Thus, medical device manufacturer has to face with medical. Additionally, testing to assess the integrity of packaging during transportation and storage can lead to modification of the packaging system. • Provide a forum to voice the device industry packaging position on issues that affect them. This standard is cited in ISO 11607-1 as an approved test for seal strength. 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. EN 868 Part 1 must include: Production and use conditions. Paavo Muhonen, R&D Manager, Wipak, looked at the manufacturing methods for medical films. Symbol development, selection and validation . He reminded delegates of the five key purposes of device packaging: to contain, inform, protect, display and transport. Wipak has a product approved to ISO 22196 that is suitable for medical devices and survives the sterilisation process, he said. At this point. to protect high-value products and  must also comply with health and safety regulations. 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. 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. Challenge the strength and robustness of the product and package combination. Additional requirements might also be necessary for drug/device combinations. At Nefab, we use ISTA testing, which is recognized by the U.S. Food and Drug Administration (FDA) as approved standards for medical device packaging. requirements of any relevant medical device or IVD medical device-specific standards should also be considered. This focus simulation uses the collected data for a real transport distribution cycle for a specific type of transport. They need to provide a premarket submission number for the device such as 510(k), PMA (Premarket Approval), HDE (Humanitarian Device Exemption), etc. : Partial Simulation Performance Tests. The Visual Inspection ASTM F1886 test, for example, covers the determination of channels in a package seal down to approx 75μm (0.003in.) Radka Peterson, Technical Sales for Medical Papers, BillerudKorsnäs, looked specifically at the ISO 11607 requirements for medical packaging papers. Every medical device and IVD must be provided with a label. 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. The proper election of packaging will ensure the integrity of the product and  prevent damages during the distribution cycle. ethylene oxide (EO), gamma irradiation, electron beam, steam, low-temp.oxidative); its intended use; expiry date; transport and storage. Seal/peel strength and the cleanliness of the latest generation papers is now at a very high level, he added. To further characterise the direct sealing process, the use of advanced imaging is being investigated, said Anderson. 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. 1 The standard provides comprehensive requirements for medical device marking and labeling. 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. Of the standards, ISO 11607-1 is among the most important. density), it provides precise thickness control for each individual thin layer. • Provide a timely list … 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. General Simulation Performance Tests. 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. 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. Must comply with the European Directive 94/62/EC on packaging and packaging waste, i.e. In his second presentation on package performance testing, Gibbons gave a comparison of different ASTM-ISTA criteria. These cookies do not store any personal information. Useful as screening tests, particularly when used as a consistent benchmark over time. 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. 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. ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage. 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. 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’. Stefan Krakow, Head of Product Management, GEA Tiromat Packaging, looked at process qualification for packaging machines. It is mandatory to procure user consent prior to running these cookies on your website. BS EN 15823:2010 Packaging. This guide brings together many key aspects of packaging validation like the material qualification, validation of seal process, whole package seal integrity. The advantages of direct seal include: reduced cost, maximised porosity and elimination of potential interactions between coatings and medical devices. Glossary The definitions given below apply specifically to the terms used in these guidelines. The standard has to satisfy all the essential requirements of the Medical Device Directive that are relevant to packaging. with a 60–100% probability. Not designed to simulate environmental occurrences. Key points to think about, he said, are: have you evaluated your sealing process during OQ and PQ? Direct seal performance is governed by the properties of both sides of the pack, i.e. The changes are mostly subtle; the biggest is (maybe) the addition of user evaluation of the sterile seal opening procedure and re-validation requirements. 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. 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. 2016-12-19In the EU medical device directives and regulations mandate that medical device packaging materials and systems conform with the requirements of the ISO 11607 series of standards Packaging for terminally sterilied medical devices. 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 to have an active life shelf-life of five years. 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. 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. She highlighted the list of demands made on packaging materials, which include: EN 868 parts 2-10 are referenced as informative documents in ISO 11607, she said, and while optional, they can be used to demonstrate compliance with parts of ISO 11607-1. Random Vibration Testing vs Sine Vibration: which one best suits your needs. The general labeling requirements for medical devices are contained in 21 CFR Part 801. Alternatively, a polyamide (PA) layer can be added (outside or embedded) for improved forming and mechanical properties; a sealing layer allows fast sealing and peel performance; or a ‘bulk’ layer can be placed inside for better cost-efficiency. In IEC 60601-1, labeling is deemed "a critical component of a medical device." This restricts the flexibility to align packs in the optimal orientation for a medical device manufacturer’s packaging process and leads to restrictions in print alignment, said Andrews. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. 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. These processes include the forming, sealing, and assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves and the packaging systems. Unmodified, paper fibres tend to orientate themselves in the machine direction. 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. 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. In May 2014, guidance on the application of ISO 11607 (ISO/TS 16775:2014) was published. 1 – Rejectable: Package seal does not meet minimum requirements The other standards in the EN 868 series are not so strictly regulated. Typically, soft wood has long fibres and hard wood has short fibres. Cleanliness of peel – which depends on a visual, tactile and aural assessment. Other visual inspection systems and automatic marking systems can help manufacturers to pick up foreign particles such as gels, black particles and pinholes. packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market. It also says ‘Accelerated ageing shall be regarded as sufficient evidence for claimed expiry dated until real time ageing data is available.’. Chloride and sulphate content may affect the acidity of the material, which can affect coatings, inks and the medical device itself. Optical brightening agents are not allowed in medical packaging papers due to a possible toxic effect. 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. The techniques being explored are scanning electron microscopy and thermography (see Figure 2). The seminar looked at the criteria for selection of packaging along with the regulatory requirements and testing procedures for the different types of packaging. Para 4.5.1 of this standard states: ‘Minimum value for seal strength……..shall be 1.5 N/ 15mm for steam sterilisation processes and 1.2 N/15mm for other sterilisation processes’. Thus, transportation testing are a necessary component of an evaluation program for medical devices. 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. Thermoforming is such an affordable material that offers you … They also provide detailed specifications for individual materials and packaging solutions. Braille on packaging for medicinal products. Source: Anecto. 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. Advertising and promotional materials may be 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. A better packaging design and a better material selection can stabilize the medical device and increase the protection. Under medical device listing requirement, organizations also need to provide details of devices they are manufacturing. All information for safe installation, use, storage, servicing, and maintenance of the device must be provided to the user. For manufacturers of terminally sterilized medical devices, compliance to ISO 11607:2006 - “Packaging for Terminally sterilized medical devices” ---Part 1 and Part 2 is a requirement. The packaging of medical devices frequently takes place in a cleanroom, and the packaged devices normally undergo some kind of sterilisation. requirements as they affect the packaging of medical devices. 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. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. Source: Wipak. The addition of antimicrobial agents to packaging materials has been adopted by some industry sectors for a while and some believe that a step change in hygiene can be achieved through their use in medical packaging. Water absorption influences the bacterial barrier performance, as does water repellency. At the same time CEN/TC102/WG4 is looking at a revision of EN 868. Several layers gives more security and wider choice of functional raw materials Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. In-line web cameras provide quality control and can detect defects smaller than 0.5mm. He discussed the requirements of machine validation and looked at the different stages involved and at assembly. 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. Noel Gibbons, Lead Programme Manager, Anecto, looked at testing procedures for final medical device packages required by the standards. Jonathan Andrews, Business Development Manager, Medical, BillerudKorsnäs, looked at the performance and characterisation of the direct sealing of papers. the paper top web and the film base web, or paper front web and film back web he explained. 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. Challenge the strength and robustness of the product and package combination. Many factors influence the functionality of a direct sealing paper, including: fibre length, fibre refining, paper formation and sizing. Labelling requirements. will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. For example, an incursion above a certain temperature or humidity or exposure to direct sunlight would affect shelf-life. 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. They may have different meanings in other con texts. Expensive individual layers can be thinner providing cost benefits But opting out of some of these cookies may affect your browsing experience. Package Integrity (ASTM F2096: Bubble Test). 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. Useful as screening tests, particularly when used as a consistent benchmark over time. Seal Integrity (ASTM F1886: Visual Inspection. 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. Thus, medical device manufacturer has to face with medical device packaging requirements  to protect high-value products and  must also comply with health and safety regulations. Package aging has the longest lead time. 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. Tensile strength is important for better protection of the contents and for speed when converting. 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.

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