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.
Related:
Water for Injection System Validation Protocol
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.
what is potable water , why using in pharmaceutical industries please explain brief ?
ReplyDelete