Types of Water used in Pharmaceutical Processes

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.

Share

Tweet

Share

Share