Barrier technologies are used in pharmaceutical manufacturing to consistently minimize the risk of microbial, particulate, and pyrogenic contamination. EU-GMP Annex 1 defines clear requirements for this purpose, particularly with regard to the safe transfer of materials into and out of such protected areas.
A central principle is to maintain the integrity of the barrier at all times and to ensure that, during transfers, no direct or indirect contact occurs between the critical interior environment and the uncontrolled external environment. Among the most important transfer systems in aseptic manufacturing practice are decontaminable material airlocks, RTP systems, and single-use connections.
All transfer systems must be validated, reproducible, and assessed on a risk-based basis with regard to contamination-free material exchange, and they must be part of a comprehensive Contamination Control Strategy (CCS).