06.12.06
Sterilization Service Providers
The following directory lists suppliers who provide sterilization services to the medical device industry.
AppTec
2540 Executive Drive
St. Paul, MN 55120
Phone: (888) 794-0077 (toll free)
Fax: (651) 675-2005
Web: www.apptec-usa.com
E-mail: info@apptec-usa.com
Contact: Dean Enrooth
Comments: AppTec’s ISO-certified, FDA-registered laboratories provide comprehensive biosafety testing and contract services for manufacturers of medical devices and medical products. Testing is GLP/cGMP compliant and based on FDA/ISO/USP guidelines.
ARMM, Inc.
17744 Sampson Lane
Huntington Beach, CA 92647
Phone: (714) 848-8190
Fax: (714) 848-6141
Web: www.armminc.com
Contact: Roger Wood
Comments: ARMM, Inc. assembles and private labels custom devices for major manufacturers and distributors of medical products. ARMM’s goal is to provide the highest possible quality and to exceed our customer’s expectations through continuous improvement.
B. Braun OEM Division, B. Braun Medical, Inc.
824 Twelfth Avenue
Bethlehem, PA 18018
Phone: (866) 8-BBRAUN (toll free) or (610) 691-6785
Fax: (610) 691-1785
Web: www.bbraunoem.com
E-mail: info-usa@bbraunoem.com
Contact: Dawn Brosious
Services: The B. Braun OEM Division of B. Braun Medical Inc.—an FDA-registered, ISO 13485 provider of contract manufacturing services and components for medical devices and other products—offers a broad range of packaging capabilities to produce custom private labeled procedure kits and trays. The B. Braun OEM Division offers 100% EtO sterilization capacity controlled via microprocessor-based technology. Validated chambers are capable of sterilizing high volumes of product, making the process fast and thorough. The B. Braun OEM Division offers medical device marketers complete project management outsourcing services—including sterilization, contract manufacturing and regulatory guidance.
BC Tech
2100 Delaware Avenue
Santa Cruz, CA 95060
Phone: (831) 459-6464
Fax: (831) 459-6465
Web: www.bctechinc.com
Contact: Jeff Baltor
Products and Equipment: Class 10,000 cleanroom assembly; sterile packaging; pouch packaging; thermoform tray packaging; sterilization and sterilization validation procurement; heat sealing and RF sealing.
Services: Flexible volume manufacturing from lot of one to clinical builds and large scale manufacturing; manufacturing engineering; complete materials management from supplier selection and control through finished device assembly with integrated MRP system.
Comments: BC Tech offers comprehensive turnkey medical control manufacturing and medical product development services.
BeamOne LLC
9020 Activity Road, Suite D
San Diego, CA 92126
Phone: (800) 438-1423 (toll-free)
Fax: (303) 320-4664
Web: www.beam-one.com
E-mail: marketing@beam-one.com
Services: Electron beam sterilization of medical devices at three locations—San Diego, Denver and Lima, Ohio.
Comments: BeamOne (formerly Titan Scan Technologies) owns and operates three electron beam contract sterilization service centers located in California, Colorado and Ohio. BeamOne’s key focus is on outstanding customer service and optimal processing quality. Building on its existing reputation for excellence in service and turnaround time, the company’s goal is to remain the premier provider of electron beam processing services. The highly efficient electron beam sterilization process allows for expedited same-day turnaround service for a reasonable fee. All service centers are ISO and EN certified, and associates are able to assist with materials qualification and process and product validation as well as routine production.
Centurion Sterilization Services
301 Catrell Drive
Howell, MI 48843
Phone: (866) 386-0530 (toll-free)
Fax: (517) 546-3356
Web: www.centurionsterile.com
E-mail: bsparks@centurionsterile.com
Comments: Centurion Sterilization Services provides quality 100% EtO contract sterilization. Each facility is ISO 13485 certified with compliance to EN 550. Our on-site laboratories help reduce overall costs and lead time during both routine sterilization and validations. Centurion specializes in turnkey validations available in six to eight weeks. Ask us about our packaging capabilities too.
E-BEAM Services, Inc.
118 Melrich Road
Cranbury, NJ 08512
Phone: (877) 413-2326 (toll free); or (609) 655-7460
Fax: (609) 655-3052
Web: www.ebeamservices.com
E-mail: ebeam@ebeamservices.com
Contact: John Messier
Services: Supplier of contract electron beam processing services. The electrons create useful changes in material properties and performance of industrial products via plastics cross-linking and chain scissioning. Also used for medical device sterilization, pharmaceutical sterilization and bioreduction.
Ethox Corp.
251 Seneca Street
Buffalo, NY 14217
Phone: (716) 842-4000
Fax: (716) 842-4043
Web: www.ethoxint.com
E-mail: info@ethoxcorp.com
Contact: Dick Malo
Services: new product development; manufacturing process: injection molding, plastics conversion, marking, general assembly, packaging; specialized manufacturing processes; ethylene oxide sterilization; analytical services; protocal & validation report packages; product sterility testing; biological indicator testing; environmental monitoring; bioburden testing; pyrogen testing; research & development/consulting services; package testing.
Gibraltar Biological Laboratories
122 Fairfield Road
Fairfield, NJ 07004
Phone: (973) 227-6882
Fax: (973) 227-0812
Web: www.gibraltarlabsinc.com
E-mail: danielprince@gibraltarlabsinc.com
Contact: Dr. Daniel Prince
Products and Equipment: Gibraltar has performed sterility validation for device and pharmaceuticals since 1970 and has published standard methods in the archived literature relating to irradiation. Ethylene oxide, E-Beam, steam and chemosterilizers. Gibraltar has pioneered the use of multi-tiered elusion methods to satisfy FDA, AAMI and GLP requirements for radiosterilization of devices, drugs and tissues so as to achieve minimal key doses.
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: sales.dm@medisize.com
Services: Medisize is a full service contract manufacturer specializing in custom-made, single use sterile devices and primary pharmaceutical packaging. Capabilities include development, project management, industrialization, injection molding, two shot molding, insert molding, silicon molding, blow molding, stretch blow molding. assembly, welding, packaging and validation. In-house gamma sterilization is also available. State of the art cleanroom facilities are located in The Netherlands, Ireland, Switzerland and the Czech Republic.
Comments: FDA Registered / ISO 13485 certified.
NAMSA
6750 Wales Road
Northwood, OH 43619
Phone: (419) 666-9455
Fax: (419) 662-4386
Web: www.namsa.com
E-mail: info@namsa.com
Contact: Rachael Lanning
Comments: For over 35 years, NAMSA has been a world leader specializing in the safety evaluation of medical devices. Our unique combination of preclinical and clinical expertise means we deliver the most cost effective testing programs that satisfy regulatory requirements worldwide. All NAMSA laboratories are fully certified and accredited according to the highest standards.
Nelson Laboratories, Inc.
6280 S. Redwood Road
Salt Lake City, UT 84123
Phone: (801) 963-2600
Fax: (801) 963-2630
Web: www.nelsonlabs.com
E-mail: sales@nelsonlabs.com
Comments: Nelson Laboratories is an independent test service provider specializing in microbiology, sterilization validations, lot release tests (sterility, bioburden, B/F, pyrogen, etc.), biocompatibility, organism identification, residuals, filter validations and much more. Within our 62,000 sq. ft. facility we maintain 80 labs and a custom built 3,000 sq. ft. sterility testing cleanroom suite. Nelson employs more than 225 staff members, including more than 100 degreed scientists, among whom are 35+ registered and specialist microbiologists (NRM).
Nutek Corp.
30958 San Antonio Street
Hayward, CA 94544
Phone: (510) 429-2900
Fax: (510) 441-9451
Web: www.nutekcorp.com
E-mail: larry@nutekcorp.com
Contact: Larry Nichols
Services: E-Beam sterilization, tubing crosslinking.
Omnica Corporation
15560-D Rockfield Blvd.
Irvine, CA 92618
Phone: (949) 472-0275
Fax: (949) 472-0276
Web: www.omnica.com
E-mail: rscully@omnica.com
Contact: Ron Scully
Services: Product development and design for the medical, industrial and consumer fields at one location. Industrial design, electronic and mechanical engineering, R & D, prototyping, FDA documentation. Everything from concept and first articles through hand-off to manufacturing.
Quality Tech Services
Address: 7359 Washington Avenue South
Edina, MN 55439
Phone: (952) 942-8321
Fax: (952) 942-8361
Web: www.qtspackage.com
E-mail: cjones@qtspackage.com
Contact: Charlie Jones
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.
Comments: Certifications include FDA Registered, EN 46002, ISO 13485.
Qosina
150-Q Executive Drive
Edgewood, NY 11717
Phone: (631) 242-3000
Fax: (631) 242-3230
Web: www.qosina.com
E-mail: info@qosina.com
Contact: Peggy Wilson
Product & Equipment: Sterilization Indicators.
Comments: Qosina has added more sterilization indicators to our product line. These indicators show a color change to signify proper exposure to EtO (ethylene oxide), Steam Sterilization or Radiation and can be applied by hand. After exposure, they retain their color change indefinitely.
Raven Biological Laboratories
8607 Park Drive
Omaha, NE 68127
Phone: (800) 728-5702 (toll free); or (402) 593-0781
Fax: (402) 593-0921
Web: www.ravenlabs.com
E-mail: info@ravenlabs.com
Contact: Dan Dwyer
Products and Equipment: Raven manufactures sterility assurance products including self-contained BI’s for steam and EtO, steam and EtO chemical integrators. Bowie-Dick test packs and autoclave tape.
Services: Raven offers steam, dry heat and EtO Dvalue testing following USP-recommended procedures. Raven can inoculate your product and perform Dvalue analysis using one of our four AAMI compliant BIER vessels, or we can verify a competitor’s claim for population and Zvalue/Dvalue using Spearman Karber (fraction negative) or survival curve methods.
Smiths Medical OEM
2231 Rutherford Road
Carlsbad, CA 92008
Phone: (800) 258-5361 (toll free); or (614) 210-7300
Web: www.smithsoem.com
Email: sales@smiths-medical.com
Contact: Davis Olney
Products and Services: Standard and custom medical components and assemblies, including luer fittings, stopcocks, check valves, infusion sets, IV catheters, corrugated tubing and silicone devices.
Services: Design, development, production, assembly, packaging, sterilization, private labeling and logistics.
Sterigenics International, Inc.
2015 Spring Road
Suite 650
Oak Brook, IL 60523
Phone: (630) 928-1700
Fax: (630) 928-1701
Web: www.sterigenics.com
E-mail: jackfitzpatrick@sterigenics.com
Contact: Jack Fitzpatrick
Services: Contract sterilization services—Gamma, EtO and E-Beam, along with consulting, lab and distribution services for the healthcare, pharmaceutical, food safety and advanced applications industries. The only company in its sectors to operate globally, Sterigenics offers 38 service centers across North America, Europe and Asia—allowing its customers the economy and convenience of cutting edge technology and expert technical support close to their distribution or production facilities.
STERIS Isomedix Services
5960 Heisley Road
Mentor, OH 44060
Phone: (877) 783-7479 (toll free)
Fax: (440) 392-7914
Web: www.isomedix.com
E-mail: Isomedix_info@steris.com
Services: Contract sterilization, technical support, product development, materials testing, protocol generation, sterility validation.
Comments: STERIS Isomedix Services provides expertise in contract sterilization and microbial reduction services for products in the medical and pharmaceutical markets. Through a North American network of 21 facilities, we offer the most comprehensive array of sterilization services, using Gamma Irradiation, 100% Ethylene Oxide (EO) and Electron Beam (E-beam) technologies. Our new SteriLink™ interactive on-line service provides customers with complete, real-time visibility into STERIS Isomedix processing facilities.
Ventrex, Inc.
3007 Bunsen Avenue, Bldg. K
Ventura, CA 93001
Phone: (805) 658-2984
Fax: (805) 658-6720
Web: www.ventrexinc.com
E-mail: bguthrie@ventrexinc.com
Contact: Bob Guthrie
Services: Full-service medical device contract manufacturing of finished sterile and non-sterile devices and instrumentation.