Pharmaceutical
water systems can be divided, amongst other criteria, into hot and cold
systems. Many purified water systems are cold systems, subject to periodic
chemical or ozone sanitization; whereas the water of highest (and thus greatest
criticality) - Water-for-Injections (WFI) - tends to be a hot system. WFI is
produced by either distillation (Vapor Compression Distillation or Multiple
Effect Distillation), or by reverse osmosis. WFI is used for the preparation of
parenteral medicines, dialysis and irrigation solutions. Large volumes are also
consumed by the biotechnology industry for the preparation of cell culture
media. The objectives of water purification are three fold:
To
reduce the levels of the chemical components in the water to prevent
interactions with the drug substance, and to prevent toxicity to the patient.
Toxicity is possible when large volumes are either infused or used in
conjunction with dialysis.
To
reduce the microbial bioburden to the specified levels and to prevent further
proliferation.
To
remove endotoxins and to prevent their future accumulation.
On
this subject Tim Sandle has written a paper. The reference is:
Sandle,
T. (2017) Pharmaceutical Water Systems: Temperatures of Operation and
Maintaining Control, Journal of GXP Compliance,
21 (6), 11-20: http://www.ivtnetwork.com/article/pharmaceutical-water-systems-temperatures-operation-and-maintaining-control
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Pharmaceutical Microbiology Resources