Usp Purified Water System Design

High purity water systems 7 93.

Usp purified water system design.

Perform sampling over a 1 month period per the sampling procedure and schedule. Dear fresh water systems regarding pharmaceutical grades of water purified water can be made using any suitable method. Operate the system per sop for operation and maintenance of purified water system. Usp purified water systems.

However it must pass the usp shelf life standards which are detailed in the folowing tables. Meltzer fda inspection guide. United states pharmacopoeia usp european pharmacopoeia ph. Test samples for conformance to current usp water for injection monograph microbial content and endotoxin content.

It is the maintainence of the water production system that is of concern to those in water treatment. Pharmaceutical water systems first edition 1997 theodore h. Discussion of pretreatment part i pharmaceutical technology 1994 18 4 38 36. Design of purified water and water for injection systems hugh hodkinson engineers ireland.

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. System regulators must operate within 2 psi of design level.