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THE PURIFIED WATER SYSTEM IN PHARMA (CHAPTER 2)

Water System Validation

Purified Water System

1) Feed water & pretreatment
PW usually starts from potable water. Pretreatment protects the purification equipment and typically includes multimedia filter (particles), activated carbon (removes chlorine), softener (hardness control), and cartridge filtration. Proper chlorine/chloramine control is essential to protect RO membranes.

2) Purification train
Most modern systems use Reverse Osmosis (RO) as the primary purification step, often followed by EDI (electrodeionization) or mixed-bed deionizers to achieve low conductivity.

3) Storage
PW is stored in a sanitary SS316L storage tank with sloped bottom, spray ball, and minimal dead legs. A 0.2 µm hydrophobic vent filter protects the tank from airborne contamination.

4) Distribution loop
PW is circulated continuously in a recirculating loop to avoid stagnation.

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