The pharmaceutical industry has particular demands over the facilities it uses. Its cleanrooms have to meet demanding specifications in terms of maintaining cleanliness, air-tightness and temperature to limit and control microbiological, chemical and particle contamination. The sector has to meet ultra-clean, aseptic and controlled environmental conditions in accordance with a raft of clean room standards for good manufacturing practice. The key ISO14644:1999 standard has been revised recently with a view to simpler calculation of cleanroom classification and introduction of random sampling of airborne particles, rather than a grid-based approach to each location. Pharmaceutical manufacturers often also have to comply with the American FDA and EMA guidance documentation, and there are moves towards better harmonisation in global facility design and a wider breadth of regulatory compliance internationally. The underlying MHRA clean room compliance document is the Orange Guide within the European Eurendex guidelines for pharmaceutical manufacture. This offers very comprehensive guidance to all aspects of cleanroom design.
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