Advancing Cleanroom Contamination Control Strategies with Automation and AI: Current Status and Future perspectives in the Manufacturing of Parenterals

Abstract

Contamination in parenterals affects products’ critical quality attributes and patient safety. lapses are frequently noticed, leading to product recalls. The most recent Annex-1 guidance expects manufacturers of parenteral products to evolve with a holistic contamination control strategy covering unit operations, processes and activities. The operation segments in cGMP environment are described wholly under 6M’s (Men, material, machines, Methods/processes, Mother nature/environment and Measurement/ controls) and their respective subfunctions. We discussed the role of critical controls to validate the process The need for automated equipment compliant with GAMP 5, the focus areas requiring technological advancement using artificial intelligence (AI) are discussed. Novel automation controls that can be installed in existing manufacturing units and the corresponding outcome for an improved CCS is summarized.