Standards in the medical packaging industry

Background information about the different global standards for sterile packaging

Healthcare is one of the most important fundamentals in our life; mankind is spending lots of money on a healthy lifestyle, health insurances and new developments. And simply because … good health is unaffordable. Over the last years, different standards have been developed in this sector to ensure that the best available techniques are used on a high level when our health is involved.

The EN868 is the most well known standard as it comes to sterile packaging. All packaging materials and systems must comply with the restrictions given in Part 1.

Part 2-10 relate to the requirements and test procedures for different packaging materials. These tests can be used to show that all requirements have been fulfilled.

The ISO 11607 standard; “Packaging for end-sterilized medical products” has already been used (first as a draft) for several years at an international level. The ISO committee has decided in 2002 to combine both the EN868-1 and ISO 11607 in one new revision; this leads to the joint revision ISO 11607 part 1 and 2. Part 1 is about the requirements and test procedures for packaging materials, part 2 about the validation requirements of packaging processes. This new revision is available in different languages.According to this new standard, all packaging processes must be able to be validated. Validation requires reproducible processes.

As it comes to the sealing of the bags, the Audion sealers are very easy to validate; they operate automatic and can therefore reproduce the same seal every time. The parameter controllers on these validatable sealers constant monitor all critical parameters and block the machine when they are out of the acceptable band width. To guarantee the accordance with the machine specifications, our calibration service can be used; the sealer parameters are measured in an official laboratory. We supply an accredited calibration certificate to proof the accuracy of the sealer. This makes the Audion validatable medical sealers to an important tool in your packaging process!

No rights can be derived from this text. For more information about the standards you can contact the European Committee for Standardization.