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Water Part2

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WHO: Supplementary Training Modules on Good Manufacturing Practice

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Water Part2

  1. 1. Supplementary Training Modules on Good Manufacturing Practice Water for Pharmaceutical Use Part 2: Water purification and engineering WHO Technical Report Series No 929, 2005. Annex 3Water | Slide 1 of 19 January 2006
  2. 2. Water for Pharmaceutical Use Objectives To examine the basic technology and requirements for: Water treatment systems Storage and distribution requirements Sampling and testing Sanitization 6.Water | Slide 2 of 19 January 2006
  3. 3. Water for Pharmaceutical Use General  Part 1 – reviewed types of water and water purification systems  Water can be used directly, or stored in a storage vessel for subsequent distribution to points of use  Design appropriately to prevent recontamination after treatment  Combination of on-line and off-line monitoring to ensure compliance with water specification 6.1Water | Slide 3 of 19 January 2006
  4. 4. Water for Pharmaceutical Use WPU system contact materials  Contact materials include: – Pipes – Valves and fittings – Seals – Diaphragms and instruments – Tanks – Pumps, etc.  Proper selection to ensure these are suitable 6.2Water | Slide 4 of 19 January 2006
  5. 5. Water for Pharmaceutical Use WPU system contact materials (2)  Factors to consider (including components) – Compatibility and leaching effect – Corrosion resistance – Smooth internal finishing, ease of jointing – Hygienic / sanitary design – Documentation – Materials of construction (MOC) - (including original/certified copies of material certificates 6.2Water | Slide 5 of 19 January 2006
  6. 6. Water for Pharmaceutical Use WPU system contact materials (3)  Compatibility – With temperature and chemicals used in the system  Leaching effect – Non-leaching at temperature range  Corrosion resistance – PW, HPW, WFI highly corrosive – Stainless steel Grade 316L to be used – System passivated after installation and modification according to SOP 6.2Water | Slide 6 of 19 January 2006
  7. 7. Water for Pharmaceutical Use WPU system contact materials (4)  Smooth internal finish – Biofilms and microbial contamination – Crevices and roughness result in problem areas associated with contamination and corrosion – Internal finish to have arithmetical average surface roughness not greater than 0.8 micrometer arithmetical mean roughness (Ra) – Mechanical and electropolishing needed when stainless steel is used 6.2Water | Slide 7 of 19 January 2006
  8. 8. Water for Pharmaceutical Use WPU system contact materials (5)  Joints – System materials easily jointed, e.g. by welding – Process controlled including requirements such as: • Qualification of operator • documentation of welder set up • work session test pieces • weld logs • visual inspection of defined proportions of welds 6.2Water | Slide 8 of 19 January 2006
  9. 9. Water for Pharmaceutical Use WPU system contact materials (6)  Suitable materials include: – Stainless steel Grade 315 L (low carbon) – Polypropylene (PP) – Polyvinylidenedifluoride (PVDF) – Perfluoroalkoxy (PFA)  Unplasticized polyvinylchloride (uPVC) used for non- hygienic designed water treatment equipment such as ion exchangers and softeners 6.2Water | Slide 9 of 19 January 2006
  10. 10. Water for Pharmaceutical Use System sanitization and bioburden control  Systems in place to control proliferation of microbes  Techniques for sanitizing or sterilization  Consideration already during design stage – then validated  Special precautions if water not kept in the range of 70 to 80 degrees Celsius 6.3Water | Slide 10 of 19 January 2006
  11. 11. Water for Pharmaceutical Use Storage and distribution - Storage vessels  Design and size important – Serves as buffer between generation and use – Avoid inefficiencies and equipment stress during frequent on- off cycles – Short-term reserve in case of failure  Contamination control consideration – Headspace (kept wet with spray ball / distributor device) – Nozzles (no dead zone design) 6.4 – Vent filters (type, testing, use of heat) – Pressure relief valves and burst discs (sanitary design)Water | Slide 11 of 19 January 2006
  12. 12. Water for Pharmaceutical Use Storage and distribution – Pipes and heat exchangers  Continuous circulating loop needed  Filtration not recommended in loop and take-off point  Heat exchangers: – Double tube plate or double plate and frame type – Designed to ensure no stasis of water  Where water is cooled before use, done in minimum time, and validated process 6.5, 6.5.1Water | Slide 12 of 19 January 2006
  13. 13. Water for Pharmaceutical Use Storage and distribution – Circulation pumps  Sanitary design with appropriate seals  Standby pumps – Can be used – Configured or managed in a way to avoid trapped dead zones 6.5.2Water | Slide 13 of 19 January 2006
  14. 14. Water for Pharmaceutical Use Typical water storage and distribution schematic Hydrophobic air filter Feed Water & burst disc from DI or RO Cartridge filter 1 µm Spray ball Water must Optional in-line filter be kept 0,2 µm circulating UV light Outlets Heat Exchanger Ozone Generator Hygienic pump Air break to drainWater | Slide 14 of 19 January 2006
  15. 15. Water for Pharmaceutical Use Biocontamination control techniques  Continuous turbulent flow circulation – Specified velocity proven (qualification), and monitored  Avoid dead legs  Hygienic pattern diaphragm valves  Shortest possible length of pipe work  Pipe work of ambient temperature systems, isolated from hot pipes 6.5.3Water | Slide 15 of 19 January 2006
  16. 16. Water for Pharmaceutical Use Biocontamination control techniques (2) There should be no dead legs D Flow direction arrows on pipes are important Dead leg section X >1.5DIf D=25mm & distance X isgreater than 50mm, we havea dead leg that is too long Sanitary Valve Water scours dead leg Water | Slide 16 of 19 January 2006
  17. 17. Water for Pharmaceutical Use Biocontamination control techniques (3) 1. Ball valves are unacceptable 2. Bacteria can grow when the valve is closed 3. The water is contaminated as it passes through the valve Stagnant water inside valveWater | Slide 17 of 19 January 2006
  18. 18. Water for Pharmaceutical Use Biocontamination control techniques (4)  Pressure gauges separated from system membranes  Pipe work laid to fall (slope) – allows drainage  Maintain system at high temperature (above 70 degrees Celsius)  Use UV radiation – Flow rate, life-cycle of the lamp  Suitable construction material 6.5.3Water | Slide 18 of 19 January 2006
  19. 19. Water for Pharmaceutical Use Biocontamination control techniques (5)  Periodic sanitization with hot water  Periodic sanitization with super-heated hot water or clean steam – Reliable – Monitoring temperature during cycle  Routine chemical sanitization using, e.g. ozone – Removal of agent before use of water important 6.5.3Water | Slide 19 of 19 January 2006

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