.
The event is one in a series of
technical seminars and workshops for medical device and pharmaceutical
manufacturers presented by Microtest Laboratories, a Mass.-based, FDA-audited
company with a history of exceptional regulatory compliance.
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.
# # #
Labels: Bioburden Testing, cleaning, endotoxin testing, manufacturers, manufacturing, medical device, Microbiology Quality Control, Sterility Testing, sterility validation, Sterilization Validation
Boston Seminar to Assist Medical Device & Pharmaceutical Manufacturers with Environmental Monitoring, Risk-Assessment
Microtest Laboratories will present an environmental monitoring seminar and risk-assessment
workshop to assist medical device and pharmaceutical manufacturers with building,
validating, and maintaining their clean rooms and sterile manufacturing environments.
The event will be held at the MIT Endicott House in Dedham, Mass.
— just outside Boston — on Wednesday, October 24, 2012, from 10 a.m. to 2 p.m.
At the event, attendees will:
- Participate
in a hands-on workshop that focuses on risk assessment in the clean room
- Discover
the best practices for qualifying and maintaining a clean room facility
- Identify
and assess the risks commonly found in a clean room environment
- Test the
information they've learned in a mock clean room floor plan exercise
A networking reception, and lunch, is
included. For more information, or to RSVP, contact Julie Adamski at Microtest
Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com.
Registration for the event is $149.
The event is one in a series of
technical seminars and workshops for medical device and pharmaceutical
manufacturers presented by Microtest Laboratories, a Mass.-based, FDA-audited
company with a history of exceptional regulatory compliance. Microtest’s
environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource
for contamination testing needs arising from the manufacturing of medical
devices or pharmaceuticals, as well as sterile compounding in hospital
pharmacies.
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.
# # #
Labels: Boston, clean room, cleanroom, Controlled Environments, disinfection, environmental monitoring, environments, manufacturers, medical device, pharmaceutical, risk-assessment, sterile manufacturing, validation
Use Notebook Studies to Ensure Successful Reusable Device Cleaning Validations, Recommends Microtest Laboratories
AGAWAM, MASS. —August 14, 2012 — A new management brief from Microtest Laboratories recommends that medical device manufacturers use notebook studies to help ensure successful reusable device cleaning validations. The lab bases the advice on its performance of validations for various types of medical instruments over the years.
The brief discusses the document, “FDA Draft Guidance for Industry and Staff, Processing /Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” which was released in May 2011.
Kenny’s brief focuses on areas of the FDA guidance document that are causing difficulties in cleaning validations, and demonstrates how pre-validation laboratory work can help save time and money. It also identifies areas that can cause issues during validations if they are not thoroughly addressed prior to initiating the protocol. These include:
- The use of worst-case conditions
- The switch from microbial-based assays to chemical-based assays
- The determination of an acceptable residual level
- The validation of a reusable device’s cleaning instructions
“The good news is that almost all of these issues can be eliminated with some up-front work,” Kenny said. “And this preparatory work can best be performed by notebook studies prior to initiating GLP studies. The information obtained in these relatively quick studies often saves significant time later in the filing process.”
“In short, we recommend the use of notebook studies prior to beginning the validation to eliminate as many unknowns as possible,” he said.
About Microtest Laboratories
Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.
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 on Twitter at http://twitter.com/MicrotestLabs.
# # # Labels: cleaning, cleaning processes, cleaning validations, medical device, resusable medical device, reusable device
Clean Room Environmental Best Practices for Medical Device & Pharmaceutical Manufacturers are Focus of Boston Seminar on June 6
AGAWAM,
MASS. – May 30, 2012 – Sterile manufacturing environments at medical
device and pharmaceutical companies require effective cleaning and disinfection
programs to maintain aseptic conditions and prevent microbial contamination. To
help, laboratory testing experts will present "Clean Room Environmental
Best Practices," a special seminar in Boston on Wednesday, June 6, 2012.
The
seminar is designed for all professionals responsible for building, validating,
and maintaining controlled environments in the medical device and
pharmaceutical industries. The program will include technical presentations on:
• Best
practices for qualifying and maintaining clean room facilities
•
"The people factor" in terms of containment control
•
Qualifying and evaluating clean room disinfectants
•
Difficult challenges: Practical advice and solutions
Opportunities
for questions and continuing interaction will be encouraged.
"Clean
Room Environmental Best Practices" is scheduled for 10 a.m. to 2 p.m. on
Wednesday, June 6, 2012, at the MIT Endicott House, 80 Haven Street, Dedham,
Massachusetts — located just minutes from Boston. The cost is $149. Breakfast,
lunch, and networking opportunities are included.
The
seminar is sponsored by Microtest Laboratories, a Massachusetts-based,
FDA-audited company with a history of exceptional regulatory compliance.
Microtest's environmental sciences group helps its clients maintain control of
their controlled environments and is a proven resource for
contamination testing needs arising from the manufacturing of medical devices
or pharmaceuticals, as well as sterile compounding in hospital pharmacies.
For more
information, contact Julie Adamski, toll-free, at 1-800-631-1680, ext. 192,
or 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.
Labels: Boston, clean room, clean room testing, cleaning validations, cleanroom, controlled environment, manufacturing, medical device, pharmaceutical, seminar
Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief
“Although the FDA guidance
document is not legally enforceable, it describes the agency’s ‘current
thinking and should be viewed as recommendations,’” said Steven Richter,
Ph.D., president and scientific director of Microtest Laboratories — a former
FDA official — and author of the brief.
- “Spore tag
reduction” and Hucker’s soil challenges
- Cleaning
methods using protein, carbohydrates, red blood cells and lipids
- Separation of cleaning,
disinfectant and sterilization validation activities
- ASTM Simulated
Use Test
- Three log
reduction for cleaning validations
- Empirical data
in 510(k) submissions
- Reducing manufacturing
materials to “safe levels”
While Richter emphasized that “the
FDA document was issued for comment and is not for implementation, the medical
device industry understands that changes from current best practices will be
required immediately.”
His brief seeks to “raise the
industry discussion of issues that must be anticipated, discussed, and thoroughly
evaluated for the time when implementation is required,” he said.
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.
Microtest Laboratories, based in Agawam, Massachusetts, is a full-service
medical device testing laboratory and a leader in medical device testing and
related services for the medical device, pharmaceutical, and biotechnology
industries. Testing is performed in-house by seasoned regulatory
microbiologists and chemists under strict GMP/GLP regulations. Microtest is
both ISO 9000 and 17025 certified. Testing services include bioburden,
sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition,
Microtest recently introduced a fast-track test to screen plastics and polymers
in medical devices for toxicity using Zebrafish embryos.
# # # Labels: cleaning validation, FDA, FDA regulations, medical device, medical device cleaning, medical device testing, testing requirements, Validation requirements
White paper Details New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos
AGAWAM, MASS. – February 13, 2012 – A new white paper detailing the new ZET™ medical device polymer biocompatibility screening test using Zebrafish embryos is available to download from Microtest Laboratories at http://www.microtestlabs.com/zebrafish-test-paper. The new ZET test was developed by Microtest Laboratories for medical device manufacturers and biomaterials researchers. It utilizes Zebrafish (Danio rerio) to screen plastics, composites, and polymers for toxicity. “Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times,” writes white paper author Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and former FDA official. “The Zebrafish test demonstrates similarities to mammalian models and humans. Its unique approach to fast-track medical device toxicity screens will save manufacturers time and reduce expenses.” In the new white paper, “New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” Richter discusses U.S. Food and Drug Administration (FDA) testing requirements to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs. Richter also provides background facts about Zebrafish and details the company’s testing that revealed ZET sensitivity is greater than USP gold standard test for BPA. In addition, he outlines the benefits of ZET versus USP cytotoxicity testing and ZET versus mouse embryo toxicity tests. Download the white paper, “New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” fromhttp://www.microtestlabs.com/zebrafish-test-paper. 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. # # # Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com Download high resolution image from: http://microtestlabs.com/photos 
Labels: manufacturing, medical device, polymer biocompatibility, screening, test, zebrafish
Environmental Monitoring and Certification in Controlled Environments - New White Paper
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 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. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. # # # Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com Labels: Controlled Environments, environmental certification, environmental monitoring, manufacturers, manufacturing, medical device, Microbial Control, pharmaceutical, regulations
New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes
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 MicrotestMicrotest 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-relationsLabels: 21 CFR Part 820, clean room validation, cleaning processes, medical device, validating, white paper, whitepaper
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
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
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