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Posts Tagged ‘validation requirements’

Monday, April 30th, 2012

Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief

AGAWAM, MASS. — April 30, 2012 — A new management brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the US Food & Drug Administration’s (FDA) draft guidance document, “Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The new brief is available from Microtest Laboratories at

“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.

In his brief titled “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” Richter discusses a variety of issues raised by the document which the FDA released last May for industry comment. The issues include:

  • “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While Richter emphasized that “the FDA document was issued for comment and is not for implementation, the medical device industry understands that changes from current best practices will be required immediately.”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.

Download a copy of the management brief, “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” from

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.

For more information, visit Microtest’s web site at or call 1-413-786-1680, or toll-free 1-800-631-1680.


Tuesday, June 9th, 2009

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

microtest-logo1AGAWAM, MASS. – June 9, 2009 – Validation requirements and combination products pose a unique set of challenges to the medical device engineer. A new whitepaper from Microtest Laboratories discusses how an engineer can best to utilize packaging validation programs and discusses options when testing medical device packaging.

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

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

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

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

To download the white paper, “Package Validation Requirements For Medical Devices and Combinatory Products“ visit:

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

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

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• Press Contact: Cortney Lusignan, Tiziani Whitmyre, Inc., 781-793-9380,

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