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Pharmaceutical Water Systems

Pharmaceutical Water Systems. Alain Kupferman. Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors, Nanjing, November 2009. FACTORS CONTRIBUTING TO QUALITY PRODUCTS. Personnel. Validated processes. Procedures. Water for Pharmaceutical Use PW HPW WFI CS.

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Pharmaceutical Water Systems

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  1. Pharmaceutical Water Systems Alain Kupferman Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors, Nanjing, November 2009

  2. FACTORS CONTRIBUTING TO QUALITY PRODUCTS Personnel Validated processes Procedures Water for Pharmaceutical Use PW HPW WFI CS Raw Materials Equipment PackingMaterials Environment Premises

  3. PREREQUISITES FOR OPERATION AND (RE)QUALIFICATION As usual……Good designGood engineeringGood executionGood operationGood documentationandGood maintenance

  4. DEFINING THE NEEDS • Regulatory (Pharmacopeia)PWHPWWFI EU ? PICS ? FDA ? • User requirements • Data on raw water

  5. DEFINING THE NEEDS: WHICH TYPE OF WATER WHERE ? • Regulatory (Pharmacopeia)PWHPWWFI EU ? PICS ? FDA ? • Regulatory (EMEA)

  6. DEFINING THE NEEDS: WHICH TYPE OF WATER WHERE ?

  7. GMP + GEP • Drainability : slopes • Flow speed • In-process controls, sampling points • Valves and accessories • Size of generator(s) and storage tanks • Critical parameters handling • Etc.

  8. USER REQUIREMENTS • Quantitative data: how much when ? • Installation type: IE, RO, double RO, EDI Multi-effect, thermocompression,.. • Loop type and storage: hot, cold, mixed, multiple fixed or variable speed pump deadlegs, valve types, … • Sanitisation: heat, chemical, ozone • Materials: stainless steel ? + treatment • Heat exchangers: type

  9. QUALIFICATION ITEMS Critical parameters handling I C R A Base for instrumentation qualification

  10. QUALIFICATION ITEMS IQ • Inspection of mechanical installation and documentation (manuals, data sheets, components certificates) • System installed in accordance with P&I diagram • Check of components (agree with description in components list) • Gap between waste water and drain • Dead legs in distribution system (6D, 3D, 1,5 D ???) FDA not having an unused portion greater in length than six diameters of the unused pipe measured from the axis of the pipe in use WHO Deadlegs in the pipework installation greater than 1,5 times the branch diameter should be avoided

  11. GMP + GEP CALCULATION Size of generator(s) and storage tanks

  12. QUALIFICATION ITEMS IQ • Welding documentation (material certificates for pipes and fittings, FDA certificates for gaskets)Isometric drawings with weld numbersWelded seam documentation (machine protocols)Welder approval test certificatePickling and passivation protocolEndoscopic photosAnalytical certificate of inert gas

  13. QUALIFICATION ITEMS OQ • Calibration of measuring equipment (Pressure, temperature, conductivity) • Leak test • Operation of softener (residual hardness, regeneration) • Operation of RO plant (flow rates, conductivity) • Operation of bisulphite dosing (if required) • Function of regulating circuits in RO plant • Operation of ozone generator and ozone meter (ozone concentration) • Operation of UV unit (Ozone concentration, intensity of light) • System parameters and limit-value settings • Flow rate (Reynolds value) • Water quality (conductivity, microbiological situation, TOC)

  14. QUALIFICATION ITEMS OQ • Gradients in distribution system • Drainability of distribution system • Inspection of electrical hardware • Emergency-off switch • Analogue inputs and outputs • Program steps disinfection softener, RO • Program steps sanitisation softener, RO, EDI, loop • Alarms • Access rights, passwords

  15. PERFORMANCE QUALIFICATION 3-phased approach Phase I (2-4 weeks) Water is not used for production purposes

  16. PERFORMANCE QUALIFICATION 3-phased approach Phase II (2-4 weeks) Same sampling scheme as phase I Water can be used for production purposes

  17. PERFORMANCE QUALIFICATION 3-phased approach Phase III (50 weeks) Water can be used for production purposes

  18. SUBSEQUENT PERIODS • Continuous system monitoring • Maintenance (preventative) • System reviews trending, performance, changesfailures, investigations, OOS, etc.

  19. Questions, please…. ?

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