The instruments to be packed and the packaging system should be combined to ensure that the product that is packed is safe both to the user and the patient. The work of the BS EN ISO 11607 is to specify standard materials that can be used to develop these products and the pre-formed systems that can be used in packaging systems that can be used to package these devices. It also defines the range of potential materials that are safe to use in producing the medical devices and the packaging bags. The designs for packaging systems and the methods for sterilizing these devices are contained also in the BS EN ISO 11607. The standard here describes the valid requirements for forming, sealing, and the whole process of assembling of the instruments that are manufactured. The document EN ISO 11607 specifies general requirements for all packaging materials. ISO 11607 part 1 specifies the sterile barrier system requirements, the packaging requirements, and the requirements for materials. The second part gives the requirements and validations for forming, sealing, and the process of assembling the devices. Part two of BS EN 868 gives the particular requirements for a range of commonly used materials. BS EN 868 series contains the requirement for particular materials contained in the European standards and also the pre-formed sterile barrier systems.
A sterile barrie...
a package validation document for terminally sterilized medical devices and 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. These standards apply regardless of the manufacturer of the instrument (McCarthy, 2002, p80). There exist process windows and specifications where a process window defines the manufacturing parameters under which the sterile barrier system will be produced. Specifications define the various properties and characteristics of the sterile barrier system, establishing limits where appropriate. Some properties that may be included in a specification are dimensional requirements, seal strength, and seal integrity to name a few. Part 1 of ISO 11607 defines the materials and designs that used in the production of the instruments while part 2 defines the processes, that is, the forming, sealing, and assembly process requirements. The device can therefore pass the package testing and validation or fail costly. The most critical processes are the forming and the sealing. A sterile barrier system is termed as a well defined system if it 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. The device is thus presented in an aseptic manner, safe to be used. There are some laid design requirements that guide the manufacturer toward the correct sterile barrier system to use. Sterile barrier system falls into two categories which are the reusable sterile barrier systems and the pre-formed sterile barrier systems (Schmelz, 2009, p11). The preformed sterile barrier system defines a partially assembled sterile barrier system that is prior to filling