HACCP AND LIMITATION OF RISKS IN CLEAN ZONES

摘要

Hazard analysis can be applied to cleanroom processes, but requires an understanding of the cleanroom and the clean zone, their function, the air flow pattern, and airborne dispersion of contaminants as well as knowledge about the flow of the product, people and material and the process itself. The method for limitation of risks (LR-Method) can be used as a tool in the HACCP work for identification and assessment of potential airborne microbiological risks and for identification of critical control points. Practical examples from aseptic manufacturing of sterile drug products are discussed.