Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers

Thursday, September 13, 2007 General News J E 4
AGAWAM, Mass., Sept. 12 Two new white papers detailingsterility testing essentials are now available for free download fromMicrotest ( The white papers, one which iscustomized for medical device manufacturers and one which is specialized forpharmaceutical manufacturers, presents the general concepts and problemsassociated with sterility testing and reviews different testing methodologies.

For medical device manufacturers, sterility testing of medical devices isrequired during the sterilization process as well as for routine qualitycontrol. Understanding sterility testing is essential when designing thevalidation process. The need to provide adequate and reliable test data is animportant quality control issue. False positive results and test failures canhave significant impact on production schedules and device time-to market.Medical device manufacturers can download the white paper at: .

For pharmaceutical manufacturers, sterility testing of pharmaceuticalarticles is an essential element of the sterilization validation process aswell as for routine release testing. USP requirements employ sterilitytesting as an official test to determine suitability of a lot. Understandingsterility testing is beneficial in terms of designing a validation process.In addition, the need to provide adequate and reliable test data is animportant quality assurance issue. Pharmaceutical manufacturers can downloadthe white paper at: .

The author of the white papers is Steven Richter, Ph.D., President andScientific Founder of Microtest, a leading provider of medical device andpharmaceutical services for medical device designers and manufacturers. Thefirm recently expanded its facilities, resources, and technology, and withmore than 15 years of experience, is a single-source manufacturing solution.

For information on Microtest's unique single-source solutions thatminimize schedule disruptions and accelerate time to revenue visit Microteston the Web: or toll-free: 1-800-631-1680.

About Microtest

Microtest is a leader in testing services and contract manufacturing forthe medical device, pharmaceutical, biotechnology industries. Based in Agawam,Massachusetts, USA, the company's expertise and flexible processes enhanceproduct safety and security, accelerate time to market, and minimize supplychain disruption. For more information, visit or call1-413-786-1680 or toll-free 1-800-631-1680.Note to Editors: For high resolution images available for publication. For pharmaceutical images, visit: For medical device images, visit: Topic Expert(s):For information on the listed expert(s), click appropriate link.Steve Richter, Ph.D.

SOURCE Microtest


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