From Clean Rooms to RABS and Isolators — Design Criteria for Barrier Technologies

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Sterile Quality and Protection for Operators

The best which can be achieved between the various RABS and the isolators is the SAL (sterility assurance level) which can be achieved with an isolator. Not only are barrier technologies present, there is also an automated and safe bio-decontamination process. The American FDA tends to prefer the isolator solution to RABS.

Processes involving high-potency pharmaceuticals also raise the issue of operator protection. Again, the isolator is the safest solution in this case. An alternative could be the active cRABS, which are likewise hermetical systems with comparable leakage rates. Depending on the OEL levels (occupational exposure limit) and on other machine-related safeguards or building safety regulations, the cRABS also offer appropriate protection.

Advantages and Disadvantages of Barrier Technologies

If sterile quality and/or staff protection per se do not suggest the need for an isolator system, then additional factors will need to be considered in the decision-making process. One of the issues needing clarification include the mandatory procedures for changing clothes in connection with barrier technologies. Always installed in clean rooms, the RABS technologies dictate stringent requirements in terms of clothing which need to be met in order to be able to rule out people as potential sources of contamination. The changing process takes considerably longer for clean room staff than for isolator machine operators. The demands on the staff in terms of operating skills are also different. There are many standard operating procedures (SOPs) to be observed when working in a clean room, but they are easy to learn.

There are also further handling requirements on RABS in clean rooms concerning the transfer equipment for the pharmaceutical products and materials and also concerning the gloveboxes. The operation of an isolator machine requires yet another skill level which is considerably higher. In addition to these skills, the operator should also have an understanding of the automated processes, including those of the decontamination facilities. The advanced software which accompanies the more complex automation also increases demands on operating staff, and the required higher-level skills have to be imparted in training and teaching sessions.

The type of containment has a major influence on the flexibility of the operating procedures, not only in respect of the staff changing procedures, but also to a great extent because of the preset automated manufacturing processes on the machines and the staff access and intervention options. Doors may be opened on the RABS, if necessary, in order to clear the system, for example, rectify faults or to disinfect the system. Once the system has been disinfected and the doors have been closed, production may be resumed.

The surfaces in the RABS are usually cleaned manually. In addition, the filling systems in the RABS frequently have an automated cleaning and sterilization system (CIP/SIP). On isolator systems the doors can be opened for set-up and preparation for a batch or process. This must be followed by the mandatory automated bio-decontamination processes and CIP/SIP procedures, which take a long time. The amount of time required for particle and microbiological monitoring, however, is identical for RABS and isolators.

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