SaniSure® Camarillo Gamma Irradiation Sterilization Validation Summary

The summary of SaniSure® at Camarillo gamma irradiation sterilization validation. Including:

  • Qualification of irradiation site
  • Single-use systems family design
  • Bio-burden characterization
  • Verification dose establishment
  • Test of sterility
  • Minimum sterilization dose establishment
  • Dose mapping
  • Process monitoring program
  • Validation standards
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