Advanced Plastiform, Inc. provides custom plastic manufacturing services, specializing in thermoforming (vacuum, pressure, twin-sheet) and injection molding since 1988. They produce high-quality plastic parts, with capabilities including CNC trimming and value-added assembly. The company offers heavy-gauge medical thermoforming, making them a direct supplier for various medical packaging components.
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Medical Packaging Companies
Last updated: January 2026
This directory lists 82 medical packaging companies across the United States, from dedicated thermoformers specializing in trays and blisters to full-service contract packagers offering sterile pouching and final kit assembly.
Buyers are solving critical problems: ensuring product sterility, managing stringent shelf-life requirements, protecting delicate instruments, and navigating complex regulatory pathways. This demands partners proficient in cleanroom manufacturing, advanced material science for barrier properties, and rigorous quality systems for process validation.
Supplier types vary significantly; some focus purely on manufacturing components like custom trays and clamshells, while others offer integrated services like form-fill-seal (FFS) operations, kitting, and final sterile barrier system assembly. Distinguishing factors include their scope of in-house capabilities, specific certifications like ISO 13485, and extensive experience with various sterilization modalities.
Before engaging, buyers should have clear specifications for device geometry, desired shelf life, proposed sterilization method, and anticipated volumes. Suppliers expect detailed design inputs, material compatibility requirements, and a clear understanding of the regulatory pathway for the device itself to ensure the packaging solution aligns seamlessly.
Company Directory
82 companies nationwide
Aphena Pharma Solutions is a U.S.-based contract pharmaceutical manufacturing and packaging company with two FDA-registered locations. It offers turnkey services for solid dose, liquids, gels, creams, ointments, and medical devices. Aphena serves the pharmaceutical, OTC, dietary supplement, consumer health, and biologics marketplaces.
Bardes Plastics specializes in custom thermoformed plastic packaging solutions, serving the medical device industry for over 40 years. The company designs and manufactures medical trays, blisters, and clamshells, all produced in their ISO-certified cleanroom facilities in the Midwestern United States.
Based in Plano, TX, Boxes 4 U specializes in providing diverse packaging and shipping materials. Their offerings include custom boxes with foam inserts and essential cold chain solutions, suitable for various industrial and commercial needs. They also supply general moving and contractor supplies.
Based in Farmersville, TX, Cello-Wrap Packaging Inc. is a manufacturer with over 70 years of experience. They specialize in medical and sterilization packaging, offering lidding films and custom multi-layer rollstock. Their products support autoclave and gamma irradiation sterilization, providing high-clarity and barrier films for various medical and industrial applications.
Based in Placentia, CA, Cleanroom Film & Bags (CFB) manufactures sterile and cleanroom packaging. They produce custom films and bags for medical, electronic, aerospace, and semiconductor industries. Their ISO 9001:2015 certified facilities ensure superior quality, utilizing pure resins and a 100% no regrind guarantee.
Cold Chain Technologies provides comprehensive thermal packaging solutions and services for the life sciences industry. They specialize in insulated packaging, ensuring product safety and integrity throughout the cold chain journey. Offerings support manufacturers, distributors, clinical trials, diagnostics, and cell & gene therapy sectors worldwide.
Cretex Medical, based in Elk River, MN, offers contract manufacturing and engineering services for the medical device industry. They provide comprehensive end-of-line solutions, including sterile packaging, kitting, and labeling. With robust quality systems, ISO 13485 certification, and FDA registration, Cretex Medical helps partners launch and scale medical products.
Cryopak delivers complete cold chain packaging solutions, specializing in temperature-controlled packaging for sensitive products. The company provides packaging design, engineering, and testing services to ensure product stability. Cryopak serves various industries worldwide, operating multiple facilities including locations within the United States.
DaklaPack, based in Wyckoff, NJ, specializes in providing innovative and custom-made packaging solutions for the medical industry. They design, assemble, and ship diagnostic or research kits, including self-collection sets. The company offers high-quality total solutions for medical packaging, shipping, and consumables from concept to delivery.
Diamond Fulfillment Services, LLC specializes in custom kitting and assembly services for complex medical devices and pharmaceuticals. They offer advanced solutions tailored to healthcare industry requirements, including comprehensive order fulfillment and subscription box fulfillment. The company emphasizes compliance and efficiency, holding relevant certifications for the medical sector.
DiNovo Cleanroom Supplies and Packaging Solutions provides specialized products and services for controlled environments. The company focuses on cleanroom supplies and comprehensive packaging solutions, crucial for industries like medical device manufacturing and pharmaceuticals. They offer essential materials and expertise to ensure sterility and integrity in sensitive applications.
Based in Woodstock, IL, Dordan Manufacturing specializes in custom thermoformed medical packaging solutions for medical device OEMs and their supply chain partners. Established in 1962, they offer robust packaging, including cleanroom manufacturing capabilities, utilizing investments in new tooling and thermoforming technologies.
Drug Plastics & Glass Co., Inc. manufactures high-quality plastic bottles and closures for medicines, supplements, and lifestyle products. Based in Boyertown, PA, the company offers an extensive selection of bottle molds for quick solutions, alongside custom packaging. They also produce a variety of compatible closures, including child-resistant styles.
Based in Paso Robles, CA, Eagle Medical Inc. provides contract packaging and sterilization solutions for medical products. The company is ISO 13485:2016 certified, offering quality assembly and sterilization methodologies to assist customers with market penetration for their medical devices.
Based in Kaufman, TX, ELIS Manufacturing & Packaging Solutions offers contract manufacturing and packaging services. Specializing in nutraceuticals and supplements, they provide precise filling for powders, liquids, creams, gels, tablets, and capsules. Packaging solutions include bottles, pouches, sachets, and stick packs.
Based in Eastvale, CA, FH Packaging provides wholesale glass and plastic containers, including bottles, jars, closures, lids, droppers, and pipettes. Serving the pharmaceutical, skincare, hemp, and essential oils industries, they also offer personalized printing and labeling for custom branding needs.
Frankston Packaging provides custom folding carton packaging solutions for various industries, including pharmaceuticals, food, beverage, and consumer products. Based in Frankston, TX, the company offers structural and graphic design, printing, die-cutting, gluing, and finishing services from its US facilities.
Based in Placentia, CA, Fruth Custom Packaging specializes in manufacturing custom plastic bags and barrier film. They provide FDA Compliant and ISO Certified Cleanroom packaging solutions, catering specifically to the medical, pharmacy, and food industries. The company offers engineering expertise and customization capabilities for various plastic packaging products.
Based in Vernon, CA, Great American Packaging manufactures custom poly bags and film, offering flexible packaging solutions. They specialize in high-quality packaging for medical, food, ice, and consumer applications. With over 50 years of experience, the company controls production from extrusion to printing and is IFS PACsecure certified.
Based in Swanton, OH, Guardian Medical designs, develops, and manufactures novel terminally sterile packaging and services for medical implants. They specialize in custom solutions for complex devices and offer CapSure™, an integrated seal and rigid system. The company emphasizes sustainable, recyclable packaging solutions.
Insulated Products Corp (IPC) manufactures advanced cold chain packaging solutions, including insulated box liners, delivery bags, and pouches. They specialize in custom-manufactured temperature-controlled packaging using paper, foam, and reflective materials, designed for frozen and refrigerated shipments lasting up to 48 hours.
Based in Rollinsford, NH, Janco, Inc. provides custom medical device packaging and cleanroom manufacturing. They offer ISO 13485 certified and FDA registered services, including thermoforming and compression molding. Capabilities span design assistance, material selection, and support for various sterilization methods.
Keystone is a contract packaging organization providing comprehensive pharmaceutical and medical device packaging solutions. They offer blister packaging, bottle filling, secondary packaging, and medical device sterile barrier packaging services from their multiple cGMP-compliant facilities in Pennsylvania.
Based in Anaheim, CA, Kiva Container manufactures custom plastic packaging solutions. They specialize in corrugated plastic fabrication and thermoforming, producing trays, blisters, clamshells, and ESD packaging. Serving various industries, including medical, they offer integrated and custom packaging answers from their facilities.
Komplete Packaging Service, based in Grand Prairie, TX, offers contract packaging, kitting, and assembly services. They specialize in medical devices, food & beverage, and health & beauty, operating an FDA-registered facility with ISO 13485:2016 certification. They provide high-quality packaging and kitting solutions for various industrial sectors.
Based in Minneapolis, MN, MDI provides medical kitting and assembly services, including OEM kitting, labeling, and comprehensive packaging solutions. They are ISO 9001 and ISO 13485 certified, as well as FDA-Registered. MDI also specializes in corrugated plastic manufacturing and production.
Based in Flemington, NJ, MedPak provides comprehensive medication packaging and labeling solutions for the healthcare and pharma industries. Specializing in unit dose packaging equipment and materials, they maintain a Drug Master File for regulatory support. MedPak serves specialty pharma, hospitals, and extended care facilities with advanced solutions.
Merrill's Packaging, based in Burlingame, CA, specializes in critical thermoformed packaging solutions for medical applications. With over 60 years of experience, they provide custom tooling and design, from concept through high-volume production. Their engineering team focuses on quality, cost, and material handling requirements.
Based in Dayton, OH, Microtek Laboratories specializes in thermal management and microencapsulation solutions. The company develops customized phase change materials and temperature-controlled packaging systems, offering standard and custom forms. They serve the Life Science and Medical Device industries for safe product transportation.
Based in San Rafael, CA, NewGen Surgical designs and manufactures sustainable medical packaging solutions. The company specializes in bio-based procedure kit packaging trays, including one and two-compartment options, made from upcycled sugarcane bagasse, reducing plastic use for healthcare providers.
Based in Conroe, TX, NovoSci Corporation provides contract manufacturing, assembly, and packaging solutions for disposable medical devices. They offer custom OEM components and supply kits from their FDA-registered and ISO 13485:2016 certified facility. NovoSci serves medical device manufacturers with integrated production and distribution capabilities.
Based in Richmond, TX, Optima Products offers custom packing solutions for various industries. Their services include capsule filling, liquid filling, and powder filling, alongside comprehensive secondary packaging. The company provides contract packaging capabilities for businesses seeking specialized filling and packing expertise.
Based in Richardson, TX, OXO Packaging provides custom packaging solutions, including medicine boxes and CBD gift boxes. They offer custom printed boxes designed to meet US Government regulatory standards and consumer compliance. The company features quick turnaround, no die & plate charges, and free shipping.
Pharma Packaging Solutions, based in Clinton, TN, offers specialized packaging services for the biopharma and biologics industries. They provide agile, compliant, and innovative solutions, emphasizing the impact of packaging on pharmaceutical stability and shelf life, and also offer medical device kitting.
Packaging Compliance Labs (PCL), based in Grand Rapids, MI, provides sterile packaging solutions for medical devices. They offer packaging validation, engineering, and contract packaging services. PCL ensures compliance with ISO 11607, supporting medical device manufacturers and startups with in-house expertise and accredited testing.
Placon offers turnkey medical device and pharmaceutical packaging solutions. They design custom packaging for delicate instruments and implants, ensuring optimal form, fit, and functionality through innovative features. Committed to sustainability, Placon utilizes EcoStar® post-consumer recycled material, made from over 75% recycled content.
Based in Janesville, WI, Prent Corporation provides advanced thermoform packaging solutions. The company specializes in manufacturing custom thermoformed packaging trays, particularly for medical devices and electronics, serving a global clientele with precision and quality in critical applications.
Based in San Diego, CA, Print247 provides custom medicine boxes and packaging crafted from high-quality materials to ensure product safety. The company also offers bespoke Mylar bags and boxes for diverse packaging requirements, serving multiple industries.
Based in Atlanta, GA, Printpack manufactures a full line of medical packaging products, including bags, forming films, laminations, and medical pouches. They specialize in flexible and specialty rigid packaging, offering advanced printing methods and extensive manufacturing and converting capabilities.
Based in Anaheim, CA, ProAmpac manufactures flexible packaging solutions. The company produces paper, poly, foil, and coextrusion structures, specifically for medical packaging applications. They focus on creative solutions and sustainability, offering ProActive Recyclable films designed to replace hard-to-recycle laminated structures and curbside recyclable fiber products.
Progressive Packaging offers custom packaging solutions, kitting, and logistics for diverse industries. They specialize in medical and healthcare packaging, providing sterile and tamper-evident designs for devices, pharmaceuticals, and healthcare supplies. Based in Texas, the company focuses on optimizing supply chain efficiency for its clients.
Based in Santa Fe Springs, CA, Pro-Tech Design & Manufacturing provides FDA and ISO 13485 registered medical device contract packaging, assembly, and outsourcing services. They specialize in custom packaging design, validation, and sterilization. With over 40 years of experience, the company serves diverse clients from multiple US locations.
Based in Youngsville, NC, Robling Medical, LLC is a contract manufacturer for medical devices and life sciences. The company offers comprehensive packaging and kitting services, alongside design and manufacturing. Their 75,000 sq. ft. facility includes four ISO-certified cleanrooms, supporting a range of sterile Class II and III devices.
Rose Plastic Medical Packaging USA, LLLP develops and manufactures customized plastic primary packaging solutions for medical devices, dental, healthcare, lab, and diagnostic products. Their offerings include protective cases and specialized packaging like QuadroPack TPU, UniCover, and DentalImplantPack, ensuring precise fit and protection for sensitive medical items.
Strategic Business Holdings, Inc. (SBH), based in Irvine, CA, provides sterile packaging systems for medical instruments and textiles. Their Sterilization Container Systems feature established filter technology and proven materials for reliability. SBH also offers 100% German-made reusable and single-use surgical instruments for various surgeries.
Based in Chino, CA, Shannon Packaging Company fabricates custom flexible barrier packaging, including pouches, tubing, and sheeting. They manage projects from infancy through mass production, handling small trial orders to complex large production runs. Their barrier solutions protect products and optimize performance for various applications.
Sharp Services, LLC provides innovative primary and secondary packaging solutions from its GMP sites in the US, EU, and UK. The company specializes in commercial packaging, sterile manufacturing, and clinical services, supporting pharmaceutical and healthcare clients from preclinical stages to commercial launch.
Based in Cypress, TX, Sigma Packaging partners with healthcare manufacturers and distributors. They specialize in medical packaging services, offering multi-component kit assembly, private-label and co-branded programs, custom packaging, and fulfillment. All processes are designed for healthcare quality, traceability, and regulatory compliance.
Based in Kingsville, TX, Sofrigam Group specializes in self-contained active and passive cold chain packaging solutions. They serve pharmaceutical, biotech, and life-sciences industries, helping clients prevent product damage and reduce hidden logistics costs associated with temperature excursions during transport.
South Atlantic Packaging is a contract packaging provider offering comprehensive services across five strategic locations. The company maintains FDA and OTC certifications, ensuring quality and compliance for regulated products including medical and pharmaceutical goods. They leverage nearly a million square feet of production area and over 700 team members to deliver customized packaging solutions.
Based in Yorba Linda, CA, SpecialTeam is an FDA registered and ISO 13485:2016 certified full-service Medical Device Contract Manufacturer. The company specializes in comprehensive medical device packaging and sterilization validation, serving clients across the medical industry.
Storopack manufactures protective packaging solutions like biobased polyurethane foam, recycled films, air and paper cushions. They also supply components for temperature-controlled shipment, including thermoboxes and coolants. These offerings are suitable for industries requiring secure transport of sensitive products, such as medical goods.
Based in Fort Worth, TX, Southwest Packaging Solutions provides comprehensive contract packaging services. They offer turnkey solutions, including material sourcing, filling, bagging, kitting, assembly, labeling, and distribution. With over 20 years of expertise, they ensure packaging meets all industry and FDA requirements, helping brands efficiently enter the market.
TPC Pack offers optimized packaging solutions with over 55 years of expertise. They specialize in cold chain and temperature-controlled packaging for various industries, including food, medicine, and other sensitive materials. The company also provides converting services and packaging automation solutions.
Tru-Form Plastics, based in Westminster, CA, focuses on custom thermoformed medical packaging. They offer full-service support, from prototyping and in-house tooling to thermoforming, trimming, and assembly. Serving medical, aerospace, and defense, they uphold AS9100 and ISO 9001:2015 quality certifications.
West Pharmaceutical Services, Inc. manufactures innovative, high-quality packaging components and drug delivery systems for injectable medicines and healthcare products. The company helps ensure the safe and effective containment and delivery of life-saving therapies, shipping billions of components and devices annually to support patients worldwide.
Based in Columbus, OH, 3Bar Biologics develops innovative, microbiology-verified packaging and delivery solutions for the biologics industry. They specialize in designs that overcome adoption hurdles, ensuring product stability and effective application. The company provides advanced packaging solutions for medical and life sciences clients, supporting biologic product use.
Based in Atlanta, GA, Altium Packaging provides rigid plastic containers and closures. Altium Healthcare offers a complete line of packaging for prescription, over-the-counter, and wellness products, emphasizing safety. The company is committed to innovative design and manufacturing excellence across diverse market segments.
Ernest Packaging Solutions, based in Durham, NC, provides comprehensive packaging services, including specialized medical packaging solutions. The company aims to solve business challenges, facilitate product market entry, and enhance brand presence for its clients through creative thinking and foresight.
Graphic Packaging International creates innovative packaging solutions tailored for healthcare and pharmaceutical markets. They provide custom packaging for prescription medications, over-the-counter drugs, and medical devices. Leveraging advanced manufacturing capabilities, the company offers a comprehensive range of solutions designed to meet stringent industry standards, ensuring product protection and consumer safety for various medical applications.
Based in Austin, TX, Mainstream Medical Devices, LLC offers contract packaging, manufacturing, and single-use instruments for the medical device industry. They provide end-to-end solutions from concept to production, focusing on cost reduction and short lead times. The company leverages decades of experience in high-quality medical device services.
Parcel Health provides ultra sustainable and eco-friendly prescription packaging. They specialize in durable, patient-centered solutions for pill delivery, offering 100% recyclable Rx bottles for hospital pharmacies, telemedicine providers, and veterinarians. The company focuses on superior functionality across diverse healthcare sectors.
Based in Doylestown, PA, Tower Cold Chain provides innovative passive temperature-controlled containers. These specialized solutions are critical for maintaining the cold chain integrity of sensitive medical and pharmaceutical shipments, preventing spoilage. They ensure reliable global transit and product safety for the healthcare industry.
Based in Morrisville, NC, Biotouch Global delivers end-to-end healthcare supply chain solutions. The company specializes in customized medical kitting services, including diagnostic kit assembly for biotech and diagnostics. They offer packaging, temperature-controlled biostorage, and courier solutions for healthcare organizations.
C-P Flexible Packaging, based in Norcross, GA, manufactures advanced flexible packaging solutions. They specialize in the medical and bio-pharmaceutical industries, offering comprehensive capabilities including film formulation, printing, laminating, and pouch making to meet stringent industry standards.
Custom Boxes and Packaging, based in Tustin, CA, specializes in providing rigid, printed, and custom medical boxes. The company offers comprehensive medical packaging design services, supported by a talented structural and graphic design team, for various medical industry needs.
Based in Hayward, CA, Gel-Pak develops and manufactures highly engineered, elastomer-based carriers and films. They provide biocompatible boxes, trays, and slides for protecting delicate medical components. Their solutions ensure secure handling, transport, and storage of valuable devices for various industries.
Based in the San Francisco Bay Area, Influence Packaging specializes in custom packaging and medical device packaging. The company provides structural design, manufacturing, and global sourcing services. They help clients achieve marketing and merchandising objectives, utilizing diverse materials and manufacturing techniques for effective product differentiation and promotion.
Oliver Healthcare Packaging develops, designs, and manufactures flexible sterile barrier packaging. The company provides solutions for medical devices, diagnostics, pharmaceuticals, and biopharmaceuticals, with a commitment to cleanliness and safety. They offer both off-the-shelf and custom packaging options, including their LumaPeel sealant layer.
Praxis Packaging Solutions provides primary and secondary contract packaging for Rx and OTC pharmaceutical products. Services include solid dose bottling, blister packaging, liquid/cream/paste filling, and DSCSA serialization. Operating five FDA and cGMP-compliant facilities in Michigan, New Jersey, and Florida, they offer comprehensive packaging solutions.
Spectrum Plastics provides sterile packaging solutions for the medical device industry. They manufacture pouches, header bags, and lids, often utilizing DuPont™ Tyvek® for superior protection. Their expertise spans from design to final product, ensuring high-quality packaging for various medical applications.
Based in Arlington Heights, IL, ThermoSafe specializes in temperature-controlled packaging for life sciences and healthcare. The company provides comprehensive cold chain solutions, including cold shipping boxes, gel packs, and custom engineering. ThermoSafe ensures the safe, efficient transport of pharmaceuticals, biologics, and vaccines, supporting critical medical product delivery.
Based in Clearwater, MN, T.O. Plastics, Inc. specializes in custom thermoforming for medical-grade plastic products and packaging. They operate state-of-the-art certified Class 8 cleanrooms for medical device manufacturing, providing comprehensive in-house capabilities from concept and design through production for the life sciences industry.
Amcor is a global leader in designing and manufacturing responsible packaging solutions for the healthcare industry. They provide effective and reliable medical device packaging, including sterile barrier systems, blister lidding, pouches, and rollstock. Their advanced solutions ensure medical-grade equipment is packaged safely and efficiently, leveraging a global network and extensive innovation.
American Health Packaging manufactures serialized, barcoded unit-dose oral solids and liquids. It provides contract packaging services, specializing in high-quality, customized pharmaceutical packaging solutions. The company focuses on regulatory compliance, patient safety, and supply chain streamlining for hospitals and caregivers.
Euclid Medical Products, a brand of Omnicell, Inc., provides comprehensive medication packaging and pharmacy automation solutions. The company offers innovative unit dose and blister packaging, alongside specialized nutraceutical packaging, designed to enhance operational efficiency and improve patient safety across various pharmacy settings.
Frontier Biologics, a Contract Development and Manufacturing Organization (CDMO), provides comprehensive aseptic fill and finish services for sterile biological products. Operating from ISO Class 5 and 7 cleanrooms, they specialize in packaging into vials and syringes for research, diagnostic, and therapeutic applications.
TEQ specializes in manufacturing medical and retail packaging, along with other specialty thermoformed products. The company operates with 100,000 and 10,000 clean room environments, ensuring high-quality and controlled production for critical applications in the medical sector.
TOPPAN Packaging Solutions specializes in concept-to-completion thermoforming and flexible packaging solutions. They offer durable, clear packaging designed to meet the highest industry standards for sterile medical, pharmaceutical, and consumer products. Their customizable solutions ensure products are fresh, secure, and market-ready.
Based in Norwalk, CA, Superior Packaging Solutions offers custom and stock packaging solutions, serving industries including medical. They provide comprehensive services from design and engineering to manufacturing, assembly, fulfillment, and warehousing. The company supplies packaging products and delivers tailored solutions to meet specific client requirements.
Based in Phoenix, AZ, Tempaid Cold Chain provides specialized, precision-controlled temperature packaging solutions for biologic drugs. They offer customizable packaging sizes and advanced monitoring technologies to ensure safe and compliant transport of sensitive medical products for the pharmaceutical and biotech industries.
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How to Choose a Company
- Verify the supplier's ISO 13485 certification is current and specifically covers the packaging of medical devices, not just general plastics manufacturing. Request their scope of certification.
- Assess their cleanroom capabilities – specify the required ISO Class (e.g., ISO Class 7 or 8) based on your device's bioburden control needs, and inquire about their environmental monitoring protocols.
- For terminally sterilized devices, confirm their expertise and track record in designing and validating sterile barrier systems compliant with ISO 11607, including seal integrity testing and accelerated aging studies.
- Scrutinize their material selection process, ensuring they can provide data on moisture vapor transmission rate (MVTR) and oxygen transmission rate (OTR) for sensitive devices, and can source medical-grade polymers or Tyvek® that won't compromise biocompatibility or sterilization.
- Red Flag/Gotcha: Be wary of suppliers who minimize the importance of Device Master File (DMF) support or seem unfamiliar with FDA 21 CFR Part 820 Quality System Regulation. A strong medical packaging partner will actively guide you on these regulatory aspects.
- For higher volume needs or complex assemblies, evaluate their in-house capabilities for automated processes like form-fill-seal (FFS) or automated tray sealing, and their capacity for scaling production without compromising quality.
Frequently Asked Questions
What's the key difference between sterile barrier packaging and secondary packaging, and why does it matter for my device?
Sterile barrier packaging, defined by ISO 11607, is the minimum package that prevents microbial ingress and allows aseptic presentation of the product. Secondary packaging provides physical protection and can include cartons or boxes. The primary difference is the strict regulatory and validation requirements for the sterile barrier, which directly impacts device sterility and patient safety, unlike secondary packaging.
How does a medical packaging supplier handle sterilization validation, especially for ETO or Gamma radiation?
A capable supplier designs packaging materials and seals to withstand the chosen sterilization modality. While the device manufacturer is ultimately responsible for full sterilization validation (e.g., ISO 11135 for ETO, ISO 11137 for Gamma), the packaging supplier provides critical data on material compatibility, post-sterilization integrity, and often performs package performance testing (like burst, creep, and peel strength) that feeds into your overall validation efforts.
When is a cleanroom environment truly necessary for medical packaging, and what ISO class should I specify?
A cleanroom is essential when packaging directly reduces microbial contamination, for sterile devices, or for devices that are highly susceptible to particulate contamination. ISO Class 7 or 8 are common for medical device packaging, preventing bioburden build-up. The specific class depends on your device's regulatory classification, intended use, and the potential impact of particulate contamination on patient safety or device function.
What are the critical material considerations for packaging implantable devices or diagnostics with sensitive reagents?
For implantable devices, biocompatibility (ISO 10993) and long-term stability are paramount, often requiring materials like medical-grade PETG or specific polyolefins that are well-characterized. For sensitive diagnostics, high-barrier properties are crucial to control moisture vapor transmission rate (MVTR) and oxygen transmission rate (OTR), often necessitating multi-layer films or foil laminates to preserve reagent efficacy and extend shelf life.
What role does a medical packaging supplier play in my Device Master File (DMF) submission to the FDA?
While your company ultimately owns the DMF, a good medical packaging supplier can provide critical documentation for their materials and processes. This includes detailed material specifications, certificates of analysis, validation reports for their manufacturing processes (e.g., sealing parameters), and proof of regulatory compliance (e.g., ISO 13485 certification). They become a key part of your supply chain documentation for regulatory submissions.