Is my packaging (sterile barrier system) seal important?

Reusable surgical instruments are subjected to a decontamination process. Which means they are cleaned, inspected, packaged, sterilized transported and stored after every use on a patient. The purpose of the packaging system is to keep the instruments sterile until they are used, and to allow them to be opened aseptically when they are used. The international standard ISO 11607-1 describes the requirements for sterile barrier systems (packaging), while the ISO 11607-2 standard describes validation of packaging processes. This standard is applicable to the medical industry, to health care facilities (hospitals, doctors and dentists).

According to ISO 11607-2 the process of sealing an instrument in packaging must be validated.   The standard places the onus on the individual hospital to ensure that the packing being used can maintain sterility. To do this the hospital should have a quality control process in place for validating their processes.

Clean dried instruments are placed in sterile barrier (packing) systems which includes wrap, paper-plastic pouches and containers. These items are then sealed using different methods. The seal should be continuous with no channels, no gaps, or open areas. There should be no punctures or tears in the packaging.

Paper-plastic pouches are sealed using a heat sealer. The heat sealer used should be manufactured in such away that it can conform to the standard.  The heat sealer must be able control and monitor the 3 critical heat sealing parameters namely; temperature, speed and force or pressure.

To maintain sterility, we must prevent the ingress of microorganisms into our packaging. Making sure we properly seal our paper-plastic pouches is part of that process, so yes, our packing sealing is indeed very important.