Life science companies continually evaluate their operations for opportunities to improve throughput, increase compliance, and reduce costs. Medical device manufacturers, laboratories, and R&D facilities can all experience greater flexibility and more control with an in-house ethylene oxide (EO) sterilization program. By reducing what can be a two-week turnaround time with outsourced sterilization, operations managers can expect faster release of finished goods and increased inventory turns for a measurable and sustainable economic benefit. In particular, companies that process small, high-value devices can benefit from the new 3M Steri-Vac Sterilizer/Aerator GSX Series ethylene oxide (EO) sterilization system, with state-of-the-art mechanical design, real-time cycle information on the high-resolution color touch screen, and the ability to quickly and easily customize sterilization cycles.
With the first-of-its-kind 3M Cycle Programmer software program, the cycle developer can design custom cycles tailored to each product or device to be sterilized. Especially useful for complex or combination drug/device type products, 3M Cycle Programmer provides a user-friendly interface with the option to adjust 28 different cycle parameters in 8 active stages of the sterilization process. Once a cycle developer creates a custom cycle on a PC, the cycle file is transferred and uploaded to the sterilizer on a standard USB drive and stored in a supervisor menu for future use or loaded to the operator menu for immediate availability.
Steri-Vac GSX Series sterilizers utilize 100 percent ethylene oxide—a traditional, efficacious and proven sterilant—delivered in sealed, single-dose 3M Steri-Gas EO Gas Cartridges. These cartridges are punctured when the sterilizer door is locked and the chamber is under vacuum. These engineering safeguards were designed with operator safety in mind.
With efficient and customizable sterilization cycles, the GSX Series sterilizers can help companies decrease cycle development and validation time, increase throughput, simplify final lot release, and adapt to varying production demands. The products and accessories provide an “order, install, qualify and run” system—reducing costs for design, start-up and maintenance compared to custom-built systems.
“Not only does the Steri-Vac GSX Series sterilizer offer incredible flexibility in customizing cycle parameters, the state-of-the-art dynamic humidification process and independent monitoring and control sensors provide a level of control not previously available,” said Janet Prust, Director, Standards and Business Development. “This means users can optimize cycles for specific products, improve inventory turns, and generate a solid return on investment.”
When setting up in-house EO sterilization operations, companies committed to environmentally sustainable business practices choose to install the 3M Abator, a highly effective device used to catalytically convert EO gas exhausted from the Steri-Vac GSX Series sterilizers to CO2 and water vapor. At normal operating conditions, removal efficiency is 99.9 + % (when EO is > 100 ppm), virtually eliminating emissions to meet environmental requirements.
3M also offers reliable, compliant sterilization monitoring products to meet manufacturing and validation requirements for ethylene oxide (EO) and other sterilization processes. 3M Attest Biological Indicators, self-contained biological indicators, are available as standard readout (24-48 hours) and rapid readout (one to four hours) systems, when used with the appropriate 3M Attest Auto-reader or Incubator. Various chemical indicators and indicator tapes are also available to provide a comprehensive set of process monitoring tools.