module 2, part 1: introduction and treatment slide 1 of 23 who - edm water for pharmaceutical use...
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Module 2, Part 1: Introduction and treatment Slide 1 of 23 WHO - EDM
Water for Pharmaceutical Use
Water for Pharmaceutical Use
Part 1:
Introduction and treatment
Supplementary Training Modules on Good Manufacturing Practice
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Module 2, Part 1: Introduction and treatment Slide 2 of 23 WHO - EDM
Water for Pharmaceutical Use
Objectives
1. Introduction to Water for Pharmaceutical Use
2. Review WHO GMP guidance
3. Sources and types of water for pharmaceutical use
4. Storage of bulk, untreated raw water
5. Pre-treatment of water
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Module 2, Part 1: Introduction and treatment Slide 3 of 23 WHO - EDM
Water for Pharmaceutical Use
Principles (1)
Like any starting material, water must conform to Good Manufacturing Practice norms
It must be “potable” and comply with WHO Guidelines for drinking-water quality
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Water for Pharmaceutical Use
Principles (2)
1. Potential for microbial growth
2. Systems must be properly validated
3. Water for parenteral use could be contaminated with pyrogens or endotoxins
4. Specifications and periodic testing is required
Annex 5, 7.2.4 Excipients,
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Module 2, Part 1: Introduction and treatment Slide 5 of 23 WHO - EDM
Water for Pharmaceutical Use
Types of water used in pharmaceutical processes
1. Purified water
2. Water for Injections – PFW & WFI
3. Softened Water
4. Water for Final Rinse
5. Pure, or clean Steam
6. Water for cooling Autoclaves
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Water for Pharmaceutical Use
Why purify raw water?
1. Although reasonably pure, it is always variable
2. Seasonal variations may occur in water
3. Some regions have very poor quality water
4. Must remove impurities to prevent product contamination.
5. Control microbes to avoid contaminating products
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Water for Pharmaceutical Use
Contaminants of water (1)
There is no pure water in nature, as it can contain up to 90 possible unacceptable contaminants
Contaminant groups:
1. Inorganic compounds2. Organic compounds3. Solids 4. Gases5. Micro-organisms
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Water for Pharmaceutical Use
Contaminants of water (2)
Treatment depends on water’s chemistry and contaminants, influenced by:
1. Rainfall
2. Erosion
3. Pollution
4. Dissolution
5. Evaporation
6. Sedimentation
7. Decomposition
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Module 2, Part 1: Introduction and treatment Slide 9 of 23 WHO - EDM
Water for Pharmaceutical Use
Contaminants of water (3)
Problem minerals
1. Calcium and magnesium
2. Iron and manganese
3. Silicates
4. Carbon dioxide
5. Hydrogen sulfide
6. Phosphates
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Water for Pharmaceutical Use
Contaminants of water (4)Further problem minerals
1. Copper
2. Aluminium
3. Heavy metals Arsenic, lead, cadmium
4. Nitrates
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Water for Pharmaceutical Use
Contaminants of water (5)Micro-organisms – Biofilm
1. Algae
2. Protozoa Cryptosporidium Giardia
3. Bacteria Pseudomonas Gram negative, non-fermenting bacteria Escherichia coli and coliforms
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Water for Pharmaceutical Use
Biofilm formation
1. Free swimming aquatic bacteria use polymucosaccharides to colonise surfaces
2. Complex communities evolve which shed micro-colonies and bacteria
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Water for Pharmaceutical Use
Turbidity
1. Silt, clay, and suspended material cause turbidity
2. Small particles include "colloids"
3. Removal of colloids is usually the first step in water treatment
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Water for Pharmaceutical Use
Water hardness classification
mg/L or ppm as CaCO3
Soft 0-60
Moderate 61-120
Hard 121-180
Very Hard > 180
Water hardness
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Module 2, Part 1: Introduction and treatment Slide 15 of 23 WHO - EDM
Water for Pharmaceutical Use
Source of raw water
1. Rain water
2. Surface or ground water
3. Well or borehole
4. Municipal or civil – “tap water”
5. Purchased in bulk
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Water for Pharmaceutical Use
Well water1. Inspect exposed parts of the well
2. Depth of well
Check:
1. Nearby septic systems
2. Hazardous materials usage (pesticides, fertilizers, etc)
3. “Potability”
4. Well maintenance
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Module 2, Part 1: Introduction and treatment Slide 17 of 23 WHO - EDM
Water for Pharmaceutical Use
Raw water storage
1. May be required prior to pre-treatment according to local circumstances
2. Check material of construction Concrete, steel are acceptable but check
corrosion Plastics or plastic linings may leach
3. Check cover To keep out insects, birds and animals
4. Check disinfection practices
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Water for Pharmaceutical Use
WHO water treatment guidance
The following should be monitored
Sources of water
Treatment procedures
Water treatment equipment
Treated water tests
Monitoring records requiredAnnex 1, 17.42
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Water for Pharmaceutical Use
Pre-treatment steps
1. Primary filtration and multi-media filter
2. Coagulation or flocculation
3. Desalination
4. Softening
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Water for Pharmaceutical Use
Chlorine removal Activated-carbon (AC) filtration
or bisulphite
1.AC removes chlorine but bacteria can then grow
2.AC filtration can remove organic impurities
3.Bisulphite leaves sulphate residues but is
anti-microbial
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Module 2, Part 1: Introduction and treatment Slide 21 of 23 WHO - EDM
Water for Pharmaceutical Use
raw water in
« S” trap to sewer
Water is kept circulating
To water softener & DI plant
Pretreatment – schematic drawing
cartridgefilter
5 micrometers
activatedcarbon
filter
spray ball
break tank
air break to draincentrifugal pump
air filter
floatoperated
valvesand filter
excess water recycledfrom deioniser
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Module 2, Part 1: Introduction and treatment Slide 22 of 23 WHO - EDM
Water for Pharmaceutical Use
brine and salt tank
brine
"hard" waterin
zeolite water softener-exchanges-Ca and Mg for Na
drain
"soft" water to deioniserby pass valve
Water Softener – schematic drawing
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Module 2, Part 1: Introduction and treatment Slide 23 of 23 WHO - EDM
Water for Pharmaceutical Use
Water pre-treatment complex
External raw water storage
Pretreatment room