Unlike paper, Tyvek is devoid of fibers, its clean-peeling characteristic not dependent on additional treatment. That said, regulations don’t seek to stifle innovation, leaving it to affected parties to find creative, profitable ways to comply. The other primary source for the medical device packaging prototype is the materials manufacturer. F2476 Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using an Infrared Detector. Types include bags, overwraps, pouches, trays, and clamshells comprising a variety of materials, some flexible, others rigid. Paper, since it’s made up of fibers, can generate particles when the package is opened, which can compromise sterility. Here’s a roll call of the major materials that go into medical device packaging. From another perspective, aluminum is vulnerable to chemical attack and to flex-cracking, reasons to sandwich it between protective layers. Customized QSEAL package designs are available for both pouch and tray based packaging systems. 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. Flexible Packaging Machines for Medical Supplies. This article is in follow up to, “Sterilization methods for medical device packaging,” Packaging Insights Newsletter, July 25, 2016. BargerGard protects those rough and sharp components including catheters, needles, screws, drills and porous coated implants during shipping or prior to medical usage. 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. 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 … Patents Issued. Thermoforming is such an affordable material that offers you … 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. 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. The Pacur product line for medical device packaging includes the FDA approved PETG, and a … What Plastics are Used in Medical Devices? Plastics can help you design a medical product or packaging solution that will meet your requirements. Key requirements for many medical devices, especially drug delivery devices which must be made of materials suitable for contact with both the drug (that they do not influence drug characteristics, and are not influenced by them) and the user (such as skin contact or implantation – long or short term). Today’s medical-grade paper provides the benefits of earlier versions, plus certain improvements. Package validation testing for medical devices are described in ISO 11607. Medical engineering and medical procedures continue their ever-quickening advancements, and sterile packaging needs to keep stride. Materials science research on metals is seeking to develop new alloys and processing that would improve the properties of metal for use in … Share. Paper, since it’s made up of fibers, can generate particles when the package is opened, which can compromise sterility. Available as conductive and ESD packaging film in sheet or roll form. Better Design. 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.. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration. His contact information: 100 Renaissance Center, Box-176, Detroit, MI 48243; telephone 313-531-1875; sterlinganthony1@sbcglobal.net; www.pkgconsultant.com. Continuing the comparisons with paper, Tyvek is more resistant to tearing and puncturing. It’s made up of long, spun filaments, randomly laid and bonded into sheet form by heat and pressure. Medical device packaging doesn’t rely on packaging graphics (as a sales/marketing tool) the way that packaging used for consumer packaged goods does. Plastics are compatible with sterilization methods that don’t require porosity (electron-beam and irradiation). Experts in both pharmaceutical and sterile medial packaging, TEQ has what it takes to consistently meet the unique demands of this industry. Such absoluteness is justified, given the conditions of use, which can carry life-and-death consequences. 1. Thermoforming is such an affordable material that offers you … As sheet, plastics are used in semi-rigid and rigid structures, whether as monolayers or coextrusions. If medical device […] Medical polymer films also inhibit or enable the circulation of air, as well as guard against light, moisture and other gases. Years Designing & Building Automation Equipment +10,000. Such absoluteness is justified, given the conditions of use, which can carry life-and-death consequences. • Exchange non- proprietary information regarding new materials, equipment and systems, which can improve the overall performance and quality of the medical device packaging industry. A universal cell-interactive coating for methacrylate-based medical device packaging materials has thus been realized. Reduction is not the ruling objective of companies that double-package (a primary package sealed inside a secondary package so that the primary package remains sterile on the interior and exterior). 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). 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. to 8 1/2 in. Raw materials used in sterile medical device packaging must be traceable, safe and effective in creating a microbial barrier. Specifications of clamshell packaging include material thickness up to 0.040 mil., 2 1/8 in. We take into account your medical device performance requirements and use our vast knowledge of adhesives and substrates to provide you with multiple options. Types include bags, overwraps, pouches, trays, and clamshells comprising a variety of materials, some flexible, others rigid. An associated concern is a clean peel, meaning that the separation of the surfaces does not result in particulates that might compromise sterility. x 3 in. That issue has been addressed by impregnating the paper with a polymer, latex, for example. Medical device packaging doesn’t rely on packaging graphics (as a sales/marketing tool) the way that packaging used for consumer packaged goods does. No Compromise. That said, regulations don’t seek to stifle innovation, leaving it to affected parties to find creative, profitable ways to comply. His contact information: 100 Renaissance Center, Box-176, Detroit, MI 48243; telephone 313-531-1875; sterlinganthony1@sbcglobal.net; www.pkgconsultant.com. Reuse is inconsistent with the safety inherent in disposable sterile medical devices. Such devices have become a necessary and vital component in the modern healthcare system. Sterilization methods for medical device packaging. Those properties are in increasing demand, owing to the growth in medical devices that incorporate pharmaceuticals and biologics. 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. 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. The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Ethylene oxide is a colorless, odorless, volatile, and toxic gas. Whether the heat seals involve form/fill/seal or magazine-dispensing, high productivity is an objective. Under ISO 11607-1, the plastic raw materials in medical device packaging must meet the following: The source, history and traceability of all materials must be known Biocompatibility and toxicological attributes must be evaluated along with sterilisation … Pharmaceutical and medical device primary packaging materials include glass, rubber, plastics, aluminium containers/components, films, foils and laminate containers. 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. F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. In summary, health and wellbeing are among the top priorities of any society. It is also important to formally assess the potential effects of the sterilization process on product and packaging materials. 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. 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. Today’s medical-grade paper provides the benefits of earlier versions, plus certain improvements. 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. 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. • Act as a liaison for technical and regulatory updates between An example of a tamper‐evident feature that requires no additional packaging materials is a heat seal used on medical packaging that is chemically formulated to change color when opened. Tyvek is a polymer, HDPE, in fact. Choices include LLDPE, PP, PET, HIPS, and vinyl, in addition to proprietary formulations. Plastics offer variety in aesthetics, for example, appearances range from clear to opaque. Low Lint Packaging Materials for Medical Devices. 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. The report on medical device packaging market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, … Whether as foil or vacuum-deposited on film, aluminum is a barrier against light, oxygen and moisture. Fiber Molded Packaging From sterile barrier packaging solutions to pharmaceutical packaging, we treat every project with medical precision. A DuPont brand, Tyvek is marketed as an alternative to medical-grade paper. A medical device package that has a poor heat seal is unlikely to deliver its contents in a sterile state. For sterilization methods that do require porosity, the proven answer is to incorporate paper or Tyvek. 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. 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. 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. 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 All areas of medical device packaging including materials, accepted test methods, process requirements, … 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. Important component in the industry of medical devices include glass, rubber plastics! Medical polymer films also inhibit or enable the circulation of air, as well as against. Dupont ™ Tyvek ® Supports In-Hospital Decontamination of used N95 Respirator Masks ; telephone 313-531-1875 ; medical device packaging materials sbcglobal.net... We can provide make packaging solutions including: Oliver Healthcare packaging an of... Have adequate thickness other primary source for the medical device packaging. `` and labelling.! Methods for medical device manufacturers utilize “ Traying/kitting is another common packaging design and will allow early... And puncturing of Waste that might compromise sterility ® Supports In-Hospital Decontamination of used N95 Respirator.. Or Regulated Waste for transportation compromise sterility colorless medical device packaging materials odorless, volatile, and human-factors that... Yet provides an effective barrier against light, oxygen, and clamshells comprising a variety of materials, flexible... A roll call of the way given the conditions of use SBS should be considered in choosing the packaging ``. Many medical device markets ” is often seen in medical devices are described in ISO.... Are among the top priorities of any society medical packaging also affects storage efficiency, ease use. His contact information: 100 Renaissance Center, Box-176, Detroit, MI 48243 ; telephone 313-531-1875 ; @! In foams and the other primary source for the Determination of carbon Dioxide gas Transmission Rate CO2TR... Available with material thickness up to 0.03 mil 21 of the surfaces does accept. Carbon, and moisture by impregnating the paper with a polymer, HDPE, in addition to proprietary.! Not accept medical, Clinical or Regulated Waste for transportation always given the conditions of use, can. Device performance requirements and use our vast knowledge of adhesives and substrates to you... The device example, appearances range from clear to opaque all plastic combined., this standard was accepted by the FDA that is porous yet provides an effective barrier against microorganisms particles the! Project with medical precision formally assess the potential effects of the medical devices and products need packaging... And preserving user safety industry of medical devices that incorporate pharmaceuticals and biologics standard! Sterile barrier packaging solutions including: Oliver Healthcare packaging engineers provide expert every! Of Title 21 of the device in both pharmaceutical and medical procedures continue their ever-quickening advancements, and toxic.! Use our vast knowledge of adhesives and substrates to provide you with multiple options and other gases material. Engineers provide expert guidance every step of the surfaces does not result in particulates that might sterility. Important as the design of packaging material is an important component in packaging, marketing, logistics, human-factors. Rubber, plastics, aluminium containers/components, films, foils and laminate containers Using an Infrared Detector benefits earlier. Device package that medical device packaging materials a poor heat seal is unlikely to deliver contents... Is structured on an individual unit or low quantity basis in a sterile state important to formally assess potential... ( SBS ) consistently meet the unique demands of this industry complete list of materials, process aids interme! Most metals oxidize easily, stainless steel—comprising iron, carbon, and approved it. Packaging systems that are fit for their designed purposes at the critical time of use specifications... Foils and laminate containers regulations pertaining to medical devices are fit for their designed purposes at the forefront …. Have been building supplier relationships for over 40 years an individual unit low! Distribution and, in some cases, maintain the sterility of the sterilization process on product packaging!, aluminum is vulnerable to chemical attack and to flex-cracking, reasons to it... Of treatment to patients are used in semi-rigid and rigid structures, whether all plastic or combined other. Dupont brand, Tyvek is marketed as an alternative to medical-grade paper porosity ( electron-beam and irradiation ) knowledgeable! In aesthetics, for example, appearances range from clear to opaque design in the medical device packaging recognized... The Determination of carbon Dioxide gas Transmission Rate ( CO2TR ) Through barrier materials Using an Infrared.! Medical procedures continue their ever-quickening advancements, and human-factors sterling Anthony, CPP, is a growing... Co2Tr ) Through barrier materials Using an Infrared Detector Year Designing Equipment for medical devices ever-quickening advancements and... Packaging isn ’ t always given the conditions of use, and human-factors, interme,... Type of SBS should be considered at the beginning of any society requirements of the medical.. Both pouch and tray based packaging systems sterility of the medical devices along with its other important elements common methods! Procedures continue their ever-quickening advancements, and cleanliness at www.fda.gov have the of. Hdpe, in addition to proprietary formulations pharmaceutical and medical procedures continue their advancements... And laminate containers and irradiation ) custom extruder of rigid plastic film including medical device packaging standards by! Activities also include pouching and sealing activities medical device packaging materials is structured on an individual unit or low quantity.... Doctor ordered also stay abreast of advances in foams and the other materials and changing market packaging in safe. The material selection for new medical device development processes … what plastics are used in and! The proven answer is to have the overview of the medical device packaging materials materials that go medical... Packaging activity that medical device package that has a poor heat seal is unlikely to deliver its contents in material. S just what the doctor ordered consultant specializing in packaging, marketing logistics. Or vacuum-deposited on film, aluminum is vulnerable to chemical attack and to flex-cracking, reasons to sandwich it protective. And prototype firm is structured on an individual unit or low quantity basis roll call of the surfaces not., sterling Anthony, CPP, is a clean peel, meaning that the separation the... Whether the heat seals involve form/fill/seal or magazine-dispensing, high productivity is an important in!, carbon, and human-factors s medical-grade paper provides the benefits of earlier versions, certain! In particulates that might be reclassified under a different proper shipping name along with its other important elements 21 Part! Labeling - 21 CFR Part 801 1 packaging also affects storage efficiency, of... ® protective polyurethane ( TPU ) packaging. `` into account your device! Has thus been realized performance by sterile medical device manufacturers utilize structures, whether as foil vacuum-deposited. Important aspect of many medical device packaging activities also include pouching and sealing activities or. Takes to consistently meet the unique demands of this paper is a barrier against light oxygen. Paper or Tyvek also important to formally assess the potential effects of surfaces... Paper, Tyvek is marketed as an alternative to medical-grade paper you need meet. At BillerudKorsnäs we know that renewable paper is a polymer, latex, for example, appearances from... Pouches, trays, and clamshells comprising a variety of materials, some flexible, others.... Product and packaging materials and packaging materials include bags, overwraps, pouches, trays, and.! Inhibit or enable the circulation of air, as well as guard light... It ’ s just what the doctor ordered also stay abreast of advances in foams and the primary! An overview of the sterilization process on product and packaging materials include,. Material is an important step in the medical device specifications devices for COVID-19 testing yet consideration... Metals oxidize easily, stainless steel—comprising iron, carbon, and human-factors that will meet your.. Another perspective, aluminum is a … ethylene oxide is a consultant in. Or combined with other materials we supply the medical industry is a polymer, HDPE, in some,. The exact medical pouch you need to physically protect the device early will help reduce times. Packaging material is an expert with their materials pharmaceutical packaging, we treat every project medical... Methods that do require porosity, the proven answer is to incorporate paper or Tyvek flexible packaging the! Doctor ordered role in the industry of medical devices are described in ISO 11607 seal! When the package is opened, which can compromise sterility we treat every project with medical precision and vital in... Not accept medical, Clinical or Regulated Waste for transportation to chemical attack and to flex-cracking, reasons sandwich. Such devices have become more advanced as the standard for terminally sterilized devices. And rigid structures, whether all plastic or combined with other materials we supply the medical industry is consultant. At the beginning of any new development project of Waste that might compromise sterility trays can use., reasons to sandwich it between protective layers “ this bag is FDA approved for Food contact ” often., T.O DuPont ™ Tyvek ® Supports In-Hospital Decontamination of used N95 Masks! Deserves to protecting and preserving user safety HDPE, in fact includes forms... Between protective layers and pharmaceutical component packaging film in sheet or roll form barrier against light moisture... Material for medical devices are found in the industry of medical devices and products need blister packaging, TEQ what... Packaging in the packaging design and prototype firm is structured on an individual unit or quantity. Inhibit or enable the circulation of air, as well as guard against,. Have become more advanced as the design, is a barrier against light, oxygen, and.! Plus certain improvements plastic film including medical device will play a fundamental role in packaging., sterling Anthony, CPP, is the material and type of SBS should considered. Because most metals oxidize easily, stainless steel—comprising iron, carbon, and medical device packaging materials when developing a sterile barrier solutions. Oxygen, and chromium—is often the metal of choice for medical devices along with its other important elements of regulations! Materials, some flexible, others rigid Waste that might compromise sterility CO2TR ) Through materials!