Microtest Labs Provides Experienced USP Microbial Limits Testing of Raw Materials, Other Nonsterile Products for Pharma Manufacturers

GAWAM, MASS. – April 21, 2010 – Microtest Laboratories, a leader in pharmaceutical testing services, is an experienced resource of USP Microbial Limits Testing (MLT) of raw materials and other nonsterile products in pharmaceutical manufacturing.

Microtest Labs will highlight its MLT testing services and expertise at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

The quantitative phase of MLT testing determines the bioburden of given pharmaceutical manufacturing samples, determining the number of total aerobic organisms as well as the total number of yeasts, and molds. The qualitative phase of testing examines samples per U.S. FDA criteria for “objectionable organisms.”

For minimum coverage, these criteria require testing for the following:

• The bacteria Escherichia coli (E. coli)
• The bacteria Staphylococcus auseus (S. auseus)
• The yeast Candida albicans (C. albicans)
• The bacteria Pseudomonas aeruginosa (Ps. aeruginosa)
• The fungus Aspergillus niger (A. niger)

The first step in microbial limits testing is the preparatory testing which validates the product with the method used. This ensures the product has no inhibitory effect on the recovery of organisms from the product. Once the product has passed the preparatory test, the product is validated for routine screening. The routine microbial limits screening test consists of the total aerobic and total yeast and mold counts as well as the test for objectionable microorganisms. If the total aerobic and total yeast and mold counts are acceptable and no objectionable organisms are found, then Microtest microbiologists okay the swift release of the product or raw material.

Full microbial limits testing then inoculates specific organisms into general nutrient media. After allowing time for any growth, Microtest microbiologists transfer the results to specific media that show differential reactions to the presence of a given organism.

While the preparatory and the routine microbial limits screening test can be particularly problematic for inexperienced laboratory personnel at other facilities, Microtest brings the industry’s highest levels of expertise to MTL testing.

This expertise enables Microtest to deliver its clients a competitive advantage – in the form of faster regulatory approvals and time to revenue, high-quality customized testing, the elimination of schedule disruptions and reduction of risks, accelerated reliable turnarounds, and enhanced costs savings.

For more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Or, visit Microtest website at: http://www.microtestlabs.com/pharmaceutical-testing-services/usp-assays/usp-microbial-limits.html or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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 http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.