Bio-decontamination Within The Efficiency of Esco BioVap™ Inside the Isolators
Esco BioVap™ is a bio-decontamination system that utilizes atomized hydrogen peroxide to decontaminate the chamber and the equipment prior and after operations. The atomization of the hydrogen peroxide is achieved through simultaneous injection of the solution and pressurized air thereby delivering a fine mist that will saturate the chamber. After injection, the solution is allowed to “dwell” to increase contact time thereby efficiently utilizing antimicrobial the activity. Finally, filtered air is allowed to enter the chamber after the excess hydrogen peroxide has been exhausted, until the concentration reaches the safe level of about <1 ppm.
Esco validation specialists with the help of the in-house microbiologists, have proved that the Esco BioVap™ can decontaminate not only the nominal part of the cabinet but also the hard-to-reach areas. Hard-to-reach areas are identified as the chamber’s corners and gloves, and the inner surface of the labware inside the isolator.
For the experiment, erlenmeyer flask (left) was used as a sample laboratory glassware since it can be contaminated easily because of its “wide-mouth” opening. The chemical indicator (3M of Hydrogen Peroxide) was placed inside the flask. The biological indicator attached in the inner areas of the gloves was inoculated with 6 log of Geobacillus stearothermophilus.
The biological and the chemical indicators are either on different sampling points. The chemical indicator is placed in the labware while the biological indicators are placed in the various points of the cabinet as shown below:
For this experiment, the bio-decontamination cycle using Esco BioVap™ took 113 minutes from the priming until the aeration.
After the cycle was finished, all the indicators were removed. The results obtained have no significant different to the passing criteria. Change of colors are observed in the chemical indicators and no turbidity is seen on all of the biological indicators, hence, there are no contamination observe.
The Esco BioVap™ is effective for the overall decontamination of the isolators. There are no growth of microorganisms observed,since no turbidity took place (left photo) and changed of colors (right photo) is obtained from the chemical indicator.
The results indicated that the H2O2 mist injected by the Esco BioVap™ could reach all the sampling points and saturate the cabinet enough to kill 6 log of Geobacillus stearothermophilus spore even on the inner part of the labware. Although the H2O2 generated by the Esco BioVap™ is not in a gas phase, due to the pressured air, the fine mist injected from the nozzle of the Esco BioVap™ was distributed evenly during the injection phase.
The experiment has established that Esco BioVap™ with atomized hydrogen peroxide system can decontaminate hard-to-reach areas of the isolator such as its corners, gloves, and insides of labware inside the isolator.
Esco BioVap™ is developed to be flexible enough to work in all areas, from cabinets and transfer hatches up to modular enclosures to isolator to meet all the customers’ process and product requirements. No pre-conditioning is needed, thus, reducing the bio-decontamination cycle.
A General Processing Platform Isolator (GPPI) integrated with Esco BioVap™.