Barrier systems such as RABS and isolators have become more important due to the revision of Annex 1 of the EU GMP guidelines. Their use is now required. Deviations from this requirement must be justified in the contamination control strategy (CCS).
There are various types of RABS and isolators that differ in terms of safety and cost. Barrier systems are used for sterile production in combination with a filling system, for the production of cell and gene therapeutics and for sterility testing.