Usp Purified Water System Design

Pharmaceutical water systems first edition 1997 theodore h.

Usp purified water system design.

United states pharmacopoeia usp european pharmacopoeia ph. One of the basic considerations in the design of a system is the type of product that is to be manufactured. High purity water systems 7 93. Dear fresh water systems regarding pharmaceutical grades of water purified water can be made using any suitable method.

Fda view on water system validation sep 1985. Perform sampling over a 1 month period per the sampling procedure and schedule. Test samples for conformance to current usp water for injection monograph microbial content and endotoxin content. Usp purified water systems.

System regulators must operate within 2 psi of design level. This design is the most common design currently used for the production of usp purified water. The most apparent difference in this system compared to systems a b and c is the fewer number of unit operations required. Design of purified water and water for injection systems hugh hodkinson engineers ireland.

It is the maintainence of the water production system that is of concern to those in water treatment. However it must pass the usp shelf life standards which are detailed in the folowing tables. System d shown in figure 5 shows a vapor compression distillation based system for usp purified water generation.