“In-house environmental isolates are not routinely included in the media fill growth promotion of Soybean Casein Digest (SCD) broth...”
- FDA Warning Letter
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The “<100 cfu” format afforded by our CryoLC® products makes them ideally suited for many GMP microbiological applications, including:
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Media Growth Promotion
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Method Suitability (USP <61>, <62> and <71>)
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Validation of Microbial Recovery (USP <1227>)
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Analyst Qualification / Proficiency Testing
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Rapid Microbial Method (RMM) Qualification
The “10 - 10 cfu” format afforded by our CryoHC® products makes them ideally suited for many GMP microbiological applications,including:
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Disinfectant Efficacy Testing
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USP <51>, “Antimicrobial Effectiveness Testing”
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Sterilizing filter studies
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Biological Indicators (USP <55>)
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