Navigation Links
White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers
Date:3/3/2009

AGAWAM, Mass., March 3 /PRNewswire/ -- Contamination by an unknown organism often calls for total shutdown of a cleanroom's operation until that organism can be identified and eliminated. Such shutdowns can have catastrophic effects on the schedules and productivity of medical device and pharmaceutical manufacturers alike.

A new white paper, "The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns," outlines common sources of contamination, discusses problems and delays associated with traditional methods of identifying those contaminants and highlights breakthrough solutions to these difficulties.

The white paper is available, free, for download at: http://www.microtestlabs.com/microseq/

"Modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry in invasive organisms on themselves -- as well as on the equipment and materials they bring into the environment," says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories.

With more than 13 years' experience in regulatory microbiology and contract laboratory operations, Champagne leads Microtest's microbiology, contract analytical chemistry, laboratory support, and virology departments. He holds a B.S. degree in microbiology from Iowa State University, and is a nationally-registered microbiologist.

"Fast action is vital. To get the cleanroom back up and running as quickly as possible, the extent and location of areas affected must be determined, and the exact organism responsible identified," Champagne said.

The white paper identifies the shortcomings of traditional identification methods, such as only identifying bacteria or yeast only; requiring live, isolated colonies; demanding colonies grown in specific media to match library; delivering subjective results; requiring matches against appropriate library for accurate ID; providing library IDs based on multiple strains/species for each entry; and long turnaround times.

As opposed to traditional methods, DNA sequencing for microbial identification has proven highly accurate and is ideal for testing applications, Champagne explains in the white paper. These include pharmaceutical quality assurance/quality control labs, finished product and in-process testing, media fill failure investigations, sterile medical products, opthalmics, medical devices, cosmetics, and nutritional supplements.

Once the organism is positively identified, managers can much more easily deduce the source or sources of contamination, and take swift corrective action to enable the resumption of manufacturing production.

Download the new white paper, "The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns," at

http://www.microtestlabs.com/microseq/

About Microtest

Microtest is a leader in testing services and contract manufacturing 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Steve Richter, Ph.D.

https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest Laboratories
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Coalition for the Advancement of Medical Research Releases New White Paper, Catalyst for Cures: Embryonic Stem Cell Research
2. Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
3. Duke researchers coax bright white light from unexpected source
4. White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers
5. White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers
6. APS Healthcare Moves Headquarters to White Plains, NY
7. White Paper Examines New Thin LIMS IT Implementation Strategy for cGMP Quality Informatics
8. Free White Paper Now Available: How to get the most from your visit to electronica 2008 in Munich
9. White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
10. Lillys Connelly Appointed to the Presidents Commission on White House Fellowships
11. White Paper Helps Hospitals Prepare Staff for Joint Commission Environment of Care Interview Sessions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... , Feb. 23, 2017 /PRNewswire/ - The Fight ... for Cancer Research (OICR) are pleased to report that ... A financing, with Johnson & Johnson Innovation – JJDC, ... include venture groups HealthCap, TPG Biotechnology Partners, and Genesys ... ...
(Date:2/23/2017)... -- Seattle,s upscale Capitol Hill neighborhood, with its swanky shops, parks and ... lice treatment salon to set up shop. But there,s ... French bistro on E Madison Ave, and CEO Maria ... lice clinic, we pride ourselves on being a destination for ... the stigma associated with lice. Everyone can get lice – ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... in a published evaluation of multiple immunoassay-based threat detection technologies by researchers ... Laboratory, PathSensors’ CANARY® biosensor threat detection technology was found to have the ...
(Date:2/23/2017)... NC (PRWEB) , ... February 23, 2017 , ... ... to announce a new partnership with Compass Research . GGI's mission is to ... a vaccine to a child in need in honor of each clinical trial volunteer. ...
Breaking Biology Technology:
(Date:2/2/2017)... Feb. 1, 2017  Central to its deep ... advances worldwide, The Japan Prize Foundation today announced ... have pushed the envelope in their respective fields ... Three scientists are being recognized with the 2017 ... not only contribute to the advancement of science ...
(Date:1/26/2017)... -- Crossmatch, a leading provider of security and identity management ... fraud, waste and abuse in assistance operations around the ... Disaster Relief conference in Panama City ... foreign assistance organizations throughout Latin America ... largely unacknowledged problem in the foreign assistance and disaster ...
(Date:1/24/2017)... Jan. 24, 2017  It sounds simple and ... that monitors vital signs and alerts parents on ... oxygen saturation level drops. But pediatric experts argue ... parents, with no evidence of medical benefits, especially ... marketed aggressively to parents of healthy babies, promising ...
Breaking Biology News(10 mins):