SOP for Cleaning and operation of sparkle filter press

1.0 OBJECTIVE: To lay down the procedure for Cleaning and operation of sparkle filter press.

2.0 SCOPE: This procedure is applicable for cleaning and operation of sparkle filter press in liquid department at Pharmaceuticals.

3.0 RESPONSIBILITY
Operator, Officer, Executive- Production Department
Officer, Executive- Quality Assurance Department
Manager –Production and Quality Assurance Department.

4.0 DEFINITION(S)
NA

5.0 PROCEDURE for Cleaning and operation of sparkle filter press
5.1 Cleaning

5.1.1 Checking Status Labeling: Check the status “TO BE CLEANED” on equipment with details.

5.1.2 Cleaning procedure after every use.

5.1.2.1 Remove “ TO BE CLEANED “ label and affix “ UNDER CLEANING “ label to the machine.

5.1.2.2 Switch off the electric supply and disconnect the plug of filter press.

5.1.2.3 Close outlet valve of tank and disconnect the outlet connection of tank (inlet connection of filter press).

5.1.2.4 First, release the pressure from filter press assembly with the help of air knob and by opening the outlet valve of pressure vessel.

5.1.2.5 Collect the remaining amount of Liquid in the filter press assembly in a S.S. Container and discard it.

5.1.2.6 Pull the filter press to the wash area.

5.1.2.7 Open the filter press assembly by loosening the locking bolts of the pressure vessel with a spanner and remove the lid.

5.1.2.8 Open the bolt fixed at the center of the filter plates and take out the plates assembly.

5.1.2.9 Open all four bolts one by one with a spanner.

5.1.2.10 Separate the plates and non-woven filter pads, S.S. Sieve plate, and spacers.

5.1.2.11 Remove the filter pads and discard them.

5.1.2.12 Wash the parts with purified water to remove the syrup solution and scrub with a lint-free cloth and nylon brush.

5.1.2.13 Wash the parts with purified water (chamber, lid, filter sieve, filter plates, pipe lines, and trolley tray) with the help of lint free cloth and nylon-brush. Open the valves and clean them. Scrub the difficult to clean areas thoroughly.

5.1.2.14 Finally, wash the parts with sufficient amount of purified water and allow them to dry.

5.1.2.15 Reassemble the filter press without the filter pads.

5.1.2.16 Send the swab sample/rinse water sample if required.

5.1.2.17 Status labeling: “CLEANED” status on the equipment.

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

5.2 Machine setup and operation

5.2.1 The filter press consists of the following parts:
• Scavenger plate
• Screen plates
• Interlocking cups
• Filter plate
• Central tie rod
• Filter pads

5.2.2 Ensure that filter press and attached SS lines are cleaned .

5.2.3 After line clearance from QA, put the “UNDER PROCESS” label dully filled and signed on the machine as per SOP (Title: Status labeling in production department).

5.2.4 Ensure that the diameter of filter press connected lines should equal or more than the diameter of filter press connections.

5.2.5 Set the cartridge bottom gasket properly.

5.2.6 Set the scavenger plate on the cartridge bottom gasket.

5.2.7 Set screen plates, filter pad, interlocking cup, and filter plate respectively on Scavenger plate one by one in correct order and position.

5.2.8 Fit the top ring properly.

5.2.9 Tighten the side tie rods and central tie rods.

5.2.10 Connect the outlet valve of the tank to inlet valve of filter press by SS lines.

5.2.11 Connect the outlet valve of the filter press to inlet valve of storage tank / mixing tank by SS lines.

5.2.12 Open the outlet valve of manufacturing tank and inlet valve of filter press.

5.2.13 Initially, keep outlet valve of filter press closed and recirculation valve open.

5.2.14 Switch on the power supply and start the filer press Pump.

5.2.15 Keep open the air vent initially. Close the air vent valve at the moment liquid starts flowing out from the air vent.

5.2.16 Check the clarity of filtered solution in Sight flow indicator (SFI).

5.2.17 In case of presence of particles, fibers etc, reset the filtration assembly of frames and plates.

5.2.18 Continuously monitor the pressure gauge reading. It should not exceed 2Kg / cm² in case of excessive pressure built up, reset the filter assembly.

5.2.19 After the filtration, Affix the new label duly filled with status of ‘TO BE CLEANED‘ on filter press.

5.2.20 Records: Record the details of machine operation in equipment usage log sheet.

6.0 ABBREVIATION (S)
SOP: Standard Operating Procedure
No. : Number
SS: stainless steel
NA: Not applicable

7.0 REFERENCE(S):
SOP: Status labeling in production department
SOP: Making entries in equipment usage and cleaning log sheet

8.0 ANNEXURE (S)
Nil

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