Sop for Operation of purified water loop
To lay down a procedure for the purified water Loop.
This Standard Operating Procedure is applicable for operation of purified water loop (Tablet and capsules, Dry powder injection and liquid and lozenges) to be followed at formulation plants
3.1 Engineering Officer / Executive shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/designee shall be responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions.
SOP : Standard Operating Procedure etc
No : Number
QA : Quality assurance
Qty : Quantity
ER : Engineering
Kg/cm² : kilogram per centimeter square
KL : Kilo litre
5.1 Check the level of 4 KL purified water tank. It should be more than 500 lit. If the level is
less. Generate the purified water as per SOP
5.2 Start the purified water pump from the GREEN push button on the panel. Open the inlet
and outlet valve.
5.3 Check the pressure at the outlet of the pump. It should be between 4-7 kg/cm2
Start the ultra violet lamps from the panel.
5.4 Check the conductivity of return line. It should be less than 1.3 micro Siemens /cm.
5.5 Repeat the steps 5.1 to 5.5 for Dry powder injection and liquid & lozenges operation of
Purified water loop.
5.6 Velocity of water in return loop of Liquid and Lozenges should be (0.8-1.5) m/s.
5.7 Vent filters of Purified Water Tanks are replaced after six month as if required.
5.8 Before connecting to stand by pump, it shall be Cleaned and sanitized with 1 % Sodium
Hypochlorite Solution. Afterwards rinsing of pump & connecting pipeline shall be done till
chlorine residue removed completely
Before Operation near by flange/ Tank
valve shall be open for 5 minutes for rinsing purpose.
6.0 Forms and Records.
6.1 Record for Distribution loop – Annexure-1
6.2 Record of replacement of vent filters – Annexure-2
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department