Cryologics, Inc. eNewsletter

 

September 2014

 

Welcome to the September 2014 issue of our eNewsletter!  In this issue, we present a recently published article by Dr. Tim Sandle on assessing microbiological media.  We also provide access to a presentation by Bob Westney, Cryologics' President, on the use of in-house isolates in compendial testing. 

 

Assessment of Culture Media in Pharmaceutical Microbiology
By Dr. Tim Sandle 

On June 18, 2014, The American Pharmaceutical Review™ published this article by Dr. Tim Sandle. Dr. Sandle provides a step-by-step pragmatic approach for assessing culture media.  He addresses the use of in-house isolates in growth promotion testing: "In addition to type cultures, environmental isolates are commonly used in media testing regimes. These organisms are designed to demonstrate that a particular lot of culture media will grow microorganisms which are representative of the types that are found in the manufacturing environment." This and other references on the use of in-house isolates can be accessed on our bibliography page.

In-House Microbial Isolates in Compendial Testing: Regulatory Requirements

By Bob Westney
Cryologics' President Bob Westney provides a presentation on the use of in-house isolates in compendial testing.  It provides a review of the current regulatory environment on the subject, and guidance on the difficult task of selecting in-house isolates.  In addition, it addresses three common arguments against inclusion of in-house isolates in compendial testing:

1. An "environmental" isolate, once cultured in the Microbiology laboratory, loses its "wild-type" traits.

2. Preparing an in-house microbial isolate to create the organism concentration necessary for compendial testing is too problematic to be practical.

3. The regulatory expectation that in-house microbial isolates be included in compendial testing is represented by only a few "rogue" FDA inspectors, and is not an Agency-wide expectation.

We invite you to download this free and informative presentation.

 

Contact us today!

 

info@cryologics.com

www.cryologics.com

(610) 847-8781

 

In This Issue
Assessment of Culture Media in Pharmaceutical Microbiology
In-House Microbial Isolates in Compendial Testing: Regulatory Requirements
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