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Sterilization Equipment

Originally Published September 2000


Sterilization Equipment

Steam sterilizers

Steam sterilizers offer a range of cycle functions to address any standard steam sterilization application. The Series 100HC sterilizers come with software that allows cycles to be configured for specific processing needs and customized cycle names. The units are shipped from the factory with 19 preloaded cycles. The units are available in a variety of sizes and configurations in both gravity displacement and prevacuum models. Getinge/Castle, 1777 E. Henrietta Rd., Rochester, NY 14623.

Sterlization system

A redesigned steam sterilizer offers enhanced features such as a new front draining system. The Ritter M7 is the fastest conventional steam sterilizer on the market, according to the company. It sterilizes unwrapped instruments in 9½ minutes cold or in 6½ minutes hot. All controls and information are located on the front of the unit for operator accessibility. The Ritter M7 is UL listed and CSA certified. Midmark Corp., 60 Vista Dr., Versailles, OH 45380.

Control system

Prevalidation support packages are available with a sterilizer control system capable of meeting all FDA CGMP requirements. The Frontier 2000 system includes a 16-color LCD, a 10-key pad for data entry, 12 preprogrammed function keys, and a 40-column impact printer. A 12-in. chart recorder provides independent monitoring and recording of cycle parameters. The system utilizes highly visible indicators to permit the operator to monitor progress while performing other tasks. An optional thermal printer is also available. ARS Enterprises, 12900 Lakeland Rd., Santa Fe Springs, CA 90670.

Composite trays

Reinforced composite trays are compatible with a range of sterilization techniques. The trays are designed to hold vials and ampules and withstand the rigors of sterilization without distortion, creep, or degradation. By eliminating the need to re-tray the product between processing steps, the trays minimize labor and reduce product spills. The units are available for EtO, gamma, steam, or microwave radiation sterilization techniques and can store product before, during, and after processing. The trays can endure continuous temperatures ranging from -60° to 250°F or more, and are unaffected by humidity. Molded Fiber Glass Tray Co., 6175 U.S. Hwy. 6, Linesville, PA 16424.

Hydrogen peroxide and gas-plasma sterilization

A sterilizer combines the use of hydrogen peroxide and gas plasma to quickly and safely sterilize most medical devices without leaving toxic residues. The Sterrad 200 GMP is designed with programmable control software that allows designated personnel to selectively modify sterilization sequences and parameters to best match product, packaging, and load configurations. Advanced Sterilization Products, 33 Technology Dr., Irvine, CA 92618.

Aseptic environments

Aseptic environments for the manufacturing, processing, or testing of sterile medical devices or pharmaceuticals may be created through a hydrogen peroxide decontamination system. The VHP-1000 series of generators flash vaporize liquid hydrogen peroxide to create sporicidal vapor concentrations that decontaminate clean, hard, and dry surfaces. The returning hydrogen peroxide vapor breaks down into oxygen and water by-products when catalyzed. The units operate at ambient pressure and room temperature and can be used to treat returned equipment at central repair facilities or to decontaminate laboratory or cleanroom workspaces. Steris Corp., 5960 Heisley Rd., Mentor, OH 44060.

Steam generators

Stainless-steel electric boilers are compatible for use with distilled, demineralized, deionized, or reverse-osmosis waters. The units are small in size, minimizing heat loss for almost 100% efficiency. All wetted boiler parts are 316/316L stainless steel, reducing impurity carryover of water and material contaminants. Applications include laboratory validation, moisturization, cleanroom humidification, autoclaves and sterilizers, and direct steam heating and/or injection. Sussman Electric Boilers, 43-20 34th St., Long Island City, NY 11101.

E-beam system

An accelerator-based system sterilizes devices by directing an E-beam at boxes containing finished product. The system's Belgium-based manufacturer specializes in the design, development, and installation of radiation and accelerator-based systems for medical and industrial applications. It offers complementary sterilization technologies--gamma, E-beam, x-ray, and EtO. IBA, Chemin du Cyclotron 3, 1348 Louvain-La-Neuve, RC Nivelles 054589, Belgium.

Pulsed-light sterilization system

Pulsed light kills high levels of microorganisms and deactivates certain enzymes with high speed. SteriPulse-XL directs intense pulsed light onto the sample at the rate of three pulses per second. The short-duration pulses prevent substrate heat buildup while generating a peak energy 25,000 times more intense than sunlight on the earth's surface. The system is free of toxins such as mercury or microwaves, ensuring the operator's safety. Xenon Corp., 20 Commerce Way, Woburn, MA 01801.

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