Types of Water used in Pharmaceutical Processes : Pharmaceutical Guidelines

Types of Water used in Pharmaceutical Processes

Types of water in Pharmaceutical: Potable Water, Purified Water, Water for injections, Bacteriostatic Water for injections, Sterile Water for injections, Sterile water for inhalations.

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.





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.
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1 comment: Post Yours! Read Comment Policy ▼

  1. what is potable water , why using in pharmaceutical industries please explain brief ?

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