Wipak has a product approved to ISO 22196 that is suitable for medical devices and survives the sterilisation process, 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. 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. 1 – Rejectable: Package seal does not meet minimum requirements 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. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. 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. • Provide a timely list … Seal Integrity (ASTM F1886: Visual Inspection. This orientation results in a significant increase in the tendency for fibre tear at 180° to the fibre lay, and an increase at 90° to the fibre lay. 5 – Acceptable: Package meets highest visual requirements These processes include the forming, sealing, and assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves and the packaging systems. 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. 2 to 4 – Acceptable: Package meets seal requirements (under sealed or over sealed) The silver-complexed ions interfere with enzyme production, stopping the cell producing energy. These cookies will be stored in your browser only with your consent. These include: Tillaéus also flagged up potential future changes. It also interrupts the cell’s DNA, preventing replication. At this point. Braille on packaging for medicinal products. 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. Seal assessment is split into two components: The cleanliness has been measured subjectively until recently but more objective assessment techniques have now been developed. The standard has to satisfy all the essential requirements of the Medical Device Directive that are relevant to packaging. 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. Medical device packaging standards will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. This leads to the last point that storing conditions for the final packaging have to be correct in terms of humidity and temperature. Several layers gives more security and wider choice of functional raw materials At this point, packaging validation requirements for medical devices are so important in order to comply with the  approved standards for medical device packaging. This category only includes cookies that ensures basic functionalities and security features of the website. The table below lists the medical device packaging standards recognized by the FDA. It is mandatory to procure user consent prior to running these cookies on your website. All medical device materials and products have a finite life span due to the materials degradation that occur over time. The objective of this set of tests is to inspect the packaging systems for any damage that may have resulted. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture. Unmodified, paper fibres tend to orientate themselves in the machine direction. However, with careful and continual product design he said this can now be avoided. Glossary The definitions given below apply specifically to the terms used in these guidelines. 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. Real-time Aging (A requirement to backup an accelerated aging study). requirements as they affect the packaging of medical devices. Similarly, a Device Master File (MAF) may be established with the Agency for materials used in the packaging of medical devices. Shelf life and stability testing are also required by ISO 11607-1. Jonathan Andrews, Business Development Manager, Medical, BillerudKorsnäs, looked at the performance and characterisation of the direct sealing of papers. A substantial amount of time, labor, and money are invested in producing ultra-clean medical devices. Some of the standards for packaging are: Package validation testing for medical devices are described in ISO 11607. Improperly designed and validated packaging can even derail a product. For example, for paper the characteristics listed in EN 868-3 and EN 868-6 include: grammage; air resistance; porosity; pore size; tear strength; wet and dry strength; tensile strength; burst strength; water absorption; water repellency; pH; fluorescent spots; and chloride and sulphate content. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). Packaging for terminally sterilized medical devices, Packaging materials and systems for medical devices to be sterilized, General requirements and test methods, Guide for Integrity Testing of Porous Medical Packages, Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products, Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. Not using coatings does, however, require that the direct seal papers are of high quality and high performance. The packaging used to seal and deliver medical devices is tested to ensure it will protect the sterility of instruments and implants. A better packaging design and a better material selection can stabilize the medical device and increase the protection. We'll assume you're ok with this, but you can opt-out if you wish. 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 Tests with at least one element of a 3 Series type General Simulation performance test, such as atmospheric conditioning or mode-shaped random vibration, in addition to basic elements of a 1 Series type Non-Simulation Integrity test. 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. At the same time CEN/TC102/WG4 is looking at a revision of EN 868. The other parts of EN 868 will be dealt with as soon as the above documents have been finalised. A good design and a validation process are the fundamental to provide customers and medical organizations with high-quality medical devices. 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. 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. Medical device packaging doesn’t rely on packaging graphics (as a sales/marketing tool) the way that packaging used for consumer packaged goods does. You also have the option to opt-out of these cookies. They need to provide a premarket submission number for the device such as 510(k), PMA (Premarket Approval), HDE (Humanitarian Device Exemption), etc. 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). But opting out of some of these cookies may affect your browsing experience. The seminar looked at the criteria for selection of packaging along with the regulatory requirements and testing procedures for the different types of packaging. 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. 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. But it is the role of packaging to keep the device sterile right up until use. ‘Sized papers represent the best Direct Seal papers available today in terms of seal strength and clean peel,’ he said, adding that sizing can be applied to any weight of paper and to both standard and reinforced grades. Requirements and testing. Left: Fibre tear; Right: Clean peel. Tillaéus highlighted recent updates on some of the existing standards. 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. 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 correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. While medical technology packaging certainly needs to protect high-value products during shipping and transport, it must also comply with health and safety regulations. This website uses cookies to improve your experience. 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. All information for safe installation, use, storage, servicing, and maintenance of the device must be provided to the user. 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. 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. An outer surface can be provided that protects the inner layers and can facilitate a wider sealing window. Intended for use in medical applications. He discussed the requirements of machine validation and looked at the different stages involved and at assembly. 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. will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. ISO 11607-2 states that for ‘preformed sterile barrier system (SBS), SBS manufacturing processes shall be validated’. Water absorption influences the bacterial barrier performance, as does water repellency. 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 ‘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. Thermoforming packing is the most common packaging design in the industry of medical devices. Raw materials used in sterile medical device packaging must be traceable, safe and effective in creating a microbial barrier. 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. Symbols to be used with medical device labels, labelling, and information to be supplied. Challenge the strength and robustness of the product and package combination. Every medical device and IVD must be provided with a label. Thermoforming is such an affordable material that offers you … As a result, focused simulation is used to assess the performance of packaging under specific  transportation or storage conditions. EN 868 Part 1 must include: Production and use conditions. Stefan Krakow, Head of Product Management, GEA Tiromat Packaging, looked at process qualification for packaging machines. 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. Other visual inspection systems and automatic marking systems can help manufacturers to pick up foreign particles such as gels, black particles and pinholes. The process of choosing cleanroom packaging for medical devices … 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.. 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. 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. Requirements of the FPLA apply to over-the-counter medical devices distributed by retail outlets. Assessments of seal strength – EN 868-5 Appendix D, ASTM F88 M-09 test methods are used to ensure compliance with ISO11607 (plus others). ‘Formation’ describes the alignment of the fibres in the paper. 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