ABX Packaging, based in Charlotte, NC, specializes in manufacturing flexible packaging solutions. Utilizing advanced blown and cast extrusion, they produce high-performance films, rollstock, and pouches, including specialized healthcare packaging films. Their comprehensive capabilities support diverse market needs for engineered packaging.
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Sterilization Pouch Manufacturers
Last updated: January 2026
This directory lists 66 sterilization pouch manufacturers across the United States, from dedicated high-volume Tyvek pouch converters to custom medical-grade paper pouch specialists.
Buyers in this category are typically solving critical problems related to medical device sterility assurance, regulatory compliance (FDA, CE Mark), and protection of delicate instruments throughout their lifecycle. This involves ensuring robust seal strength, consistent delamination resistance, and appropriate gas exchange properties for methods like Ethylene Oxide (ETO) or steam, while also accommodating specific device geometries and weight distribution.
Suppliers in this space range from large, integrated converters offering a broad array of standard sizes and materials, to specialized fabricators capable of highly customized solutions, including multi-color printing, unique pouch configurations (e.g., gusseted or header bags), and tailored material laminations. The distinction often lies in their minimum order quantities (MOQs), lead times for custom tooling, and their depth of expertise in specific sterilization modalities or advanced barrier technologies.
To effectively engage with these manufacturers, buyers should arrive prepared with detailed specifications including device dimensions, chosen sterilization method (ETO, Gamma, Steam, e-beam), desired sterile shelf life, and the target regulatory markets. Manufacturers, in turn, expect clear guidance on material requirements, desired barrier properties, and any specific validation or testing protocols that align with their customers' quality management systems.
Company Directory
66 companies nationwide
Based in Dallas, TX, BAYLAB USA manufactures premium self-seal sterilization pouches with color-changing process indicators. The company also produces ASTM-rated medical-grade face masks and exam gloves for infection control. All products are made in their FDA Registered US facility.
Beacon Converters manufactures custom flexible sterilization packaging systems and sterile barrier solutions. Utilizing medical-grade materials like Tyvek®, films, and laminations, they serve the medical device, pharmaceutical, biologics, and animal health industries. Their packaging accommodates all sterilization methods, with the company being ISO 13485:2016 certified.
NovoSci is a vertically integrated contract manufacturer specializing in single-use, sterile medical products for cardiovascular and general surgery. They provide manufacturing, assembly, and sterile packaging services in Class 7 cleanrooms. NovoSci offers customized sterile packaging solutions for medical instruments and kits, ensuring quality and distribution.
Based in Placentia, CA, Cleanroom Film & Bags (CFB) manufactures sterile packaging and cleanroom bags for the medical, electronic, aerospace, and semiconductor industries. With over 35 years of experience, their ISO 9001:2015 certified, vertically integrated facility produces custom packaging solutions without regrind materials.
Based in Elk River, MN, Cretex Medical is a contract manufacturer for the medical device industry. They offer custom packaging development services for devices, leveraging multiple cleanrooms and specialized packaging equipment. The company maintains robust quality systems with ISO 13485 certification and FDA registration.
Based in Oceanside, CA, Custom Converting, Inc. is an ISO 9001:2015 and FDA registered contract manufacturer. They specialize in custom parts, offering precision die cutting, slitting, assembly, and pouching services to cGMP specifications. Serving the biotech, medical device, and medical testing industries.
DeRoyal is a global medical manufacturer established in 1973, offering OEM product manufacturing with specialized sterilization capabilities. The company provides solutions for secure and convenient storage of surgical instruments, including multi-pocket organizers and products with extended sleeves, designed for use close to the surgical site.
Based in Paso Robles, CA, Eagle Medical Inc. engineers full-spectrum sterile barrier systems for complex medical devices. They provide contract packaging and sterilization services for medical products, optimizing methodologies for market penetration. Eagle Medical is ISO 13485:2016 certified, specializing in quality assembly and packaging solutions.
Fruth Custom Packaging, based in Placentia, CA, manufactures and distributes ISO 9001:2015 certified standard and custom autoclave bags and pouches. They provide FDA Compliant cleanroom plastic packaging solutions, including custom bags and barrier films for medical, pharmaceutical, and food industries.
Genesee Scientific manufactures high-temperature autoclavable bags from heavy gauge polypropylene, suitable for sterilization processes. The company also supplies a broad selection of lab essentials, including chemicals, acids, bases, solvents, and various pipette tip options for research and laboratory use.
Based in Indian Trail, NC, General Hospital Supply develops deliberately designed products for hospital sterilization and infection prevention. They offer solutions such as fold-n-hold® instrument pouches, providing superior protection and organization for medical instruments. The company focuses on challenges faced by sterile processing and operating room professionals.
Based in Swanton, OH, Guardian Medical designs and manufactures novel terminally sterile packaging for medical implants and complex medical devices. They provide custom packaging solutions, including their CapSure™ integrated seal and rigid packaging system, prioritizing device protection, ease of use, and regulatory compliance.
GWC Packaging, Inc. specializes in custom manufacturing sterile barrier pouches, bags, and lids for the medical device industry. Based in Chicago, IL, the company combines materials science expertise with manufacturing capabilities to produce reliable packaging engineered for stringent sterilization requirements, handling, and extended shelf life.
Based in Buffalo, NY, Harmac specializes in comprehensive medical device sterilization packaging solutions. The company offers a full suite of options designed for various sterilization methods, including Ethylene Oxide (ETO), Gamma Radiation, and Electron-Beam (E-Beam), providing essential packaging for medical device manufacturers.
Impak Corporation specializes in validated protective flexible packaging solutions, including sterile barrier bags for medical devices. The company offers custom manufacturing, sourcing, distribution, and supply chain management services to meet diverse flexible packaging needs for various industries.
Based in Houston, TX, KM Act produces medical pouches, including the Perpak brand, in a cleanroom environment conforming to international standards for medical and pharmaceutical applications. The company also supplies various cleanroom accessories, garments, and healthcare products.
LPS Industries, LLC is a vertically integrated flexible packaging manufacturer. They provide high barrier products, including printed or unprinted bags and pre-formed pouches, for various applications. Their solutions serve the food and medical packaging industries, as well as industrial applications like hazardous material transport.
Based in Burlingame, CA, Merrill's Packaging specializes in critical packaging for medical devices, pharmaceuticals, and life sciences. They offer precision engineering, custom tooling, and scalable capacity, creating new or reverse-engineering existing designs.
M&Q Packaging creates U.S.-made sterilization films and bags from medical-grade nylon for critical industries. Their high-performance packaging solutions protect medical devices and patient safety in cleanrooms and hospitals. With over 50 years of experience, M&Q provides custom, reliable sterilization packaging.
Based in Cranston, RI, Nelipak manufactures custom-designed healthcare packaging solutions for Class II and Class III medical devices. The company provides protective packaging throughout the product life cycle, partnering with clients to safeguard life-saving medical products.
Based in Ontario, CA, Nexus Plastics, Inc. is an ISO 9001 certified polyethylene manufacturer providing custom flexible packaging solutions. With over 38 years of experience, they serve diverse industries such as pharmaceutical, food, and agriculture, focusing on product quality and customer satisfaction through long-term partnerships.
Based in Fontana, CA, New Wave Converting, Inc. is a family-owned flexible packaging manufacturer with over 40 years of experience. The company produces packaging for national customers, emphasizing protection through the latest flexible packaging technology. They are active members of the FTA and R&DA.
P1 Technologies specializes in precision contract manufacturing for the medical industry. They offer cleanroom and sterile barrier packaging, including sealed pouches, supported by validated sealing methods and ISO-certified cleanrooms. The company provides custom molding and assembly, assisting clients from initial concept through full production.
Based in Hayward, CA, Pacific Die Cut Industries provides custom die-cut solutions for diverse markets. Specializing in medical packaging, the company manufactures foil pouches, surgical trays, and catheter cards. They also offer converted products and services for the automotive, electronic, and energy sectors.
PAXXUS manufactures engineered flexible materials and packaging solutions for the healthcare and life sciences markets. They offer tailored material structures like high-barrier films, aluminum foil composites, and peelable solutions, suitable for medical device, pharmaceutical, and diagnostic packaging. The company operates a US manufacturing facility in Addison, IL.
Based in San Diego, CA, Peek Packaging is a custom packaging manufacturer serving the medical and biotech industries nationwide. They specialize in flexible packaging solutions, alongside chipboard, corrugated boxes, and displays. The company offers design-to-production services and is FSC Certified.
Based in Stillwater, OK, Plasma Bionics provides specialized Tyvek pouches for air plasma sterilization. The company offers self-seal pouches in four different sizes and heat-seal rolls in two sizes. These essential consumables support medical and industrial sterilization processes by ensuring compatible and effective containment.
Based in Janesville, WI, Prent Corporation manufactures sterile medical packaging products for medical and pharmaceutical applications. They provide essential packaging solutions designed to ensure product sterility and integrity. Their offerings support various critical healthcare and drug-related needs.
Based in Owings Mills, MD, Pristine Clean Bags manufactures cleanroom poly bags, tubing, and polyethylene film. They produce nonsterile and sterile products using virgin, non-animal origin, and surfactant-free materials, adhering to FDA and EU compliance. The company serves medical, semiconductor, automotive, and aerospace industries.
Based in Anaheim, CA, ProAmpac manufactures flexible packaging solutions, including specialized medical device packaging developed for stringent aseptic handling. They offer creative and sustainable options, like recyclable films and fiber products, alongside custom packaging prototypes. ProAmpac focuses on material science innovation for diverse global markets.
Based in Santa Fe Springs, CA, Pro-Tech Design & Manufacturing specializes in medical device contract packaging, assembly, and outsourcing. They provide end-to-end solutions, including packaging design, assembly, and validation in their ISO 17025 accredited lab. The company also offers sterilization services to support medical device manufacturers.
Based in Youngsville, NC, Robling Medical, LLC provides contract manufacturing for medical devices and life sciences. Their end-to-end solutions include packaging and kitting for single-use sterile Class II and III devices. The company operates ISO-certified cleanrooms and specializes in meeting medical device packaging forms and sterilization requirements.
Based in Charlotte, NC, Selenium Medical is a contract manufacturer specializing in sterile packaging for medical devices. They provide cleaning, assembly, and pouch and blister packaging in ISO 7 cleanrooms. Additional services include surface treatment, plastic injection molding, and consulting for diverse healthcare markets.
Based in Sebastian, FL, Sorbent Systems specializes in manufacturing 100% breathable HDPE medical sterilization pouches. They offer flexible packaging solutions for diagnostic tests, drug delivery devices, and syringes. The company also provides repair services for heat sealers, supporting medical and industrial packaging needs.
Based in Yorba Linda, CA, SpecialTeam provides medical device manufacturing services from its six certified cleanroom suites. They specialize in medical device assembly, custom packaging, and sterilization. The company offers solutions for diverse medical device packaging needs, including the manufacturing of sterilization pouches, adhering to stringent industry standards.
Stephen Gould, based in Huntsville, AL, develops packaging solutions for medical and clinical applications. The company manufactures thermoformed trays, multi-layer cartons, and labeling systems, specializing in Tyvek® pouches designed to align with various sterilization methods.
Based in Mentor, OH, STERIS provides a complete line of sterilization wraps, tray liners, and pouches as part of its comprehensive sterile processing solutions. The company offers surgical instrument cleaning chemistries, sterility assurance products, and equipment for medical device and pharmaceutical manufacturers.
Based in Cedar Park, TX, Texas Technologies manufactures cleanroom film and poly bags within a controlled cleanroom environment. The company provides critical packaging and medical solutions, including moisture barrier bags and various packaging films for the medical industry and other critical environments. They also offer industrial sealers and related supplies.
Based in Newburyport, MA, UFP Technologies is a manufacturing partner specializing in comprehensive solutions for medical devices and sterile packaging. They offer design, development, and engineering services, crafting custom products from foams, films, plastics, and other specialty materials for the MedTech industry.
Based in Tinley Park, IL, Vital Care Industries is a manufacturer and supplier of medical surgical supplies, specializing in sterilization packaging. They produce 'Peel Pouches', including Tyvek heat seal and self-seal pouches, and sterilization tubing for hospitals and surgical centers nationwide.
Based in Trevor, WI, Vonco Products, LLC is a contract manufacturer specializing in medical fluid bags, devices, plastic components, and flexible packaging. They offer solutions from concept to commercialization, serving medical and consumer markets with innovative spouted stand-up pouches and custom medical device packaging.
Based in Plano, TX, Agile Medical Packaging and Devices specializes in streamlined medical packaging solutions for terminal sterilization. They provide fully integrated, turnkey packaging that meets ISO 13485, ISO 11607, and FDA requirements. The company maintains an ISO 6 certified cleanroom for packaging and sealing operations.
Getinge manufactures self-seal sterilization pouches for steam, ethylene oxide, and formaldehyde sterilizers, ensuring effective and safe sterile reprocessing. The company provides medical technology solutions for operating rooms and intensive care. Getinge serves global healthcare professionals, leveraging over a century of experience.
Based in Tempe, AZ, Molded Devices Inc. is a contract manufacturer with 50+ years experience. They specialize in producing single and double sterile barrier packaging for medical devices, utilizing custom plastic injection molding, dip molding, and cleanroom manufacturing for the healthcare industry.
Based in Martinsburg, WV, Brentwood Industries specializes in custom thermoplastic packaging and equipment enclosures for the healthcare industry. They provide custom medical packaging and components, among other product lines like water treatment, cooling tower products, stormwater management, and battery components, offering tailored solutions.
Cadillac Products Packaging Company is a full-service manufacturer of coextruded and monolayer blown films, cast films, and flexible packaging laminations. The company provides high-quality solutions for various industries, including medical packaging, designed to meet stringent standards.
CarePac, a family-owned company based in San Dimas, CA, specializes exclusively in manufacturing custom flexible barrier packaging. They provide tailored solutions for various bags and pouches, serving clients across diverse industries with their specialized production capabilities.
Based in Greeneville, TN, Contract-Packaging.net provides a broad range of in-house packaging services. They specialize in blister packaging, blister carding, and medical device packaging. The company also offers pouching solutions for dietary supplements and OTC drugs, indicating capabilities relevant to manufacturing sterile pouches for various industries.
CP Flexible Packaging is a leading manufacturer of high-quality flexible packaging materials for medical and pharmaceutical industries. Utilizing multiple ISO Class 7 and 8 cleanrooms, they produce custom medical packaging, barrier films, foil pouches, peelable lidding, and sterile packaging solutions, adhering to stringent regulatory requirements for various applications.
EnviroPouch, an FDA-registered medical device manufacturer based in Peachtree City, GA, specializes in reusable steam sterilization pouches. Their products, proven for efficacy and durability, offer an environmentally friendly infection control solution. Trusted by dentists, doctors, veterinarians, tattoo studios, clean rooms, labs, blood banks, and biotech, EnviroPouch reduces waste and costs.
Based in Boca Raton, FL, Extra Packaging offers over 50 years of experience providing custom cleanroom packaging and manufacturing solutions. They supply a comprehensive range of cleanroom packaging, available in various sizes and thicknesses, with custom fabrication capabilities to serve the medical industry and other applications.
Based in Circleville, OH, Health Care Logistics manufactures and packages products tailored for healthcare professionals. They specialize in sterilization solutions, directly producing self-sealing sterilization pouches, wraps, and indicators. The company provides essential supplies to support critical infection prevention and medication safety initiatives across healthcare settings.
Oliver Healthcare Packaging designs and manufactures flexible sterile barrier packaging, including solutions ideal for pouching applications. Serving medical device, diagnostics, pharmaceutical, and biopharmaceutical markets, they create off-the-shelf and custom options to keep products sterile and safe. Based in Anaheim, CA.
Based in Fort Worth, TX, Platinum Press specializes in custom printed packaging solutions for the healthcare, medical device, personal care, and pet care industries. They provide premium packaging expertise, partnering with CMOs to meet diverse and stringent product requirements.
Based in Carrollton, TX, Protective Packaging custom manufactures Tyvek barrier bags. They utilize Protect 585 barrier material, which combines Tyvek with a foil layer, providing robust protective solutions for various applications requiring high barrier properties.
Remington Medical is a full-service contract manufacturer for medical devices, specializing in comprehensive medical sterilization and packaging solutions. Based in Alpharetta, GA, the company offers everything required for efficient and compliant medical device packaging.
Sealed Air manufactures flexible parenteral films, FDA-approved solutions known for consistent performance and reliable seals for large-volume parenterals and multi-chamber applications. The company also provides a wide range of food and protective packaging solutions, including its CRYOVAC brand, aiming to enhance product shelf life and safety while reducing waste.
Spectrum Plastics manufactures sterile medical packaging products, including pouches, header bags, and lids. The company also specializes in custom film conversions for these applications, leveraging extensive expertise in medical devices and materials science.
Based in Crystal Lake, IL, Technipaq, Inc. manufactures custom and stock sterilizable packaging solutions for medical device, diagnostic, and pharmaceutical applications. They offer autoclavable, barrier, and peelable pouches, specializing in DuPont™ Tyvek® materials. ISO 13485 certified, Technipaq supports R&D prototypes to long production runs.
Based in Folcroft, Pennsylvania, Top Quality Manufacturing produces sterilization pouches. Their nationally recognized pouches feature self-seal closures, incorporating both built-in internal and external indicator strips for reliable sterilization processes in various medical and healthcare settings.
UFP MedTech specializes in manufacturing sterile packaging solutions for medical devices. Based in Newburyport, MA, they offer expert design, development, and production services. Their advanced medical-grade materials are compatible with autoclave, gamma, and EtO sterilization methods, supporting single-use and single-patient device manufacturing needs.
Amcor is a global leader in responsible packaging solutions, including robust medical device packaging. They directly manufacture effective and reliable sterilization pouches and other flexible packaging for medical grade equipment, ensuring safe containment and sterilization. Their solutions support the healthcare and pharmaceutical industries.
Medline, a leading global manufacturer and distributor of medical supplies, provides essential healthcare products including medical-grade paper pouches. These sterilization pouches feature an external indicator for proper organization and separation of instruments within wrapped sets or sterilization containers, ensuring optimal hygiene and safety.
Paragon Medical offers comprehensive contract manufacturing solutions for the medical device industry. They provide sterile barrier packaging services, including custom pouching, tray sealing, and material selection, performed within Class 7 & 8 cleanroom environments. The company specializes in compliant and precise packaging solutions for medical devices and components.
Viant Medical provides comprehensive finished device services for the MedTech industry, including sterile barrier packaging, labeling, and sterilization management. The company offers design, development, and manufacturing capabilities, ensuring medical devices meet stringent regulatory standards for global distribution.
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How to Choose a Company
- Verify the manufacturer's ISO 13485 certification and, crucially, their demonstrated compliance with ISO 11607 Parts 1 and 2 for packaging materials and packaging processes for terminally sterilized medical devices.
- Assess their proven capability and experience with your specific sterilization modality (e.g., ensuring Tyvek material specifications are appropriate for ETO or Gamma, or medical-grade paper for steam, including material permeability and strength after exposure).
- Demand quantifiable data on critical performance metrics such as seal strength (e.g., ASTM F88, F1140), microbial barrier properties, and puncture resistance relevant to your device’s sterile shelf life and handling requirements.
- For market entry in the US, confirm their FDA registration (21 CFR Part 820 Quality System Regulation) and their track record in providing comprehensive documentation packages suitable for regulatory submissions.
- Scrutinize their in-house quality control and testing capabilities, including visual inspection for defects (ASTM F1929), burst testing (ASTM F2097), and peel force analysis, rather than solely relying on third-party validation.
- Red Flag: Be highly cautious of any manufacturer who doesn't thoroughly inquire about your device's specific geometry, weight, or intended use environment, or who provides a generic quote without discussing the interplay of material, design (e.g., chevron seals), and sterilization method.
- Inquire about their capabilities for custom indicator inks (e.g., Class 1 Process Indicators) or multi-color branding, ensuring they have validated processes for ink adhesion, color stability post-sterilization, and biocompatibility to prevent migration into the sterile field.
Frequently Asked Questions
What is the primary difference in material choice between Tyvek and medical-grade paper for sterilization pouches?
Tyvek (a spun-bonded olefin material) offers superior tear strength, puncture resistance, and excellent microbial barrier properties, making it ideal for ETO and Gamma sterilization. Medical-grade paper, typically a specialty cellulose, is highly breathable and cost-effective, best suited for steam (autoclave) sterilization due to its moisture vapor transmission rate.
How do I ensure my sterilization pouches are compatible with my chosen sterilization method (ETO, Gamma, Steam, E-beam)?
Pouch material selection is paramount. Tyvek is generally compatible with ETO, Gamma, and E-beam due to its chemical inertness and robust structure. Medical-grade paper is primarily for steam sterilization. Always specify your method to the manufacturer, as they will select materials and seal configurations (e.g., breathable membranes, special coatings) validated for the specific energy or gas exposure required.
What are the critical tests to verify sterilization pouch integrity and sterility assurance?
Key tests include seal strength (ASTM F88) to ensure the pouch remains sealed, dye penetration (ASTM F1929) to detect channel leaks in seals, burst testing (ASTM F2097) for overall package integrity under pressure, and microbial barrier testing to confirm the prevention of microorganism ingress. These tests, along with visual inspections, are essential for demonstrating compliance with ISO 11607.
When should I opt for a chevron peel pouch versus a flat pouch or header bag design?
Chevron peel pouches are specifically designed for aseptic presentation, allowing healthcare professionals to peel open the pouch cleanly without tearing or contaminating the sterile contents. They are ideal for devices requiring sterile transfer or those used in a sterile field. Flat pouches or header bags might be suitable for simpler devices where the primary concern is containment, or for devices that are removed from the package and then presented aseptically.
What kind of documentation should a sterilization pouch manufacturer provide for regulatory submissions (e.g., FDA 510(k))?
A reputable manufacturer should provide a comprehensive documentation package, including Certificates of Conformance for each lot, raw material datasheets (e.g., for Tyvek, films, adhesives), validation reports (IQ/OQ/PQ) for their manufacturing processes, and potentially biocompatibility statements or data for the packaging materials, all critical for demonstrating the packaging's suitability and regulatory compliance.
Can I get custom printing and indicator inks on my sterilization pouches? What should I watch out for?
Yes, custom printing and integrated process indicator inks are common. You can specify branding, device information, and sterilization process indicators (e.g., Class 1 indicator inks for ETO, Steam, or Gamma that change color upon exposure). Key considerations include ensuring ink compatibility with your sterilization method, validating ink adhesion to prevent flaking, and confirming the ink's biocompatibility and non-migration properties to avoid contamination of the sterile device.