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