Cleanroom Supply Standards in Aseptic Manufacturing Environments


IF YOU ARE MANUFACTURING in an aseptic environment, it’s important for your cleanroom supplies to be sterilized with a validated process. This whitepaper, written by Lynn Stanard, Berkshire’s Senior Quality Manager, will help you understand the sterilization methods used by consumables suppliers and what to look for when procuring supplies

Sterile Cleanroom Management

This whitepaper provides details about:

  • Irradiation vs. Sterilization
  • ANSI/AAMI/ISO Standards & Guidelines
  • Bioburden Studies and Validation
  • Quarterly Sterilization Audits
  • Bacteriostasis/Fungistasis Testing
  • Certificates of Sterility
  • Environmental Monitoring

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