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