Cryologics, Inc. eNewsletter

Spring 2015

Welcome to the Spring 2015 issue of our eNewsletter! In this issue, we're very excited to present our 2014 turnaround time metrics for our CryoHCŽ and CryoLCŽ products. We also highlight a recent 483 observation by the FDA regarding the use of in-house microbial isolates in compendial testing.

Turnaround Times

Cryologics' 2014 Success!

Cryologics is pleased to present our 2014 metrics for average turnaround times for a variety of organisms for both our CryoLCŽ and our CryoHCŽ products. We have demonstrated that we can deliver organisms in the format required for compendial tests in less than one month on average! We invite you to join us in achieving your compliance goals.

FDA 483 Observation

April 14, 2014

Yet another company has recently been cited for not incorporating its in-house microbial isolates into its compendial testing. An excerpt from the 483 states:

"In-house environmental isolates are not routinely included in the media fill growth promotion of Soybean Casein Digest (SCD) broth..." FDA

And in the same 483:

"In-house environmental isolates were not included in the growth promotion of TSA-32ml and TSA-80 [redacted] plates."

The full 483 can be viewed here, and additional references on this topic can be found here. We encourage you to adhere to regulatory requirements. We are ready to assist you in meeting these requirements. Our solution is rapid and cost-effective.

Contact us today!

info@cryologics.com

www.cryologics.com

(610) 847-8781

In This Issue

Cryologics' Turnaround Time

FDA 483

Product Spotlight

PRODUCT SPOTLIGHT

Our CryoLCŽ and CryoHCŽ 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.

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

* Lowest cost and lead time in the industry.

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

* Eliminates your risk of regulatory non-compliance.