VALIDATION OF WATER SUPPLY SYSTEM

VALIDATION OF WATER SUPPLY SYSTEM

MALIBA PHARMACY COLLEGE. 1

CONTENTS  Objectives  Introduction  Validation & System Qualification

 Monitoring  Maintenance  Revalidation & Change control  Validation documentation  Summary 2

OBJECTIVE To understand: 1. 2. 3. 4. 5. 6. 3

The need for water quality manual reason for usage of pharmaceutical water supply systems. The technical requirements for water supply systems. Different types of water supply systems. Validation requirements. Qualification & inspection requirement

INTRODUCTION  High-quality water is essential for the manufacturing of

pharmaceuticals. Water is the most commonly used raw material in pharmaceutical manufacturing.  water is directly or indirectly used in the pharmaceutical

manufacturing such as a major component in injectable products and in cleaning of manufacturing equipment.  It is one of the raw material that is usually processed by the

pharmaceutical manufacturer prior to use because it cannot be supplied by the vendor.  Water is thus an important raw material in GMP and in

validating the manufacturing process. 4

INTRODUCTION Why purification? o Although tap water is reasonably pure, it is

always variable due to seasonal variations, regional variation in quality. o One must remove impurities and control microbes

to avoid contamination of products. o Pretreatment depends on quality of feed water. 5

INTRODUCTION Quality of water should be specific for product quality. Water contains,  Organic and inorganic impurities  Microbial contamination  Endotoxin  Particulate contamination

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Low quality of water can lead to  product degradation  product contamination  loss of product and profit

TYPES OF WATER  Different grades of Water for Pharmaceutical

Purposeseach type has its on characteristic for all parameters.  Potable water  Purified water  Water for injection(WFI)  Sterile water for injection, inhalation, irrigation  Sterile bacteriostatic water for injection

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DIFFERENT TECHNIQUES USED FOR WATER TREATMENT  De-chlorination (Sodium Bisulphite,

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Carbon Filter)  Filtration  Ultra Filtration  Softening  Demineralization  Reverse Osmosis  UV Treatment  Deionization  Ozonization

DIFFERENT EQUIPMENTS AND COMPONENTS FOR WATER SYSTEM  Piping  Valves  Pumps  Pressure gauges  Heat exchangers  Distillation unit  Filters  Deionizers  Sensors 11

 Auxiliary equipment

WATER STORAGE AND DISTRIBUTION – CONSIDERATIONS  Materials

of Construction (Chemical and Compatibility)  Stainless Steel (316 or 316L)  Teflon, Silicone, Viton (gaskets, diaphragms)

Heat

 Minimize Dead Legs (