Navigation Links
White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers
Date:11/11/2008

AGAWAM, Mass., Nov. 11 /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 http://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
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. New White Paper Details Strategies for Biotechnology Companies to Improve EH&S Compliance
2. Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
3. New White Paper Details Six Steps to Investigate and Prevent Laboratory Accidents
4. Microtest Offers Free White Paper: Virus Testing for Biological Products: Partnering With a Contract Lab
5. Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
6. Medco Chooses AllPoints at Anson in Whitestown, Indiana as Site for the Worlds Largest, Most-Advanced Automated Pharmacy
7. Free White Paper Helps Biotech Laboratories Maintain a High Level of Infection Control
8. Free White Paper Available for Clinical Laboratory Managers: Effectively Isolating Anaerobic Bacteria
9. White Paper Details Infection Control Challenges Hospitals Must Address During Construction
10. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
11. Marteks lifesDHA(TM) Now Featured in Two New Flavors of Rachels(R) Wickedly Delicious Yogurt from WhiteWave Foods
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... and NEWARK, Del. , March 29, ... regenerative medicine company, and W. L. Gore ... today announced a collaborative research agreement whereby the two ... therapy delivery device technologies that provide protection from immune ... ViaCyte has been developing innovative stem cell-derived cell replacement ...
(Date:3/29/2017)... March 29, 2017 /PRNewswire/ -  GeneNews Limited (TSX:GEN) ("GeneNews" ... , a new risk stratification test for breast cancer, via ... Diagnostics Laboratory ("IDL"). BreastSentry incorporates a blood-based biomarker test with ... risk for developing breast cancer.   ... BreastSentry measures the fasting plasma ...
(Date:3/29/2017)... India , March 29, 2017 The ... to 2022 report is a specialized and comprehensive study on the ... North America , Europe and ... Middle East and Africa ... Browse 172 ...
(Date:3/28/2017)... Kong (PRWEB) , ... March 28, 2017 , ... ... selected NetDimensions Learning to replace paper-based processes and enhance training plan management for ... are very pleased to partner with the SHL Group to help improve and ...
Breaking Biology Technology:
(Date:3/13/2017)... -- Future of security: Biometric Face Matching software  ... ... Face Matching enables to match face pictures against each other or against large ... Identification Systems) ... is the fastest software for biometric Face Matching on the market. The speed ...
(Date:3/7/2017)... 2017   HireVue , the leading provider of ... the best talent, faster, today announced the additions of ... and Diana Kucer as Chief Marketing Officer ... team poised to drive continued growth in the company,s ... of record bookings in 2017. "Companies worldwide ...
(Date:3/2/2017)... , March 2, 2017 Who risk ... lawsuits? Download the full report: https://www.reportbuyer.com/product/4313699/ ... THE FINGERPRINT SENSOR FIELD? Fingerprint sensors using capacitive ... The fingerprint sensor vendor Idex forecasts an increase of ... mobile devices and of the fingerprint sensor market between ...
Breaking Biology News(10 mins):