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Water for Pharmaceutical Use Part 3: Inspection of water systems Presented by Dr. Errol Allcoc 30 June 2005, Pretoria, South Africa Errol.Allcock@microsep.co.za 083-459 6267. Supplementary Training Modules on Good Manufacturing Practice. Objectives To understand:

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supplementary training modules on good manufacturing practice

Water for Pharmaceutical UsePart 3: Inspection of water systemsPresented byDr. Errol Allcoc 30 June 2005, Pretoria, South AfricaErrol.Allcock@microsep.co.za083-459 6267

Supplementary Training Modules on Good Manufacturing Practice

slide2
Objectives

To understand:

  • The specific requirements for inspecting water systems, including
    • the need for a Water Quality Manual
    • validation of water treatment systems
  • Water system inspection techniques
slide3
Review
  • What is the water to be used for?
    • sterile products
    • non-sterile products
    • liquid products
    • solid dose products
    • washing and rinsing
  • Check specifications and trends
slide4
WHO water treatment guidance (1)
  • All water-treatment systems should be subject to:
    • planned maintenance
    • validation
    • monitoring
  • Maintenance work should be documented

Annex 1, 17.32

slide5
WHO water treatment guidance (2)

For reliable production, water treatment plants should be:

  • Designed
  • Constructed
  • Maintained
  • Operated within design limits
  • Controlled to prevent microbial growth

Annex 1, 17.33

slide6
Prepare a checklist or an aide-memoire

and review:

  • Water Quality Manual
  • Water system drawing
  • Validation
  • Sampling procedures, locations and plan
  • Records of testing
  • Sanitation and maintenance
  • Schedules of maintenance
slide7
Reviewwater quality manual (1)
  • A water quality manual is advisable
  • A brief description of water systems is required
  • Include drawings of the purification, storage distribution system (P&ID)
slide8
Review of water quality manual (2)
  • The water quality manual should show:
    • pipelines
    • non-return (or check) valves
    • breather points
    • couplings
    • pipe slopes
    • velocities
  •  valves
  •  sampling points
  •  drain points
  •  instrumentation
  •  flow rates
  • s
slide9
Reviewwater quality manual (3)

The manual should contain:

  • Specification for each system element
  • Standard procedures for use
  • System changes
  • Routine and non-routine maintenance
  • Investigations and corrective action
  • Validation studies
slide10
Reviewwater quality manual (4)

The manual should contain

  • Chemical and microbiological specifications
  • Sampling instructions
  • Test procedures
  • Responsible persons
  • Training requirements
slide12
Reviewvalidation (1)

Validation for water systems consists of three phases

  • Phase 1: 2 – 4 weeks
  • Phase 2: 4 weeks
  • Phase 3: 1 year
slide13
Reviewvalidation (2)

Phase 1 – Investigational Phase (2 – 4 weeks)

  • DQ, IQ and OQ
  • Develop
    • operational parameters
    • cleaning and sanitization procedures and frequencies
  • Sample daily at each point of use
  • End of Phase I,develop SOPs for the water system
slide14
Reviewvalidation (3)

Phase 2 – verifying control(4 - 5 weeks)

  • Demonstrate the system is in control
  • Same sampling as in phase 1

Phase 3 – verifying long-term control (1 year)

  • PQ
  • Demonstrate the system in control over a long period of time
  • Weekly sampling
slide15
Conducting the inspection (1)
  • Take the drawing and walk around the entire system
  • Check:
    • dead legs
    • filter
    • pipes and fittings
    • DI
    • storage tanks
    • by-pass lines
  •  pumps
  •  UV lights
  •  sample points
  •  RO
  •  non return valves
  •  heat exchangers
slide16
Conducting the inspection (2)

Check:

  • Stainless steel - PVC and most plastics not recommended
  • Weld quality
  • Hygienic couplings
  • Passivation
  • Air breaks or “Tundish”
slide17
Conducting the inspection (3)
  • Check pipes and pumps
    • hygienic couplings
    • welded pipes
    • hygienic pumps
    • hygienic sampling points
    • acceptable floor
    • no leaks
slide18

Conducting the inspection (4)

Check condition of equipment

Staining on water storage tanks

Corrosion on plates of heat exchangers indicates possible contamination

slide19
Conducting the inspection (5)
  • Check maintenance records
  • Check maintenance of pump seals and O rings
slide20

Conducting the inspection (6)

  • Check air filters
  • Check integrity testing, sterilization and replacement frequency
  • Check burst discs
slide21

Softened water

out to deionizer

By-pass lines

By-pass valve

Zeolite water softener

exchanges Ca and Mg for Na

Conducting the inspection (7)

  • Carefully check by-pass valves and lines
  • These sometimes leak or are inadvertently left open
  • A blanking piece is better during operation phase
slide22
Conducting the inspection (8)

Further points to check:

  • Activated carbon bed sanitization
  • Temperature-compensated conductivity meters
  • Influence of plastic pipe adhesive on TOC
  • Non-condensable gases in pure steam
slide23
Conducting the inspection (9)

Further points to check: (Contd.)

  • Polypropylene welding inspection
    • checking pin holes
  • Retrospective validation of WFI system
  • Rouging of WFI storage systems
  • Spray ball efficacy
slide24
Conducting the inspection (10)

Further points to check (Contd.)

  • UV light – monitoring performance and

lamp life and intensity

  • Validating ozone dosage
  • Specifications for acids, alkalis for DI and sodium chloride for water softener
  • “Normally open” and “normally closed” valves
slide25
Group Session
  • You are given a schematic drawing of a water system to discuss
  • List any problems and their solutions.