Sterility Assurance Labratories
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How we can help your business

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 LimitsMicrobial 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:

  • The first phase is a series of preparatory tests demonstrating that the Method is appropriate for use with the item(s) to be tested and that those items will not be inhibitory to microbiological growth.
  • The second phase, specific to USP <61>, is a microbial enumeration test quantifying any aerobic bacteria, mold and yeast that may be present in the sample.
  • The third phase, conducted according to USP <62>, is a series of tests intended to screen the sample for specific microorganisms which typically include S. aureus, P. aeruginosa, E. coli, S. enterica and C. albicans, with C. sporogenes included as a representative anaerobe.

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