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Posts Tagged ‘medical device testing’


Tuesday, January 14th, 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.

Download the brief from: http://microtestlabs.com/endotoxin-testing.

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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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 http://www.microtestlabs.com/reusable-med-device-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.

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 http://www.microtestlabs.com/reusable-med-device-brief.

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

 


Wednesday, July 6th, 2011

Microtest Laboratories Announces New Fast-Track Toxicity Testing for Medical Devices Using Zebrafish Embryos

AGAWAM, MASS. - July 6, 2011 - Microtest Laboratories has announced a new fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos (Danio rerio), a technique already widely utilized in drug development studies.

zebrafish“Testing has revealed that Zebrafish embryos are highly susceptible to toxins. In fact, Zebrafish labs are ubiquitous in most universities and research hospitals,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and former U.S. Food & Drug Administration (FDA) official.

“We’ve confirmed the application of Zebrafish embryos in the toxicity testing of materials used in medical devices,” Dr. Richter said. “With our in-vitro test, manufacturers and bio materials researchers can screen thousands of polymers in less than a week – yielding significant economic savings in both the time and expense of medical device testing.”

In its research, Microtest Laboratories found that the current “gold standard” USP Cytotoxicity Assay, which utilizes live mouse fibroblasts (L929) cells in culture, failed to detect the toxicity of a BPA extract during testing – while Microtest’s new Zebrafish embryo screen succeeded.

BPA (bis-phenol A) is a suspected toxic polymer assumed as having both carcinogenic and teratogenic effects on humans. The U.S. Environmental Protection Agency (EPA) has indicated that BPA will be slated for screening soon.

“Microtest’s new Zebrafish embryo assay has better sensitivity and generates more scientific data than the small animal tests currently recommended by the FDA,” Dr. Richter said.

“The use of Zebrafish embryos will reduce or eliminate the current animal testing required for all medical devices testing. This important vertebrate model has demonstrated similarities to mammalian models and humans in toxicity testing,” he noted.

Microtest Laboratories’ new Zebrafish embryo assay for the toxicity testing of medical devices is immediately available. For more information, visit http://www.microtestlabs.com/zebrafish-embryos-testing or call 1-413-786-1680 or toll-free 1-800-631-1680

About Microtest Laboratories

Microtest Laboratories is a leader in medical device testing and related services 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, Tiziani Whitmyre, 781-793-9380, dgoncalves@tizinc.com

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


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