Pharmaceutical Purified Water System
About the design of pharmaceutical purified water system, the top issue that is being strictly evaluated is microbial control methods. Concord Technology provides suitable and complete designs to satisfy customers’ requirements on the sanitization and sterilization for purified water system, as well as stable and continuous product water quality in accordance with pharmacopoeia requirements.
Our systems comply with the requirements, codes and standards of cGMP, PIC/S GMP, BPE, FDA, GAMP, 21CFR Part II and ISPE Guideline.
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All systems are applied with fully drainable design.
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We provide designs with least dead-legs as possible.
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We provide adequate design for sanitization and sterilization in system.
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We provide complete certification documents for spec qualification.
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We provide validation protocols for the follows:
1. Design Qualification
2. Installation Qualification
3. Operational Qualification
Pretreatment System
The pretreatment system consists of multi-media filter, dual serial softener, transfer pumps and regeneration unit. It operates on a continuous basis and our design is applicable with chemical or periodic hot water sanitization for microbial control.
Generation System
Generation system is composed of soft water tank, activated carbon filter, heat exchanger, hot water sanitizable reverse osmosis and hot water sanitizable electrodeionization. It operates on a continuous basis and is designed with periodic hot water sanitization at 85℃.
Distribution System
Distribution system consists of purified water tank, distribution pump, 254nm ultraviolet and shell and tube heat exchanger. It operates on a continuous basis and is designed with periodic 85℃ hot water sanitization and 121℃ hot water sterilization.
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