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Module 2, Part 3: Inspection of water systems Slide 1 of 25 WHO - EDM Water for Pharmaceutical Use Water for Pharmaceutical Use Part 3: Inspection of water.

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Presentation on theme: "Module 2, Part 3: Inspection of water systems Slide 1 of 25 WHO - EDM Water for Pharmaceutical Use Water for Pharmaceutical Use Part 3: Inspection of water."— Presentation transcript:

1 Module 2, Part 3: Inspection of water systems Slide 1 of 25 WHO - EDM Water for Pharmaceutical Use Water for Pharmaceutical Use Part 3: Inspection of water systems Presented by Dr. Errol Allcoc 30 June 2005, Pretoria, South Africa Supplementary Training Modules on Good Manufacturing Practice

2 Module 2, Part 3: Inspection of water systems Slide 2 of 25 WHO - EDM Water for Pharmaceutical Use Objectives To understand: 1. The specific requirements for inspecting water systems, including ä the need for a Water Quality Manual ä validation of water treatment systems 2. Water system inspection techniques

3 Module 2, Part 3: Inspection of water systems Slide 3 of 25 WHO - EDM Water for Pharmaceutical Use Review l What is the water to be used for? ästerile products änon-sterile products äliquid products äsolid dose products äwashing and rinsing l Check specifications and trends

4 Module 2, Part 3: Inspection of water systems Slide 4 of 25 WHO - EDM Water for Pharmaceutical Use WHO water treatment guidance (1) l All water-treatment systems should be subject to: ä planned maintenance ä validation ä monitoring l Maintenance work should be documented Annex 1, 17.32

5 Module 2, Part 3: Inspection of water systems Slide 5 of 25 WHO - EDM Water for Pharmaceutical Use WHO water treatment guidance (2) For reliable production, water treatment plants should be: 1. Designed 2. Constructed 3. Maintained 4. Operated within design limits 5. Controlled to prevent microbial growth Annex 1, 17.33

6 Module 2, Part 3: Inspection of water systems Slide 6 of 25 WHO - EDM Water for Pharmaceutical Use Prepare a checklist or an aide-memoire and review: 1. Water Quality Manual 2. Water system drawing 3. Validation 4. Sampling procedures, locations and plan 5. Records of testing 6. Sanitation and maintenance 7. Schedules of maintenance

7 Module 2, Part 3: Inspection of water systems Slide 7 of 25 WHO - EDM Water for Pharmaceutical Use Review water quality manual (1) 1. A water quality manual is advisable 2. A brief description of water systems is required 3. Include drawings of the purification, storage distribution system (P&ID)

8 Module 2, Part 3: Inspection of water systems Slide 8 of 25 WHO - EDM Water for Pharmaceutical Use Review of water quality manual (2) l The water quality manual should show: ä pipelines ä non-return (or check) valves ä breather points ä couplings ä pipe slopes ä velocities valves sampling points drain points instrumentation flow rates s

9 Module 2, Part 3: Inspection of water systems Slide 9 of 25 WHO - EDM Water for Pharmaceutical Use Review water quality manual (3) The manual should contain: 1. Specification for each system element 2. Standard procedures for use 3. System changes 4. Routine and non-routine maintenance 5. Investigations and corrective action 6. Validation studies

10 Module 2, Part 3: Inspection of water systems Slide 10 of 25 WHO - EDM Water for Pharmaceutical Use Review water quality manual (4) The manual should contain 1. Chemical and microbiological specifications 2. Sampling instructions 3. Test procedures 4. Responsible persons 5. Training requirements

11 Module 2, Part 3: Inspection of water systems Slide 11 of 25 WHO - EDM Water for Pharmaceutical Use

12 Module 2, Part 3: Inspection of water systems Slide 12 of 25 WHO - EDM Water for Pharmaceutical Use Review validation (1) Validation for water systems consists of three phases l Phase 1: 2 – 4 weeks l Phase 2:4 weeks l Phase 3:1 year

13 Module 2, Part 3: Inspection of water systems Slide 13 of 25 WHO - EDM Water for Pharmaceutical Use Review validation (2) Phase 1 – Investigational Phase (2 – 4 weeks) l DQ, IQ and OQ l Develop ä operational parameters ä cleaning and sanitization procedures and frequencies l Sample daily at each point of use l End of Phase I, develop SOPs for the water system

14 Module 2, Part 3: Inspection of water systems Slide 14 of 25 WHO - EDM Water for Pharmaceutical Use Review validation (3) Phase 2 – verifying control (4 - 5 weeks) l Demonstrate the system is in control l Same sampling as in phase 1 Phase 3 – verifying long-term control (1 year) l PQ l Demonstrate the system in control over a long period of time l Weekly sampling

15 Module 2, Part 3: Inspection of water systems Slide 15 of 25 WHO - EDM Water for Pharmaceutical Use Conducting the inspection (1) l Take the drawing and walk around the entire system l Check: ä dead legs ä filter ä pipes and fittings ä DI ä storage tanks ä by-pass lines pumps UV lights sample points RO non return valves heat exchangers

16 Module 2, Part 3: Inspection of water systems Slide 16 of 25 WHO - EDM Water for Pharmaceutical Use Conducting the inspection (2) Check: l Stainless steel - PVC and most plastics not recommended l Weld quality l Hygienic couplings l Passivation l Air breaks or Tundish

17 Module 2, Part 3: Inspection of water systems Slide 17 of 25 WHO - EDM Water for Pharmaceutical Use Conducting the inspection (3) l Check pipes and pumps ä hygienic couplings ä welded pipes ä hygienic pumps ä hygienic sampling points ä acceptable floor ä no leaks

18 Module 2, Part 3: Inspection of water systems Slide 18 of 25 WHO - EDM Water for Pharmaceutical Use Staining on water storage tanks Corrosion on plates of heat exchangers indicates possible contamination Conducting the inspection (4) Check condition of equipment

19 Module 2, Part 3: Inspection of water systems Slide 19 of 25 WHO - EDM Water for Pharmaceutical Use Conducting the inspection (5) l Check maintenance records l Check maintenance of pump seals and O rings

20 Module 2, Part 3: Inspection of water systems Slide 20 of 25 WHO - EDM Water for Pharmaceutical Use l Check air filters l Check integrity testing, sterilization and replacement frequency l Check burst discs Conducting the inspection (6)

21 Module 2, Part 3: Inspection of water systems Slide 21 of 25 WHO - EDM Water for Pharmaceutical Use Carefully check by-pass valves and lines These sometimes leak or are inadvertently left open A blanking piece is better during operation phase Conducting the inspection (7) Zeolite water softener exchanges Ca and Mg for Na Softened water out to deionizer By-pass valve By-pass lines

22 Module 2, Part 3: Inspection of water systems Slide 22 of 25 WHO - EDM Water for Pharmaceutical Use Conducting the inspection (8) Further points to check: 1. Activated carbon bed sanitization 2. Temperature-compensated conductivity meters 3. Influence of plastic pipe adhesive on TOC 4. Non-condensable gases in pure steam

23 Module 2, Part 3: Inspection of water systems Slide 23 of 25 WHO - EDM Water for Pharmaceutical Use Conducting the inspection (9) Further points to check: (Contd.) 1. Polypropylene welding inspection ä checking pin holes 2. Retrospective validation of WFI system 3. Rouging of WFI storage systems 4. Spray ball efficacy

24 Module 2, Part 3: Inspection of water systems Slide 24 of 25 WHO - EDM Water for Pharmaceutical Use Conducting the inspection (10) Further points to check (Contd.) 1. UV light – monitoring performance and lamp life and intensity 1. Validating ozone dosage 2. Specifications for acids, alkalis for DI and sodium chloride for water softener 3. Normally open and normally closed valves

25 Module 2, Part 3: Inspection of water systems Slide 25 of 25 WHO - EDM Water for Pharmaceutical Use Group Session l You are given a schematic drawing of a water system to discuss l List any problems and their solutions.

26 Module 2, Part 3: Inspection of water systems Slide 26 of 25 WHO - EDM Water for Pharmaceutical Use Group Session


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