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

Related Vendors

Comparison of Investment Costs

Does the customer already have clean rooms? Investment must be made in building services and HVAC systems in order to be able to acquire the class B clean room standards required for RABS lines. Building-related investment costs for RABS systems are high and have to be allocated to the costs for the RABS equipment. However, a comparison of the pure machine investment costs — in isolation from the building costs — shows that RABS are cheaper than isolator systems.

In terms of operating costs, it is not only the time-consuming clothes-changing procedures with RABS which are of consequence. Account must also be taken of the monitoring costs in this regard, and especially the energy costs for the HVAC building services, which make a noticeable difference. Frequent format changeovers accompanied by the mandatory time-consuming decontamination cycles are a factor with isolators, however, and one which can quickly drive up operating costs. Validation costs in connection with the installation of an isolator system are high, mainly because the automatic decontamination equipment also has to be checked and validated.

In addition, isolator machines are automated systems involving a high degree of complexity with correspondingly high validation costs. The transfer processes for products and materials have to be demonstrated and evaluated for both systems, including the RABS.

* J. Rothbauer and J. Schäfer are both managing directors at Optima Group Pharma, Schwäbisch Hall.

(ID:28173300)