Water for Pharmaceutical Use Part 1: Introduction and treatment

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Water for Pharmaceutical Use Part 1
Introduction and treatment

• Supplementary Training Modules on Good
  Manufacturing Practice

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• Objectives
• Introduction to Water for Pharmaceutical Use
• Review WHO GMP guidance
• Sources and types of water for pharmaceutical use
• Storage of bulk, untreated raw water
• Pre-treatment of water

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• 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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• Principles (2)
• Potential for microbial growth
• Systems must be properly validated
• Water for parenteral use could be contaminated
  with pyrogens or endotoxins
• Specifications and periodic testing is required

Annex 5, 7.2.4 Excipients,
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• Types of water used in pharmaceutical processes
• Purified water
• Water for Injections PFW WFI
• Softened Water
• Water for Final Rinse
• Pure, or clean Steam
• Water for cooling Autoclaves

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• 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

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• 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

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• Contaminants of water (2)
• Treatment depends on waters chemistry and
  contaminants, influenced by
• Rainfall
• Erosion
• Pollution
• Dissolution
• Evaporation
• Sedimentation
• Decomposition

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

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

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

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• Biofilm formation
• Free swimming aquatic bacteria use
  polymucosaccharides to colonise surfaces
• Complex communities evolve which shed
  micro-colonies and bacteria

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• Turbidity
• Silt, clay, and suspended material cause
  turbidity
• Small particles include "colloids"
• Removal of colloids is usually the first step in
  water treatment

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Water hardness
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• Source of raw water
• Rain water
• Surface or ground water
• Well or borehole
• Municipal or civil tap water
• Purchased in bulk

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• Well water
• Inspect exposed parts of the well
• Depth of well
• Check
• Nearby septic systems
• Hazardous materials usage (pesticides,
  fertilizers, etc)
• Potability
• Well maintenance

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• 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
• Check cover
• To keep out insects, birds and animals
• Check disinfection practices

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• WHO water treatment guidance
• The following should be monitored
• Sources of water
• Treatment procedures
• Water treatment equipment
• Treated water tests
• Monitoring records required

Annex 1, 17.42
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• Pre-treatment steps
• Primary filtration and multi-media filter
• Coagulation or flocculation
• Desalination
• Softening

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• 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

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Water Softener schematic drawing
by pass valve
brine and salt tank
brine
drain
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Water pre-treatment complex External raw water
storage

Pretreatment room