USP <797> Compliance Testing

Aemtek offers microbiology consulting and testing to compounding pharmacies, especially in the following areas:

Sterile Compounding Consultation

• Sterile compounding procedures and policies
• USP <797> compliance gap analysis
• Environmental control and monitoring plan
• Environmental sampling and testing
• Sterile compounding personnel competency testing
• Sterility and endotoxin testing
• Microbiology consulting and testing

U.S. Pharmacopeia Testing

• USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• USP <62> Microbiological Examination of Nonsterile Products: Tests for Specific Microorganisms
• USP <71> Sterility Tests
• USP <85> Bacterial Endotoxins Test
• USP <797> Pharmaceutical Compounding - Sterile Preparations
• USP <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments.

Pre sterilization Testing

• Bioburden for raw and finished products
• Total microbial populations
• Yeasts and fungi
• Spore formers
• Anaerobes

Post sterilization Testing

• Endotoxin/pyrogen
• Biological indicator