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Water for Pharmaceutical Use: Introduction & Treatment

This training module covers WHO GMP guidance, sources & types of water for pharmaceutical use, pre-treatment principles, contaminants, treatment methods, and water storage. Learn about the importance of purifying raw water, controlling microbial growth, and removing contaminants to maintain product quality. Understand the different types of water used in pharmaceutical processes and the pre-treatment steps required to ensure water meets GMP norms. Explore the contaminants found in water, treatment methods, and the significance of monitoring water quality.

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Water for Pharmaceutical Use: Introduction & Treatment

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  1. Water for Pharmaceutical UsePart 1: Introduction and treatment Supplementary Training Modules on Good Manufacturing Practice

  2. 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

  3. 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

  4. 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,

  5. 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

  6. 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 productcontamination. • Controlmicrobesto avoid contaminating products

  7. 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

  8. Contaminants of water (2) Treatment depends on water’s chemistry and contaminants, influenced by: • Rainfall • Erosion • Pollution • Dissolution • Evaporation • Sedimentation • Decomposition

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

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

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

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

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

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

  15. Source of raw water • Rainwater • Surface or ground water • Well or borehole • Municipal or civil – “tap water” • Purchased in bulk

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

  17. 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

  18. 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

  19. Pre-treatment steps • Primary filtration and multi-media filter • Coagulation or flocculation • Desalination • Softening

  20. 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

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

  22. "soft" water to deioniser "hard" water in • zeolite water softener • exchanges • Ca and Mg for Na Water Softener – schematic drawing by pass valve brine and salt tank brine drain

  23. Water pre-treatment complex External raw water storage Pretreatment room

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