A documented validation program to demonstrate the efficacy and reproducibility of all sterilization and packaging processes is required in all health care facilities where medical devices are packed and sterilized. To support healthcare facilities in their validation programs, Wipak is now offering a new Steriking® service to assist in the validation of the sealing process.
The sterile barrier system (SBS) is a minimum package that prevents ingress of microorganisms 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 the validation programs is to demonstrate the efficacy and reproducibility of all sterilization and packaging processes.” Explained Mira Santala, product manager, Health Care Facilities, at Wipak Group.
“The validation of sealing process according to ISO 11607-2 includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). In the validation process it is verified that the sealer makes a proper closing and that the final sealed package performs as a safe sterile barrier system. “
Part of new regulation (EU) 2017/745 on medical devices (MDR) requires that devices labelled as sterile shall be processed, manufactured, packaged and sterilized according to appropriate, validated methods, which means that also packaging process has to be validated.
To support healthcare facilities with their validation programs, Wipak is now offering a new service to assist with the validation of the sealing process. The Wipak Sealing Process Validation Service package for one sealing machine comprises of: templates for documenting the Installation, Operational and Performance Qualifications, seal testing of sterilized pouches/packs, pinhole and peel testing, a Multi Seal test kit (MS300) for routine control, validation report with conclusions and recommendations and an access to Steriking® Seal Validation platform.
To find out more about the Seal Validation service, and Wipak’s other sterile barrier systems, please visit https://www.steriking.com/seal-validation-service.