Testing laboratory evaluation of medicine product quality

Microbiology parameters

Микробиологические показатели

  • Bacterial endotoxins (LAL test)
  • Sterility
  • Microbial purity of drugs
  • Microbial purity of excipients
  • Microbial purity of drug substances
  • Microbial purity of primary packing materials for non-sterile API
  • Sterility of primary packing materials for sterile API
  • Testing washings from working surfaces, staff hands, clean-room garment, equipment
  • Microbiology tests of distilled water, water for injection, water purified:
    • Total microbial count (TMC)
    • Pathogenic flora (Enterobacteriaceae)
    • Staphylococcus and Pseudomonas Aeruginosa
  • Microbiology test of water potable
    • Total microbial count (TMC)
    • Total Coli forming bacteria and Thermo tolerant Coli forming bacteria of potable water
  • Microbiology tests of air in production areas as well as compressed air.

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