THE GUIDING PRINCIPLES FOR PHARMACEUTICAL WATER SYSTEMS DESIGN

WATER SYSTEMS ARE ALWAYS A MAJOR AREA OF INTEREST DURING REGULATORY INSPECTIONS, AND STILL REPRESENT A SIGNIFICANT CAUSE OF MANY NON-COMPLIANCE ISSUES.

- RAHEEL SHAH

WATER IS USED THROUGHOUT THE pharmaceutical industry raw material, a process intermediate, a product ingredient and in the manufacturing of active pharma ingredients, intermediates and analytical reagents. Its wide use in many applications demands that manufacturers look very closely at regulatory requirements, specifications, purification methods, installation and validation.

Its usage as a diluent for reconstitution of products, vehicle during synthesis, ingredient as per composition, during the production of the finished product is also well established. Wide usage of water as a cleaning agent for rinsing vessels, equipment, primary packaging materials, etc.

The emphasis on the type of water used determines the quality of the water required and the guiding principle for the water processing system. Accordingly, usage of water can be broadly classified into the following categories:

1. Raw Water, for General purpose usage

2. Treated Water for drinking & Cleaning purposes

3. Purified water for Non-Aseptic formulations

4. Pyrogen-free WFI(water for injection) for Aseptic formulations

Therefore, special care and attention must be taken to ensure that the water used meets the required standard quality and that the purification process is designed suitably.

Water received from the corporation or drawn from the bore well is not used directly for any processes but is suitably treated before use and based on its classification. It is imperative to have the water tested & ensure it meets the specification in respective categories.

GENERAL PRINCIPLES FOR PHARMACEUTICAL WATER SYSTEMS

To ensure the appropriateness of water quality as per the usage, pharmaceutical water processing, storage, and distribution systems must be designed, installed, and qualified before use and essentially maintained following the stipulated guidelines.