Amy Karren, B.S.

Chair, Small Molecules 5 Expert Committee
Amy Karren, B.Sc.

Career Highlights:

  • Nelson Laboratories: Director of Scientific Development, Microbiology Section Leader, Study Director for Bacterial Endotoxins Testing
  • W.L. Gore and Associates: Microbiologist, Sterilization Microbiologist, Sterility Assurance Subject Matter Expert

Education:

  • Utah State University – B.S., Biology
  • Humboldt State University, Special studies in marine biology

Awards, Recognition, Admissions:

  • AAMI Standards Developer Award
  • Convenor: ISO TC198 – WG8 – Microbiological Methods
  • U.S. Delegate: ISO TC198 – Sterilization Standards Committee
  • Co-chair: AAMI TC 198 – WG8 – Microbiological Methods
  • Specialist and Registered Microbiologist (American Academy of Microbiology) – Pharmaceutical and Medical Device (RM)/Specialist in Microbiology (SM) [National Registry of Certified Microbiologists (NRCM)]
  • USP Volunteer
    • Chair: USP Expert Committee 5, Chemical Medicines Member: USP Expert Committee, Small Molecules
    • Member: USP Advisory Panel Member for USP <81> Antibiotic Potency

A Few Favorite Professional Achievements:

  • Designed, developed, and validated a new standard test procedure for determination of objectionable organisms in human tissue proposed to be made an American Association of Tissue Banks (AATB) standard test procedure
  • Pioneer and thought leader for bacterial endotoxin testing (BET)
    • Championed the effort for the first commercial lab to employ the kinetic test methods
    • Draft committee for the development of the standard for alternatives to batch testing for the BET
    • Member of the Kilmer PAT committee for the advancement of the use of parametric release for sterilization and aseptic processes ·
  • Author/Co-author of multiple industry standards and published articles, including:
    • ISO 11737-3 – Sterilization of healthcare products – Microbiological methods – Part 3: Bacterial endotoxin testing
    • ANSI/AAMI ST72 - Bacterial Endotoxin Test Methodology; Alternatives to Batch Testing
    • PDA Technical Report No.13 – Monitoring of Controlled Environments
    • PDA Technical Report No. 3 – Dry Heat Sterilization and Depyrogenation
    • ASTM standard for Bacterial Endotoxin Testing of Sterile Medical Gloves
    • Block’s Disinfection, Sterilization and Preservation – 6th Edition
      • Chapter 60: Control and Monitoring of Microbiological Quality in Nonsterile Manufacturing Facilities, and
      • Chapter 66: Bacterial Endotoxin

LinkedIn Icon