ART GmbH

Vacuum isolators for personal and environmental protection, guaranteed OEL/OEB Class 5 (< 1 μg/cbm)

Work involving highly toxic substances is performed in toxic isolators. Personal and environmental protection is consequently a mandatory requirement. The substances in question are frequently sensitive to humidity and/or oxygen, and require certain processing conditions. For cases such as these, we create customer-specific operating modes. The systems are designed and built in an ex-proof version, and this also applies to all the relevant devices and components, with explosive gas protection possible up to zone 1 and explosive dust protection up to zone 21.
The processing of toxic substances requires process machinery such as tablet presses, mills or fluid bed granulators. These process machines are integrated into the isolator or attached to it. To guarantee that no highly toxic substances are able to escape at the interface between the isolator and outside area, material transfer takes place using interlock ports or RTPs.

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.

To ensure a continuous low-particle atmosphere in the work area of open or closed RABS (Restricted Access Barrier Systems), the low-turbulence displacement flow provides practically complete coverage. Escaping aerosols and particles are captured and discharged. In order to increase product safety, the system is operated at excess pressure. Material is fed in and out using interlock ports and RTP.

The dispensing cabin provides a walkable low-particle work zone with low-turbulence displacement flow directed from top to bottom with a defined air speed. Released particles and aerosols are reliably captured and discharged using different filter stages. Adjusting tables with integrated fume hood or machines required for processing can be placed under the cabin.

Safety work benches are designed to provide personal and environmental protection. The room air is suctioned in through the work opening and discharged over the filter in the return air channel (class I safety work bench). In class II safety work benches, the low-turbulence displacement flow ensures that particles or aerosols are separated out in the filters located in the return air channel. A support jet or a sliding panel separates the work zone and the operator, preventing the escape of particles or aerosols. A class III safety work bench is a closed system under vacuum accessed using glove ports.