MCO-19AIC: Sterisonic™ GxP Cell Culture CO2 Incubator from SANYO North America Corporation

Description

The SANYO Sterisonic™ GxP incubator is designed for a wide array of demanding and highly regulated applications in the biomedical, pharmaceutical, medical research and clinical laboratory. Representing years of research, development and component testing, the Sterisonic™ GxP incorporates a collective of mutually functional systems and design attributes to offer a holistic solution to cell culture protocols, from the most sophisticated to more familiar and conventional processes.

• The unique Sterisonic™ GxP H2O2 decontamination system limits downtime to less than three hours when total chamber decontamination with verification is desired.
• All interior components and CO2 sampling loop are decontamined in situ; no need for removal and autoclaving.
• Active Background Contamination Control™ fights contamination while cell culture protocols are in process.
• The patented SafeCell™ UV system scrubs interior airflow to destroy airborne and humidity pan contaminants.
• Exclusive InCu SaFe™ copper-enriched stainless steel interior surfaces assure constant germicidal protection

• SANYO proprietary single-beam, dual detector infrared (IR2) CO2 sensor delivers precise CO2 control, quick recovery following door openings, and auto sampling with no moving parts.
• Continuous zero calibration is standard.

• The patented Direct Heat and Air™ conditioning system manages setpoint temperature through multiple, variable warming points under microprocessor control.
• The H2O2 decontamination 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 decontamination of the CO2 system at the same time.
• 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.

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

Intelligent Interface through Integrated LCD Control with Graphical Display

The Sterisonic™ GxP incubator is managed by an integrated microprocessor controller with LCD graphical display to simplify all incubator functions

• Stable temperature and humidity conditions are achieved through a combination of performance systems supervised by the controller complete with alarm, programming, calibration and diagnostic protocols.
• The Sterisonic™ GxP control and information center includes an intuitive pop-up menu, high resolution LCD for inputs, outputs and performance at-a-glance.
• An optional PC interface permits remote transmission for GMP/GLP protocols as required.
• Selected performance histories can be acquired in graphical format for easy interpretation.
• Precise PID logic controls and adjusts to all temperature and CO2 setpoints and alarm parameters.

Specifications/Features

Advantages:
Hydrogen Peroxide Vapor Decontamination

The use of H2O2 Decontamination 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 decontamine 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 Decontamination

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.