Sop for Sanitization of Hot Sanitization & Electro Deionization unit
To lay down a procedure for Sanitization of Hot Sanitization Reverse Osmosis & Electro Deionization Unit.
This Standard Operating Procedure is applicable for Sanitization of Hot Sanitization Reverse Osmosis & Electro Deionization Unit 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
QA : Quality assurance
PW : Purified Water
KL : Kilo liter
ER : Engineering
HSRO : Hot Sanitization Reverse Osmosis
EDI : Electro Deionization Unit
RO-1 : Reverse Osmosis-1
5.1 Ensure that there is not production.
5.2 Use necessary safety wears, while doing the work.
5.3 Check the level of water in Multi Purpose Water Tank. It should be between 250 to 300 Lit.
If the level is less generate the water by RO-1. Open inlet/outlet valves and start the pump
5.4 Open the steam inlet valve and Start heating in the Multipurpose water tank so that return
water temperature reaches a limit of 80-85 Deg.
5.5 Circulate the water for 1 hour and stop the pump and Hold it for 3-4 Hours to cool it
5.6 Drain off the water by opening dump valve and individual drain points of Sanitization of
Record Hot Sanitization Reverse Osmosis & Electro Deionization Unit as well as tank
and fill the RO-1 Product water in the tank.
5.7 Sanitization is to be carried out with frequency of 30±5 days or as and when quality of
water Crosses action level.
5.8 Sanitization record is maintained as shown in Annexure – 1.
6.0 Forms and Records
6.1 Sanitization Record for Hot Sanitization Reverse Osmosis&
Electro Deionization Unit – Annexure-1
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department