Usp Purified Water System Design

Discussion of pretreatment part i pharmaceutical technology 1994 18 4 38 36.

Usp purified water system design. System d shown in figure 5 shows a vapor compression distillation based system for usp purified water generation. The most apparent difference in this system compared to systems a b and c is the fewer number of unit operations required. Perform sampling over a 1 month period per the sampling procedure and schedule. It is the maintainence of the water production system that is of concern to those in water treatment.

This design is the most common design currently used for the production of usp purified water. Meltzer fda inspection guide. United states pharmacopoeia usp european pharmacopoeia ph. High purity water systems 7 93.

Test samples for conformance to current usp water for injection monograph microbial content and endotoxin content. Design of purified water and water for injection systems hugh hodkinson engineers ireland. Fda view on water system validation sep 1985. System regulators must operate within 2 psi of design level.

However it must pass the usp shelf life standards which are detailed in the folowing tables. Pharmaceutical water systems first edition 1997 theodore h. Operate the system per sop for operation and maintenance of purified water system.