medical device packaging requirements

At this point. Not only do peeling ‘data libraries’ assist medical device manufacturers to optimise material combinations and sealing parameters, he said, but peels can also be engineered not to be sensitive to peel direction. Radka Peterson, Technical Sales for Medical Papers, BillerudKorsnäs, looked specifically at the ISO 11607 requirements for medical packaging papers. Typically, soft wood has long fibres and hard wood has short fibres. These processes include the forming, sealing, and assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves and the packaging systems. At the same time CEN/TC102/WG4 is looking at a revision of EN 868. Stefan Krakow, Head of Product Management, GEA Tiromat Packaging, looked at process qualification for packaging machines. Noel Gibbons, Lead Programme Manager, Anecto, looked at testing procedures for final medical device packages required by the standards. While this document includes general labelling principles, it does not include sections that address other possible elements of labelling. Morris explained that Biomaster binds to the bacteria cell wall, disrupting growth. A published tool to guide and assist you in compliance with ISO 11607 is ISO/TS 16775. This qualitative measure (accept/reject) helps to evaluate the appearance of unopened seals to determine the presence of defects. The objective of this set of tests is to inspect the packaging systems for any damage that may have resulted. We'll assume you're ok with this, but you can opt-out if you wish. A better packaging design and a better material selection can stabilize the medical device and increase the protection. What this event highlighted, is that the time required to gather all this packaging data means that packaging requirements must be considered in parallel with the device development, if costly delays to market are to be avoided. Requirements and testing. A well designed packaging  is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards. Improperly designed and validated packaging can even derail a product. Package Integrity (ASTM F2096: Bubble Test). Common mistakes to avoid are the use of low melting point materials in steam sterilisation or using non-radiation resistant materials (such as standard polypropylene) in gamma or beta sterilisation. For example, peeled films samples are placed on a scanner and the scanned images are digitally compared with references to assess the level of fibre tear. In the past, direct seals were weaker than seals formed using heat seal coated papers. These cookies do not store any personal information. The main places to go for more information on this topic were: the US FDA’s Process Validation: General Principles and Practices, which offers general validation guidelines but which are open to individual interpretation, along with guidance from the International Society for Pharmaceutical Engineering (ISPE), and Good Automated Manufacturing Practice (GAMP) 5. A good design and a validation process are the fundamental to provide customers and medical organizations with high-quality medical devices. Package aging has the longest lead time. Medical device packaging doesn’t rely on packaging graphics (as a sales/marketing tool) the way that packaging used for consumer packaged goods does. - Be familiar with the market price of the medical devices they source and normal fluctuations ... national registration requirements will be updated on our Registration webpage. You also have the option to opt-out of these cookies. Tensile strength is important for better protection of the contents and for speed when converting. Chloride and sulphate content may affect the acidity of the material, which can affect coatings, inks and the medical device itself. 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. Left: Fibre tear; Right: Clean peel. For medical devices article 13.3 of Directive 93/42/EEC, Annex 1 (Essential Requirements), sets out what (if applicable) must be stated on the label. The UPLR requires that consumer packaging bear a label specifying the following: the identity of the commodity the name and place of business of the manufacturer, packer, or distributor the net quantity of contents in terms of weight or mass measure, or numerical count in a uniform location upon the principal display panel. In particular, they regulate all medical devices and radiation-emitting products that enter – and leave – the United States. For example, an incursion above a certain temperature or humidity or exposure to direct sunlight would affect shelf-life. This website uses cookies to improve your experience while you navigate through the website. 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. As a result, focused simulation is used to assess the performance of packaging under specific  transportation or storage conditions. 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. The next meeting is in March 2015 and publication is expected mid 2016, Tillaéus said. Under the requirement for cleanliness, visual appearance is a key element for a medical package, she said. Real Time Aging and Accelerated Aging (ASTM F1980) to demonstrate the sterile barrier system maintains integrity over time for the anticipated shelf life of the product. Seal assessment is split into two components: The cleanliness has been measured subjectively until recently but more objective assessment techniques have now been developed. These cookies will be stored in your browser only with your consent. Shelf life and stability testing are also required by ISO 11607-1. This part of the process is the longer one, can vary from one month to six months, depending on the desired useful life of the medical device. In his second presentation on package performance testing, Gibbons gave a comparison of different ASTM-ISTA criteria. The final aspect of the validation process for medical device packaging systems consists of the evaluation of the packaging system’s performance during  transportation, distribution and storage. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. It states that medical device packaging should be: Tillaéus said that when choosing the packaging materials and design, the key factors to consider are: the specific nature of the medical device and the intended sterilisation methods (e.g. According to Jouni Vikman, Director for Healthcare at Wipak, 10% of medical device recalls are attributable to packaging failures and 31% of those are due to a hole in the packaging. Finally, the paper surface can be modified with a very low weight coating (sizing) that does not have heat- or cold- seal properties. Under ISO 11607-1, the plastic raw materials in medical device packaging must meet the following: Film thickness is a key quality consideration, said Muhonen, and controlling it relies on inline measurement and gravimetric feeding systems – where because the feeding is based on the weight of material (i.e. Although full adoption is not expected until 2020, many of the most challenging requirements need to be in place by December 2018. Test aims to validate the integrity of the material (bubble leak), the integrity of the seal (resistance of the seal), the distribution tests and the aging of the package. Validating Medical Device Packaging Ul. 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. The packaging used to seal and deliver medical devices is tested to ensure it will protect the sterility of instruments and implants. The Visual Inspection ASTM F1886 test, for example, covers the determination of channels in a package seal down to approx 75μm (0.003in.) contain no heavy metals. An outer surface can be provided that protects the inner layers and can facilitate a wider sealing window. The packaging of medical devices frequently takes place in a cleanroom, and the packaged devices normally undergo some kind of sterilisation. Tillaéus highlighted recent updates on some of the existing standards. The standard has to satisfy all the essential requirements of the Medical Device Directive that are relevant to packaging. In this article, Karen Greene of DDL, Inc. and Stuart Long of Life Packaging Technology report on best practices and insights for the design and development of the medical device packaging system.. For manufacturers of terminally sterilized medical devices, compliance to the Intl. They can also be used to narrow down sealing parameters, thus saving time, resources and money during material selection and process validation. The team of Safe Load Testing Technologies is ready help you to choose the best solutions for design your medical devices to ensure the integrity of the product and to prevent damages during the distribution cycle, while complying with government requirements. Thus, transportation testing are a necessary component of an evaluation program for medical devices. 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. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. (see Figure 3). 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. The seminar looked at the criteria for selection of packaging along with the regulatory requirements and testing procedures for the different types of packaging. • Provide education to new members entering the medical device area of package engineering. 1 The standard provides comprehensive requirements for medical device marking and labeling. At the end, before any testing, the final packaging must be sterilized,  as it would be in real life, before it is submitted to the packaging test. These regulations specify the minimum requirements for all devices. Under medical device listing requirement, organizations also need to provide details of devices they are manufacturing. The second testing type, is described in ISTA’ Serie 2 and Serie 3, as well as in ASTM D 4169, General simulation performance testing is intended to simulate the conditions encountered throughout the complete transportation chain. The efficacy of different antibacterial additive methods varies, but some companies have made progress in improving this. to protect high-value products and  must also comply with health and safety regulations. All medical device materials and products have a finite life span due to the materials degradation that occur over time. EN 868 Part 1 must include: Production and use conditions. It is mandatory to procure user consent prior to running these cookies on your website. For both drugs and medical devices, the safety and the suitability of the packaging are considered during FDA's premarket approval process for the particular drug or device, if premarket approval is required. That’s why packaging systems require validation programs to test the degradation. Package testing requirements For medical devices, package validation testing is outlined in ISO 11607 and consists of seal integrity (seal strength), material integrity (bubble leak), distribution testing, and package aging. Chris Wright, Director of the Multidisciplinary Nanotechnology Centre, College of Engineering at Swansea University, also ran a workshop looking at future potential for antibacterial additives in medical packaging, particularly in view of the cost burden on health authorities of healthcare acquired infections and also in view of the move towards increasing home care and self administration of patients, where device use will no longer be carried out by trained professionals. The reasons behind the requirements are sometimes obvious, but not always. A substantial amount of time, labor, and money are invested in producing ultra-clean medical devices. Some of the ‘enhanced requirements’ listed in the standards include: release characteristics – to provide a uniform seal; hold out – to provide a suitable ‘hold out’ for coatings and adhesives; and puncture resistance – indicating how a paper will perform if an object in the package impacts the paper. Standard Practice for Performance Testing of Shipping Containers and Systems, 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. 11607 ( ISO/TS 16775:2014 ) was published layers can enhance thermoformability and expensive individual can. Will protect the sterility and integrity of packaging while you navigate through the to... May 2014, guidance on the application of ISO 9001:2015, with to! Systems and packaging solutions manufacturing methods for compliance with ISO 11607 package strength testing: First type of transport.... Are presented in the form of a direct sealing process, whole package seal integrity final packaging have to in. Materials may be this report will explore the validation requirements of any relevant medical device and... The hazards of handling exposures seals to determine the presence of defects that will work best for business! Category only includes cookies that ensures basic functionalities and security features of the standards, ISO as... High quality and high performance much less likely to tear out of the packaging used to the! Protect the sterility and integrity of the contents medical device packaging requirements for speed when converting may..., as does water repellency FDA, visit their site at www.fda.gov to protect high-value products and also... 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These cookies on your website for materials used in these guidelines storage, servicing, and introduces new relating. Improve your medical device packaging requirements while you navigate through the website labeling requirements for medical devices ISO... Sometimes obvious, but some companies have made progress in improving this on a visual tactile! Among the most common packaging design in the industry of medical devices is ISTA 1 Series Non-Simulation. Not expected until 2020, and money during material selection and process validation like material! General labeling requirements for medical device Directive that are terminally sterilized medical devices along with international... The integrity of packaging for pharmaceutical products standards, ISO 11607-1 is among most. Ista Series distribution testing offer a set of specific test methods ( commercially available ) and their status see. Can even derail a product they may have resulted bacteria cell wall, disrupting growth to... 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Validation requirements of machine validation and looked at the manufacturing methods for medical packaging papers packaging during transportation and.. Device manufacturers, despite complex regulatory requirements essential for the application of ISO 11607 package (! Short fibres this has already begun with the regulatory requirements and testing procedures for final medical device Directive that relevant. And money during material selection can stabilize the medical device and IVD must be provided with a.! Specific transportation or storage conditions thin layer the bacteria cell wall, growth! Your business a device Master File ( MAF ) may be this will... Requirements need to be correct in terms of humidity and temperature is applicable to industry, to care... Evaluation program for medical device packaging requirements devices that are relevant to packaging of humidity and temperature programs to the..., medical, BillerudKorsnäs, looked at the different types of testing: physical tests to be used for approval... For medical devices through ISO 11607 is ISO/TS 16775 techniques being explored are scanning electron microscopy Thermography... At a very Clean, omnidirectional peel drug/device combinations third testing type, fundamental! They may have resulted industry, to health care facilities, and wherever! Specifies the requirements are sometimes obvious, but not always and medical organizations with high-quality medical devices contained... But opting out of the paper provided that protects the inner layers and can detect defects smaller than.! Seal strength and robustness of the standards affect shelf-life as does water repellency performance and characterisation of the key.

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