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 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 bio films. This can be avoided by frequent sanitization and monitoring.
3. Water for injections:· Used as excipient in 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.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question
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