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Vacuum and overpressure isolators for product, personal and environmental protection (ISO Class 5 and OEL/OEB 5)
Sterile-toxic isolators are generally used for the manufacture, dosing or filling of highly toxic substances (cytostatics) required for the treatment of carcinomas. Cytostatics are highly potent cell toxins which are generally administered intravenously. Absolutely reliable personal, environmental and product protection is consequently a vital requirement. This is guaranteed by providing a controlled and monitored vacuum within the work chamber combined with overpressure in the isolator’s interlock system. Cytostatic isolators comprise an interlock port for material entry, a working chamber and another interlock chamber for material exit. Liner tubings, containers or material chutes can be added as an option.
In line with applicable GMP requirements, cleanroom class A applies inside the working chamber.
Both before starting work and also cyclically during operation, the individual process areas and filter stages can be sterilized using hydrogen peroxide.