ISO 11137 meeting the for sterile products

Accountability for the ISO 11137 requirements

Common question in audits

  • Why are the dose mapping reports not meeting the basic requirements of the ISO 11137–3?
  • Lack of process knowledge at the sterilization provider site. How can you be sure that the product is sterile when you get it back from the provider?
  • Do you have the calculation of the dose range verified?
  • etc.

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