Summary
Summary Water in drug formation
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Industrial pharmacy - 1st semester Includes bullet points, key diagrams and images
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WaterMicro-organisms
Used for preparations, washing and cooling
Found in fresh water- Pseudomonas and Flavobacterium
Rainfall- B megaterium and Enterobacteria
Sewage- E coli and Strep
Most are gram negative
Pharmacopoeal Water
Purified water in bulk
Purified water in containers
Highly purified water
Water for injection in bulk
Sterile water for injection
Water BET (bacterial endotoxin test)
Uses
Mains water used to wash bulk chemicals, remove impurities or reaction
products
De-ionised water used for washing equipment
Purified water- used for preparations (not sterile)
Highly purified water- next grade for preparations (not sterile)
Water for injections in bulk- used for parenteral preparations
Sterile water for injection- used for dissolving substances for preparations or
parenteral formulations
Water BET- BP endotoxins test or water for injection
Water Preparation
Deionised- mains water passed through anion and cation exchange resin.
Doesn’t remove bacterial count and can sometimes increase it as they aren’t
cleaned
Reverse osmosis- mains water passed through semi-permeable membrane
(mw>250). This removes microorganisms and pyrogens
Distillation- water vapour condensed so microbial and chemically pure. Usually
passed through deioniser and reverse osmosis too
Water Distribution
Water storage must also be sterile/clean
Design features to prevent contamination:
Constant circulation at positive pressure
Sanitary fittings
Maintain temperature above 80 degrees
Use non-chemical disinfection like UV 254nm
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