The PDA has announced the publication of this informative book. It includes 19 chapters, authored by recognized industry experts including Scott Sutton, Anne Marie Dixon, Ziva Abraham, Jim Polarine, Jeanne Moldenhauer, Karen McCullough, Tim Sandle and T.C. Soli, among others. The book includes a chapter authored by Cryologics’ President Bob Westney, “The Role of In-House Microbial Isolates in Contamination Control”. This chapter presents a review of the current regulatory environment, a strategy for choosing which in-house isolates are suitable for inclusion in compendial testing, and the role of these isolates in contamination control. Click here to order your copy.Continue Reading
Cryologics’ President Bob Westney presented at the Controlled Environment Testing Association’s (CETA) 21st Annual Meeting on April 14, 2013. His presentation, “A Risk-Based Approach for Investigating Environmental Monitoring Excursions”, provides for an excellent means of creating and implementing an EM investigation procedure, or for performing a gap analysis of your current procedure. Click below to download a pdf version of the presentation.Continue Reading
In this issue, Dr. Michael Miller discusses the current state of Rapid Microbiological Methods (RMMs). His discussion includes Quality, regulatory and validation considerations.
Dr. Tim Sandle presents an article addressing the variability of the Limulus amebocyte lysate (LAL) assay. This compendial test for bacterial endotoxin has several aspects of inherent variability. Dr. Sandle discusses each area, and provides recommendations for statistical analyses.
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Cryologics’ President Bob Westney, who is also a member of the prestigious Microbiology Network of consultants, posted a blog article addressing the debate over who is the appropriate person to perform environmental monitoring.
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In this issue, we present the latest PMF Newsletter and a spotlight on Cryologics’ President Bob Westney’s presentation for the upcoming CETA annual meeting.
Click here for the web version of our February 2013 e-Newsletter.Continue Reading