Medical device sterilisation and packaging system, also known as “sterile barrier system”, is an important part of the medical device; to provide packaging and protection for sterile medical devices, can effectively block microorganisms and bacteria, and after sterilisation can be maintained for a certain period of time to maintain aseptic environment inside the system, but also need to meet the aseptic presentation of the medical device and operation (e.g. clean opening).

Seal creep

Possible reasons

Instruments and packages are tightly fitted, with sealing edges under pressure;

Environmental pressure changes, and less permeable materials, experiencing vacuum and high temperatures (ethylene oxide sterilisation).

Countermeasures:

Specially designed adhesive coating formulations that reduce the risk of sealing creep (water-based adhesive coatings);

Improvement of air permeability of the top/lid material (hot melt adhesive coating);

Avoidance of labels covering air permeability windows and optimisation of carton layout.