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Home » FDA SPELLS OUT RULES FOR STERILE DRUG FIRMS
FDA SPELLS OUT RULES FOR STERILE DRUG FIRMS
October 1, 2004
Maintaining the highest degree of environmental control, limiting the exposure of sterile product elements, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance.