sop for Sanitization of multi column plant
To lay down a procedure of Sanitization of multi column plant.
This Standard Operating Procedure is applicable for Sanitization of multi column plant 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
PSG : Pure Steam Generator
5.1 Ensure that there is not production and Remove all sensors.
5.2 Use necessary safety wears, while doing the work.
5.3 Fill the circulation tank with the feed water.
5.4 Mix 4 Kg of sodium hydroxide in feed water.
5.5 Switched ON feed pump.
5.6 Circulate the water for 3-4 hours.
5.7 Drain out the total system and flush the system by using feed water.
5.8 Check the ph at distillate out, it should be around it to feed water.
5.9 Fill the circulation tank with the feed water and add 20 kg citric acid.
5.10 Circulate above mixture.
5.11 Add 25% of the total ammonia solution out of 40 lit.
5.12 Circulate the mixture for 5-6 hrs.
5.13 Again add balance ammonia solution and get the ph of the outlet solution around 10.
5.14 Also add 1kg sodium nitrite and 1 lit T-pol.
5.15 Again Circulate the mixture for 5-6 hrs.
5.16 Drain out the system and flush by using feed water / pure steam.
5.17 Check the quality of Water for injection.
5.18 Sanitization is to be carried out with frequency of six month or as and when quality of water Crosses action level.
5.19 Sanitization record is maintained as shown in Annexure – 1.
6.0 Forms and Records
6.1 Sanitization Record of multi column plant. – Annexure-1
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department.