Seal Validation Service

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. Aim of the validation programs is to demonstrate the efficacy and reproducibility of all sterilization and packaging processes.

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 finally 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 sealing process validation.

Wipak Sealing Process Validation Service package for one sealing machine comprises of:

• Templates for documenting Installation (IQ), Operational (OQ) and Performance Qualifications (PQ)

• Testing of 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

• Access to Seal Validation platform