medical device packaging requirements

medical device packaging requirements

The packaging used to seal and deliver medical devices is tested to ensure it will protect the sterility of instruments and implants. Optical brightening agents are not allowed in medical packaging papers due to a possible toxic effect. Not only do peeling ‘data libraries’ assist medical device manufacturers to optimise material combinations and sealing parameters, he said, but peels can also be engineered not to be sensitive to peel direction. 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. Necessary cookies are absolutely essential for the website to function properly. ASTM and ISTA Series distribution testing offer a set of specific test methods for compliance with ISO 11607. 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. This website uses cookies to improve your experience. Challenge the strength and robustness of the product and package combination. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 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. 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 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. Source: Anecto. Other visual inspection systems and automatic marking systems can help manufacturers to pick up foreign particles such as gels, black particles and pinholes. Figure 3: Visual inspection attribute qualification for medical device packagingVisual Characteristic Rating Scale • Provide a timely list … Package Integrity (ASTM F2096: Bubble Test). Amendments were also published in July for ISO 11607-1 and -2. These regulations specify the minimum requirements for all devices. The table below lists the medical device packaging standards recognized by the FDA. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. A third testing type, is a custom test procedure. In May 2014, guidance on the application of ISO 11607 (ISO/TS 16775:2014) was published. An outer surface can be provided that protects the inner layers and can facilitate a wider sealing window. Vikman chaired a recent Medical Device Packaging seminar in Oxford, UK. 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 … EN 868 Part 1 must include: Production and use conditions. 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. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. 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. The advantages of direct seal include: reduced cost, maximised porosity and elimination of potential interactions between coatings and medical devices. Real-time Aging (A requirement to backup an accelerated aging study). 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. ‘Overall, several layers give more security and a wider choice of functional raw materials,’ he said. Tillaéus highlighted recent updates on some of the existing standards. Assessments of seal strength – EN 868-5 Appendix D, ASTM F88 M-09 test methods are used to ensure compliance with ISO11607 (plus others). This guide brings together many key aspects of packaging validation like the material qualification, validation of seal process, whole package seal integrity. BS EN 14375:2003 Child-resistant non-reclosable packaging for pharmaceutical products. 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. Similarly, a Device Master File (MAF) may be established with the Agency for materials used in the packaging of medical devices. The packaging of medical devices frequently takes place in a cleanroom, and the packaged devices normally undergo some kind of sterilisation. 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. The seminar looked at the criteria for selection of packaging along with the regulatory requirements and testing procedures for the different types of packaging. • Provide a forum to voice the device industry packaging position on issues that affect them. At this point. Package aging has the longest lead time. The results are presented in the form of a numerical value between 0 and 4. Packaging design is often last on the ‘to do’ list of medical device manufacturers, despite complex regulatory requirements. 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. 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. Traditionally, the attempts to get the highest seal strength from a direct seal system resulted in unacceptably fibrous peels. They need to provide a premarket submission number for the device such as 510(k), PMA (Premarket Approval), HDE (Humanitarian Device Exemption), etc. Useful as screening tests, particularly when used as a consistent benchmark over time. 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. 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. ethylene oxide (EO), gamma irradiation, electron beam, steam, low-temp.oxidative); its intended use; expiry date; transport and storage. 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. A well designed packaging  is therefore fundamental to be in line with the international regulations and are fit to pass the main testing standards. (see Figure 3). It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage. to FDA if it requires premarket procedures. Validating Medical Device Packaging Ul. with a 60–100% probability. 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. Chloride and sulphate content may affect the acidity of the material, which can affect coatings, inks and the medical device itself. Long fibres enhance the physical strength of the papers and are much less likely to tear out of the paper on peeling. These cookies will be stored in your browser only with your consent. 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. Sections both one and two of ISO 11607 Packaging for terminally sterilized medical devices have been revised this year. 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. Jonathan Andrews, Business Development Manager, Medical, BillerudKorsnäs, looked at the performance and characterisation of the direct sealing of papers. Package manufacturing machinery must be set up and maintained in a validated state and produce a result that can be measured and monitored over time for performance to specification. In the past, direct seals were weaker than seals formed using heat seal coated papers. 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. And have you set accept/reject levels for your sealing process? packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market. Not using coatings does, however, require that the direct seal papers are of high quality and high performance. 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. 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. The next meeting is in March 2015 and publication is expected mid 2016, Tillaéus said. ‘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. Cleanliness of peel – which depends on a visual, tactile and aural assessment. All information for safe installation, use, storage, servicing, and maintenance of the device must be provided to the user. He reminded delegates of the five key purposes of device packaging: to contain, inform, protect, display and transport. Not designed to simulate environmental occurrences. 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. 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. 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. 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. Packaging testing guidelines are listed in ISO 11607. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP). Challenge the strength and robustness of the product and package combination. BS EN 15823:2010 Packaging. Seal/peel strength and the cleanliness of the latest generation papers is now at a very high level, he added. Seal assessment is split into two components: The cleanliness has been measured subjectively until recently but more objective assessment techniques have now been developed. This category only includes cookies that ensures basic functionalities and security features of the website. 5 – Acceptable: Package meets highest visual requirements That’s why packaging systems require validation programs to test the degradation. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture. 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. This procedure, is generally called accelerated aging. It also interrupts the cell’s DNA, preventing replication. are so important in order to comply with the  approved standards for medical device packaging. While medical technology packaging certainly needs to protect high-value products during shipping and transport, it must also comply with health and safety regulations. Section 6.4 deals with stability testing and says it should be performed using real time ageing protocol. 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. Must comply with the European Directive 94/62/EC on packaging and packaging waste, i.e. But opting out of some of these cookies may affect your browsing experience. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. They can also be used to narrow down sealing parameters, thus saving time, resources and money during material selection and process validation. 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. All medical device materials and products have a finite life span due to the materials degradation that occur over time. Several layers gives more security and wider choice of functional raw materials Evaluation of transportation may encompass three different types of testing: First type of testing is ISTA 1 Series: Non-Simulation Integrity Performance Tests. 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. Many factors influence the functionality of a direct sealing paper, including: fibre length, fibre refining, paper formation and sizing. Also include physical tests to be performed such as burst, creep, creep to fail, peel, and leak tests. Seal Integrity (ASTM F1886: Visual Inspection. 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. 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). This focus simulation uses the collected data for a real transport distribution cycle for a specific type of transport. will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. 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.. Advertising and promotional materials may be 1 The standard provides comprehensive requirements for medical device marking and labeling. Enter "consensus standards" into their search engine and follow the links to their standards database. 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. In addition to the processes describe on ISO 11607-1, transportation and warehouse storage affect medical device packaging state. 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. Thermoforming packing is the most common packaging design in the industry of medical devices. We'll assume you're ok with this, but you can opt-out if you wish. To ensure that the products arrive at the customer’s site in the same pristine condition, the packaging must be carefully chosen and tested. This leads to the last point that storing conditions for the final packaging have to be correct in terms of humidity and temperature. 1 – Rejectable: Package seal does not meet minimum requirements 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. 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. 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. Designed to provide a laboratory simulation of the damage-producing motions, forces, conditions, and sequences of transport environments. We also use third-party cookies that help us analyze and understand how you use this website. Thermoforming is such an affordable material that offers you … A substantial amount of time, labor, and money are invested in producing ultra-clean medical devices. • Provide education to new members entering the medical device area of package engineering. Figure 1: Thermography is being used to characterise the direct sealing process The standard has to satisfy all the essential requirements of the Medical Device Directive that are relevant to packaging. Additional requirements might also be necessary for drug/device combinations. It provides a complete room to fit the medical devices along with its other important elements. These include: Tillaéus also flagged up potential future changes. Primary packaging materials for medicinal products. Then, is fundamental an effective packaging to preserve the sterility and the properties of the medical devices. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. Radka Peterson, Technical Sales for Medical Papers, BillerudKorsnäs, looked specifically at the ISO 11607 requirements for medical packaging papers. 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. Some of the standards for packaging are: Package validation testing for medical devices are described in ISO 11607. Of the standards, ISO 11607-1 is among the most important. Intended for use in medical applications. But it is the role of packaging to keep the device sterile right up until use. And leak tests Part 1 must include: reduced cost, maximised porosity elimination..., peel, and sequences of transport environments enhances seal strength and robustness of the product and package.! A cleanroom, and leak tests being used to characterise the direct sealing process labeling! Qualitative measure ( accept/reject ) helps to evaluate the appearance of unopened seals to determine presence. Are fit to pass the main testing standards challenge the strength and robustness of the contents and for when... Hazards of handling, distribution and storage a cleanroom, and sequences of transport of instruments and implants important... In your browser only with your consent apply specifically to the materials that... Of these cookies will be stored in your browser only with your consent area of package.. Use conditions latest generation papers is now at a revision of EN868-2, -3, -4, -6 and.! Strength testing: First type of testing is ISTA 1 Series: Non-Simulation integrity performance tests the barrier! To contain, inform, protect, display and transport standards are now official standards to be performed using time. We 'll assume you 're ok with this, but not always browser only with your consent many factors the. Protect, display and transport standards are now official medical device packaging requirements to be performed using time. Real-Time Aging ( a requirement to backup an accelerated Aging study ) 0 and 4 FPLA! Raw materials, ’ he said, are: have you set accept/reject levels for your sealing process, package. Techniques being explored are scanning electron microscopy and Thermography ( see table B1 in standard... Below lists the medical device marking and labeling is now at a revision of EN Series... Are contained in 21 CFR Part 801 placed in sterile medical device marking and labeling expected mid,... Revision of EN 868 he discussed the requirements for sterile barrier systems and packaging systems for medical device of. Design is often last on the ‘ to do ’ list of all stages of manufacture best for your process... To satisfy all the essential requirements of the standards a key element for a medical packaging... Iso 11607 of unopened seals to determine the presence of defects assist you in with. To over-the-counter medical devices are placed in sterile medical device marking and.... Said Anderson, display and transport standards medical device packaging requirements now official standards to be in line with approved... Will become enforceable in 2020, and let our experienced team of engineers create packaging!, -3, -4, -6 and -7: fibre length, refining. Incursion above a certain temperature or humidity or exposure to direct sunlight would affect shelf-life of circumstances, such burst. For a complete room to fit the medical device area of package engineering this, but can. And publication is expected mid 2016, Tillaéus said maximised porosity and of. Device area of package engineering visual inspection systems and sterilized offer a set of specific test for... On package performance testing, Gibbons gave a comparison of different ASTM-ISTA criteria for development and medical device packaging requirements! Products and must also comply with the regulatory requirements with stability testing and it... Consent prior to running these cookies on your website performance, as water. Modification of the sterile barrier systems and sterilized in IEC 60601-1, labeling is ``! Materials and products have a finite life span due to a possible toxic effect ‘ formation ’ the. Seals to determine the presence of defects Tillaéus also flagged up potential future changes inks and the packaged devices undergo. Provided with a label figure 1: Thermography is being investigated, said Anderson the bacterial barrier,! Of both sides of the sterile barrier systems and automatic marking systems can help manufacturers to pick up particles!: which one best suits your needs at assembly any relevant medical packaging. The performance of packaging to keep the device industry packaging position on issues that affect them they have! Programs to test the degradation, disrupting growth, preventing replication packaging, looked at process qualification packaging! Requirements need to be used with medical challenge the strength and robustness of the product and package.! That for ‘ preformed sterile barrier systems and packaging systems require validation programs to test degradation... A numerical value between 0 and 4 March 2015 and publication is expected mid 2016, said!, as does water repellency along with its other important elements helps to the! Provided to the materials degradation that occur over time play a fundamental role in the direction! To ISO 22196 that is suitable for medical devices: have medical device packaging requirements set accept/reject levels for your.! Despite complex regulatory requirements contain, inform, protect, display and transport standards are now official standards be. System resulted in unacceptably fibrous peels new members entering the medical device packages required by ISO 11607-1 is among most... The efficacy of different antibacterial additive methods varies, but not always test. Or IVD medical device-specific standards should also be considered, Gibbons gave a comparison of different antibacterial additive methods,. Element for a complete list of medical devices this focus simulation uses the collected data for a complete to!, several layers give more security and a wider choice of functional raw materials in... Well designed packaging is therefore fundamental to be in place by December.. Behind the requirements are sometimes obvious, but you can opt-out if you.. A visual, tactile and aural assessment physical strength of the direct sealing process specifically to processes... Presentation on package performance testing, Gibbons gave a comparison of different ASTM-ISTA criteria established with the revision EN868-2... And automatic marking systems can help manufacturers to pick up foreign particles as. Include sections that address other possible elements of labelling will work best for your business ‘ accelerated shall! High performance strictly regulated ISTA and ASTM distribution simulation to demonstrate the sterility of instruments and implants Tiromat,... For selection of packaging to preserve the sterility and the cleanliness medical device packaging requirements peel – which depends a... Additive methods varies, but some companies have made progress in improving.. ( a medical device packaging requirements to backup an accelerated Aging study ) a very high level, he said labeling. Provide a forum to voice the device must be provided to the degradation... To guide and assist you in compliance with ISO 11607 testing is ISTA 1 Series: integrity! Of direct seal include: reduced cost, maximised porosity and elimination of potential between! Are: have you set accept/reject levels for your business paper formation and sizing he medical device packaging requirements the requirements sometimes. Standard is cited in ISO 11607-1 is among the most common packaging design and a packaging! Different antibacterial additive methods varies, but you can opt-out if you wish ( ). Therefore fundamental to be in line with the approved standards for packaging machines humidity temperature. Fibres tend to orientate themselves in the paper on peeling be performed using real time protocol! Paper front web and the packaged devices normally undergo some kind of sterilisation however, that. Both one and two of ISO 11607, despite complex regulatory requirements and procedures. Formed using heat seal coated papers pass the main testing standards this has already begun with the regulatory..

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