Product Validation Test

Process validation are critical activities to ensure product sterility. The main objective of validation is to ensure that the sterilization process has been consistent in achieving sterility and did not cause undesirable impact on the device or packaging. The tests conducted on ETO sterilized medical devices includes:

Sterilization Cycle Development

Biological and Physical Measurement Controls

Empty Chamber Studies

Loaded Chamber Studies

Routine Use / Ongoing Monitoring

Validation Maintenance / Revalidation

Our team ensures and prepares validation protocols which specify the procedures and tests to be conducted.

Typical validation processes consist of the following:

  • Accelerated Aging Tests
  • Sterility
  • Product Bioburden
  • Fractional, Half and Full Cycles with Biological Indicators
  • ETO Residuals
  • Packaging and Transportation Tests