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SOP for Vial Washing Machine

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SOP for Vial Washing Machine | Vial Machine Cleaning | Vial Machine Procedure.

SOP for Vial Washing Machine

1.0 Aim:

This SOP applies to the operation and maintenance of the vial washing machine at the Pharmaceutical facility.

2.0 Objective:

This Standard Operating Procedure (SOP) outlines the procedure for operating, cleaning, product changeover, and maintenance of the vial washing machine at the Vaccine Formulation Plant.

3.0 Responsibility:

  • Asst. Manager / Sr. Officer / Officer / Line Coordinator: Responsible for executing this SOP.
  • Manager / Sr. Manager: Responsible for supervising the process.
  • Head Quality Assurance: Responsible for ensuring compliance with this SOP.

4.0 Safety Considerations:

  • Do not remove installed protection devices.
  • Safety switches should not be bypassed.
  • Do not reach into the machine while it is running.
  • Do not climb on the machine during production.
  • Do not reach over open-top protection covers.
  • Before starting up the machine, inform everyone working on the line.
  • Do not touch the moving machine parts.
  • Do not stand too close to moving machine parts.
  • During production, do not clean moving machine parts.
  • Do not clean the machine by spraying water on it.
  • Before opening the protective covers, switch off the main power and lock out the machine.
  • Do not run the hand wheel in the opposite direction of the machine’s motion.
  • Depressurize all pneumatic equipment/connections before opening any for repair and cleaning.
  • Wear personal protective equipment like goggles, masks, gloves, etc. while cleaning the equipment.

5.0 Procedure for Vial Washing Machine:

5.1 Cleaning Procedure:

  • Switch off the device for cleaning to prevent accidental triggering from the touch panel.
  • Lift the acrylic protective guard by pressing the up arrow key on the control panel to access the machine’s interior.
  • Manually remove larger glass particles with forceps and clean with compressed air.
  • Use a moist cloth for cleaning, wetting it with filtered 70% IPA v/v.
  • Clean the machine with the moistened cloth; do not use aggressive solvents or scouring agents.
  • After cleaning, lower the acrylic protective guard by pressing the down arrow key on the control panel.

Related SOPs:

5.2 Operating Procedure:

(Note: Check the integrity of filters used for Air & WFI as per SOP No. PR/041 before every batch.)

5.2.1 Start-Up Procedure:

  • Switch on the main switch at the control cabinet, and check for any faults.
  • Use the password for any changes in the assigned data in PLC (3, 5, and 7 levels).
  • Start in Manual Mode:
  • Select the operating panel and check the required working stations.
  • Plug in the jog button in the operating console and switch on the machine drive with the button.
  • Start in Auto Mode:
  • Select the operating panel and check the required working stations.
  • Switch on the machine drive with the button.
  • Perform utility checks for water pressure.
  • Check the format of vials to be run in the machine and adjust settings as required.
  • Adjust the rotor height and confirm at the operating panel.
  • Adjust the height of the rinsing needle.
  • Verify flushing needle positions at different stroke settings.
  • Ensure the flushing needles are in the top position.
  • Run the machine in jogging mode until the flushing needles are in the top position.
  • In its bottom position, the flushing needle must be outside the vial.
  • Check the washing scheme for different steps.

5.2.2 Switch Off Machine:

  • Stop production (batch end) to allow all containers to be processed, and the machine resumes its home position.
  • If the machine needs to be shut down completely, press a key to resume the standby state (control off), and then switch off the main switch.
  • To stop the machine during running production:
  • In manual operation, release the jog button or key.
  • In automatic operation, press Key.

6.0 References:

Operating manual of Vial Washing machine.

7.0 Annexure:

  • Log Book of Vial Washing Machine
  • Set parameters of various formats at the vial washing machine

8.0 Abbreviations:

SOP: Standard Operating Procedure
QA: Quality Assurance
IPA: Iso Propyl Alcohol
LAF: Laminar Air Flow
ºC: Degree Celsius
WFI: Water For Injection
IPQC: In-Process Quality Control
No.: Number

Annexure for Vial Washing Machine logbook
Annexure to set parameters for SOP for Vial Washing Machine

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