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by Diane Hansen A New World Ok… it’s not a completely new world. But changes in ISO 11607, in particular ISO 11607-01, can leave a manufacturer with many questions. How do I educate myself? Am I compliant? Will I need to change my vendors to continue doing business? ISO 11607-01, the foremost package validation document for terminally sterilized medical devices, provides assurance that a medical device has been maintained in a sterile environment and has not been impacted by the elements, manufacturing processes, shipping or storage. This standard applies whether the medical device was produced industrially or in an individual health care facility. To bring the impact of ISO 11607-01 into human terms, it assures that when Aunt Peggy receives a cardial stent that the device didn’t retain environmental toxins manufacturing to delivery that could be hazardous to her.
Revisions to the ISO 11607 standard could mean the difference between a devise passing package testing and validation or receiving a costly fail. Forming and sealing are the two processes that are considered the most critical. ISO 11607 provides a basic framework of lab tests and evaluations that can be used to test package performance prior to removal from a sterile environment. It is suggested that you download and adhere to the latest ISO 11607 revisions, available at www.iso.org. In addition, the AAMI guidance document Technical Information Report (TIR) 22:2007 has been updated. The Sterilization Packaging Manufacturers Council (SPMC), part of the Flexible Packaging Association (FPA) has a two-article series available that can provide additional education. It is available for purchase at www.aami.org. The Sterile Barrier System A well-designed sterile barrier system allows a medical device to be sterilized, maintains sterility and proves the device to be sterile until the time of use or the expiration date. As a result, the device will be presented in an aseptic manner, safe to be used. The design requirements will guide the manufacturer toward the correct sterile barrier system to use. Types of Sterile Barrier Systems
Protective packaging protects the sterile barrier system and its contents. As with all projects, the development of the sterile barrier system and packaging should be fully specified and documented. Critical Questions about ISO Regulation of Sterile Barrier Systems Since ISO 11607-1 specifies the requirements and test methods for, among other systems, the sterile barrier system, it’s important to understand how the regulations on sterile barrier systems will affect your operation. Who is it applicable to? Does ISO 11607-1 cover all the requirements for sterile barrier systems? What qualifies as a sterile barrier? The ISO definition of a sterile barrier system (SBS) is a “minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use.” Another type of SBS are preformed sterile barrier systems. These are systems that are “supplied partially assembled for filling and final closure.” For a package to be considered terminally sterilized, it must provide a microbial barrier between the medical device and the outside environment. This barrier must maintain its integrity against all physical, chemical or microbial challenges. The sterile package must be able to maintain integrity when both the seals and the medical device packaging are under stress. Are any sterile barriers exempt from the standard? No. No matter what SBS a manufacturer is producing, it is held to the new standard. So what is the change from the older standard to the newer standard? The change is the definition of what a sterile barrier system is. The definitions above were set by ISO to help eliminate ambiguities in what qualifies as a sterile barrier system. Two other definitions were also supplied. The terms protective packaging and packaging system were also defined. Protective packaging is a “configuration of materials designed to prevent damage to the sterile barrier system and its content from their time of assembly to the point of use. A packaging system is a “combination of the sterile barrier system and protective packaging. It may seem comedic that the important changes that the industry is buzzing about are four seemingly simple definitions. But, in fact, it’s these definitions that were a major hurdle in creating this global standard. Now the industry has a clear and consistent understanding of what these terms mean. More Definitions In order to understand the full picture, it’s essential that manufacturers understand the meaning of verification, qualification and validation. Verification – Occurs when specific requirements have been met through combined test and inspection results Qualification – A combination of verifications of how well equipment, a process or a product performs Validation – A combination of qualification and objective evidence that the processes used would create a consistent product that would meet predetermined specifications According to ISO 11607, these definitions are more than dictionary terms. They are key components to a process that proves that manufacturing equipment delivers ISO compliant results, within specific tolerances, under established operating conditions. What Does This All Mean? ISO-11607 helps manufacturers fine tune their process development and validation. It outlines test methods, operations, installation and methods of performance qualification. Sterilization is a critical issue. ISO is making it clearer what scenarios will pass sterilization tests and which will not. In fact, part one provides an extensive list of recommended testing methods to aid manufacturers in evaluation. Objectives of package testing:
The process of sterilization must be decided prior to designing the packaging system and subsequent testing. For example, the package may need to withstand more than one sterilization process or many rounds of processing. The FDA considers ISO 11607 to be the foremost resource for medical device packaging validation protocol. So, a pass on ISO 11607 is fully recognized by the FDA during their evaluation process. Below is the consensus list of physical test methods, issued by the FDA. FDA Consensus List of Physical Test Methods ASTM Standard Test Method for Determination of Leaks in ISO 11607 – A History 1997: For the first time in the history of the medical device industry, ISO 11607:1997, “Packaging for Terminally Sterilized Medical Devices” was created to provide a common platform and language for qualifying materials and processes for sterile barrier packaging 2003: The first update of the standard was made with a general revision 2006: ISO 11607 was aligned with EN 898-1 “Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized,” providing clarity to the myriad of requirements for sterile barrier systems, reflecting advancements in technology in the industry No Fear In summary, changes in ISO 11607 aren’t as hairy as industry buzz may suggest. Through the development of standardized language and definitions, ISO is seeking to help eliminate ambiguities in what qualifies as a sterile barrier system. By providing these definitions, it allows manufacturers to clearly see what they must do in order to pass critical tests. Through verification, qualification and validation, manufacturers can show a well-documented development process and obtain FDA and other administration approvals so their product can proceed into the open market. And, at the end of the day, the open market, the provider and patient, is why manufacturers are in business.
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