Usp Purified Water System Design

This design is the most common design currently used for the production of usp purified water.

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. Pharmaceutical water systems first edition 1997 theodore h. System d shown in figure 5 shows a vapor compression distillation based system for usp purified water generation. High purity water systems 7 93.

However it must pass the usp shelf life standards which are detailed in the folowing tables. Operate the system per sop for operation and maintenance of purified water system. Fda view on water system validation sep 1985. The most apparent difference in this system compared to systems a b and c is the fewer number of unit operations required.

It is the maintainence of the water production system that is of concern to those in water treatment. Dear fresh water systems regarding pharmaceutical grades of water purified water can be made using any suitable method. Perform sampling over a 1 month period per the sampling procedure and schedule. Usp purified water systems.

Meltzer fda inspection guide. System regulators must operate within 2 psi of design level. Design of purified water and water for injection systems hugh hodkinson engineers ireland.