Contract packaging services and equipment directory.The following directory lists suppliers that provide contract packaging services and equipment to the medical device industry. Advertisers are listed in bold. Photo courtesy of AccuPlace. Avail 1600 Wells Fargo Tower 201 Main Street Fort Worth, TX 76102 Phone: (817) 877-4343 Fax: (817) 877-4909 Web: www.availmed.com E-mail: contact@availmed.com Contact: Megan Morrow Locations: US, Mexico, Europe, China Capabilities: Avail is the largest outsource manufacturer of sterile, single-use medical devices. Serving the top 10 global medical device manufacturers, the company offers turnkey services from initial product development through production, supply-chain management and fulfillment. Avail offers a wide variety of packaging options, high-speed liquids filling and custom packaging design and validation. B. Braun OEM Division, B. Braun Medical, Inc. 824 Twelfth Avenue Bethlehem, PA 18018 Phone: (866) 8-BBRAUN; (610) 691-6785 Fax: (610) 691-1785 Web: www.bbraunoem.com E-mail: info-usa@bbraunoem.com Locations: Allentown, PA; Cherry Hill, NJ; Irvine, CA; Sabana Grande, Puerto Rico; Santo Domingo, Dominican Republic. Capabilities: B. Braun Medical's OEM Division offers a broad range of packaging capabilities to produce custom private labeled procedure kits and trays. Packaging options range from custom formed blister packs, flexible pouches and polybags to disposable procedure kits. Private labeled or non-sterile bulk packaging is also available. Creative design engineers, utilizing flexible in-house resources, work with customers to develop a custom package that enhances existing product lines. Bailey Plastics Group 1991 So. Lowell Blvd. Denver, CO 80219 Phone: (303) 922-9787 Fax: (720) 294-8476 Web: www.baileyplastics.com E-mail: PBaileyCo@comcast.net Contact: Philip Bailey Location: 2622 So. Zuhi Street, Englewood, CO 80110 Capabilities: Turnkey/custom medical assembly and packaging. A contract manufacturer of medical products in a class 10,000 cleanroom. We also are ISO 13488:2003/9001:2000 certified and FDA registered. You will find many of our products in hospitals, surgery rooms and clinics. Services included are Tyvek pouch packaging, silicone--PVC tubing assembly, surgical prep kits and IV sets. Product sterilization and validation services are available. Note: We sub-contract out the sterilization. (ETO/Gamma or E-Beam). Also, we provide a turnkey thermoforming program for custom surgical trays. We are a total turnkey cleanroom assembly and packaging outsourcing alternative company. BC TECH 2100 Delaware Avenue Santa Cruz, CA 95060 Phone: (831) 459-6464 Fax: (831) 459-6465 Web: www.bctechinc.com E-mail: J.baltor@bctechinc.com Contact: Jeffrey Baltor Capabilities: BCTech provides medical device packaging in a modem ISO 13485 certified FDA registered facility as part of our arsenal of scalable turn key manufacturing solutions. We also can provide distribution, materials and sterilization management. Call us for a solution today. Beacon Converters, Inc. Andrea Boulevard Saddle Brook, NJ 07663-8208 Phone: (201) 797-2600 Fax: (201) 797-3015 Web: www.beaconconverters.com E-mail: info@beaconconverters.com Contact: Kathleen Mascolo Capabilities: Flexible packaging. Beacon Converters, Inc. provides medical device manufacturers with superior packaging products including pouches-on-a-roll, rollstock, header bags and flat/square bags. Available in Dupont Tyvek, paper, foil, films and laminations, they are suitable for all sterilization methods. Specialty products include foil peel pouches made with Tyvek header strips and custom plastic, die cut insert cards to organize and contain multiple components within a package. Biotest Laboratories, Inc. 8990 Springbrook NW Suite 100 Minneapolis, MN 55433 Phone: (763) 785-2414 Fax: (763) 785-9054 Web: wwwbiotestlabs.com E-mail: info@biotestlabs.com Contact: Jay Mosley Location: Minneapolis, MN Capabilities: Validation planning/PMA submission preparation, manufacturing, packaging (tray sealing, pouch sealing, seal integrity testing, boxing), steam sterilization, sterilization validation, laboratory testing (bioburden, LAL, sterility), controlled environmental monitoring and microbial management. (FDA, ISO 13485:2003, ISO/IEC 17025:2005, EN 554). CarletonTechnologies/Test-A-Pack Systems 10 Cobham Drive Orchard Park, NY 14127 Phone: (716) 662-0006 Fax: (716) 662-0747 Web: www.carltech.com E-mail: zynda@carltech.com Contact: Jim Zynda Capabilities: Test-A-Pack manufactures package testing equipment for use in the medical, food and pharmaceutical industries. The model 2600 Seal Strength Tester uses pressurized air to check the seal integrity on a wide range of packages. The model 2700 Integrity Tester is an easy and repeatable non-porous package leak detector. Reliability, accuracy and ease of use are built into every Test-A-Pack product. Coeur Inc. 704 Cadet Court Lebanon, TN 37227 Phone: (800) 296-5893 Fax: (615) 547-7937 Web: www.coeurinc.com E-mail: don.mcclintock@coeurinc.com Contact: Don McClintock Locations: Sheboygan, WI; Washington, NC Capabilities: Coeur's capabilities include tubing extrusion, injection molding, assembly in controlled environments and packaging. Command Medical Products, Inc. 15 Signal Avenue Ormond Beach, FL 32174 Phone: (386) 672-8116 Fax: (386) 677-7781 Web: www.commandmedical.com E-mail: smcgee@commandmedical.com Contact: Stephanie McGee Locations: Ormond Beach, FL; Managua, Nicaragua Capabilities: Command Medical offers cleanroom packaging services from both its Florida and Nicaragua facilities. Focusing 100% on the medical industry, Command offers assembly and packaging services for all types of devices. Products are packaged in a wide variety of Tyvek and nylon pouches as well as blister sealed trays, shelf cartons and shippers. Package integrity testing such as peel testing and burst testing services are available onsite. Post packaging sterilization management, bar-coding and dock to stock shipping programs also are available. Command is FDA registered and ISO 13485 certified. For more information, please visit the Web at www.commandmedical.com or call (386) 672 8116. Computer Designs-Custom Thermoforming 5235 W. Copcay Road Whitehall, PA 18052 Phone: (610) 261-2100 Fax: (610) 261-2800 Web: www.computer-designs.com E-mail: ericl@computer-designs.com Contact: Eric Layfert Locations: Whitehall, PA; Liberty, NC; Tucson, AZ Capabilities: Computer Designs is an ISO-9001 medical thermoform packaging company with capabilities in innovative design, advanced tooling technology and in-line high speed production. Specializing in rapid development of CAD/CAM design and prototyping. Thin gauge (.010-.080); 18 years' experience. Covington Associates 75 Central Street Boston, MA 02109 Phone: (617) 314-3950 Web: www.covllc.com E-mail: jessica@covingtonassociates.com Contact: Jessica Rosenbloom Capabilities: Covington Associates is a specialty investment banking firm offering financial advisory services in the areas of mergers, acquisitions and capital raising. We have established a track record of success in the healthcare sector based on deep domain experience and a superior level of sense from a team of senior advisors. DDL, Inc. 10200 Valley View Road, #101 Eden Prairie, MN 55344 Phone: (952) 941-9226 Fax: (952) 941-9318 Web: www.testedandproven.com E-mail: pat.nolan@testedandproven.com Capabilities: Medical device package testing, product testing and material testing services. Package and product testing for simulating transportation: vibration, shock and compression testing. ASTM D3580; D3332; D4169; D642; D999; F88; F1140 and others. DOT approved "Third Party Testing Agency" for HazMat package certification; medical device process and package validation ISO 11607; accelerated testing and shelf life, thermal conditioning; leak testing, environmental data acquisition; protective cushion evaluation; random vibration testing and simulation. Diagnostic Laminations Engineering, Inc. 2613-B Temple Heights Drive Oceanside, CA 92056 Phone: (877) 353-4968 Fax: (760) 407-4202 Web: www.dleinfo.com E-mail: sales@dleinfo.com Contact: Duane Lawson Capabilities: Diagnostic Laminations Engineering is a design and manufacturing group providing custom fabrication and converting services for medical device and diagnostic test manufacturers including engineering, prototyping, production, assembly and packaging. This innovative and diversified team will direct full development and manufacturing per your requirements and assist with technical recommendations. Donatelle 501 County Road E2 Extension New Brighton, MN 55112 Phone: (651) 633-4200 Fax: (651) 633-5486 Web: www.donatelle.net E-mail: sales@donatelle.net Contact: Cindy Dupay Location: New Brighton, MN Capabilities: Donatelle offers component manufacturing through device assembly, packaging and sterilization management. We operate under ISO-9001 and ISO-13485:2003 certified systems and are FDA compliant. Capabilities include engineering services, R&D/prototyping, in-house tooling design and fabrication, processing capabilities for the entire range of engineered resins, white room molding, class 10,000 liquid silicone molding, class 100,000 cleanroom assembly, class 10,000 deanroom molding and assembly, extensive contract manufacturing services and machined metal component fabrication. DuPont Medical Packaging 4417 Lancaster Pike Wilmington, DE 19805 Phone: (800) 44-TYMEK Web: www.medicalpackaging.dupont.com E-mail: medicalpackaging@usa.dupont.com Contact: Raffaella Christianetti Capabilities: DuPont Tyvek brand protective materials are used in every from of sterile medical packaging, including pouches, lidstock, breather patches and headers. Highly resistant to bacterial penetration, water, tear's, and punctures, Tyvek is compatible with EtO radiation, steam (under controlled conditions), E-beam and Sterrad. Tyvek delivers optimum balance of resistance to bacterial penetration, strength and compatibility with existing and emerging sterilization methods. Eagle Outsource 10201-A Trademark Street Rancho Cucamonga, CA 91730-5850 Phone: (909) 481-0011 Fax: (909) 481-4481 Web: www.eaglelabs.com E-mail: rdecamp@eaglelabs.com Contact: Richard J. De Camp Location: Rancho Cucamonga, CA Capabilities: Eagle Outsource provides form/fill/seal multivac packaging, Tyvek pouch and tray sealing, assembly, sterilization and validation services. Our manufacturing facility is ISO 13485 certified and FDA registered with an ISO class 8 cleanroom. We offer cost-effective packaging and sterilization services for high or low volume single-use medical devices. Ethox International 251 Seneca Street Buffalo, NY 14204 Phone: (716) 842-4000; (800) 521-1022 Fax: (716) 842-4040 Web: www.ethoxcorp.com E-mail: info@ethoxcorp.com Capabilities: Ethox Corp. is a vertically integrated disposable medical device manufacturer and sterilizer. Contract services include engineering, research and development, validations, project and supplier management, prototyping, injection-molding, plastics conversion, marking, custom assembly, packaging, package testing, accelerated aging, sterilization, sterilization validations, BIER testing, HPPLC analysis for drug and drug combination products, as well as extractable metals analysis, warehousing and fulfillment. Ethox is FDA registered, cGMP compliant and ISO 13485 certified. Helix Medical 1110 Mark Avenue Carpinteria, CA 93013 Phone: (805) 684-3304 Fax: (805) 684-1934 Web: www.helixmedical.com Contact: Sean McPherson Capabilities: Explore the advantages of partnering with Helix Medical, LLC for your outsourced platinum-cured silicone manufacturing needs: * We apply more than 20 years of experience to the extrusion, molding, assembly and finished goods packaging of silicone devices and components. * As a true medical device manufacturer, all products manufactured by Helix Medical benefit from our finished medical device quality system and the application of GMP and ISO 13485 certifications. * Dedicated and experienced medical device engineering staff available for technical assistance. Integrated BioSciences Inc. (IBS) 637 Lowther Road Lewisberry, PA 17339 Phone: (717) 938-9323 Fax: (717) 938-9364 Web: www.ibiosci.com E-maih info@ibiosci.com Contact: Jody Sheaffer Capabilities: Integrated BioSciences Inc. (IBS) is a full service contract manufacturer of class I and II medical devices and disposables and specializes in the design, fabrication and operation of the automated equipment used in the production of these devices. IBS can package your product based on your specific packaging needs. Packaging options include non-sterile or sterile packaging in polybags, pouch, blister packs or custom packaging. J-Pac, LLC 25 Centre Road Somersworth, MN 03842 Phone: (603) 692-9955 Fax: (603) 692-0909 Web: www.j-pac.com E-mail: rcrane@j-pac.com Locations: Somersworth, NH Contact: Rick Crane Capabilities: J-Pac provides all formats of sterile, disposable, medical packaging, as well as unit of use packaging for OTC applications. J-Pac specializes in packaging sensitive healthcare products requiring dry room processing and barrier packaging. J-Pac operates both batch and continuous flow processes in class 10,000 and class 100,000 cleanrooms. J-Pac is FDA registered and EN13485 certified. Lake Region 340 Lake Hazeltine Drive Chaska, MN 55318 Phone: (952) 448-5111 Fax: (952) 448-7012 Web: www.lakergn.com E-mail: mktgsales@lakergn.com Locations: Minneapolis, MN; Wexford, Ireland Contact: Ron Von Wald Capabilities: For more than 40 years, Lake Region has designed, developed, manufactured and packaged class II and III medical devices. Lake Region experts in device engineering, quality and regulatory provide oversight in design controlled packaging deliverables. From user needs assessment and IFD creation to pouch, box and carton strategy, Lake Region delivers. Medisize Edisonstraat 1, 2181 AB Hillegom The Netherlands Phone: (31) 0-252-576-888 Fax: (31) 0-252-519-825 Web: www.medisize.com/dm E-mail: info@medisize.com Locations:The Netherlands; Ireland; Switzerland; Czech Republic Capabilities: Medisize is a full service contract manufacturer specializing in custom-made, single use, sterile devices and primary pharmaceutical packaging. Medisize specializes in custom made drug delivery devices, infusion technology, surgical and wound care devices, radioactive applications and primary pharmaceutical packaging including bottles, closures, containers and single and multi-chamber bag manufacture. The MedTech Group, Inc. 6 Century Road Plainfield, NJ 07080 Phone: (908) 561-0717 Fax: (908) 561-7314 Web: www.medtechgrp.com E-mail: info@medtechgrp.com Contact: Esther Seeney Locations: South Plainfield, N J; Middlesex, N J; West Haven, CT; Milford, CT; Vega Baja, PR; Heredia, CR Capabilities: The MedTech Group is a leading global contract medical device manufacturer with facilities in New Jersey, Connecticut, Puerto Rico and Costa Rica. As an ISO certified 13485:2003 and FDA registered medical device manufacturer, The MedTech Group provides its customers with design through complete manufacturing services. Areas of expertise include product design and development, tooling design and fabrication, process design and validation, surgical staple manufacturing, cleanroom molding including two-shot and insert molding, complete device assembly and packaging, sterility validation and management. Nelson Laboratories, Inc. 6280 S. Redwood Road Salt Lake City, UT 84123 Phone: (801) 290-7500 Fax: (801) 963-2630 Web: www.nelsonlabs.com E-mail: sales@nelsonlabs.com Capabilities: Nelson Laboratories, an independent contract laboratory, offers more than 400 microbiological and analytical tests. Packaging tests offered include physical (burst, creep, dye migration, bubble emission, seal peel), microbiological test methods (aerosol challenge, container closure, ranking of packaging material) and accelerated aging/shelf life studies. Distribution/shipping tests also can be arranged. PAC Machinery Group 25 Tiburon Street San Rafael, CA 55439 Phone: (415) 454-4868 Fax: (415) 454-6853 Web: www.pacmachinery.com E-mail: ciones@qtspackaging.com Contact: Charlie Jones Capabilities: PAC Machinery Group--Audion Automation (AA), Packaging Aids Corporation (PAC), Vertrod (VT) and Converting Technology Inc (CTI). PMG's extensive product line of validatable medical equipment includes band sealers, vacuum gas flush machines and impulse sealers. PMG also offer automatic roll baggers and vacuum chambers. Custom design services are available. Perfecseal, Inc. 3500 North Main Street Oshkosh, WI 54901 Phone: (920) 303 7000 Fax: (920) 303-7002 Web: www.perfecseal.com E-mail: Perfecseal@bemis.com; elhaedt@bemis.com Contact: Ed Haedt Locations: Londonderry, Northern Ireland; San Juan, Puerto Rico; Selangor, Malaysia; and multiple North American sites, including New London, WI and Oshkosh, WI; Mankato, MN and Philadelphia, PA. All sites are ISO certified. Capabilities: Perfecseal Inc., a division of the Bemis Company, serves the medical device, diagnostic, pharmaceutical and in-hospital sterilization packaging markets, specializing in the manufacture of coextruded films, laminated films, flexible forming films, foil barrier films, high barrier films, pouches, bags, thermoformed tray and lid systems, labels, coated Tyvek and coated paper. QTS Tech Services 7359 Washington Avenue South Edina, MN 55439 Phone: (952) 942-8321 Fax: (952) 942-8361 Web: www.qtspackaging.com E-mail: info@qtspackaging.com Contact: Charlie Jones Capabilities: Products and Equipment--Full range of contract medical services including assembly, packaging and contract sterilization (EO, Gamma & E-beam). We provide innovative process development solutions, material sourcing, purchasing and package design. Complete project management, from sterilization and package validations to routine processing, is offered. Services--Additional Services include cleaning and passivation, assembly, kit & instrument tray designs, pouch and tray packaging, liquid packaging and package evaluation engineering. Traceability is maintained through Class 10,000 environments. Certifications include: FDA registered, EN 46002, ISO 13485. Specialized Medical Devices 300 Running Pump Road Lancaster, PA 17603 Phone: (717) 392-8570 Fax: (717) 392-8578 Web: www.specializedmedical.com E-mail: jackf@specializedmedical.com Contact: Jack F. Fulton Capabilities: SMD is an FDA-registered and ISO 13485:2003 certified contract manufacturer and packager of medical devices. SMD's packaging services are performed inside class 10,000 cleanrooms, where SMD packages products in thermoform trays, Tyvek pouches and production boxes, which are ultimately shrink wrapped before being shipped to our customers. Ultrasonic welding of plastic handles, suturing and complete assembly of devices are just a few of SMD's services. Contact SMD for your next packaging requirement Tanaka Kapec Design Group, Inc. 11 Brookfield Street Norwalk, CT 06851 Phone: (203) 846-3666 Fax: (203) 846-3669 Web: www.tkdg.com E-mail: tkdg@tkdg.com Contact: Susan Bryn Capabilities: Tanaka Kapec Design Group is an award-winning industrial design product and packaging development consulting firm developing packaging designs from concept/ideation to manufacturing. Develop packaging systems/families and logo placements. Tapemark 1685 Marthaler Lane West St. Paul, MIN $5118 Phone: (800) 535-1998 Fax: (651) 450-8403 Web: www.tapemark.com E-mail: tmsales@tapemark.com Contact: Pat Cody Location: West St. Paul, MN Capabilities: Tapemark is a full-service cGMP contract manufacturer/packager offering innovative design, manufacturing and finished packaging. We specialize in laminated and die-cut device components and single-use products such as pads, patches and soluble films with your API. Tapemark is ISO 9001 and 13485 certified and FDA registered for food, drug, device and cosmetics. Technipaq, Inc. 975 Lutter Drive Crystal Lakes, IL 60014 Phone: (815) 477-1800 Fax: (815) 477-0777 Web: www.technipaq.com E-mail: info@technipaq.com Contact: Brian Rosenburg Capabilities: Flexible Packaging. As a manufacturer of flexible packaging, we meet our customer specifications regarding sterilization method, peelable or fusion seals, clarity strength, porosity and barrier properties. A large selection of Tyvek pouches for use with gas or radiation sterilization are available for immediate shipment. Custom printing, laminating and coating services also are offered. TOLAS Healthcare Packaging 905 Pennsylvania Blvd. Feasterville, PA 19053 Phone: (215) 322-7900 Fax: (215) 322-9034 Web: www.tolas.com E-mail: marketing@tolas.com Contact: Denise DiLissio Capabilities: TOLAS Healthcare Packaging is an ISO 9001:2000 certified supplier of packaging to the medical device and pharmaceutical markets. We provide Tyvek, paper, film and foil as printed rollstock, pouches and lidding. Materials are suitable for EtO, steam or radiation sterilization and are available overall or zone coated. |
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