Usp Purified Water System Design

However it must pass the usp shelf life standards which are detailed in the folowing tables.

Usp purified water system design.

One of the basic considerations in the design of a system is the type of product that is to be manufactured. The most apparent difference in this system compared to systems a b and c is the fewer number of unit operations required. Operate the system per sop for operation and maintenance of purified water system. This design is the most common design currently used for the production of usp purified water.

Perform sampling over a 1 month period per the sampling procedure and schedule. Discussion of pretreatment part i pharmaceutical technology 1994 18 4 38 36. System d shown in figure 5 shows a vapor compression distillation based system for usp purified water generation. Fda view on water system validation sep 1985.

Test samples for conformance to current usp water for injection monograph microbial content and endotoxin content. 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. United states pharmacopoeia usp european pharmacopoeia ph.

It is the maintainence of the water production system that is of concern to those in water treatment. System regulators must operate within 2 psi of design level. Usp purified water systems.