Follow
1. Potable Water:
=>> Used in early stages of chemical synthesis
=>> Used Early stages of Equipment Cleaning
=>> Sources: Public water supply, wells or combination of > 1 of these
=>> Must meet Requirements of USEPA (40 CFR 141)
=>> Seasonal variations in quality may occur and must be considered for treatment before usage.
2. Purified Water:
=>> Used as excipients in the manufacturing of pharmaceuticals.
=>> Used for Equipment Cleaning esp. product contact surfaces of nonsterile chemicals.
=>> Preparation of bulk chemicals.
=>> Prepared using potable water as feed.
=>> Types of Purification: Deionisation, Distillation, Ion exchange, Reverse Osmosis, Filtration.
=>> Must meet ionic, organic chemical and microbial requirements.
=>> Systems that produce, store and circulate water under ambient conditions are susceptible to biofilms. This can be avoided by frequent sanitization and monitoring.
3. Water for injections:
=>> Used as an excipient in the manufacturing of potentials.
=>> Used for Equipment Cleaning esp. product contact surfaces of sterile products.
=>> Preparation of sterile bulk chemicals.
=>> Prepared using purified water as feed.
=>> Method of preparation is multicolumn distillation.
=>> Must meet ionic, organic chemical, microbial and endotoxins requirements.
=>> Factors like microbial contamination and endotoxins should be controlled by circulation, frequent sanitization and monitoring.
4. Bacteriostatic Water for injections:
Contains added preservatives.
5. Sterile Water for injections:
Packaged and rendered sterile used for reconstitution of dry powder injections.
6. Sterile water for inhalations:
For inhalation solutions.
