For pharmaceuticals that cannot be given terminal sterilization at the end of production, the alternative of aseptic fill is available, requiring sterile materials placed in sterile containers in a cleanroom. Nonviable particles >10 µm and viable particles must be kept away from the product. Part of contamination control involves wiping the walls, tables, and equipment so as to remove contamination. Another part is disinfection. The cleaning of aseptic fill areas must be done in a systematic manner, described here, and audited for effectiveness. Removal of contaminants aids disinfection and is usually carried out by chemical means, using sterile wiping materials.
Cleaning Aseptic Fill Areas
Category: Product Knowledge
Useful details and standards concerning various aspects of sterilization are available in the recent book by the Association for the Advancement of Medical Instrumentation, covering ethylene oxide, steam, other chemical sterilants; gamma radiation; and electron beam radiation2. Background information on cleanroom microbiology is available in a new book by Carlberg3.
Cleaning the aseptic fill area is made more difficult by the variety of surfaces that need attention: barrier curtains, walls, windows, floors, ceilings, table tops, and machinery with complicated inner and outer surfaces. In what follows, general principles of cleaning and making surfaces sterile are put in the context of cleaning aseptic fill rooms.5, 6
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