FEATURE
R. Neu and G. Strassmann Kobusch-Sengewald, Pregis Group, Warburg, Germany
Important decisions
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When selecting materials for packaging medical products various factors are considered. These include the shape, size and consistency of the product to be packaged, the requirement for sterility, and the packaging machine that will be used to manufacture the product. All these factors are addressed in ISO EN 11607. Part I of ISO EN 11607 deals with requirements for materials, sterile barrier systems and packaging systems and replaces Part 1 of EN 868.1 Parts 2 to 10 of EN 868, which refer to particular materials such as paper with or without sealing coating, continue to be used. Part 2 of ISO EN 11607 is concerned with validation requirements for the forming, sealing and assembly processes.2 Complying with ISO EN 11607 shows that the packaged sterilised medical device meets the requirements of the Medical Device Directive (93/42/EEC); thus, this recently introduced standard also serves to harmonise international regulations.
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Table I. (click to enlarge) Material options for EtO sterilisation.
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ISO EN 11607-1 makes it clear that packaging is an important part of the manufacturing process that has to be controlled and validated. It specifies that the packaging material must be compatible with the intended sterilisation method. The essential criteria when selecting the optimal packaging material for top and base web is the type of sterilisation process that will be employed. Tables I, II and III (with a key to the acronyms provided in Table IV) show the optimal combination of packaging materials by the sterilisation methods: ethylene oxide (EtO), irradiation and steam.
Responsibility for compliance
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Table II. (click to enlarge) Material options for EtO sterilisation.
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ISO EN 11607 applies to industry and to all health institutions in which medical products are packed and sterilised in the sterile barrier system. The party responsible for fulfilling the requirements of the standard is the medical device manufacturer or those who place the product on the market. The selection of suitable material or packaging machines for the production of sterile barrier systems is the responsibility of the medical device manufacturer. He must ensure that the parts of ISO EN 11607 that apply to the packaging system are observed and that a validation of the packaging system is guaranteed. However, fulfilment of these requirements depends on close collaboration between the manufacturers of the medical device, the packaging system and the packing machine. The experience of the packaging film and machine manufacturers can be valuable. Below are examples of where this collaborative effort takes place in relation to sections 4, 5 and 7 of Part 1 of ISO EN 11607.
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Table III. (click to enlarge) Sterilisation by steam.
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Design and development of a secure and efficient packaging system. The packaging film manufacturer can advise on the most suitable packaging film, that is, the film that fulfils the physical requirements of the packaging system.
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Table IV. (click to enlarge) Key to acronyms used in the Tables.
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Selection of materials used. The packaging film manufacturer ensures the film fulfils the physical requirements through validation of test methods such as tensile strength and material thickness testing. This must be documented by the packaging film manufacturer together with the microbial barrier test report (whether the test is performed internally or externally). The medical device manufacturer is responsible for biocompatibility and toxicity in relation to the packaged medical device.
Compatibility with the sterilisation process. The packaging film manufacturer advises on the materials that are suitable for the intended sterilisation process to thereby guarantee, for example, that after sterilisation there is no change to the material and no deviation in colour.
All the steps mentioned above must be documented. Fulfilment of the requirements of ISO EN 11607-1 is made easier if the packaging film manufacturer has an established and certified quality management system according to ISO EN 9001 as well as a hygienic management system such as the Hazard Analysis Critical Control Point. There are also technical standards developed by the British Retail Consortium in cooperation with the Institute of Packaging. Certification according to these standards is not required by ISO EN 11607-1.
Successful products
Using all the gathered information, an appropriate material is selected, processed and then tested. Local trials of the packaging machine with all relevant requirements such as sealing, forming, sterilisation, transport and storage all lead to the selection of the best material for the sterile barrier system. The result is a packaging system that meets the latest regulations and the specific demands of the medical product, and thus offers the highest standard of safety and reliability.
References
1. ISO EN 11607-1:2006, Packaging for Terminally Sterilised Medical Devices, International Organisation for Standardisation, Geneva, Switzerland.
2. ISO EN 11607-2:2006, Packaging for Terminally Sterilised Medical Devices, Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, International Organisation for Standardisation, Geneva, Switzerland.
Rita Neu is Quality Management Representative and Guenter Strassmann is Manager, Product Development/Technical Support at Kobusch-Sengewald GmbH, Anton-Böhlen-Strasse 5, D-34414 Warburg, Germany, tel. +49 5641 960, e-mail: kobusch-sengewald@pregis.com, www.kobusch-sengewald.com.
