sop for Sanitization of Purified Water Loop
To lay down a procedure for Sanitization of Purified Water Loop.
This Standard Operating Procedure is applicable for Sanitization of Purified Water Distribution Loops for TAC, Liquid, Lozenges and DPI Block, to be followed at formulation
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
PW : Purified Water
KL : Kilo liter
ER : Engineering
0C : Degree centigrade
5.1 Inform the schedule to all user department and Quality Assurance department.
5.2 Close the valves of all user points and put “Sanitization in Progress” tags on all user points.
5.3 Check the level of purified water tank. It should be between 50 to 60%. If the level is less generate the purified water as per SOP Open inlet/outlet valves and start the PW pump by SCADA.
5.4 Open the steam inlet valve number AV-C03. Start heating the purified water in the purified water tank so that return water temperature reaches a limit of 800C -850C.
5.5 Circulate the water for 1 hour.
5.6 Drain off the water by opening dump valve and individual drain points of loop as well as tank and fill the purified water in the tank as per SOP
5.7 The same sanitization of purified water Distribution Loop procedure is applicable for L&L, TAC and DPI Block.
5.8 Frequency of Sanitizations is once in a 15 ± 5 days or after intimation of QA with respect to microbiological test, which ever is earlier. For planning prior intimation to such effect is to be given to all user departments and quality assurance department.
5.9 Maintain the Sanitization Distribution Loop Record in Annexure – 1
5.10 Vent filter shall be replaced once in a six month
6.0 Forms and Records
6.1 Sanitization Distribution Loop Record – Annexure-1
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department