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  1. 1. Mission Vivacare Ltd.<br />Pharmaceutical Water<br />Poorvesh Pancholi<br />Microbiology Section<br />Quality Control <br />Mission Vivacare Ltd.<br />
  2. 2. Water – The Essential Fluid<br />For:<br /> Municipal, residential, commercial,<br /> institutional, industrial<br />Focus on industrial:<br /> Chemical, petrochemical, refining, pulp and<br /> paper, power, food and beverage,<br />pharmaceutical, and semiconductor<br /> manufacturing<br /> Water can be used as a utility, a reactant, or a<br />raw material <br />
  3. 3. Water – The Essential Fluid<br />Types of Water<br />Raw or Source Water<br />Potable or Drinking Water<br />Purified Water<br />Water for Injection<br />Water for Hemodialysis<br />Pure Steam<br />Sterile Water (Purified, WFI etc)<br />
  4. 4. Pharmaceutical Water<br />Three Major Aspects<br />Regulatory<br />Aspect<br />Quality<br />Aspect<br />Engineering<br />Aspect<br />
  5. 5. Pharmaceutical Water<br />Regulatory Aspects:<br /> No. of Regulatory Guidelines direct the Acceptance criteria, Some are:<br />US-FDA<br />EU<br />WHO<br />ISO<br />BIS<br />US-EPA <br />ICH <br />
  6. 6. Pharmaceutical Water<br />Engineering Aspects: <br /> In Mission Vivacare, we are having Water Generation and Distribution system, which complies the overall requirement of Pharmaceutical Water. Our system is having number of different components which are consistently producing the desired Quality of Purified Water <br />
  7. 7. Water Generation System(In General)<br />Pretreatment<br />Of Raw Water<br />Generation of Potable Water<br />Storage of Purified Water<br />Generation of Purified Water<br />
  8. 8. Water Generation System<br />Bore-well<br />AKVN supply<br />Raw Water Storage Tank<br />To Pretreatment<br />
  9. 9. Water Generation System<br />MGF<br />UF<br />Softner<br />UF Treated water Storage Tank<br />
  10. 10. Water Generation System<br />HI-UV<br />RO<br />RO<br />RO<br />RO<br />RO<br />RO<br />Storage Tank<br />Storage Tank<br />To Osmotron<br />To Utility<br />
  11. 11. Osmotron System<br />Cartridge Filter<br />RO<br />RO<br />RO<br />RO<br />RO<br />RO<br />Storage Tank<br />EDI<br />HI-UV<br />TOC<br />User <br />Points<br />
  12. 12. Quality Aspects<br />Water System Qualification is going on in our Industry, which comprise at least but not limited the following<br />Design Qualification<br />Installation Qualification<br />Operational Qualification<br />Performance Qualification<br />
  13. 13. Quality Aspects<br />Our QC unit having the SOP’s, Spec’s, STP’s, GTP’s etc for Sampling and analysis of Water, which have been prepared and approved by well trained qualified peoples . <br />The references have been taken from various Regulatory authorities.<br />
  14. 14. Quality Aspects<br />General qualitative description of water <br />Color, odor, clarity<br />Quantitative measurements of water quality <br /> pH – hydrogen ion concentration<br /> ORP – oxidation-reduction potential <br /> Conductivity – total ionic concentration<br /> Dissolved oxygen – specific applications<br /> TOC – Total Organic Carbon<br />
  15. 15. Quality Aspects<br />Water Quality – Measurement Tools<br />pH, ORP, Conductivity, DO, TOC<br />Probe , electrodes based upon potentiometric methods <br />Devices used must be adapted to meet ANSI/ISA 76.00.02<br />
  16. 16. Microbial Quality Aspects<br /> Purified Water must be free from Specified Objectionable Microorganism viz.<br />E.coli<br />Salmonella<br />P.aeruginosa <br />S.aureus<br />
  17. 17. Microbial Quality Aspects<br />Total Aerobic Microbial Count (TAMC) Limits for different grade of waters are as follow:<br />Raw Water- NMT 500 CFU/ml<br />Process Raw Water- NMT 500 CFU/ml<br />Potable Water- NMT 500 CFU/ml<br />Purified Water-NMT 100 CFU/ml<br />
  18. 18. Microbial Quality Aspects<br />Our system is having 24 Hrs. re-circulation of purified water, which prevent the generation of Biofilms. The system is free from the dead legs. Sampling techniques applied here are made to prevent any environmental contamination.<br />
  19. 19. Sanitization of the System<br />Microbial control in water system is achieved primarily through sanitization practices. System can be sanitized using either Thermal or Chemical means.<br />Thermal approaches to system sanitization include periodic or continuously circulation of hot water and the use of steam.<br />
  20. 20. Sanitization of the System<br />Although the Thermal approach of sanitization control the generation of Biofilm, they are not effective in removing established Biofilms. Killed but intact Biofilm may serve as a nutrient for upcoming Microbes within the system and they can form a new Biofilm, if the sanitization condition removed or halted. <br />
  21. 21. Sanitization of the System<br />In such cases a combination of routine Thermal and periodic supplementation with chemical sanitization would be more effective. <br />Chemical methods, where compatible can be used on a wider verity of construction material.<br />
  22. 22. Sanitization of the System<br />Chemical methods typically employ oxidizing agents such as Hydrogen peroxide, Ozone, peracitic acid or combination thereof. <br />These chemicals oxidize bacteria and Biofilms by forming reactive peroxides and free radicals. <br />
  23. 23. Operation, Maintenance and control<br />A preventive maintenance program should be established to ensure that the water system remain in the state of control. This program should include:<br />Procedure for operating the system<br />Monitoring Program for critical Quality Attributes<br />Approved schedule for Sanitization<br />Preventive maintenance of the components<br />Control of changes in operation<br />
  24. 24. Conclusion<br />The system installed over here is consistently producing the water which is meeting with the regulatory requirements. <br />
  25. 25. Pharmaceutical Water<br />Questions??<br />
  26. 26. Pharmaceutical Water <br />Thank You<br />