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

Thursday, September 13, 2007 General News
Email Print This Page Comment
AGAWAM, Mass., Sept. 12 Two new white papers detailingsterility testing essentials are now available for free download fromMicrotest (http://www.microtestlabs.com). 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:

http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm .

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:

http://www.microtestlabs.com/sterilitypaper/pharma-paper.htm .

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: http://www.microtestlabs.com 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 www.microtestlabs.com 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: http://www.flickr.com/gp/10956940@N08/9H4T4z For medical device images, visit: http://www.flickr.com/gp/10956940@N08/g1y88vAvailable Topic Expert(s):For information on the listed expert(s), click appropriate link.Steve Richter, Ph.D.http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622

SOURCE Microtest


Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store

Facebook