Sterility Method Suitability/Validation

Sterility Method Suitability/Validation
USP <71>

This is a one-time test per formulation to establish a suitable method of routine testing for sterility. The samples will be prepared in triplicate per the chosen method determined by the sample matrix, container, or batch size as dictated by the USP requirements.  The validation confirms that the samples have been prepared in a way that has eliminated any antimicrobial agents from the sample and are capable of recovering microbial contamination if any is present. An inoculum containing <100 CFU of microorganism will be added to the media per USP <71>. If the antimicrobial agents have been properly eliminated, growth will be observed in the media. The following microorganisms will be used:

• Candida albicans (ATCC No. 10231)
• Aspergillus brasiliensis (ATCC No. 16404)
• Pseudomonas aeruginosa (ATCC No. 9027)
• Staphylococcus aureus (ATCC No. 6538)
• Bacillus subtilis (ATCC No. 6633)
• Clostridium sporogenes (ATCC No. 19404)

This test can be run concurrently with Sterility or on its own.

Sterility Method Suitability/Validation

USP <71>
$ 400