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. Not designed to simulate environmental occurrences. Useful as screening tests, particularly when used as a consistent benchmark over time. 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. 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. The changes are mostly subtle; the biggest is (maybe) the addition of user evaluation of the sterile seal opening procedure and re-validation requirements. 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. In addition, divided PA layers can enhance thermoformability and expensive individual layers can be made thinner giving further cost benefits. They can also be used to narrow down sealing parameters, thus saving time, resources and money during material selection and process validation. For example, an incursion above a certain temperature or humidity or exposure to direct sunlight would affect shelf-life. Direct seal performance is governed by the properties of both sides of the pack, i.e. Validating Medical Device Packaging Ul. Long fibres enhance the physical strength of the papers and are much less likely to tear out of the paper on peeling. The proper election of packaging will ensure the integrity of the product and prevent damages during the distribution cycle. The results are presented in the form of a numerical value between 0 and 4. contain no heavy metals. 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. However, with careful and continual product design he said this can now be avoided. 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. This guide brings together many key aspects of packaging validation like the material qualification, validation of seal process, whole package seal integrity. 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. Requirements of the FPLA apply to over-the-counter medical devices distributed by retail outlets. That’s why packaging systems require validation programs to test the degradation. They may have different meanings in other con texts. The seminar looked at the criteria for selection of packaging along with the regulatory requirements and testing procedures for the different types of packaging. Raw materials used in sterile medical device packaging must be traceable, safe and effective in creating a microbial barrier. These include: Tillaéus also flagged up potential future changes. 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. When assessing the quality of a direct seal a critical requirement (as per ISO 11607) is to ensure a sterile barrier has been achieved, he said. 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. We'll assume you're ok with this, but you can opt-out if you wish. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture. Package Integrity (ASTM F2096: Bubble Test). 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. 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. Assessments of seal strength – EN 868-5 Appendix D, ASTM F88 M-09 test methods are used to ensure compliance with ISO11607 (plus others). The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. Chloride and sulphate content may affect the acidity of the material, which can affect coatings, inks and the medical device itself. Medical device packaging standards will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. Seal Integrity (ASTM F1886: Visual Inspection. 1 – Rejectable: Package seal does not meet minimum requirements Some of the standards for packaging are: Package validation testing for medical devices are described in ISO 11607. The type of regulations that apply will depend on the kind of device and due to of the kind of packaging used to protect it. Must comply with the European Directive 94/62/EC on packaging and packaging waste, i.e. 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. 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. 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). The silver-complexed ions interfere with enzyme production, stopping the cell producing energy. For example, ISO/TC198/WG7 is carrying out a systematic review of ISO 11607-1 and -2, which is expected in early 2015, to which national standards bodies are required to respond by March 2015. Thermoforming is such an affordable material that offers you … Tensile strength is important for better protection of the contents and for speed when converting. This qualitative measure (accept/reject) helps to evaluate the appearance of unopened seals to determine the presence of defects. A published tool to guide and assist you in compliance with ISO 11607 is ISO/TS 16775. And have you set accept/reject levels for your sealing process? Many factors influence the functionality of a direct sealing paper, including: fibre length, fibre refining, paper formation and sizing. Sections both one and two of ISO 11607 Packaging for terminally sterilized medical devices have been revised this year. A substantial amount of time, labor, and money are invested in producing ultra-clean medical devices. The other parts of EN 868 will be dealt with as soon as the above documents have been finalised. Primary packaging materials for medicinal products. Designed to provide a laboratory simulation of the damage-producing motions, forces, conditions, and sequences of transport environments. 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. Source: Wipak. The other standards in the EN 868 series are not so strictly regulated. 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. It also says ‘Accelerated ageing shall be regarded as sufficient evidence for claimed expiry dated until real time ageing data is available.’. Morris explained that Biomaster binds to the bacteria cell wall, disrupting growth. EN-868 Parts 2-10 Packaging for terminally sterilised medical devices provides specific requirements for most kinds of medical packaging, including: sterilisation wraps, paper, paper bags, pouches and reels, paper for low temperature sterilisation, adhesive coated paper, containers, nonwoven (uncoated) and nonwoven (adhesive-coated). The standard has to satisfy all the essential requirements of the Medical Device Directive that are relevant to packaging. to FDA if it requires premarket procedures. 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. 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. Typically, soft wood has long fibres and hard wood has short fibres. 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. This standard is cited in ISO 11607-1 as an approved test for seal strength. This leads to the last point that storing conditions for the final packaging have to be correct in terms of humidity and temperature. will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. They also provide detailed specifications for individual materials and packaging solutions. 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. 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. A well designed packaging is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards. This would include, for example, processes such as rigid and flexible blister forming; pouch, reel or bag forming and sealing; form/fill/seal automated processes; kit assembly and wrapping; assembly of sterile fluid-path products; tray/lid sealing; filling and closing of reusable containers; and sterilisation sheets folding and wrapping. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage. But opting out of some of these cookies may affect your browsing experience. Labelling requirements. The two categories, nonetheless, share regulatory requirements that the migration or bleeding of inks not be a source of product contamination, or specific to medical devices, a source of lost sterility. Get the highest seal strength from a direct seal performance is governed by the for. Device-Specific standards should also be necessary for drug/device combinations ASTM F2096: Bubble test ) said. Right: Clean peel testing offer a set of tests is to inspect the of... The minimum requirements for medical devices deemed `` a critical component of an program! It also interrupts the cell ’ s DNA, preventing replication requirements as they affect the packaging medical... 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