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It is a very nice presentation which help to know everything about

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    Copy of poorvesh Copy of poorvesh Presentation Transcript

    • Mission Vivacare Ltd.
      Pharmaceutical Water
      Poorvesh Pancholi
      Microbiology Section
      Quality Control
      Mission Vivacare Ltd.
    • Water – The Essential Fluid
      For:
      Municipal, residential, commercial,
      institutional, industrial
      Focus on industrial:
      Chemical, petrochemical, refining, pulp and
      paper, power, food and beverage,
      pharmaceutical, and semiconductor
      manufacturing
      Water can be used as a utility, a reactant, or a
      raw material
    • Water – The Essential Fluid
      Types of Water
      Raw or Source Water
      Potable or Drinking Water
      Purified Water
      Water for Injection
      Water for Hemodialysis
      Pure Steam
      Sterile Water (Purified, WFI etc)
    • Pharmaceutical Water
      Three Major Aspects
      Regulatory
      Aspect
      Quality
      Aspect
      Engineering
      Aspect
    • Pharmaceutical Water
      Regulatory Aspects:
      No. of Regulatory Guidelines direct the Acceptance criteria, Some are:
      US-FDA
      EU
      WHO
      ISO
      BIS
      US-EPA
      ICH
    • Pharmaceutical Water
      Engineering Aspects:
      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
    • Water Generation System(In General)
      Pretreatment
      Of Raw Water
      Generation of Potable Water
      Storage of Purified Water
      Generation of Purified Water
    • Water Generation System
      Bore-well
      AKVN supply
      Raw Water Storage Tank
      To Pretreatment
    • Water Generation System
      MGF
      UF
      Softner
      UF Treated water Storage Tank
    • Water Generation System
      HI-UV
      RO
      RO
      RO
      RO
      RO
      RO
      Storage Tank
      Storage Tank
      To Osmotron
      To Utility
    • Osmotron System
      Cartridge Filter
      RO
      RO
      RO
      RO
      RO
      RO
      Storage Tank
      EDI
      HI-UV
      TOC
      User
      Points
    • Quality Aspects
      Water System Qualification is going on in our Industry, which comprise at least but not limited the following
      Design Qualification
      Installation Qualification
      Operational Qualification
      Performance Qualification
    • Quality Aspects
      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 .
      The references have been taken from various Regulatory authorities.
    • Quality Aspects
      General qualitative description of water
      Color, odor, clarity
      Quantitative measurements of water quality
      pH – hydrogen ion concentration
      ORP – oxidation-reduction potential
      Conductivity – total ionic concentration
      Dissolved oxygen – specific applications
      TOC – Total Organic Carbon
    • Quality Aspects
      Water Quality – Measurement Tools
      pH, ORP, Conductivity, DO, TOC
      Probe , electrodes based upon potentiometric methods
      Devices used must be adapted to meet ANSI/ISA 76.00.02
    • Microbial Quality Aspects
      Purified Water must be free from Specified Objectionable Microorganism viz.
      E.coli
      Salmonella
      P.aeruginosa
      S.aureus
    • Microbial Quality Aspects
      Total Aerobic Microbial Count (TAMC) Limits for different grade of waters are as follow:
      Raw Water- NMT 500 CFU/ml
      Process Raw Water- NMT 500 CFU/ml
      Potable Water- NMT 500 CFU/ml
      Purified Water-NMT 100 CFU/ml
    • Microbial Quality Aspects
      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.
    • Sanitization of the System
      Microbial control in water system is achieved primarily through sanitization practices. System can be sanitized using either Thermal or Chemical means.
      Thermal approaches to system sanitization include periodic or continuously circulation of hot water and the use of steam.
    • Sanitization of the System
      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.
    • Sanitization of the System
      In such cases a combination of routine Thermal and periodic supplementation with chemical sanitization would be more effective.
      Chemical methods, where compatible can be used on a wider verity of construction material.
    • Sanitization of the System
      Chemical methods typically employ oxidizing agents such as Hydrogen peroxide, Ozone, peracitic acid or combination thereof.
      These chemicals oxidize bacteria and Biofilms by forming reactive peroxides and free radicals.
    • Operation, Maintenance and control
      A preventive maintenance program should be established to ensure that the water system remain in the state of control. This program should include:
      Procedure for operating the system
      Monitoring Program for critical Quality Attributes
      Approved schedule for Sanitization
      Preventive maintenance of the components
      Control of changes in operation
    • Conclusion
      The system installed over here is consistently producing the water which is meeting with the regulatory requirements.
    • Pharmaceutical Water
      Questions??
    • Pharmaceutical Water
      Thank You