Standard Operating Procedure (SOP) for Cleaning and Operation of Vial Washing Machine

1.0 Objective:
To establish a clear procedure for the cleaning and operation of the vial washing machine, ensuring that vials are free from particulate matter.

2.0 Scope:
This SOP applies to the Injectable area within the production department.

3.0 Responsibility:
3.1 The Production Officer is responsible for executing this procedure.
3.2 The Head of Production is responsible for ensuring overall compliance with this SOP.

4.0 Procedure:

4.1 Precautions:
4.1.1 Ensure that both the area and the machine are clean and free from any residue from previous batches or products.
4.1.2 Turn on the LAF (Laminar Air Flow) unit at least 30 minutes before starting the operation.
4.1.3 Restrict access to unauthorized personnel; minimize movement in the working area.
4.1.4 Operators must wear clean overalls, surgical gloves, and nose masks while handling and arranging the washed vials in stainless steel (S.S.) boxes.
4.1.5 Inspect and confirm that the water and compressed air line filters are in optimal condition.

4.2 Operation of Vial Washing Machine:
4.2.1 Turn on the main power supply.
4.2.2 Before initiating the washing process, verify the following parameters:

• Compressed air pressure: Should be between 1.5 to 2.0 kg/cm².
• Ensure the D.M. (Deionized) water supply line is properly connected.
• Water flow pressure: Should be at least 2.0 kg/cm².
• Confirm the washing cycle steps, which include air and D.M. water stages. 4.2.3 Fill the tank with D.M. water for the initial washing cycle.
  4.2.4 Open the WFI (Water for Injection) line valve for the final washing cycle.
  4.2.5 Open the compressed air valve.
  4.2.6 Start the machine by switching it on.
  4.2.7 Run the machine empty to check the water jet pressure from the needles; if any needle is clogged, clean it immediately.
  4.2.8 Ensure that the water clarity is satisfactory; if clarity is poor or jet pressure is insufficient, replace the corresponding filter.
  4.2.9 Place the washed, empty S.S. boxes under the LAF unit.
  4.2.10 Unbox the vials and place them on the vial holder. Position the holder on the washing machine.
  4.2.11 Lower the handle to ensure that all needles correctly enter the vials; manually adjust any vials if necessary.
  4.2.12 Close the machine lid and start the washing cycle.
  4.2.13 Upon completion of the cycle, open the lid, lift the handle, and remove the vial holder.
  4.2.14 Place an S.S. plate over the vial holder, invert the holder, and unload the vials onto the plate.
  4.2.15 Transfer the washed vials from the S.S. plate to the washed S.S. vial boxes under the LAF unit.
  4.2.16 At the end of the shift, load all washed vial boxes into the Dry Heat Sterilizer.
  4.2.17 Check water clarity every two hours and before resuming operation after any breaks.
  4.2.18 Record all necessary details in the batch manufacturing record and update the Equipment Log Sheet.
  4.2.19 After completing the day’s operations, drain the water from the tank and clean the machine thoroughly.

4.3 Cleaning of Vial Washing Machine:
4.3.1 Switch off the main power supply.
4.3.2 Close the water supply line.
4.3.3 Open the Perspex guard covering the vial washing needles.
4.3.4 Use compressed air to clean the washing needle assembly, removing any broken glass or foreign particles.
4.3.5 Wipe the inverter with a sponge to remove any residue.
4.3.6 Clean the pusher wheel thoroughly.
4.3.7 Rinse the PVC tube with D.M. water to ensure cleanliness.
4.3.8 Scrub the platform side plate and side cover with D.M. water.
4.3.9 Document the cleaning observations in the Equipment Log Sheet.

5.0 Abbreviations:
SOP: Standard Operating Procedure
QA: Quality Assurance
LAF: Laminar Air Flow
D.M.: Deionized Water
WFI: Water for Injection