Cryologics converts your in-house isolates into the format required for compendial tests
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“In-house environmental isolates are not routinely included in the media fill growth promotion of Soybean Casein Digest (SCD) broth...”
- FDA Warning Letter, April 2014
Are you in compliance with regulatory requirements?
The “<100 cfu” format afforded by our CryoLC® products makes them ideally suited for many GMP microbiological applications, including: • Media Growth Promotion • Method Suitability (USP <61>, <62> and <71>) • Validation of Microbial Recovery (USP <1227>) • Analyst Qualification / Proficiency Testing • Rapid Microbial Method (RMM) Qualification
The “106 - 107 cfu” format afforded by our CryoHC® products makes them ideally suited for many GMP microbiological applications,including: • Disinfectant Efficacy Testing • USP <51>, “Antimicrobial Effectiveness Testing” • Sterilizing filter studies • Biological Indicators (USP <55>)