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 facilities where 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