SOP for Vial Washing Machine

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

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

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.

• 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.

• 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.

• 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:

• SOP for Rounding off Analytical Results
• SOP for Analytical Method Transfer

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

• 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.

• 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.

Operating manual of Vial Washing machine.

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

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