SOP for Operation on vial washing machine
To lay down a procedure for the operation of vial washing machine (Make-Ambica).
Scope of SOP :
This SOP is applicable for operation of vial washing machine.
Responsibility:
Production operator / technician – responsible for operation of machine.
Production officer / Executive – to ensure that operation of the machine is carried out as per SOP.
Accountability:
Production Head and Head QA shall be accountable for the compliance of SOP.
Abbreviations
WFI: Water for Injection
MMI: Man Machine Interface
PLC: Programmable logic controller
Procedure
Pre Start-Up
Ensure that the vial washing machine is visibly clean and no vials of the previous batch are present
Check the line clearance of the machine.
Check below the machine, inside the machine, and in-feed and out-feed for the presence of any broken left over glass vials.
Check the machine is properly assembled with required change parts.
Check the re-circulated water tank is empty and visually cleaned.
Check the Purified water and WFI tank is empty and visually cleaned.
Check the Purified, WFI, Re circulating purified water and Compressed air filter are visually cleaned and tagged.
Check all level sensor of WFI tank, purified water tank and recicirculating purified water tank are properly connected and cleaned.
Check the correct centering of all the pockets and spray nozzles of all 25 stations (for 5 ml, 10 ml, 20ml and 30 ml vials) and 12 stations (for 50ml and 100 ml vials).
Check the guards and covers are properly closed before starting of operation.
Check the availability of the water for injection, purified water and compressed air.
Switch on the laminar air flow unit above the outfeed conveyor at least 30 minutes before starting the washing operation and ensure that differential pressure on magnahelic gauge is between 5-15 Pascal.
Switch on the mains from control panel.
Collect the WFI and purified water in the respective tank.
Start the PLC by the rotary switch.
Press mode button on MMI display to select the Manual/Auto mode.
By pressing the button and go to mode selection.
Then by press to shift cursor and select manual mode and press enter button.
Press the button to check al the set parameter:
Solenoid valve timer:
15 ml vial: 2.5 sec
20 ml vial: 2.5 sec
100 ml vial: 4.5 sec
Mode selection
Mode 1
5ml – 30 ml: upto 300 vials/minutes
Mode 2
50ml – 100ml: upto 150 vials/minutes
Press button to select manual mode and then MMI display the start up mode as per
Given below:
Main drive: OFF
Pump 1: OFF
Pump 2: OFF
Pump 3: OFF
Infeed conveyor: OFF
Solenoid valve: OFF
Out feed conveyor: OFF
Press the button to start main drive, pump. Again press the button to go next step and press button to start pump, Infeed and solenoid valve.
Again press button to go the next step and press button to start out feed conveyor.
Check all the motor of main drive, pump, infeed conveyor, out feed
Conveyor is working properly.
Check pressure of WFI line, purified water line, Recirculating purified water line and Air line as per given below:
WFI line: 1.5 Kg/cm²
Purified water line: 1.5 Kg/cm²
Recirculating purified water line : 1.5 Kg/cm²
Air line: 1.5 Kg/cm²
Carry out the sensor challenge test for critical sensor as per mentioned steps.
Low water level in WFI tank: start the machine slowly and drain the water from tank. The machine should stop when the level of water reaches below the sensor and display on the MMI.
Low water level in purified water tank: start the machine slowly and drain the water from the tank. The machine should stop when the level of water reaches below the sensor and display on the MMI.
Low water level in Recirculating purified water tank: start the machine slowly and drain the water from the tank. The machine should stop when the level of water reaches below the sensor and display on the MMI.
Start the machine in manual mode slowly and check the vials at least 2 vials from each 25 channels for 10-30 ml vials and 12 channels for 50-100 ml for movemen through the infeed conveyor, infeed lifter, washing station and outfeed guide.
Load the vials approximately 200 vials on infeed conveyor of washing machine.
Check the inspected empty vials are ready for washing as per SOP.
Check the type of vial, item code, AR.No, quantity of vials received for the batch.
Visually check the water spray from needles of all stations into the vials and sequence of washing cycles.
Washing Sequence
Internal Wash –
Station No. 1: Compressed Air
Station No. 2: Re- circulated Purified Water
Station No. 3: Re- circulated Purified Water
Station No. 4: Purified Water
Station No. 5: Purified water
Station No. 6: Water for Injection
Station No. 7: Water for Injection
Station No. 8: Compressed Air
Station No. 9: Spare for silicon treatment
Station No. 10:Spare for silicon treatment
External Wash –
Station No. 2: Re- circulated Purified Water
Station No. 5: Purified water
Station No. 7: water for injection
If the movement of vials and spray from needles are found OK, switch off the machine and start the washing operation in auto mode.
Stop the machine. Send 25 washed vials to the IPQA Officer from the out feed conveyor for checking the particulate matter.
Fill the vials with WFI under LAF.
Stopper the vials with clean rubber stopper.
Check the vials visually against illuminated black and white background for any particulate matter contamination.
Acceptance criteria: The washed vial should be essentially free from visual particulate matter.
Record the observations in Batch Production Record.
Check the sub visible particulate matter of the pooled sample for all the 25 vials.
Acceptance criteria: The washed vial should meet the sub visible particulate matter as per the following limits:
≥ 10µ: Not more than 6000 particles / vial
≥ 25µ: Not more than 600 particles / vial.
Start up
Start the machine after getting approval from the IPQA Officer.
Load the vials to the in feed conveyor of the machine from the tray.
Ensure that the temperature in the Sterilizing Tunnel is more than 320°C.
Start the machine in Auto mode.
Auto mode operation
To start the machine in auto mode. Press button and MMI display manual, auto and set.
Press button to go mode step then after shift the cursor by press to select Auto/manual mode. Select auto mode and Enter press button and MMI display “start system in auto”.
Press button and machine start in auto mode.
Manual mode with PLC
To start the machine in manual mode. Press button and go display manual, auto and set.
Press button to go mode step then after shift the cursor by press to select Auto/manual mode. Select manual mode and Press Enter button.
MMI display start up mode of main drive, pump on screen.
Press button to start main drive, pump respectively.
Press button to go next step and MMI display Pump, Infeed conveyor and solenoid valve.
Press button to start pump, infeed conveyor and solenoid valve.
Again presses button to go next step and display machine speed and outfeed conveyor.
Press button to increase the speed of machine as per required.
Press button to start out feed conveyor and machine start in manual mode.
Operation in manual mode without PLC
To start the machine in manual mode, switch on manually.
To start the main drive, pump1, pump2 and pump3 – press green push button of all one by one and light is glow.
Press red push button A.C.drive to increase the speed of machine as per requirement.
Rotary switch on, of in feed conveyor and out feed conveyor. Light is glow.
Carry out the in process checks for particulate matter of washed vials and record in BPR.
If the washed vial samples fail to meet the acceptance criteria, stop the washing and filing of the vials. Reject all the vials, clean the entire area including washing tracks and restart the operation using fresh inspected good vials.
Collect fresh samples of washed vials and re-check.
In case the failure of the repeat sample, investigation will be carried out to find out the cause and action will be taken on the basis of out come of investigation.
Operator concerned observes washing process continuously, to check for any vial breakage. If any breakage is observed, stop the washing operation and remove all the vials of that channel and adjacent area. These removed vials shall be considered as rejected.
If any breakage is observed, clean the entire vial washing machine. Remove any broken vials or glass pieces, if present.
Shut Down
Shut down of machine in auto mode
In auto mode to stop machine, press F2 button after completion of the washing operation of the batch.
Shut down of machine in manual mode with PLC
Press button to stop the main drive, Pump respectively.
Press button to go next step and press button to stop Pump, infeed Conveyor and solenoid valve respectively.
Press button to go next step and press button to stop out feed conveyor.
Shut down of machine in manual mode without PLC
Press red push button to stop main drive, pump and glow of light is stop.
Rotary switches off, to stop the in-feed conveyor and out feed conveyor and glow of light is stop.
Ensure that all the washed vials are transferred to the Sterilizing Tunnel.
Clean the machine as per SOP.
Record the details of operation, cleaning and preventive maintenance of machine in equipment log book as per SOP and BPR. Get the details checked by the Production officer/Supervisor
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production
History
| Date | Revision Number |
Reason for Revision |
| – | 00 | New SOP |
