GMP water system

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Water System: 

Water System Supaporn Phumiamorn 17-18 Jan, 2006 GMP course


Topic Water system - Objectives and Principles - Storage, Treatment - Contaminants, Sampling Water system inspection


Objectives - Introduction to water for pharmaceutical use - Sources and types of water for pharmaceutical use - Storage of bulk, untreated raw water - Pre-treatment of water

Principles : 

Principles Like any starting material, water must conform to GMP norms. It must be “potable and comply with WHO guidelines for drinking-water quality.


Potential for microbial growth Systems must be properly validated Water for parenteral use could not be contaminated with pyrogens or endotoxins Specifications and periodic testing is required Principles

Water hardness: 

Water hardness Water hardness mg/L or ppm Classification as CaCO3 Soft 0-60 Moderate 61-120 Hard 121-180 Very hard >180

Raw water storage: 

Raw water storage May be required prior to pre-treatment according to local circumstances Check material of construction - Concrete, steel are acceptable but check corrosion - Plastics or plastic linings may leach

Raw water storage: 

Check cover - to keep out insects, birds and animals Check contamination Raw water storage


Water for Injections – PFW & WFI Softened Water Water for Final Rinse Pure, or Clean Steam Purified Water Water for Cooling Autoclaves Types of water used in pharmaceutical processes

Pre-treatment steps : 

Pre-treatment steps Primary filtration and multi-media filter Coagulation of flocculation Desalination Softening


Water pre-treatment complex External raw water storage Pretreatment room

Chlorine removal: 

Chlorine removal Activated-carbon (AC) filtration or bisulphite AC removes chlorine but bacteria can then grow. AC filtration can remove organic impurities. Bisulphite leaves sulphate residues but is anti-microbial.

Why purify raw water?: 

Why purify raw water? Although reasonably pure, it is always variable Seasonal variations may occur in water Some regions have very poor quality water Must remove impurities to prevent product contamination. Control microbes to avoid contaminating products

Contaminants of water (1) : 

Contaminants of water (1) There is no pure water in nature, as it can contain up to 90 possible unacceptable contaminants Contaminant groups: Inorganic compounds Organic compounds Solids Gases Micro-organisms

Contaminants of water (2): 

Contaminants of water (2) Treatment depends on water’s chemistry and contaminants, influenced by: 1. Rainfall 5. Evaporation 2. Erosion 6. Sedimentation 3. Pollution 7. Decomposition 4. Dissolution

Contaminants of water (3): 

Contaminants of water (3) Problem minerals Calcium and magnesium Iron and manganese Silicates Carbon dioxide Hydrogen sulfide Phosphates


Further problem minerals Copper Aluminium Heavy metals Arsenic, lead, cadmium Nitrates Contaminants of water (4)


Micro-organisms – Biofilm Algae Protozoa Cryptosporidium Giardia Bacteria Pseudomonas Gram negative, non-fermenting bacteria Escherichia coli and coliforms Contaminants of water (5)


raw water in « S” trap to sewer Water is kept circulating To water softener & DI plant Pretreatment – schematic drawing cartridge filter 5 micrometers activated carbon filter spray ball break tank air break to drain centrifugal pump air filter float operated valve sand filter excess water recycled from deioniser


Plumbing chlorination S S S S Pre-treatment Distillation Holding Take  80oc S Pump S S S Source water * S: Sampling . 1.Filtration -Sand filter -Charcoal filter -Cartridge filter 2. Primary water treatment Water solftener Deionizer Reverse Osmosis


Water Softener – schematic drawing

Water purification: 

Water purification Cartridge filtration RO / Deionizer

Water purification: 

Water purification Remove particles, bacteria, pyrogen, organic, inorganic ions and silica Reverse Osmosis

Water purification: 

Water purification Deionization Remove organic, inorganic ions, silica and carbon dioxide

Water purification: 

Water purification Distillation Remove particles, bacteria, pyrogen, organic, non-volatile, inorganic ions and silica for WFI

Water purification: 

Water purification Ultrafiltration Kill bacteria and breakdown TOC


Auto DI RO/Auto DI 2 stages RO Purified water


-Conductivity meter - pH meter -Temperature meter(80oC) -Alarm meter


Sampling There must be a sampling procedure. Sample integrity must be assured. Sampler training Sample point Sample size Sample container


Sample label Sample storage and transport Arrival at the laboratory Start of test Sampling

Water for Injections: 

Water for Injections International pharmacopoeia requirements for WFI are those for purified water plus it must be free from pyrogens. Usually prepared by distillation. Storage time should be less than 24 hours. Microbial limits must be specified.

Pyrogens and endotoxins: 

Pyrogens and endotoxins Any compound injected into mammals which gives rise to fever is a “Pyrogen”.

WFI testing: 

WFI testing Microbial test, < 1 CFU/10 ml WFI Endotoxin test, < 0.25 Eu/ml Total organic count, < 500 g/l

Water system inspection: 

Water system inspection

Inspection plan: 

Inspection plan Water quality manual - water system drawing - validation - sampling procedures, location and plan - records of testing - sanitation and maintenance - schedules of maintenance

Review water quality manual : 

Review water quality manual A water quality manual is advisable. A brief description of water systems is required. Include drawings of the purification, storage distribution system.

The manual should contain: 

The manual should contain Chemical and microbiological specifications Sampling instructions Test procedures Responsible persons Training requirements

Review validation: 

Review validation Validation for water systems consists of 3 phases: Phase 1: 2-3 weeks Phase 2: 4 weeks Phase 3: 1 year

Phase 1: 

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 1, develop SOPs for the water system

Phase 2 : 

Phase 2 Verifying control (4- 5 weeks) - Demonstrate the system is in control -Sampling as in phase 1

Phase 3: 

Phase 3 Verifying long- term control ( 1 year) - Demonstrate the system in control over a long period of time -Weekly sampling

Conducting the inspection: 

Conducting the inspection Take the drawing and walk around the entire system Check: - dead legs - pumps -filter - UV light -pipe and fittings - sample points -DI - RO -storage tank - non return valves -by –pass lines - heat exchangers


Check: - stainless steel – PVC and most plastics not recommended - water quality - hygienic couplings - passivation - air breaks or “Tundish”


Check: - condition and equipment corrosion on plates of heat exchangers indicates possible contamination - maintenance records


Check: - air filter - integrity testing, sterilization - replacement frequency - burst discs


References WHO,1997. Joint training on GMP for biological products in Thailand, 2-11 September, 1997 Chung Keel Lee, 2003. GMP and related topics, 13-15 October, 2003. Chung Keel Lee, 2004. Current GMP for biological products and its practical implementation, 22-23 March, 2004. FDA and WHO, 2004. GMP inspection workshop, 21-29 June, 2004.

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