working condition, addressing any mechanical issues that arise during operation.

Quality Control (QC) Team: Responsible for ensuring that the starting and stopping procedures do not impact the quality of the product being produced, and that the filling machine is calibrated and operating according to specifications.

Health and Safety Officer: Ensures that safety protocols are followed throughout the starting and stopping of the filling machine, particularly in handling pressurized equipment.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that all aerosol filling machines are started and stopped safely. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Start Checks

1. Before starting the aerosol filling machine, ensure that the area around the machine is clear of any obstructions and that all safety guards and covers are in place.
2. Check that all necessary raw materials (e.g., propellants, product formulations, cans) are available and properly prepared for the filling process.
3. Inspect the machine to ensure that it is in good working condition. Look for signs of wear, damage, or leaks, especially in areas that handle pressurized components.
4. Verify that the filling machine has been calibrated according to the manufacturer’s specifications and that the filling volume is set to the correct levels for the batch.
5. Ensure that all electrical and mechanical components are functioning correctly, including the power supply, controls, and pneumatic systems.
6. Check that the emergency stop and other safety features are operational and within reach of the operator.
7. Log all pre-start checks in the Pre-Start Inspection Log (Annexure-1) to ensure accountability and traceability.

5.2. Starting the Aerosol Filling Machine

1. Ensure that the machine is properly set up and that all pre-start checks have been completed and documented.
2. Turn on the main power supply and verify that the control panel lights up and shows the machine status (e.g., “Ready” or “Standby”).
3. Start the machine by following the startup procedure in the control panel. This may include pressing the “Start” button and selecting the appropriate production mode (e.g., filling mode, testing mode).
4. Observe the machine as it begins to operate to ensure that it starts smoothly and that there are no unusual noises, vibrations, or error messages.
5. Check that the filling machine is dispensing the correct amount of product and that all cans are being properly filled and sealed.
6. Monitor the machine’s performance for a few minutes to ensure that it is operating within the specified parameters (e.g., temperature, pressure, speed).
7. Record the start time and batch number in the Batch Production Log (Annexure-2).

5.3. Stopping the Aerosol Filling Machine

1. When production is complete or if a stoppage is necessary, initiate the machine stop procedure using the control panel.
2. Gradually reduce the filling speed and ensure that the machine stops without causing any sudden movements or damage to the equipment.
3. Turn off the machine’s power supply and ensure that all safety features are activated to prevent any accidental startups.
4. Perform a post-stop check of the machine to ensure that it is fully stopped and that there are no remaining pressurized components (e.g., gas in cylinders).
5. Ensure that all remaining product is removed from the machine and that it is properly stored or disposed of in accordance with company procedures.
6. Log the stop time, batch number, and any anomalies encountered during the process in the Machine Stop Log (Annexure-3).

5.4. Post-Start and Post-Stop Checks

1. After the machine has started and during its operation, monitor its performance regularly to ensure that it is filling within specified parameters. Check for product consistency, can alignment, and seal integrity.
2. Once the machine has stopped, perform a thorough inspection to ensure that all components are safe and that the machine is ready for the next production run.
3. Ensure that any issues encountered during the operation (e.g., filling inconsistencies, malfunctions) are documented in the Deviation Report (Annexure-4) and addressed promptly.

5.5. Documentation and Record-Keeping

1. Ensure that all actions related to starting and stopping the filling machine are documented in the relevant logs (Pre-Start Inspection Log, Batch Production Log, Machine Stop Log, and Deviation Report).
2. Store all records in accordance with the company’s document retention policy to ensure traceability and compliance with regulatory requirements.
3. Review records regularly to ensure that SOP compliance is being maintained and that any necessary adjustments are made for continuous improvement.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment

7. Documents

1. Pre-Start Inspection Log (Annexure-1)
2. Batch Production Log (Annexure-2)
3. Machine Stop Log (Annexure-3)
4. Deviation Report (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pre-Start Inspection Log

Machine ID	Check Description	Operator Name	Date & Time	Remarks
F-12345	Checked all components	Rajesh Patel	06/02/2025	No issues found

Annexure-2: Batch Production Log

Batch No.	Start Time	Operator Name	Product Yield	Test Results
12345	06/02/2025	Rajesh Patel	5000 cans	Pass

Annexure-3: Machine Stop Log

Batch No.	Stop Time	Operator Name	Reason for Stop
12345	06/02/2025	Rajesh Patel	End of batch

Annexure-4: Deviation Report

Batch No.	Deviation Description	Corrective Action	Operator Name	Time
12345	Filling inconsistency	Adjusted filling machine settings	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated machine start and stop procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures