Development of the Industry’s Fastest Cell Culture CO2 Incubator Decontamination Process Using H2O2
The value of the laboratory cell culture incubator used in highly regulated research and clinical protocols is directly related to the proportion of incubator uptime vs. downtime.
Advantages to H2O2 Decontamination
The value of the laboratory cell culture incubator used in highly regulated research and clinical protocols is directly related to the proportion of incubator uptime vs. downtime in applications where frequent interior chamber decontamination is required or desired. The need for interior decontamination before initiating new applications for in vitro fertilization, stem cell research and regenerative tissue culture is more frequent than longer-term cell culture work. The return on investment favors short, laborsaving decontamination cycles with validation of the decontamination process for GMP applications.
The use of a hydrogen peroxide vapor (H2O2) atomizer in situ to decontaminate the cell culture CO2 incubator without the use of heat decontamination offers significant advantages in routine clinical and highly regulated research laboratories where costly downtime must be avoided. The combination of a sevenminute H2O2 vapor fog in the chamber, circulated by the incubator airflow blower, followed by exposure to narrow-bandwidth ultraviolet light establishes a thorough antimicrobial impact on all incubator walls, shelves, reservoirs, air plenums, sensors and other interior components without the time and expense of high heat cycles, leaving only small amounts of sterile water droplets as a residual. Because all interior components are designed to remain in the chamber for decontamination during the process, use of a separate autoclave is avoided and the incubator can be returned to service in less than three hours.
In 2009, SANYO Biomedical Solutions introduced the Sterisonic™ GxP MCO-19AIC(UVH) cell culture CO2 incubator with H2O2 vapor decontamination. The Sterisonic™ GxP complements the company’s proactive in situ contamination control systems first marketed in 2001. In a layered and orchestrated approach to cell culture incubation predicated on good laboratory technique, the addition of H2O2 vapor to an extensive arsenal of existing contamination control techniques, both passive and active, confronts a wide range of laboratory conditions and culture applications.
Independent Test Results
Independent testing commissioned by SANYO supports the efficacy of the concentric contamination control technique based on H2O2 vapor followed by ultraviolet light exposure to render the H2O2 to trace amounts of sterile water and oxygen. The decontamination of the inner chamber of the incubator by hydrogen peroxide gas was verified with no BI (biological indicator) growing as observed in every BI collected from all setting locations inside the chamber. While a proposed ISO standard 11138-612 is under consideration by the association for the Advancement of Medical Instrumentation, standards for the use of EtO have been suggested for H2O2 protocols.
The SANYO Sterisonic™ GxP Model MCO- 19AIC(UVH) incorporates a series of internal systems, processes and design factors that work together to maintain a multi-layered defense against contamination. Integration of a safe and effective two-hour decontamination process, the fastest in the industry, using an H2O2 vapor atomizer offers total decontamination of all interior surfaces and return to service more quickly than conventional incubators that use high heat decontamination.
For additional product details visit: www.sterisonic.com