Medical Device Link.

Originally Published PMPN April 2002

PRODUCT UPDATE

In-house sterilization systems offer several benefits, including rapid cycle times for JIT manufacturing.

Libra Blue Galaxy
A VHP sterilization tunnel is designed to be inserted in a production line that requires continuous depyrogenation by means of dry heat. Precise construction of the chambers (in particular the hot chamber) guarantees distribution and penetration of heat by means of a flow of hot air treated with HEPA filters, which strikes the bottles with vertical laminar motion. Class M3.5 air as per Federal Standard 209/e is guaranteed along the entire path. The heat treatment can be set according to the container to be treated and guarantees a reduction of endotoxins greater than 3 log. All instrumentation can be fitted with devices for easy adjustment and calibration. Process parameters can be set and recorded according to the container to be treated. Technical specifications and technological characteristics guarantee stability of set temperatures in time and space. The system can be coupled with the firm's Libra Hydra linear washing machines, which can treat vials at speeds up to 34,000 pieces per hour. IMA North America Inc., Bristol, PA; 215/826-8500; imausa@worldnet.att.net.

VHP MD Series
A sterilization system offers low-temperature vaporized hydrogen peroxide (VHP) sterilization of packaged medical and diagnostic devices. Designed for on-site, point-of-manufacture use, the VHP MD series offers the following advantages: rapid sterilization cycle time, safe and environmentally friendly by-products (water vapor and oxygen), no postprocessing aeration, excellent material compatibility, and low operating costs. System features include single-door or double-door pass-through, customized or standard chamber sizes available (8.8 or 20 cu ft), touch screen control for permanent cycle records, and parametric release capability. The VHP cycle consists of four phases: conditioning to remove air from the chamber and packaging and to equilibrate product temperature; vacuum leak testing to ensure a leak-tight chamber; sterilization in which hydrogen peroxide vapor is injected into the chamber via a series of sterilization pulses; and aeration in which the chamber is evacuated to remove residual hydrogen peroxide vapor. Cycle times vary with chamber size and product configuration. Steris Corp., Mentor, OH; 949/495-7974; larry_lachowski@steris.com.

Rhodotron
One of the largest companies specializing in contract sterilization also offers design, development, installation, and operation of gamma and accelerator-based systems. The company's engineering and design expertise has resulted in the development of numerous systems and industry innovations, including the Rhodotron, an accelerator-based system capable of providing e-beam and X-ray processing. In addition, the firm offers complementary sterilization services and technologies to include gamma, E-beam, x-ray and EtO, providing technical assistance and expert analysis to companies that wish to modify or upgrade their existing sterilization systems and equipment. IBA Medical Sterilization & Analytical Labs, Oak Brook, IL; 630/928-1700; www.iba-sni-americas.com.

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