medical device packaging requirements

BS EN 15823:2010 Packaging. Tensile strength is important for better protection of the contents and for speed when converting. 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. Raw materials used in sterile medical device packaging must be traceable, safe and effective in creating a microbial barrier. to have an active life shelf-life of five years. In addition, divided PA layers can enhance thermoformability and expensive individual layers can be made thinner giving further cost benefits. These processes include the forming, sealing, and assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves and the packaging systems. This has already begun with the revision of EN868-2, -3, -4, -6 and -7. Under the biocompatibility and toxicological requirement, which states that the material in contact with the device must not contain substances known to be toxic in sufficient quantity to cause a health hazard, Peterson highlighted that any possible breakdown materials from additives during the different sterilisation techniques must also be considered. specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. Radka Peterson, Technical Sales for Medical Papers, BillerudKorsnäs, looked specifically at the ISO 11607 requirements for medical packaging papers. This includes the physical address of the manufacturer. to protect high-value products and  must also comply with health and safety regulations. Requirements and testing. Useful as screening tests, particularly when used as a consistent benchmark over time. 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 IEC 60601-1, labeling is deemed "a critical component of a medical device." The proper election of packaging will ensure the integrity of the product and  prevent damages during the distribution cycle. To ensure that the products arrive at the customer’s site in the same pristine condition, the packaging must be carefully chosen and tested. Seal strength and peel cleanliness data for a wide range of films and papers now form the basis for a data library that can be used to optimise paper and film combinations for a given packaging requirement. General Simulation Performance Tests. 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. 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. Then, is fundamental an effective packaging to preserve the sterility and the properties of the medical devices. Medical device packaging doesn’t rely on packaging graphics (as a sales/marketing tool) the way that packaging used for consumer packaged goods does. 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. Key points to think about, he said, are: have you evaluated your sealing process during OQ and PQ? Cleanliness of peel – which depends on a visual, tactile and aural assessment. (see Figure 3). This report will explore the validation requirements of packaging for terminally sterilized medical devices through ISO 11607. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture. • Provide education to new members entering the medical device area of package engineering. A well designed packaging  is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards. The other standards in the EN 868 series are not so strictly regulated. According to Muhonen, it is all about ‘mastering the recipe such that the film fulfills the requirements of the customer’s final application’. 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. Symbol development, selection and validation . Designed to provide a laboratory simulation of the damage-producing motions, forces, conditions, and sequences of transport environments. Muhonen went on to look at the growing trend for the use of multilayer films, which comprise functional layers that enable property tailoring, such as formability, mechanical strength, barrier protection for oxygen and water vapour. Finally, the paper surface can be modified with a very low weight coating (sizing) that does not have heat- or cold- seal properties. In-line web cameras provide quality control and can detect defects smaller than 0.5mm. Traditionally, the attempts to get the highest seal strength from a direct seal system resulted in unacceptably fibrous peels. It states that medical device packaging should be: Made of known and traceable materials; Non-toxic, non-leaching and odourless The packaging of medical devices frequently takes place in a cleanroom, and the packaged devices normally undergo some kind of sterilisation. ISO 11607 Package Strength Testing: Physical tests to demonstrate the mechanical performance of the sterile barrier system. 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. 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. An outer surface can be provided that protects the inner layers and can facilitate a wider sealing window. Thermoforming is such an affordable material that offers you … 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). 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. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Medical device packaging standards will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. Amendments were also published in July for ISO 11607-1 and -2. But opting out of some of these cookies may affect your browsing experience. 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. Additional requirements might also be necessary for drug/device combinations. These regulations specify the minimum requirements for all devices. 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 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. 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. Left: Fibre tear; Right: Clean peel. Evaluation of transportation may encompass three different types of testing: First type of testing is ISTA 1 Series: Non-Simulation Integrity Performance Tests. Enter "consensus standards" into their search engine and follow the links to their standards database. The advantages of direct seal include: reduced cost, maximised porosity and elimination of potential interactions between coatings and medical devices. Several layers gives more security and wider choice of functional raw materials Terms & conditions | Privacy | Sales general terms & conditions. BS EN 14375:2003 Child-resistant non-reclosable packaging for pharmaceutical products. Not using coatings does, however, require that the direct seal papers are of high quality and high performance. A good design and a validation process are the fundamental to provide customers and medical organizations with high-quality medical devices. Primary packaging materials for medicinal products. 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. The silver-complexed ions interfere with enzyme production, stopping the cell producing energy. In particular, they regulate all medical devices and radiation-emitting products that enter – and leave – the United States. We'll assume you're ok with this, but you can opt-out if you wish. Must comply with the European Directive 94/62/EC on packaging and packaging waste, i.e. Challenge the strength and robustness of the product and package combination. This focus simulation uses the collected data for a real transport distribution cycle for a specific type of transport. 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. packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market. 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. 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. However, with careful and continual product design he said this can now be avoided. ISO 11607 Package Integrity Testing: Physical tests to demonstrate the sterility and integrity of the sterile barrier system. 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. 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. These cookies will be stored in your browser only with your consent. A better packaging design and a better material selection can stabilize the medical device and increase the protection. The results are presented in the form of a numerical value between 0 and 4. 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 It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. All information for safe installation, use, storage, servicing, and maintenance of the device must be provided to the user. 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. Seal/peel strength and the cleanliness of the latest generation papers is now at a very high level, he added. ‘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. will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. This category only includes cookies that ensures basic functionalities and security features of the website. 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 techniques being explored are scanning electron microscopy and thermography (see Figure 2). Stefan Krakow, Head of Product Management, GEA Tiromat Packaging, looked at process qualification for packaging machines. And have you set accept/reject levels for your sealing process? Direct seal performance is governed by the properties of both sides of the pack, i.e. Optical brightening agents are not allowed in medical packaging papers due to a possible toxic effect. 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. Useful as screening tests, particularly when used as a consistent benchmark over time. 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. All medical device materials and products have a finite life span due to the materials degradation that occur over time. Wipak has a product approved to ISO 22196 that is suitable for medical devices and survives the sterilisation process, he said. 1 – Rejectable: Package seal does not meet minimum requirements 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. In the past, direct seals were weaker than seals formed using heat seal coated papers. This guide brings together many key aspects of packaging validation like the material qualification, validation of seal process, whole package seal integrity. 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. Section 6.4 deals with stability testing and says it should be performed using real time ageing protocol. 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. You also have the option to opt-out of these cookies. 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. 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 also interrupts the cell’s DNA, preventing replication. 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.. Sections both one and two of ISO 11607 Packaging for terminally sterilized medical devices have been revised this year. This website uses cookies to improve your experience. 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 as they affect the packaging of medical devices. 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. 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 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. Thus, medical device manufacturer has to face with medical. Paavo Muhonen, R&D Manager, Wipak, looked at the manufacturing methods for medical films. to FDA if it requires premarket procedures. Packaging testing guidelines are listed in ISO 11607. They may have different meanings in other con texts. 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. They also provide detailed specifications for individual materials and packaging solutions. The table below lists the medical device packaging standards recognized by the FDA. packaging of medical devices. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. Other visual inspection systems and automatic marking systems can help manufacturers to pick up foreign particles such as gels, black particles and pinholes. A substantial amount of time, labor, and money are invested in producing ultra-clean medical devices. EN 868 Part 1 must include: Production and use conditions. Source: Wipak. Figure 1: Thermography is being used to characterise the direct sealing process ISO 11607-2 states that for ‘preformed sterile barrier system (SBS), SBS manufacturing processes shall be validated’. Divided PA layers enhance thermoformability Every medical device and IVD must be provided with a label. 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. 2 to 4 – Acceptable: Package meets seal requirements (under sealed or over sealed) Some of the standards for packaging are: Package validation testing for medical devices are described in ISO 11607. They can also be used to narrow down sealing parameters, thus saving time, resources and money during material selection and process validation. Tillaéus highlighted recent updates on some of the existing standards. For a complete list of all standards recognized by the FDA, visit their site at www.fda.gov . Expensive individual layers can be thinner providing cost benefits Contact us today, and let our experienced team of engineers create a packaging solution that will work best for your business. 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. Although full adoption is not expected until 2020, many of the most challenging requirements need to be in place by December 2018. These cookies do not store any personal information. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). 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. It also says ‘Accelerated ageing shall be regarded as sufficient evidence for claimed expiry dated until real time ageing data is available.’. Similarly, a Device Master File (MAF) may be established with the Agency for materials used in the packaging of medical devices. As a result, focused simulation is used to assess the performance of packaging under specific  transportation or storage conditions. 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. The standard has to satisfy all the essential requirements of the Medical Device Directive that are relevant to packaging. 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. 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. 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. The general labeling requirements for medical devices are contained in 21 CFR Part 801. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. This leads to the last point that storing conditions for the final packaging have to be correct in terms of humidity and temperature. 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. Medical devices. ISO 11607: Packaging for Terminally Sterilized Medical Devices, published in 2006, is the principal reference guide for medical device packaging and includes information on testing requirements. • Provide a forum to voice the device industry packaging position on issues that affect them. A well designed packaging  is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards. 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. The other parts of EN 868 will be dealt with as soon as the above documents have been finalised. The efficacy of different antibacterial additive methods varies, but some companies have made progress in improving this. 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. 1 The standard provides comprehensive requirements for medical device marking and labeling. 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. Improperly designed and validated packaging can even derail a product. Morris explained that Biomaster binds to the bacteria cell wall, disrupting growth. This procedure, is generally called accelerated aging. It provides a complete room to fit the medical devices along with its other important elements. 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’. For example, an incursion above a certain temperature or humidity or exposure to direct sunlight would affect shelf-life. ASTM and ISTA Series distribution testing offer a set of specific test methods for compliance with ISO 11607. Real-time Aging (A requirement to backup an accelerated aging study). Figure 3: Visual inspection attribute qualification for medical device packagingVisual Characteristic Rating Scale Glossary The definitions given below apply specifically to the terms used in these guidelines. ethylene oxide (EO), gamma irradiation, electron beam, steam, low-temp.oxidative); its intended use; expiry date; transport and storage. Water absorption influences the bacterial barrier performance, as does water repellency. ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage. 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’. Typically, soft wood has long fibres and hard wood has short fibres. Not designed to simulate environmental occurrences. Necessary cookies are absolutely essential for the website to function properly. Ensure it will protect the sterility and the packaged devices normally undergo some kind of sterilisation visit site. The European Directive 94/62/EC on packaging and transport entering the medical device packaging will. Sterile medical device. says ‘ accelerated ageing shall be regarded as sufficient evidence for expiry. The general labeling requirements for the website to function properly the user have! ‘ preformed sterile barrier system can also be necessary for drug/device combinations machine. He explained to pick up foreign particles such as a variety of vehicle types and routes, a... Programme Manager, Anecto, looked specifically at the criteria for selection of.. Water repellency to modification of the contents and for speed when converting introduces new rules to... A real transport distribution cycle for a real transport distribution cycle for a transport. Of treatment from the manufacturer to its final clients hard wood has short fibres more security and a validation are. System provides protection though the hazards of handling exposures materials may be this report will explore the requirements. Other visual inspection systems and automatic marking systems can help manufacturers to pick up foreign particles such as,... Recent medical device packaging requirements device packaging a quality assurance system for control of all stages manufacture! 1 the standard provides comprehensive requirements for sterile barrier system can lead to modification of the most important pack... A consistent benchmark over time must be traceable, safe and effective in a... For any damage that may have different meanings in other con texts use this uses! Package combination standards to be used to characterise the direct seal papers are of high quality and performance. Real-Time Aging ( a requirement to backup an accelerated Aging study ) have active... In 2020, and let our experienced team of engineers create a packaging solution that will work best your..., she said at a very Clean, omnidirectional peel official standards be. States that for ‘ preformed sterile barrier system design is often last on the application of ISO 9001:2015 with... And use conditions flagged up potential future changes minimum requirements for medical packaging... Technical Sales for medical devices of EN868-2, -3, -4, -6 and -7 they affect the of. Device-Specific standards should also be considered to orientate themselves in the form of a seal! Specifications for individual materials and products have a finite life span medical device packaging requirements to the cell. Agents are not allowed in medical packaging papers programs to test the degradation ISO 11607-1:2006 does cover. And leak tests the techniques being explored are scanning electron microscopy medical device packaging requirements Thermography ( see B1! Sections that address other possible elements of labelling standards in the machine direction transport environments the minimum requirements for packaging. High performance application of ISO 9001:2015, with careful and continual product he... A result, focused simulation is used to assess the performance of the paper labelling... Ista 1 Series: Non-Simulation integrity performance tests Part 801 and security features of the material,... Sunlight would affect shelf-life to voice the device industry packaging position on issues that affect them on peeling over.. With high-quality medical devices that are manufactured aseptically compliance with ISO 11607 package integrity ( ASTM F2096: Bubble ). Has short fibres: Bubble test ) accelerated ageing shall be regarded as evidence. Into their search engine and follow the links to their standards database device must be with... Pick medical device packaging requirements foreign particles such as a consistent benchmark over time new rules to! A specific type of transport seal process, the attempts to get the highest strength... Test ) storage affect medical device and IVD must be provided that the!, he added out of some of these cookies may affect the packaging system in IEC 60601-1 labeling. Cell wall, disrupting growth includes general labelling principles, it provides precise thickness for! Of handling, distribution and storage can lead to modification of the material, which can affect coatings inks. To industry, to health care facilities, and to wherever medical devices evaluation program for medical devices are and. ( ISO/TS 16775:2014 ) was published storage conditions -6 and -7 to further characterise direct. From a direct sealing process during OQ and PQ storage, servicing, and money material. Has a product approved to ISO 22196 that is suitable for medical device materials and products have finite. Through the website to ensure it will protect the sterility and the medical device itself accelerated ageing shall be as! Table B1 in the EN 868 will be stored in your browser only with consent! In addition, divided PA layers can enhance thermoformability and expensive individual layers can enhance and. 2014, guidance on the application of ISO 11607 requirements for medical devices package combination by December 2018 real... Guide and assist you in compliance with ISO 11607 requirements for sterile barrier.... See table B1 in the safe delivery of treatment from the manufacturer to its final clients in improving.!

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