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

Press Release – For Immediate Release

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

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

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

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

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

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

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

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

About Microtest Laboratories

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

About Microtest Laboratories

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.

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

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