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Summary Water in drug formation

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Industrial pharmacy - 1st semester Includes bullet points, key diagrams and images

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  • June 8, 2023
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  • 2019/2020
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Water

Micro-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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