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Current USP Perspectives on Sterilization & Sterility Assurance

Sterilization, Sterility Assurance & Sterility Testing. What’s on the Horizon?

Who’s on the MSA Committee?

  • James Akers, Ph.D., AK&A, Chairman
  •  Scott Sutton, Ph.D., Vectech, Vice-Chair
  •  James Agalloco, A&A
  • Ivan Chin, Ph.D., J&J
  • Anthony Cundell, Schering Plough
  • J. Kirby Farrington, Ph.D., Eli Lilly
  • Dennis Guilfoyle, Ph.D., FDA ORA
  • David Hussong, Ph.D., FDA CDER
  • Leonard Mestrandrea, Ph.D., Pfizer (ret.)
  • David Porter, Ph.D., Vectech
  • Donald Singer, GSK
  • Radha Tiramuli, Ph.D, USP Staff liaison

  KEY AREAS OF ACTIVITY

<1211> Sterilization & Sterility Assurance

<1116> Microbiological Control & Monitoring of Aseptic Processing Environments

<1222> Terminally Sterilized Pharmaceutical Products – Parametric Release

<1208>Sterility Testing – Validation of Isolator Systems

[…]

                                                                                                                                      Current USP Perspectives on
                                                                                                                                 Sterilization & Sterility Assurance

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  • Moist Heat Terminal Sterilization for Controlled Release Materials
  • author: Agalloco James

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related articles

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related articles

  • What is a sterilization autoclave?
  • Moist-heat sterilization of blood bags
  • F0 value – What it means, how to calculate it…
  • Non-heat terminal sterilization of controlled released material
  • Moist Heat Terminal Sterilization for Controlled Release Materials

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