Medical device packaging standards will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. The other standards in the EN 868 series are not so strictly regulated. Many paper properties depend upon the cellulose fibres from which the paper is manufactured; similarly the fibre length is directly related to the type of tree from which the pulp is manufactured. 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. Designed to provide a laboratory simulation of the damage-producing motions, forces, conditions, and sequences of transport environments. Enter "consensus standards" into their search engine and follow the links to their standards database. 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. Chloride and sulphate content may affect the acidity of the material, which can affect coatings, inks and the medical device itself. Some of the standards for packaging are: Package validation testing for medical devices are described in ISO 11607. We'll assume you're ok with this, but you can opt-out if you wish. 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. 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. Package Integrity (ASTM F2096: Bubble Test). Under medical device listing requirement, organizations also need to provide details of devices they are manufacturing. Noel Gibbons, Lead Programme Manager, Anecto, looked at testing procedures for final medical device packages required by the standards. In his second presentation on package performance testing, Gibbons gave a comparison of different ASTM-ISTA criteria. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. While medical technology packaging certainly needs to protect high-value products during shipping and transport, it must also comply with health and safety regulations. But it is the role of packaging to keep the device sterile right up until use. Not designed to simulate environmental occurrences. Furthermore this process will help to avoid costly mistakes due to a bad selection of packaging materials and incorrect packaging design, that could compromise the medical device during storage and transportation. It provides a complete room to fit the medical devices along with its other important elements. He reminded delegates of the five key purposes of device packaging: to contain, inform, protect, display and transport. Medical device packaging doesn’t rely on packaging graphics (as a sales/marketing tool) the way that packaging used for consumer packaged goods does. Contact us today, and let our experienced team of engineers create a packaging solution that will work best for your business. In-line web cameras provide quality control and can detect defects smaller than 0.5mm. The results are presented in the form of a numerical value between 0 and 4. The general labeling requirements for medical devices are contained in 21 CFR Part 801. 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. We also use third-party cookies that help us analyze and understand how you use this website. Seal Integrity (ASTM F1886: Visual Inspection. Paavo Muhonen, R&D Manager, Wipak, looked at the manufacturing methods for medical films. Other visual inspection systems and automatic marking systems can help manufacturers to pick up foreign particles such as gels, black particles and pinholes. Requirements and testing. ‘Formation’ describes the alignment of the fibres in the paper. Cleanliness of peel – which depends on a visual, tactile and aural assessment. density), it provides precise thickness control for each individual thin layer. 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. Seal/peel strength and the cleanliness of the latest generation papers is now at a very high level, he added. To assist manufacturers of non- in vitro diagnostic devices in complying with the labelling requirements under sections 21 - 23 of the Medical Devices Regulations (Regulations). Of the standards, ISO 11607-1 is among the most important. Peterson also looked at some of the particular properties required by the standards for: heat sealability and peel performance; clean peel performance; quick seal development; and an even and consistent seal. contain no heavy metals. 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. ASTM Packaging Strength Testing Standards are: Package Strength Testing by Peel Adhesion Testing, Package Strength Testing by Seal Peel Testing, Package Strength Testing by Burst Testing, Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates. the paper top web and the film base web, or paper front web and film back web he explained. Characteristics will include simple shaped random vibration, different drop heights applied to the sample package, and/or atmospheric conditioning such as tropical wet or winter/frozen. It also interrupts the cell’s DNA, preventing replication. to minimise safety hazards to both patient and user, to protect the device during transport and storage, to minimise the risk of contaminants to the patient and those involved in device transportation, storage and use, to ensure that the device is sterile until point of use, to be compatible with the sterilisation process. Divided PA layers enhance thermoformability 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. You also have the option to opt-out of these cookies. Similarly, a Device Master File (MAF) may be established with the Agency for materials used in the packaging of medical devices. 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. Shelf life and stability testing are also required by ISO 11607-1. Typically, soft wood has long fibres and hard wood has short fibres. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. Not using coatings does, however, require that the direct seal papers are of high quality and high performance. At this point, packaging validation requirements for medical devices are so important in order to comply with the  approved standards for medical device packaging. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. 1 – Rejectable: Package seal does not meet minimum requirements Of the standards, ISO 11607-1 is among the most important. Figure 3: Visual inspection attribute qualification for medical device packagingVisual Characteristic Rating Scale A published tool to guide and assist you in compliance with ISO 11607 is ISO/TS 16775. The packaging used to seal and deliver medical devices is tested to ensure it will protect the sterility of instruments and implants. 2 to 4 – Acceptable: Package meets seal requirements (under sealed or over sealed) 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. 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. 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. Thermoforming packing is the most common packaging design in the industry of medical devices. In particular, they regulate all medical devices and radiation-emitting products that enter – and leave – the United States. This includes the physical address of the manufacturer. Necessary cookies are absolutely essential for the website to function properly. 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. The advantages of direct seal include: reduced cost, maximised porosity and elimination of potential interactions between coatings and medical devices. These regulations specify the minimum requirements for all devices. Jonathan Andrews, Business Development Manager, Medical, BillerudKorsnäs, looked at the performance and characterisation of the direct sealing of papers. The process of choosing cleanroom packaging for medical devices … 1.2 Policy Statements Medical devices offered or imported for sale or use in Canada must meet the labelling requirements listed in sections 21 - 23 of the Regulations. Some of the standards for packaging are: ISO 11607 Packaging for terminally sterilized medical devices EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods ASTM D1585 Guide for Integrity Testing of Porous Medical Packages ASTM … That’s why packaging systems require validation programs to test the degradation. Expensive individual layers can be thinner providing cost benefits The reasons behind the requirements are sometimes obvious, but not always. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. are so important in order to comply with the  approved standards for medical device packaging. Many factors influence the functionality of a direct sealing paper, including: fibre length, fibre refining, paper formation and sizing. According to Muhonen, it is all about ‘mastering the recipe such that the film fulfills the requirements of the customer’s final application’. Symbols to be used with medical device labels, labelling, and information to be supplied. Sections both one and two of ISO 11607 Packaging for terminally sterilized medical devices have been revised this year. This procedure, is generally called accelerated aging. Challenge the strength and robustness of the product and package combination. with a 60–100% probability. This standard is cited in ISO 11607-1 as an approved test for seal strength. The seminar looked at the criteria for selection of packaging along with the regulatory requirements and testing procedures for the different types of packaging. Left: Fibre tear; Right: Clean peel. 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. - 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. 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. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). ISO 11607-1 requires that it be demonstrated that the materials are suitable for a specified sterilisation process and Muhonen suggested this is the first matter to check when starting to choose packaging materials. The size enhances seal strength and gives a very clean, omnidirectional peel. Every medical device and IVD must be provided with a label. At the same time CEN/TC102/WG4 is looking at a revision of EN 868. A well designed packaging  is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards. Section 6.4 deals with stability testing and says it should be performed using real time ageing protocol. There are few medical packaging standards on the market that fits the requirements of the Medical Device Directives of the European Union and  the U.S. Food and Drug Administration (FDA) in U.S. This guide brings together many key aspects of packaging validation like the material qualification, validation of seal process, whole package seal integrity. ISO 11607-2 states that for ‘preformed sterile barrier system (SBS), SBS manufacturing processes shall be validated’. To further characterise the direct sealing process, the use of advanced imaging is being investigated, said Anderson. The proper election of packaging will ensure the integrity of the product and  prevent damages during the distribution cycle. 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. specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. Vikman chaired a recent Medical Device Packaging seminar in Oxford, UK. This leads to the last point that storing conditions for the final packaging have to be correct in terms of humidity and temperature. An overview of the current status of the relevant medical packaging standards was provided by Nina Tillaéus, a Member of the Board of the Sterile Barrier Association. Figure 2: An example of multilayer formable film benefits, 8-layer multilayer film versus 3-layer filmEnables down-gauging, use of thinner structure for specified thermoforming ratio Source: Wipak. The objective of this set of tests is to inspect the packaging systems for any damage that may have resulted. A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes, tears and broken seals, it also has to withstand sitting on a shelf, possibly for years, without breaking down. BS EN 15823:2010 Packaging. 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 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. General Simulation Performance Tests. Improperly designed and validated packaging can even derail a product. While this document includes general labelling principles, it does not include sections that address other possible elements of labelling. 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. : Partial Simulation Performance Tests. Unmodified, paper fibres tend to orientate themselves in the machine direction. 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. In the past, direct seals were weaker than seals formed using heat seal coated papers. Traditionally, the attempts to get the highest seal strength from a direct seal system resulted in unacceptably fibrous peels. 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. Real-time Aging (A requirement to backup an accelerated aging study). He said many medical device manufacturers struggle with deciding what they need to do to comply with ISO 11607 and which procedure to utilise for performance testing – ASTM or ISTA. 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. Amendments were also published in July for ISO 11607-1 and -2. Packaging testing guidelines are listed in ISO 11607. Intended for use in medical applications. 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. Under the requirement for cleanliness, visual appearance is a key element for a medical package, she said. 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. This qualitative measure (accept/reject) helps to evaluate the appearance of unopened seals to determine the presence of defects. Terms & conditions | Privacy | Sales general terms & conditions. The Visual Inspection ASTM F1886 test, for example, covers the determination of channels in a package seal down to approx 75μm (0.003in.) Multilayers mean that thinner films can be used without compromising security and they enable the down-gauging and use of thinner structure for a specified thermoforming ratio. to protect high-value products and  must also comply with health and safety regulations. 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. These processes include the forming, sealing, and assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves and the packaging systems. But opting out of some of these cookies may affect your browsing experience. 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