sop for Sanitization of Purified Water Loop
1.0 Objective
To lay down a procedure for Sanitization of Purified Water Loop.
2.0 Scope
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
3.0 Responsibility
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
5.0 Procedure:
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
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department
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cleaning and preventive maintenance of LAF and RLAF
sop for replacement of water system filters
cleaning and preventive maintenance of insectocutor
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sop for Operation and regeneration of softener plant
Procedure Of Issuance Of material from Engineering Store
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sop for Preventive Maintenance of ROPP Cap Elevator
sop for Preventive Maintenance of Liquid Transfer Pumps
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sop for Methodology to Dispose ETP Sludge
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sop for Disposal of Engineering Waste
Filter Cleaning of HVAC System RLAF & LAF
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Procedure for Calibration of Vacuum Gauge
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sop for Preventive Maintenance of Infrared Dryer Umbrella Type
sop for Preventive Maintenance of Battery stacker
sop for Preventive Maintenance of Lift
sop for Preventive Maintenance of Vacuum Cleaner
sop for Preventive Maintenance of laminar air flow unit
sop for Preventive Maintenance of Lozenges Manufacturing Line
sop for Preventive Maintenance of Garment Washing Machine
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sop for Preventive Maintenance of Pure steam Generator
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sop for Preventive Maintenance of Vial Washing Machine
sop for Preventive Maintenance of Inspection Table
sop for Preventive Maintenance of Hi-Cart
sop for Preventive Maintenance of Turn table
sop for Preventive Maintenance of sticker labeling machine
sop for Preventive Maintenance of Liquid Filling and Sealing Machine
sop for Preventive Maintenance of Linear Bottle Washing Machine
sop for Preventive Maintenance of De-Foiling Machine
sop for Preventive Maintenance of Strip Packing Machine
sop for Preventive Maintenance of Blister Packing Machine
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sop for Preventive Maintenance of Capsule Filling Machine
sop for Preventive maintenance of Auto Coater
sop for Preventive Maintenance of Compression Machine
sop for preventive maintenance of packing conveyor belt
sop for Preventive Maintenance of Sifter Cum Multi mill
sop for Preventive Maintenance of Rapid Mixer Granulator
sop for Preventive Maintenance Of Fluid Bed Dryer
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sop for Preventive Maintenance of Lifting and Positioning Device
sop for Preventive Maintenance of Paste Preparation vessel
sop for preventive maintenance of Vibro-Sifter
sop for preventive maintenance of air curtain
sop for preventive maintenance of air handling units
Preventive Maintenance of Diesel Generator
sop for Preventive Maintenance of cooling towers
sop for Preventive Maintenance of Boiler
sop for Preventive Maintenance of Air Compressor
sop for Preventive Maintenance of Chilling Plant
sop for Preventive Maintenance of Transformers
sop for Preventive maintenance of Purified Water System
sop for Break Down maintenance of Machine and Work Requisition
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sop for Operation Of Diesel Generator
sop for Operation of Multi Column Distillation Plant
sop for Operation of Pure Steam Generator
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sop for Sanitization of multi column plant
sop for Sanitization of Ultrafiltration System
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sop for Sanitization of Purified Water Loop
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sop for Operation & back wash of multi grade filter
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