Navigation Links
USP Microbial Examination of Non-Sterile Products: New White Paper is Roadmap of Regulations for Manufacturers

AGAWAM, Mass., Oct. 5 /PRNewswire/ -- Manufacturers examining their microbial limits testing policies and assessing the impact of the recent harmonization of USP, EP, and JP requirements will find guidance in a new white paper titled "USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World." It's available for download from

Manufacturers required to evaluate the microbial content of their non-sterile products utilize the Microbial Limits Test used to determine the bioburden of the product and also if objectionable organisms are present. In 2009, the harmonized test method became effective, requiring manufacturers to meet the new guidelines set forth in it.

"The new white paper examines how the recent harmonization of USP, EP, and JP requirements affects the processing of raw materials and finished products by manufacturers. It also examines the considerations that manufacturers should examine when establishing a microbial limits testing policy," said white paper authors James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services; and Kimberly Kitch, A.S., Laboratory Technician II – both of Microtest Laboratories.

In the paper, Gebo and Kitch examine:

  • The Affects of Harmonization
  • Sample Requirements
  • Sample Processing
  • Suitability Testing v. Validation
  • Essential Product Information Required for Testing

Download a free copy of "USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World," from

Both authors are members of the Laboratory Services group at Microtest Laboratories. Gebo has had hands-on experience in regulatory microbiology and virology testing since 2004. He holds a B.S. in Biology, a Masters in Public Administration, and is a Registered Microbiologist (NRCM). Kitch has been employed by Microtest Laboratories since January, 2006, and has worked in Microbial Limits, Genetic Identification of Bacteria and Fungi, LAL/Biocompatibility, Bioburden Testing, and other areas. She holds an A.S. in Biology.

Follow Microtest Labs on Twitter: @MicrotestLabs at

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., 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 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.

SOURCE Microtest Labs
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AVMA Testifies in Support of Judicious Use of Antimicrobials in Food Animals
2. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
3. Dal-Tile Corp. Launches Two New Lines of Ceramic Tile with Microban(R) Silver Antimicrobial Technology
4. Data From Optimers Second Phase 3 Study of Prulifloxacin Presented at Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
5. Calixa Therapeutics to Make Multiple Presentations on CXA-101 and CXA-101/tazobactam at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
6. Lytix Presents LTX-109 Anti-Microbial Data at ICAAC
7. Paratek Reports Positive Phase 2 Clinical Data on its New Antibiotic PTK 0796 in Late Breaker Presentation at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
8. Novexel to Present Five Posters at the Joint Annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Disease Society of America (ICAAC/IDSA) Meeting
9. Paratek to Present Clinical Data in Late Breaker Presentation at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
10. Journal of Antimicrobial Chemotherapy Paper Supports Additional Role for Cethromycin as Potential Treatment for Infections Caused by Community- Associated Methicillin Resistant Staphylococcus Aureus (CA-MRSA)
11. Prospective Microbial Analysis of Bronchoalveolar Lavage Fluids with Immune Function Testing Can Distinguish Between Fungal Colonization and Fungal Disease In Lung Transplant Recipients
Post Your Comments:
(Date:11/29/2015)... 2015  The GE Health Cloud 1 was unveiled ... North America (RSNA) meeting in ... the new cloud ecosystem and its applications will connect radiologists ... and multidisciplinary teams – both inside and outside the hospital ... of GE. "As the digital industrial leader, we are betting ...
(Date:11/29/2015)... CORALVILLE, Iowa , Nov. 29, 2015 /PRNewswire/ ... in ultrasound guidance technology at the Radiological Society ... conference in Chicago November ... guidance system is designed to offer customers unrivaled ... outcomes. --> ...
(Date:11/29/2015)...  National Decision Support Company (NDSC) continues to ... notable statewide implementations. As a result, ordering providers ... more than 1 million times per month—all from ... provides real-time feedback on the most appropriate imaging ... implemented at over 100 healthcare systems nationally, representing ...
Breaking Medicine Technology:
(Date:11/29/2015)... ... November 29, 2015 , ... While conventional walkers afford considerable help with ... to exercise weights. Fortunately, an inventor from Uniontown, Pa., has found a way to ... the benefits of a standard walker to improve the user’s quality of life. To ...
(Date:11/29/2015)... ... ... Doctors who missed a case of mesothelioma in a 70-year-old Japanese truck driver ... a diagnosis, especially in people exposed to asbestos. Surviving Mesothelioma has just posted details ... , Researchers at Gifu Prefectural Tajimi Hospital in Japan say the patient complained ...
(Date:11/29/2015)... ... November 29, 2015 , ... ProStatic Analog Distortion from ... designed specially for Final Cut Pro X. FCPX users can now ... modification controls. Destoying and creating chaotic distortion is now quick and simple, putting ...
(Date:11/29/2015)... ... 29, 2015 , ... Effective immediately, every single IguanaMed scrub style will be ... Target is offering a “Buy One Scrub Set, Get the 2nd Scrub Set 50% ... IguanaMed at a discounted price. , IguanaMed’s mission is to outfit every ...
(Date:11/29/2015)... ... November 29, 2015 , ... Key Housing, a top-rated ... announce their December, 2015, featured apartment community: Epic. In showcasing this featured apartment community ... the tight Bay Area rental market to efficiently find housing suitable to their needs ...
Breaking Medicine News(10 mins):