Medical device Sterilization Validation Studies are performed for all processes, including radiation sterilization by either gamma radiation or electron beam, ethylene oxide gas sterilization, hydrogen peroxide sterilization and thermal sterilization (both moist and dry heat).

At NAMSA, we’re known for our ability to design custom protocols that not only meet your testing budget, but are backed by a complete documentation package fulfilling all necessary regulatory requirements.

Sterilization Validation Assignments

Tests include:

  • Bioburden testing
  • Dose Verification Experiment testing
  • Biological Indicator Sterility testing
  • Half-Cycle Study testing
  • Pharmacopoeia Sterility testing
  • Fractional Cycle Study testing
  • Bacteriostasis/Fungistasis testing
  • EO Cycle Development testing
  • Growth Promotion testing
  • EO Residual testing
  • Monitor/Notification of Quarterly testing
  • Dose Audits testing