SOP for Cleaning and Operation of Holding Tank (Capacity –3000 ltrs)

1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of holding tank(capacity –3000 ltrs).

2.0 SCOPE: This procedure is applicable for cleaning and operation of holding tank (capacity –3000 ltrs) in Liquid department Pharmaceuticals.

3.0 RESPONSIBILITY:
Operator, officer, executive – Production department
Manager- Production Department

4.0 DEFINITION(S)
NA

5.0 PROCEDURE for Cleaning and Operation of Holding Tank:
5.1 Cleaning:

5.1.1 Checking Status Labeling: Check the status “TO BE CLEANED” on equipment with details filled. If next product is the same as previous product (campaign production), follow batch-to-batch changeover procedure. If next product is different from previous product, follow product-to-product changeover procedure

5.1.2 Batch-to-Batch change over procedure( Type A):

5.1.2.1 Remove “ TO BE CLEANED “ label and affix “ UNDER CLEANING “ label to the machine as per SOP (Title: Status labeling in production department).

5.1.2.2 Switch OFF the electric supply from tank’s panel board.

5.1.2.3 Open outlet valves of 3000 ltrs tank and connect to drain point by using flexible hose pipe.

5.1.2.4 Wash the inner surface of 3000 liter tank with purified water by connecting purified water supply to spray ball for five minutes or till there are no visible traces of the product.

5.1.2.5 Close the outlet valves of 3000 ltrs tank after complete water is drained out.

5.1.2.6 Mop the 3000 ltrs tank’s outer surface with the help of wet lint-free cloth, followed by a dry lint-free cloth.

5.1.2.7 Status labeling: After cleaning, Put ‘CLEANED’ status label containing Unit, Department, Equipment name, Cleaned by, Checked by Production Officer, Date, and finally certified by Quality Assurance (QA).

5.1.2.8 Records: Record the details of cleaning in equipment usage sheet as per SOP (Title: Making entries in equipment usage and cleaning log sheet).

5.1.3 Product-to-product change over procedure (Type B): This procedure is applicable if -There is a change in product or during campaign production, 7 batches have been processed, or equipment is taken for maintenance during processing, and maintenance work continues for more than 24 hours, or maintenance work involves any part, that comes in direct contact with product.

5.1.3.1 Switch OFF the electric supply from 3000 ltrs tank’s panel board.

5.1.3.2 Open outlet valves of 3000 ltrs tank and connect to drain point by a flexible hose pipe.

5.1.3.3 Wash the inner surface of 3000 ltrs tank with purified water by connecting purified water supply to spray ball to remove all traces of previous product.

5.1.3.4 Open and clean the triclover clamps and valves with the help of purified water.

5.1.3.5 Refit the valves and S.S process lines and connect the 3000 ltrs tank to the pump.

5.1.3.6 Take 450 liters of purified water in 3000 ltrs. tank and raise the temperature to 60-65°C. Circulate the hot water through spray ball for 10 minutes and drain the water completely.

5.1.3.7 Close the outlet valves of 3000 ltrs tank.

5.1.3.8 Mop the tank’s outer surface with wet lint-free cloth followed by dry lint-free cloth.

5.1.3.9 Inform the Q.A. person/ department to collect swab/rinse water sample if required.

5.1.3.10 Record the details of cleaning in equipment usage sheet as per cleaning SOP.

5.1.3.11 Protection of clean equipment: Shrink wrap all the ports, outlet points, and tighten the manhole lid if the equipment is not planned for use within a day.

5.1.3.12 Status labeling: Put ‘CLEANED’ status label having Unit, Department, Equipment name, Cleaned by, Checked by Production Officer, Date, and finally certified by Quality Assurance (QA).

5.2 Operation for Cleaning and Operation of Holding Tank:

5.2.1 Ensure that Holding tank (capacity –3000 liters) is cleaned.

5.2.2 After line clearance from Q. A. put “WORK IN PROGRESS” label on the machine.

5.2.3 Close the outlet valve of the tank and fix blank on outlet line.

5.2.4 Start the transfer of bulk from manufacturing vessel through filter press/colloid mill.

5.2.5 After completion of transferring the bulk, dismantle the SS process line, cleaned it.

5.2.6

5.2.7 In case of a requirement for steam heating:

5.2.7.1 Open the bottom drain valve followed by air vent valve of tank’s jacket and ensure that it is completely empty. Close air vent valve and drain valve of tank’s jacket.

5.2.7.2 Switch ‘ON’ the electric supply from tank’s panel board.

5.2.7.3 Set the required temperature (if needed) by pressing SET POINT key and increasing/decreasing (/) key.

5.2.7.4 Set RPM of stirrer by rotating knob in a clockwise or anticlockwise direction on VFD.

5.2.7.5 Switch ‘ON’ the compressed air valve from tank’s panel to regulate the steam supply to tank jacket through solenoid valve.

5.2.7.6 Ensure that steam trap valve No 01 and 02 are open in initial stage until condensed water is removed, and then after closing valve No 01.

5.2.7.7 Load the material / purified water into the tank and switch ON the stirrer from the main panel.

5.2.7.8 Open the steam inlet valve.

5.2.7.9 Switch ‘ON’ the electric supply from tank’s panel board.

5.2.7.10 After the completion of operation, switch ‘OFF’ electric supply from panel board.

5.2.7.11 Close the steam inlet valve.

5.2.7.12 Open the drain valve of tank’s jacket from the bottom. Ensure the complete drainage of steam from the tank’s jacket.

5.2.7.13 Affix the status of “TO BE CLEANED”.

5.2.7.14 Record the details of operation of tank in equipment usage record as per current version of SOP.

5.3 NOTE:

5.3.1 Ensure water level in COOLING POT before starting the stirrer.

5.3.2 Ensure air pressure in the unit is not less than 4 Kg/cm².

6.0 ABBREVIATION (S):

SOP: Standard Operating Procedure
No.: Number
BMR: Batch Manufacturing Record
RPM: Revolution per minute
VFD: variable frequency drive

7.0 REFERENCES:

SOP: Status labeling in production department
SOP: Making entries in equipment usage and cleaning log sheet

8.0 ANNEXURE (S):
NA

9.0 DISTRIBUTION:
9.1 Master copy: Quality Assurance
9.2 Controlled copy ( s): Production department
9.3 Reference copy (s): Production department