Clean Steam Systems in the Pharmaceutical （清洁蒸汽系统制药）.pdfVIP

www.PDH PDH Course K109 www.PDH Clean Steam in the Pharmaceutical Industry Tim Latham, M.Sc., C.Eng., MIChemE. COURSE CONTENT 1. What is Clean Steam ? Clean steam is used in the pharmaceutical and healthcare industries in processes where the steam or its condensate can come into contact with a pharmaceutical or medical product and cause contamination. In such cases, steam from a conventional boiler (often called utility or plant steam) is unsuitable because it may contain boiler additives, rust or other undesirable materials. The use of clean steam is determined by the rules of Good Manufacturing Practice (GMP). These are general rules applicable to pharmaceutical manufacture, detailed in the Code of Federal Regulations (CFR Title 21, Part 211). They do not provide any specific recommendations regarding steam, but do present the general requirements of facilities, systems, equipment and operation needed to prevent contamination of pharmaceutical products during their manufacture. 2. Uses of Clean Steam The main use of clean steam in pharmaceutical manufacturing is for the sterilization of products or, more usually, equipment. Steam sterilzation is encountered in the following processes : • Manufacture of injectable or parenteral solutions, which are always sterile. • Biopharmaceutical manufacturing, where a sterile environment must be created to grow the biological production organism (bacterium, yeast or animal cell). • Manufacture of sterile solutions, such as ophthalmic products. Typically in these processes, clean steam is injected into equipment or piping to create a sterile environment, or into autoclaves where loose Page 1 of 19 www.PDH PDH Course K109 www.PDH equipment, components (such a