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    SA Labs offers an array of microbiological and chemical services including EO, radiation and steam sterilization validations, sterility testing, quantitative bioburden and microbial assessments of medical devices, pharmaceutical preparations, water and fresh produce, also heterotrophic plate counts of water and other solutions for hemodialysis. SA Labs offers analytical services for sterile devices including EO Residuals and Endotoxin testing. SA Labs is ISO-17025:2017 accredited.

Microbial Limits

Microbial limits testing per USP <61> with additional specificity per USP <62> are common microbiological assays performed on non-sterile pharmaceutical preparations, the precursors to those preparations, and waters for pharmaceutical purposes. 
This testing is typically performed in 3 phases:

If an acceptance criterion is specified in a monograph, then microbial limits are provided.

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Above: Microbial limits sample membrane filter after incubation with fluorescent imaging, ready for enumeration

Product Category: Microbial Testing Services