《water2_0506》.ppt

Water for Pharmaceutical Use Part 2: Water purification engineering Presented by Dr. Errol Allcoc 30 June 2005, Pretoria, South AfricaErrol.Allcock@microsep.co.za083-459 6267 Supplementary Training Modules on Good Manufacturing Practice Objectives To examine the basic technology and requirements for: Water treatment systems Storage requirements Sampling and testing Different types of water used in pharmaceuticals Microbial limits, disinfection Water system design Pipes sloped so water does not pool and can drain easily Sanitary fittings connections Constructed of suitable materials such as stainless steel Circulate the water Incorporate non-return valves (NRV) Further water treatment purification stages downstream of the pre-treatment system Filtration Disinfection Reverse osmosis or de-ionization Distillation or ultra-filtration Water system design (1) There should be no dead legs Sanitary pumps Clamps and O rings  versus threaded fittings Heat exchangers Side arm level measuring devices are unacceptable Up and Down Flow SEM of Ion-Exchange Resin Bead Ion-Exchange Resin Bead model Use of reverse osmosis Advantages Disadvantages Many uses purified water feeding of distillation units or ultra-filtration units Water for Final Rinse Water for Injections (if permissible) Ultra-filtration Can be used for WFI or for Water For Final Rinsing for parenteral manufacturing (if permitted) Removes organic contaminants, such as endotoxins Operation at 80°C, and sterilization at 121 °C Ultrafilters are asymetric membranes, sometimes composite Under pressure,small size molecules go through the membrane,whereas molecules larger then the NMWL are retained Single-effect distillation simple distillation, single effect vapour compression, thermo compression Multi effect distillation multiple effect stills Clean steam generators used where steam can come into contact with product contact surfaces, e.g. sterilization-in-place (SIP)