BS EN ISO 11607-2:2006 pdf free.Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.
Medical devices delivered in a sterile state should be designed, manufactured and packed to ensure that they are sterile when placed on the market and remain sterile, under documented storage and transport conditions, until the sterile barrier system is damaged or opened. Additionally, medical devices delivered in a sterile state should have been manufactured and sterilized by an appropriate, validated method.
One of the most critical characteristics of a sterile barrier system and packaging system for sterile medical devices is the assurance of sterility maintenance. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is attained and will remain so until opened by the users of sterile medical devices.
There should be a documented process validation program demonstrating the efficacy and reproducibility of all sterilization and packaging processes. Along with the sterilization process, some of the packaging operations that can affect sterile barrier system integrity are forming, sealing, capping or other closure systems, cutting and process handling. This part of ISO 11607 provides the framework of activities and requirements to develop and validate the process used to make and assemble the packaging system. ISO 11607-1 and ISO 11607-2 are designed to meet the Essential Requirements of the European Medical Device Directives.
One significant barrier to harmonization was terminology. The terms “package”, “final package”, “final pack”, “primary pack”, and “primary package” all have different connotations around the globe and choosing one of these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful completion of this document. As a result, the term “sterile barrier system” was introduced to describe the minimum packaging required to perform the unique functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier systems” would include any partially assembled sterile barrier systems such as pouches, header bags or hospital packaging reels.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. Preformed sterile barrier systems sold to healthcare facilities for use in internal sterilization are considered as medical devices in many parts of the world.
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.BS EN ISO 11607-2:2006 pdf free download.