Determining the Right Sterilization ProcessDetermining the Right Sterilization Process
July 8, 2006
Originally Published MPMN July 2006
Determining the Right Sterilization Process
Jody Birks, RA/QA manager, Eagle Medical Inc., Paso Robles, CA
The diversity of sterile medical products on the market is staggering. New, innovative developments are continually being introduced. Determining the best method for sterilization is not as easy as it once was. Material compatibility, temperature concerns, radiation stability, off-gassing, design configurations, and quick turnaround are all concerns that manufacturers must address when considering sterilization options. Fortunately, there are a variety of sterilization methods available to meet their needs.
Steam sterilization, irradiation, and ethylene oxide (EtO) are by far the most common methods used in the industry, but limitations exist with each. Steam exposes devices to high heat and humidity. Irradiation can change the molecular makeup of plastics and silicones in an undesirable manner. Ethylene oxide requires off-gassing that is time-consuming with some materials. Gas plasma (vaporized hydrogen peroxide) is a relatively new option that can provide low-heat sterility cycles with none of the off-gassing concerns present with EtO. This process is a viable option for many devices that present sterilization challenges.
Understanding that no single method is appropriate for every device can help the manufacturer ask the right questions while researching sterility options. Contract sterilization providers can provide a wealth of information useful in determining the sterilization method that is best for each product.
Packager Provides Tray Design and Production Services
Thermovacuum-formed packaging trays can be designed and manufactured for medical device OEMs. The company can produce short runs of 250 trays for testing purposes and start-up firms. High-impact polystyrene, PETG, and polycarbonate materials are available for making medical kit trays, surgical packs, and catheter and instrument trays. CAD software is used in the design of models. The company also offers prototyping and samples to verify form, fit, and function.
PMC -- Plastic & Metal Center Inc., Laguna Hills, CA
Packager Offers Blisters and Flow- and Shrink-Wrapping
A nonprofit corporation providing contract packaging services has achieved ISO 9001:2000 certification. Blister packaging, flow-wrapping, filling, and shrink-wrapping are among the services offered. The company's facilities include a Class 100,000 cleanroom for packaging dispensers and syringes. Package design and engineering services are also available.
CWS Packaging, Norwich, NY
VHP Sterilization Is Well Suited for Small Production Runs
Sterilization services using vaporized hydrogen peroxide (VHP) are available from a contract assembly, packaging, and sterilization company. VHP is particularly suited to the sterilization of heat- and moisture-sensitive devices. Benefits include fast sterility cycle times, no toxic residues, and a low-moisture environment. The process does not exceed 50°C. EtO and gamma sterilization are also offered by the company.
Eagle Medical Inc., Paso Robles, CA
Package Design and Development Services Are Available
A contract manufacturer works with medical device customers to provide design, development, production, packaging, and shipping services. Material selection, design for manufacturing, imprinting, and final assembly are offered. The company can provide one-of-a-kind, handmade prototypes to prackage small quantities of finished devices for clinical testing or to tool up for large production runs. Simple fixtures to high-speed automatic assembly machines can be built in an in-house machine shop. Packaging capabilities include kit packaging, poly bags, blister cards, Tyvek pouches, labeling, UPC coding, overpacking, autobagging, shrink-wrapping, pouch sealing, vacuum-forming of trays, and automatic counting and bagging.
HPC MEDX, Hanover, PA
Supply-Chain Management Firm Focuses on Packaging
A supply-chain management company provides a turnkey approach to medical packaging. The firm represents local molders, assemblers, and packagers that specialize in the medical industry. Services include package design, prototyping, cleanroom assembly, molding, tool design, and sterilization and validation. The companies in the group offer thermoformed trays, blister packs, Tyvek pouching, sealing, and kitting for surgical tools, IV sets, and other medical components.
Bailey Plastics Group, Denver, CO
Cleanroom Packaging Is Available for Sterile and Nonsterile Devices
A contract packager supplies cleanroom packaging services for Class I, II, and III medical devices, including sterile and nonsterile products. The company has expertise in flexible-pouch packaging applications and formed packages and trays using flexible, semirigid, or rigid materials. Assistance is available in material selection, process qualification, and package design. Assembly, kitting, and component packaging are also offered.
Advanced Concept Innovations Inc., Lakeland, FL
Tube Assembly Packaging Offered
Packaging of silicone and PVC tubing assemblies is available. The company's Class 10,000 cleanroom features laminar-flow benches and medical-grade sealers. Tyvek pouches or thermoformed trays are used for packaging. The company also offers solvent bonding, barbed connections, and ultrasonic cleaning.
IPAX Inc., Englewood, CO
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