The proper election of packaging will ensure the integrity of the product and  prevent damages during the distribution cycle. will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. These regulations specify the minimum requirements for all devices. Second-generation Direct Seal medical packaging papers are produced to ensure that the natural tendency for the fibres to align with the machine direction is eliminated, leading to a cleaner peel and more flexible product for the end user. He reminded delegates of the five key purposes of device packaging: to contain, inform, protect, display and transport. Primary packaging materials for medicinal products. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. Enter "consensus standards" into their search engine and follow the links to their standards database. The source, history and traceability of all materials must be known, Biocompatibility and toxicological attributes must be evaluated along with sterilisation effects on these according to ISO 10993, Must not contain or release any toxic substances before, during and after sterilisation, Must be FDA- and EU-compliant for food contact. This includes the physical address of the manufacturer. They need to provide a premarket submission number for the device such as 510(k), PMA (Premarket Approval), HDE (Humanitarian Device Exemption), etc. Andrews looked at the minimum seal strength requirements detailed in EN 868-5:2009 Packaging for terminally sterilised medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods. Several layers gives more security and wider choice of functional raw materials • Provide a forum to voice the device industry packaging position on issues that affect them. UK hospitals invest in antimicrobial pullcords to help reduce the spread of germs, ISO 11607-1 Packaging for terminally sterilised medical devices, requirements for materials, sterile barrier systems and packaging systems, ISO 11607-2 Packaging for terminally sterilised medical devices, validation requirements for forming, sealing and assembly processes, ISO/TS 16775 – Guidance for use of ISO 11607, EN-868 Parts 2-10 Packaging for terminally sterilised medical devices (wraps, pouches and reels…), particular requirements, ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes, Free of holes, cracks, tears, creases and localised thinning. Any medical or radiation-emitting device that is used, produced in, or imported to the U.S. is required to have a packaging release test completed in a certified lab – including our state-of-the-art Nefab facilities. On May 5, 2017, the European Commission released the new Europe (EU) Medical Device Regulations (MDR) in an effort to create a more unified and transparent system for medical devices.. It also relies on the type of packaging/pouch making machine to be used, its set-up and condition, the direction of the peel with respect to the paper fibre lay, and the sterilisation processes. Shelf life and stability testing are also required by ISO 11607-1. It also interrupts the cell’s DNA, preventing replication. In-line web cameras provide quality control and can detect defects smaller than 0.5mm. Package manufacturing machinery must be set up and maintained in a validated state and produce a result that can be measured and monitored over time for performance to specification. 5 – Acceptable: Package meets highest visual requirements Additional requirements might also be necessary for drug/device combinations. A good design and a validation process are the fundamental to provide customers and medical organizations with high-quality medical devices. However, with careful and continual product design he said this can now be avoided. The technology for direct seal paper has advanced significantly over the years and the objective assessment of the cleanliness of a peel as well as of seal strength is now possible, he said. • Provide a timely list … Every medical device and IVD must be provided with a label. The reasons behind the requirements are sometimes obvious, but not always. In the past, direct seals were weaker than seals formed using heat seal coated papers. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Seal/peel strength and the cleanliness of the latest generation papers is now at a very high level, he added. This website uses cookies to improve your experience while you navigate through the website. Package Integrity (ASTM F2096: Bubble Test). Symbols to be used with medical device labels, labelling, and information to be supplied. Packaging materials and systems for medical devices which are to be sterilized, Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods The silver-complexed ions interfere with enzyme production, stopping the cell producing energy. The table below lists the medical device packaging standards recognized by the FDA. This has already begun with the revision of EN868-2, -3, -4, -6 and -7. In addition, divided PA layers can enhance thermoformability and expensive individual layers can be made thinner giving further cost benefits. specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. As a result, appropriate testing procedures that meet requirements of the governing agencies, the Food and Drug Administration (FDA) and/ or Medical Device Directives of the European Union are mandatory to ensure the integrity of the product and to comply with the medical device packaging standards. 1 – Rejectable: Package seal does not meet minimum requirements Contact us today, and let our experienced team of engineers create a packaging solution that will work best for your business. And have you set accept/reject levels for your sealing process? For a complete list of all standards recognized by the FDA, visit their site at www.fda.gov . The changes are mostly subtle; the biggest is (maybe) the addition of user evaluation of the sterile seal opening procedure and re-validation requirements. Stefan Krakow, Head of Product Management, GEA Tiromat Packaging, looked at process qualification for packaging machines. Validating Medical Device Packaging Ul. All information for safe installation, use, storage, servicing, and maintenance of the device must be provided to the user. It should have a shelf-life of five years after the sterilisation process, and it should be noted that shelf life is not only a time-related issue but also event-related, explained Muhonen. But it is the role of packaging to keep the device sterile right up until use. For sterile barrier packaging systems, ISO 11607 Part 1 outlines four key requirements: This ISO standard also addresses packaging materials by presenting requirements for their physical properties and material performance. Useful as screening tests, particularly when used as a consistent benchmark over time. For example, pore size influences bacterial barrier performance; tear strength influences controlled tearing when opening; dry strength is for better protection of the contents during handling, while wet strength is required during steam and EO sterilisation. Industry experts at a recent Medical Device Packaging seminar gave many good reasons why companies should think about it earlier, Picture courtesy of GEA Tiromat Packaging. to have an active life shelf-life of five years. It states that medical device packaging should be: Made of known and traceable materials; Non-toxic, non-leaching and odourless Maintain sterility up to the point of use, Changes to definitions: 3.4 closure integrity, 3.8 microbial barrier, 3.19 seal integrity, Adding ‘prevents the ingress of microorganisms, demonstrated under test conditions which consider sterilisation process, handling, distribution, transport and storage’. Then, is fundamental an effective packaging to preserve the sterility and the properties of the medical devices. Other visual inspection systems and automatic marking systems can help manufacturers to pick up foreign particles such as gels, black particles and pinholes. This report will explore the validation requirements of packaging for terminally sterilized medical devices through ISO 11607. Chloride and sulphate content may affect the acidity of the material, which can affect coatings, inks and the medical device itself. ASTM D642 Determining Compressive Resistance of Shipping Containers, Components and Unit Loads, ASTM D695 Compressive Properties of Rigid Plastics, ASTM D1621 Compressive Properties of Rigid Cellular Plastics, ASTM D4169 Performance Testing of Shipping Containers and Systems. packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market. Cleanliness of peel – which depends on a visual, tactile and aural assessment. Thermoforming is such an affordable material that offers you … Package aging has the longest lead time. This category only includes cookies that ensures basic functionalities and security features of the website. Challenge the strength and robustness of the product and package combination. But opting out of some of these cookies may affect your browsing experience. A well designed packaging  is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards. requirements of any relevant medical device or IVD medical device-specific standards should also be considered. This guide brings together many key aspects of packaging validation like the material qualification, validation of seal process, whole package seal integrity. Morris explained that Biomaster binds to the bacteria cell wall, disrupting growth. The other parts of EN 868 will be dealt with as soon as the above documents have been finalised. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. When looking at medical grade film properties, Muhonen said the main considerations are: the packaging method, the cost and nature of the device; shape, size and weight of the device, and the sterilisation resistance. suitability of packaging or packaging material for any particular requirements and conditions can only be ascertained through det ailed packaging and stability studies on the product concerned. He looked at the tests used to validate sterile integrity and strength of the primary package: Visual inspection, burst test, peel/tensile test, dye penetration, bubble leak, microbial challenge and gas trace (Sniffer) testing. To further characterise the direct sealing process, the use of advanced imaging is being investigated, said Anderson. BS EN 15823:2010 Packaging. Depending on the type of packaging materials, test models used in evaluating packaging systems during transportation, distribution and storage may include compression testing, shock testing, vibration  testing,impact testing and testing under climatic exposure. A third testing type, is a custom test procedure. For these reasons, it is important to choose the proper packaging to ensure the integrity of the product and to prevent damages during the distribution cycle. Typically, soft wood has long fibres and hard wood has short fibres. While this document includes general labelling principles, it does not include sections that address other possible elements of labelling. packaging of medical devices. It also says ‘Accelerated ageing shall be regarded as sufficient evidence for claimed expiry dated until real time ageing data is available.’. The other standards in the EN 868 series are not so strictly regulated. Paul Morris, MD, Addmaster, a company offering permanent antibacterial protection for products, said there are currently more than 40 products with ‘Biomaster’ antibacterial protection being used in a medical setting ranging from floors, bed frames, uniforms and case note folders to vacuum sacks. While medical technology packaging certainly needs to protect high-value products during shipping and transport, it must also comply with health and safety regulations. Traditionally, the attempts to get the highest seal strength from a direct seal system resulted in unacceptably fibrous peels. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture. Section 6.4 deals with stability testing and says it should be performed using real time ageing protocol. Thermoforming packing is the most common packaging design in the industry of medical devices. New medical device regulations (MDRs) are now in place that impose major requirements on anyone involved in the design, manufacture, approval and commercialisation of devices that are sold in the EU. Cleanroom production also provides the required hygienic production environment and the requirements are covered in the Quality system ISO 9001, ISO 13485 for medical devices, and GMP (good manufacturing process), while bioburden limits are discussed in ISO 11737. In particular, they regulate all medical devices and radiation-emitting products that enter – and leave – the United States. Long fibres enhance the physical strength of the papers and are much less likely to tear out of the paper on peeling. At the same time CEN/TC102/WG4 is looking at a revision of EN 868. He outlined the raw material requirements, the important processing parameters, and the quality considerations such as thickness control, in-line web camera control and cleanroom production. Source: Wipak. Improperly designed and validated packaging can even derail a product. Raw materials used in sterile medical device packaging must be traceable, safe and effective in creating a microbial barrier. specifies the requirements for materials and test methods, pre-formed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. Vikman chaired a recent Medical Device Packaging seminar in Oxford, UK. Medical devices placed on the Great Britain market must have a UKCA mark or a CE marking, depending on which legislation the device has been certified under. Water absorption influences the bacterial barrier performance, as does water repellency. ISO 11607: Packaging for Terminally Sterilized Medical Devices, published in 2006, is the principal reference guide for medical device packaging and includes information on testing requirements. 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