Sterilization Consulting

Microrite consultants are highly experienced in sterilization, including ethylene oxide, radiation(gamma and electron beam), steam, dry heat, chemical, and novel processes. Take advantage of our decades of experience in the pharmaceutical and medical device industry and participation in AAMI, ISO and ASTM standards committees related to sterilization and microbiology. We are able to provide sterilization consulting services throughout product development and commercialization such as:

  • Selection of sterilization mode
  • Product design for sterilization
  • Selection and audit of contract sterilizers and laboratories
  • Sterilization process development and optimization
  • Sterilization validation-write protocols and reports, review protocols for compliance, or complete management of sterilization validation
  • Annual sterilization review and requalification
  • Dose audits and dose mapping for radiation sterilization
  • Adoption of products into families for sterilization, bioburden, sterilization residuals
  • Assist in development and validation of test methods for bioburden, sterility, EtO residuals, and endotoxin
  • Write or review sterilization section of regulatory submissions
  • Response to questions and observations from regulatory agencies
  • Troubleshooting and root cause analysis
  • Sterilization risk assessment
  • Analysis of sterilization non-conformance and product disposition
  • Compliance with ISO, AAMI, and FDA regulations and guidance