Hydrogen Peroxide Vapor Sterilization

The use of H₂O₂ sterilization in biological safety cabinets and barrier isolators is a popular alternative to ethylene oxide (EtO) as a safer, more efficient decontamination method. H₂O₂ has long been widely used in the pharmaceutical industry. In aerospace research, H₂O₂ is used to sterilize satellites.

The FDA has recently granted 510(k) clearance to use H₂O₂ in individual medical device manufacturing applications. EtO criteria outlined in ANSI/AAMI/ISO 14937 may be used as a validation guideline.

The Sterisonic™ GxP Design Permits Safe, Effective H₂O₂ Sterilization

Unlike conventional incubators, unique features of the SANYO Sterisonic™ GxP incubator permit use of the H₂O₂ process in situ with complete safety, zero impact on adjacent equipment or the environment, and speed to return the incubator to service.

• The H₂O₂ sterilization process functions with the patented SANYO SafeCell™ UV system. Following a seven-minute H₂O₂ vaporization, circulation and dwell cycle, vaporization is stopped and the SafeCell™ UV lamp turned ON for up to ninety minutes.
• When exposed to UV light, the H₂O₂ vapor breaks down into water and oxygen, leaving only traces of water droplets. These droplets automatically condense onto a naturally cooler section of the interior floor for easy wipe-up.
• Throughout the entire cycle the Sterisonic™ GxP airflow system continues to gently circulate interior air assuring 100% vapor contact with all interior surfaces, ultimately creating a serial dilution of H₂O₂ as it passes over the UV lamp.
• Orientation of interior sample ports of the single beam, dual detector IR CO₂ sensor creates a slight Venturi flow through the sample chamber, permitting total sterilization of the CO₂ system at the same time.
• Shape and location of interior components such as shelves, shelf brackets, plenum covers and the humidity pan permit the components to remain in the chamber during the sterilization process, conveniently bypassing the need for a separate autoclave cycle.
• Once the cycle is complete, the door locking system is released; the inner door can be opened, interior components repositioned and the incubator is returned to service.

Sterisonic™ GxP Performance and Availability Delivers Best Value

The documented two-hour in situ H₂O₂ sequence puts the fully sterilized Sterisonic™ GxP available and ready for use quicker than any other incubator worldwide.

Ideal for Highly Regulated or Sensitive Applications

The combination of Sterisonic™ GxP incubator performance functions permit use with confidence in high-value cell protocols among hard-to-grow cell lines, cells highly sensitive to contamination, ultra-sensitive media and reagents, or protocols that require a strict isolation and sterilization between processes.
These include but are not limited to:

• Stem cell research
• Autologous tissue regeneration & regenerative medicine
• In vitro fertilization¹
• Genomic and proteomic expression
• Esoteric plant and amphibian cell culture
• Hypersensitive and transgenic cell culture
• Low media volume microplate work

1. 501(k) clearance applied for. Contact SANYO for status. MCO-18AIC and MCO-20AIC CO₂ incubators have received U.S. Food and Drug Administration 510(k) clearance for in vitro fertilization applications in accordance with the FDA Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992. Reference: Number K013703. Regulation Number: 21 CFR 884-6120, Assisted Reproduction Accessories, Regulatory Class II, Product Code 85MOG, October 30, 2001

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