Tuesday, March 11, 2014

Webinar Exploring “What’s the Risk? Fearing the Failure in Environmental Monitoring Systems” is Offered for Life Science Companies

AGAWAM, MASS. — March 11, 2014 — A webinar to help life science companies explore the importance of a well-implemented and understood environmental monitoring program, and its ability to generate valuable data, will be offered on Wednesday, March 26, from 1:30 p.m. to 3:30 p.m. EST. The online event will identify the common mistakes and misconceptions regularly encountered when managers “fear the failure” of environmental excursions.

Environmental monitoring systems demonstrate that a company’s various contamination control strategies are operating properly. Such systems can illustrate whether operations are in a state of control. Variations in the data can indicate a drift which could potentially impact product and patient safety.

But the data generated by environmental monitoring system may become skewed when a culture is created which fears environmental failures or excursions. The webinar, What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” will detail how key life science company management can work to avoid such cultures.

Webinar topics — tailored for quality assurance and control, manufacturing, microbiology, and facilities management in pharmaceutical, biotech, and medical device organizations — will include:
  • The big picture: what systems need to be monitored and why the data is valuable
  • Risk-based environmental monitoring program implementation
  • Culture and “buy-in:” how to create a culture of employee acceptance for contamination control programs
  • Responding to data: how to identify trends in the data and respond with appropriate actions
The webinar will be offered Wednesday, March 26, 1:30 p.m. to 3:30 p.m. EST. Featured speakers include Valerie Montgomery, environmental services manager, and Alison Zulick, environmental services leader, both of Microtest Laboratories, a leading provider of testing services and contract manufacturing for the life science industries.


About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and compounding pharmacy industries. Based in Agawam, Massachusetts, USA, Microtest leverages its 30 years industry experience to help its clients meet their regulatory requirements.  For more information, visit http://www.microtestlabs.com or toll-free 1-800-631-1680.

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Tuesday, January 14, 2014

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

AGAWAM, MASS. — January 14, 2014  The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.

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.

The Fundamentals of Endotoxin Testing,” available for download at http://microtestlabs.com/endotoxin-testing, is a step-by-step information resource for medical device manufacturers discussing and detailing the:
  • 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.

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Tuesday, December 3, 2013

Microtest Laboratories Offers OECD Fish Embryo Toxicity Testing

AGAWAM, MASS. — December 3, 2013 — Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, is adding OECD Fish Embryo Toxicity Testing to its portfolio of services.

Pharmaceutical, chemical, and related manufacturing plants are under increased scrutiny for the potential impact of their products or waste water on the environment. Pesticides are a major example. But recently, the European Commission added three pharmaceutical compounds to its pollutant watch list, citing them as potential risk to the safety of surface water.

“Fish Embryo Toxicity (FET) testing has been developed for environmental and hazard classification applications. The test utilizes the embryo of the Zebrafish and exposes it to various compounds to observe potential toxic effects, thus making FET an ideal method to use in monitoring or investigating environmental cases,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and former FDA official.

The FET test is an approved OECD (Organization for Economic Co-Operative Development) guideline, published in August, 2013.

““Microtest Laboratories is deeply experienced in fish embryo toxicity testing. We are particularly well-suited to undertake FET testing due to the expertise we’ve developed in creating our Zebrafish Embryo Toxicity (ZET) test, which we’ve been providing as a preliminary screening method in the biocompatibility testing of medical devices and polymers.

“Zebrafish embryos are extensively used in drug development studies due to their transparent embryos and fast development times. The Zebrafish is a well-studied and characterized organism, and ideal as an animal testing model,” Richter noted.

For more information about Microtest Laboratories’ FET testing services, visit http://www.microtestlabs.com/zebrafish-embryos-testing. Or, call 1-413-786-1680 or toll-free at 1-800-631-1680.


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 at 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Tuesday, November 12, 2013

Current Regulatory Expectations Affecting the Validation of Reusable Medical Devices is Subject of Dec. 4th Seminar in Boston

AGAWAM, MASS. — Nov. 12, 2013 — A half-day seminar focusing on current regulatory expectations in the validation of reusable medical devices is the subject of a seminar set for Dec. 4th in Waltham, Mass., near Boston.

The validation of reusable medical devices is at the forefront of the FDA’s efforts to ensure patient safety. Requirements for the cleaning, disinfection, and sterilization of reusable devices are constantly changing. The situation challenges manufacturers both in terms of deciding which testing methods to employ as well as the planning of end points.

The seminar will provide attendees with the knowledge they need to know about current regulatory expectations so they may better prepare their submissions for FDA acceptance — and avoid the time-consuming and costly requirements of additional testing.

Seminar topics will include:
  • Discussion of the FDA’s draft guidance for industry and FDA staff, “Processing/ Preprocessing Medical Devices in Healthcare Settings”
  • Methods used for the cleaning and validation of reusable devices
  •  Methods for the disinfection of reusable devices
  • Methods for the sterilization of reusable devices
  • Testing requirements
  • Detailed discussion of endpoints for cleaning validation
The seminar will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, on Wednesday, Dec. 4, 2013, from 9 a.m. to 1 p.m. at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston. Registration is at 9 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit the Validation of Reusable Medical Devices seminar event webpage or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

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Monday, November 4, 2013

Outsourcing to a Contract Testing Laboratory is Focus of 2013 AAPS Expo Workshop

AGAWAM, MASS. – Nov. 5, 2013 – The strategies and timing of outsourcing pharmaceutical development processes to a contract testing laboratory will be the focus of a mini-workshop at the 2013 AAPS Annual Meeting and Exposition on Nov. 12, 2013.

“Outsourcing to a contract testing laboratory can save pharmaceutical manufacturers both time and money in drug development and commercialization. But knowing the appropriate time and place to outsource can mean the difference between success and failure,” said Shawn Sherry of Microtest Laboratories.

At the mini-workshop, titled “Outsourcing to a Contract Testing Laboratory, Sherry will overview:

  • The benefits of using turnkey contract laboratory services
  • How to establish a smooth working relationship with your laboratory
  • The importance of the auditing process
  • Quality system, timeline, and pricing factors
  • How Microtest Laboratories can help

The mini-workshop will be presented Nov. 12th from 2:00 p.m. to 2:15 p.m. in the Microtest Laboratories booth, #1325, at the AAPS 2013 Annual Exposition.

Shawn Sherry, Account Development Manager at Microtest Laboratories Inc., has over 11 years’ experience in regulatory microbiology and contract laboratory operations. Sherry holds a BS degree in microbiology and is a nationally registered microbiologist. His experience ranges from compendia testing requirements to aseptic manufacturing, with emphasis on disinfectant qualifications, clean room testing, product testing, and water system validations. He is the co-author of the whitepaper, “Disinfectant Qualifications: Insight and Perspective,” available at http://www.microtestlabs.com/disinfectant-qualifications.


Microtest Laboratories will exhibit in booth #1325 throughout the 2013 AAPS Annual Meeting and Exposition. Microtest Labs is a leader in pharmaceutical contract manufacturing as well as microbiological, analytical, and cleanroom testing services. The company services the pharmaceutical, medical device, and biotechnology industries. Based in Agawam, Mass., Microtest's testing facilities are ISO 9001 and ISO 17025 certified, FDA regulated, and meet all GLP/GMP standards. 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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Monday, October 21, 2013

Use of Stability Studies in Drug, Combination Products & Medical Device Development are Reviewed in New Whitepaper


AGAWAM, MASS. — October 22, 2013 —The use of stability testing in new product development — of drug substances, drug products, combination products and some medical devices — is reviewed in a new whitepaper from Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

The paper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development” (download from: http://microtestlabs.com/stability-studies), outlines how stability studies can be used to gather valuable information about a new product and prevent unnecessary manufacturing costs and time delays.

Stability studies can help determine formulation and manufacturing strategy, analytical assay development and validation — and help explain unexpected and failing results. They can also provide input to manufacturing controls, and help identify final packaging requirements. The paper examines three specialized stability studies as examples:
  • Forced degradation studies, which involve exposing the product to predetermined stress conditions in order to intentionally form likely degradation products;
  • Photostability testing, used to determine the product’s ability to withstand exposure to light without any adverse effects;
  • Temperature cycling studies, used to assess the impact of temperature changes on the product.
Two case studies, one involving a drug product and one a combination product, are also presented.

The use of stability studies in the development of new drug or combination products can ease both the planning and execution of a development strategy. Moreover, the studies may also help prevent unnecessary costs and time delays due to poor formulations, assay failures, and manufacturing problems.


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://microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Wednesday, October 2, 2013

“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.

To register, download the form at http://www.microtestlabs.com. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

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.

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