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Steriking® Validation Service

 

Steriking® service platform

Welcome to Wipak’s Steriking® service platform for the validation of the sealing process. The Steriking® Validation Service can be ordered through Wipak’s distributor network.

The sterile barrier system (SBS) is the minimum packaging configuration that prevents microorganisms from entering and allows aseptic presentation at the point of use. Only intact packaging can serve as a sterile barrier and the loss of package integrity can compromise patient safety. ISO 11607-2 standard for sterilization packaging states that there needs to be a documented validation program in all health care facilities where medical devices are packed and sterilized. The aim of this validation program is to demonstrate the efficacy and reproducibility of all sterilization and packaging processes.

The validation of the sealing process according to ISO 11607-2 includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The validation process includes, verifying that the sealer makes a proper closing seal and that the final sealed package performs as a safe sterile barrier system. To support healthcare facilities in their validation programs, Wipak is now offering a new service to assist in the validation of the sealing process.

The Wipak Validation Service for one sealing machine comprises of:

  • Templates for documenting Installation (IQ), Operational (OQ) and Performance Qualifications (PQ)
  • Testing of the seals of sterilized pouches/packs
  • Pinhole testing for sterilized pouches
  • Peel testing/evaluation
  • One Multi Seal test kit (MS300) for routine control
  • Validation report with conclusions and recommendations

To order the validation service, please e-mail your contact details to: specialist.steriking@wipak.com

After we have processed your order, you will receive a username and password for the service and be able to start your validation.


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