Ethylene oxide is a colorless, odorless, volatile, and toxic gas. Types include bags, overwraps, pouches, trays, and clamshells comprising a variety of materials, some flexible, others rigid. General Device Labeling - 21 CFR Part 801 1. Here’s a roll call of the major materials that go into medical device packaging. packaging material. This is especially true in the realm of medical packaging, where the efficiency and durability of packaging can either preserve or corrupt essential medical tools. Blister & clamshell packaging are available with material thickness up to 0.03 mil. packaging system is developed by one source. Plastics also offer variety in function, for example, differing in machinability and in barrier (especially when combined with foil or some other barrier material). • Act as a liaison for technical and regulatory updates between Moreover, if a medical device has sharp features, thicker materials may be needed or additional protective packaging materials may be required (such as protective sleeves or retaining lids). Medical Packaging Materials. A few weeks back we shared a post about how important it is for medical device manufacturers to carefully consider the packaging stage when bringing a new product to market. Dwell needs to be as short as feasible, pressure needs to be as low as feasible, and temperature needs to have the widest range as possible──quite the balancing act for whatever formulation that is tasked with achieving acceptable seals under acceptable production rates. We also stay abreast of advances in foams and the other materials we supply the medical … The most common sterilization methods for medical devices are gamma, electron beam (E-beam), ethylene oxide (ETO) and autoclave. PACK EXPO East showcases the very latest packaging machinery and equipment, materials, containers, automation technology and controls for the pharma/medical device packaging industry. We take into account your medical device performance requirements and use our vast knowledge of adhesives and substrates to provide you with multiple options. The pursuit of sustainability should not violate federal regulations that dictate uncompromised performance by sterile medical device packaging. This can be done as a strip or patch on flexibles such as pouches and as lidding on rigids such as trays; even then, the plastic must be able to withstand the elevated temperatures involved with the latter-mentioned methods. x 10 7/8 in. We have been building supplier relationships for over 40 years. Unlike paper, Tyvek is devoid of fibers, its clean-peeling characteristic not dependent on additional treatment. Better Design. The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Because most metals oxidize easily, stainless steel—comprising iron, carbon, and chromium—is often the metal of choice for medical device manufacturers. of a pharmaceutical product, excluding any outer packaging used for. As film, plastics are used in flexible structures, whether all plastic or combined with other materials. Today’s medical-grade paper provides the benefits of earlier versions, plus certain improvements. Medical Solutions. Available as conductive and ESD packaging film in sheet or roll form. Nonsterile Packaging A medical device package that has a poor heat seal is unlikely to deliver its contents in a sterile state. Continuing the comparisons with paper, Tyvek is more resistant to tearing and puncturing. Plastic film can be use in form, fill and seal machines. Hours Per Year Designing Equipment for Medical & Pharmaceutical Industries. Square Feet of R&D It is also important to formally assess the potential effects of the sterilization process on product and packaging materials. The variables affecting the integrity of a heat seal are pressure, temperature, and dwell; that is to say, two surfaces are held together (pressure) for a specified time (dwell) while heat (temperature) is applied. The table below lists the medical device packaging standards recognized by the FDA. Paper, since it’s made up of fibers, can generate particles when the package is opened, which can compromise sterility. From dental devices to post-partum medical supplies, Viking Masek has a flexible packaging solution to increase your production and provide high accuracy in accordance with your package filling specifications. Thermoforming is such an affordable material that offers you … It provides a complete room to fit the medical devices along with its other important elements. Sterilization of medical devices & packaging The effect on polymer properties & color A wide variety of sterilization methods are used in the medical industry, including electron beam (e-beam) irradiation, gamma irradiation, ethylene oxide (EtO), autoclave, and low-temperature hydrogen peroxide gas plasma. Medical device packaging requirements: ensuring your material Package testing requirements. Choices include LLDPE, PP, PET, HIPS, and vinyl, in addition to proprietary formulations. to 7 1/2 in. Further regarding the latter, there are sterility-indicator inks, typically a stripe that turns a different color after being exposed to a sterilization method, for example, steam, EtO, hydrogen peroxide, and radiation. Reuse is inconsistent with the safety inherent in disposable sterile 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. Further regarding the latter, there are sterility-indicator inks, typically a stripe that turns a different color after being exposed to a sterilization method, for example, steam, EtO, hydrogen peroxide, and radiation. Some of the primary workhorses in sterile medical packaging are modified polyethylene terephthalate glycol (PETG) and high-impact polystyrene (HIPS). The Medical Device Packaging market was valued at 12500 Million US$ in 2021 and is projected to reach 17700 Million US$ by 2025, at a CAGR of 3.0% during the forecast period. ______________________________________________________________________, Sterling Anthony, CPP, is a consultant specializing in packaging, marketing, logistics, and human-factors. Oliver Healthcare Packaging engineers provide expert guidance every step of the way. When aluminum is the barrier layer in a lamination, there needs to be a heat-seal layer, since aluminum doesn’t seal by itself. Plastics also offer variety in function, for example, differing in machinability and in barrier (especially when combined with foil or some other barrier material). The report on medical device packaging market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, … For sterilization methods that do require porosity, the proven answer is to incorporate paper or Tyvek. Unlike paper, Tyvek is devoid of fibers, its clean-peeling characteristic not dependent on additional treatment. Patents Issued. The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. x 9 1/2 in. From another perspective, aluminum is vulnerable to chemical attack and to flex-cracking, reasons to sandwich it between protective layers. Plastics are compatible with sterilization methods that don’t require porosity (electron-beam and irradiation). The result is a clean peel, so highly valued in pouches and in lidding. The package of a medical device will play a fundamental role in the safe delivery of treatment to patients. All areas of medical device packaging including materials, accepted test methods, process requirements, … As sheet, plastics are used in semi-rigid and rigid structures, whether as monolayers or coextrusions. A DuPont brand, Tyvek is marketed as an alternative to medical-grade paper. No Compromise. Life-Cycle Assessment is so new at this stage that companies of every type use it to support their sustainability claims; even so, recycling, reuse, and reduction are subject to limitations specific to sterile medical device packaging. 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). Since the majority of heat seals on medical device packages are the peelable variety, as opposed to permanent, the challenge is to strike the optimal balance between bond strength and ease of opening. And that’s just what the doctor ordered. Medical Device Packaging: The Materials. Yet another consideration is aluminum’s susceptibility to pinholes, necessitating that it have adequate thickness. On-time delivery. This only means that the polymer is not recycled but … Thermoforming is such an affordable material that offers you … Medical engineering and medical procedures continue their ever-quickening advancements, and sterile packaging needs to keep stride. Sustainability is an intangible, and as such, isn’t unloaded at receiving docks, nor warehoused, nor run on filling lines; yet it’s embodied, to whatever degree, in each of the discussed materials. 182,500. Thermoforming packing is the most common packaging design in the industry of medical devices. The pursuit of sustainability should not violate federal regulations that dictate uncompromised performance by sterile medical device packaging. It’s made up of long, spun filaments, randomly laid and bonded into sheet form by heat and pressure. Additional factors that are expected to drive the market growth are rise in the need for flexible packaging for medical device and increase in unrolling of innovative products, such as tamper evident and child resistant medical packaging are expected to fuel the expansion of the … BargerGard protects those rough and sharp components including catheters, needles, screws, drills and porous coated implants during shipping or prior to medical usage. Materials for medical device packaging | Packaging World Medical Packaging Inc produces medical, pharmaceutical, & medication packaging machines, equipment, systems, & materials such as unit dose & pill packaging 609.466.8991 Toll-Free: 800.257.5282 info@medpak.com LinkedIn Many medical-packaging converters are investing in research and development for the next generation of polymers and manufacturing processes to maintain properties necessary for sterile barrier performance and continuous … F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. Years Designing & Building Automation Equipment +10,000. Low Lint Packaging Materials for Medical Devices. x 4 1/2 in. As film, plastics are used in flexible structures, whether all plastic or combined with other materials. Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). The random, pressed-spaghetti composition results in a material that is porous yet provides an effective barrier against microorganisms. Flexible Packaging Machines for Medical Supplies. Use of Symbols - 21 CFR Part 801.15 2. Whether as foil or vacuum-deposited on film, aluminum is a barrier against light, oxygen, and moisture. Medical device packaging doesn’t rely on packaging graphics (as a sales/marketing tool) the way that packaging used for consumer packaged goods does. Enter "consensus standards" into their search engine and follow the links to their standards database. for the Medical Device, Pharmaceutical & Healthcare Industries. From another perspective, aluminum is vulnerable to chemical attack and to flex-cracking, reasons to sandwich it between protective layers. to 8 1/2 in. “Typically, medical device packaging activities also include pouching and sealing activities. x 3 in. A smart alternative to foam or vinyl protective packaging is our BargerGard ® protective polyurethane (TPU) packaging. As sheet, plastics are used in semi-rigid and rigid structures, whether as monolayers or coextrusions. This article is in follow up to a recent article, “Sterilization methods for medical device packaging.". Any material, including printed material, employed in the packaging. Those properties are in increasing demand, owing to the growth in medical devices that incorporate pharmaceuticals and biologics. We are knowledgeable about the unique requirements of the medical device markets. Experts in both pharmaceutical and sterile medial packaging, TEQ has what it takes to consistently meet the unique demands of this industry. Typically, costs from the packaging design and prototype firm is structured on an individual unit or low quantity basis. A DuPont brand, Tyvek is marketed as an alternative to medical-grade paper. Sterilization options . Medical polymer films also inhibit or enable the circulation of air, as well as guard against light, moisture and other gases. Tyvek® Packaging for Sterile Swabs is an important component in packaging medical devices for COVID-19 testing. The result will be the delivery of devices that are fit for their designed purposes at the critical time of use. That said, regulations don’t seek to stifle innovation, leaving it to affected parties to find creative, profitable ways to comply. Medical Packaging Pacur has been a major supplier of rigid polyester and polypropylene to the OEM medical device and custom thermoforming market for over 30 years. The material and type of SBS should be considered at the beginning of any new development project. We have experience working with medical device startups as well as Fortune 100 and 500 medical device companies. Tamper‐evident packaging usually requires additional packaging materials, which exacerbates disposal issues, but the benefits generally outweigh any drawback. That pursuit should be a collaborative effort among all members of the value supply-chain, among them: designers, converters, packaging material suppliers, sterilization services, and medical device manufacturers. The other primary source for the medical device packaging prototype is the materials manufacturer. Medical device packaging must allow its contents to be sterilized and then must maintain that sterility until the time of use, all while optimally balancing the multitude of considerations that are part of the package development process. DuPont ™ Tyvek ® medical and pharmaceutical packaging provides the tear resistance, durability, breathability, clean peel and superior microbial barrier to keep medical equipment and pharmaceuticals sterile throughout their lifecycle—protecting the health and well-being of millions without compromise.. Packaging will need to physically protect the device during distribution and, in some cases, maintain the sterility of the device. “This bag is FDA Approved for Food Contact” is often seen in Medical Device specifications. It is also important to formally assess the potential effects of the sterilization process on product and packaging materials. At BillerudKorsnäs we know that renewable paper is a … Custom extruder of rigid plastic film including medical device and pharmaceutical component packaging film. That issue has been addressed by impregnating the paper with a polymer, latex, for example. Polymer impregnation does not sacrifice the porosity required by sterilization by steam or by ethylene-oxide (EtO); in addition, impregnation contributes against later contamination by denying microorganisms direct surface-to-interior pathways. 1. From dental devices to post-partum medical supplies, Viking Masek has a flexible packaging solution to increase your production and provide high accuracy in accordance with your package filling specifications. The variables affecting the integrity of a heat seal are pressure, temperature, and dwell; that is to say, two surfaces are held together (pressure) for a specified time (dwell) while heat (temperature) is applied. A medical device package that has a poor heat seal is unlikely to deliver its contents in a sterile state. The Pacur product line for medical device packaging includes the FDA approved PETG, and a … That pursuit should be a collaborative effort among all members of the value supply-chain, among them: designers, converters, packaging material suppliers, sterilization services, and medical device manufacturers. In light of recent material changes within the medical device packaging industry, it is imperative manufacturers respond to triggers built into their change management process so they can (1) assess the impact a change in materials or processes has on new or old product packaging and (2) revalidate packaging following any changes to the materials or processes deemed at risk. Polymer impregnation does not sacrifice the porosity required by sterilization by steam or by ethylene-oxide (EtO); in addition, impregnation contributes against later contamination by denying microorganisms direct surface-to-interior pathways. Materials for Medical Device Packaging | Healthcare Packaging Each country or region defines these categories in different ways. His contact information: 100 Renaissance Center, Box-176, Detroit, MI 48243; telephone 313-531-1875; sterlinganthony1@sbcglobal.net; www.pkgconsultant.com. Medical Device Packaging Handbook, Revised and Expanded (Packaging and Converting Technology): 9780824701994: Medicine & Health Science Books @ Amazon.com Such absoluteness is justified, given the conditions of use, which can carry life-and-death consequences. Flexible packaging in the medical industry is a rapidly growing and changing market. If you have any questions about shipping Infectious Substances with UPS, contact your UPS Salesperson or call the Hazardous Materials Support Center at 1-800-554-9964. Today, it isn’t just new packaging that manufacturers need to worry about — economic and environmental conditions are also driving manufacturers to revalidate their packaging. This can be done as a strip or patch on flexibles such as pouches and as lidding on rigids such as trays; even then, the plastic must be able to withstand the elevated temperatures involved with the latter-mentioned methods. DuPont ™ Tyvek ® Supports In-Hospital Decontamination of Used N95 Respirator Masks. A term used to denote starting materials, process aids, interme diates, active pharmaceutical ingredients, packaging and labelling materials. Tyvek is a polymer, HDPE, in fact. Xiaojuan Wei, Jian Shen, Zheng Gu, Yazhi Zhu, Feng Chen, Mingqiang Zhong, Li Yin, Yao Xie, Zhenjie Liu, Wei Jin, Mehdi Nouri, Lingqian Chang. https://www.ufpt.com/resource-center/medical-device-packaging-the-materials Sep 5th, 2016. ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed 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. 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