Water-Microbiology 水中微生物-微生物学.ppt

Pharmaceutical Microbiology PM22 * Pharmaceutical Water Systems Sylvia Healy Pharmaceutical Microbiology PM22 * These lectures Types of water used in pharmaceutical manufacturing Standards Components of water purification system Water treatment: Deionisation, reverse osmosis and distillation Water storage and distribution Water system design Water testing Pharmaceutical Microbiology PM22 * Pharmaceutical Water There are various types of water used in pharma industry. May be used in: formulation, processing operations (e.g. cooling, cleaning, sterilisation) Final rinsing of product contact surface. Different grades required depending on use and type of product Water classified based on its source, quality (chemical and microbiological purity), treatment and use. Note that water also required for microbial growth. Pharmaceutical Microbiology PM22 * Water types 3 main types used in pharma industry: Potable water: Ordinary drinking water from mains (tap water) Fit to drink but not usually suitable for pharma applications, especially manufacture of sterile products. Contains wide range of dissolved solids and gases – harmless if swallowed, but potentially harmful if injected, could also interact with product. Has variable degree of hardness and added Cl for microbial control. Pharmaceutical Microbiology PM22 * Water Types (contd) Purified water: Specifications for purified water contained in British Pharmacopoeia (BP), EP and USP that describe chemical purity limits. Not necessarily sterile, therefore not suitable for manufacture of parenterals. Used for non-parenteral product formulation Can also be used as initial cleaning agent for some processes. Usually prepared from potable water by deionisation, which removes dissolved substances. May also be produced by distillation or reverse osmosis Pharmaceutical Microbiology PM22 * Water types (contd): Water for Injections (WFI): Standards contained in BP, EP and USP Prepared from potable or purified water by distillation.