Cryologics, Inc. Newsletter


April 2013



Welcome to the April 2013 issue of our e-newsletter!  This issue includes several informative articles.


The Parenteral Drug Association (PDA) has announced the upcoming publication of an invaluable book on contamination control in healthcare product manufacturing.


Cryologics' President Bob Westney presented at the Controlled Environment Testing Association (CETA) 21st Annual Meeting, and his presentation is available for download.


The latest issue of the PMF Newsletter includes articles by Dr. Tim Sandle and by Sung-Oui Suh et al. from the American Type Culture Collection (ATCC).

Contamination Control in Healthcare Product Manufacturing, Volume 1
Parenteral Drug Association 

PDA Contamination Control The PDA has announced the upcoming publication of this informative book. It includes 21 chapters, authored by recognized industry experts including 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 pre-order your copy.


CETA 21st Annual MeetingCETA   
Orlando, Florida
April 12-16, 2013
Cryologics' President Bob Westney presented at the 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 here to download a pdf version of the presentation.  
PMF NewsletterPMF Logo
April 2013
Dr. Sandle returns to discuss mitigation of error in the Limulus amebocyte lysate (LAL) assay, including minimizing and detecting errors and evaluating control data.  Sung-Oui Suh et al. from the American Type Culture Collection (ATCC) discuss results of their study to clarify the true taxonomic identity and phylogenetic position of drug testing reference strain ATCC® 2601TM , an organism that has long been classified as Saccharomyces cerevisiae.  Click here to access the newsletter.

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In This Issue
PDA Book: Contamination Control
CETA 21st Annual Meeting
PMF Newsletter April 2013
Product Spotlight
Vendor Spotlight

Our CryoLC® and CryoHC® products are your cost-effective solution to preparing your in-house microbial isolates for use in compendial testing.


* No advance planning. Ready in minutes. Simply thaw, mix and aliquot.


* Eliminate the time and resources needed to prepare your organisms.


* Lowest cost and lead time in the industry.


* Straightforward pricing.  No hidden or non-refundable fees.


* Eliminate your risk of regulatory non-compliance.


Steven Lane Consulting, LLC
We are a full service GMP Microbiology Laboratory conducting many of the USP tests for Environmental as well as Pharmaceutical Ingredients and Products.  Please contact our expert staff today for more information on Disinfectant Efficacy Studies, USP Growth Promotion of Media, Bioburden, Purified Water Analysis or any of our other high quality GMP offerings.   We also have experienced consultants for any GMP/Quality needs.
Ask us, we can help!

4539 Metropolitan Ct
Frederick, MD  21704

(301) 360-3536