Discussion on the Process Design of Pharmaceutical Purified Water Systems from the Perspective of Microbial Control
Microbial contamination is a major problem in the application of pharmaceutical purified water.Microorganisms can attach to solid surfaces and form biofilms by producing extracellular polymers,which can reduce the filtration efficiency of filtration units.They may also detach and enter the purified water distribution system,posing a risk to the quality and safety of pharmaceutical products.Therefore,it is necessary to explore methods for optimizing the current pharmaceutical purified water system process from the perspective of the three major factors influencing microbial growth in such systems:the surface area of the filtration media,the adsorbed nutrients,and the quantity of planktonic microorganisms.This exploration,combined with the concept of quality by design(QbD),aims to provide valuable insights and references for pharmaceutical manufacturers in addressing microbial control issues in pharmaceutical purified water systems.
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