Usp Purified Water System Design

The most apparent difference in this system compared to systems a b and c is the fewer number of unit operations required.

Usp purified water system design.

System d shown in figure 5 shows a vapor compression distillation based system for usp purified water generation. It is the maintainence of the water production system that is of concern to those in water treatment. Operate the system per sop for operation and maintenance of purified water system. United states pharmacopoeia usp european pharmacopoeia ph.

Fda view on water system validation sep 1985. Discussion of pretreatment part i pharmaceutical technology 1994 18 4 38 36. Usp purified water systems. High purity water systems 7 93.

Test samples for conformance to current usp water for injection monograph microbial content and endotoxin content. However it must pass the usp shelf life standards which are detailed in the folowing tables. Meltzer fda inspection guide. One of the basic considerations in the design of a system is the type of product that is to be manufactured.

Perform sampling over a 1 month period per the sampling procedure and schedule. Pharmaceutical water systems first edition 1997 theodore h. Dear fresh water systems regarding pharmaceutical grades of water purified water can be made using any suitable method.