SOP for Monitoring Temperature and Pressure in Filling Operations
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/035/2025 |
| Supersedes | SOP/Aerosol/035/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for monitoring temperature and pressure during aerosol filling operations. The objective of this SOP is to ensure that the filling process remains within the defined temperature and pressure parameters to maintain product quality, consistency, and safety. Proper temperature and pressure control is critical to achieving the correct fill volume and ensuring proper sealing of aerosol cans.
2. Scope
This SOP applies to all aerosol filling operations at [Company Name], including the monitoring and control of temperature and pressure during the filling process. It covers the setup, monitoring, and adjustment of temperature and pressure parameters to ensure they meet product specifications. This SOP does not cover the calibration of equipment or routine maintenance, which is addressed by separate procedures.
3. Responsibilities
- Production Team: Responsible for operating the filling equipment, monitoring the temperature and pressure during the process, and ensuring that the parameters are maintained within the specified range.
- Quality Control (QC) Team: Responsible for verifying that the temperature and pressure are within the defined limits and conducting periodic checks to ensure compliance with specifications.
- Maintenance Team: Responsible for ensuring that the temperature and pressure control systems are properly maintained and calibrated to function accurately during the filling process.
- Health and Safety Officer: Ensures that safety measures are followed, particularly regarding pressure-related hazards and temperature-related risks during filling operations.
4. Accountability
The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that temperature and pressure are properly controlled during filling operations. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.
5. Procedure
5.1. Setup of Temperature and Pressure Parameters
- Prior to starting the filling process, verify that the temperature and pressure control systems are set according to the product specifications and the filling equipment’s manufacturer guidelines.
- Ensure that the filling machine is calibrated and that the temperature and pressure sensors are functioning correctly. Perform a quick test cycle to verify proper operation.
- Consult the product specification sheet to confirm the required temperature and pressure ranges for the aerosol product being filled.
- Set the filling equipment’s temperature and pressure controls based on the specified ranges. Record the initial settings in the Process Monitoring Log (Annexure-1).
5.2. Monitoring Temperature and Pressure During Filling
- During the filling process, continuously monitor the temperature and pressure using the integrated sensors on the filling machine.
- Ensure that the temperature and pressure remain within the specified ranges throughout the filling cycle. Any deviation from the specified ranges should be addressed immediately.
- Record the temperature and pressure readings at regular intervals in the Temperature and Pressure Monitoring Log (Annexure-2). The frequency of checks should be determined based on batch size and equipment specifications.
- If temperature or pressure deviates from the specified range, stop the filling process and investigate the cause of the deviation. Adjust the settings as necessary to restore the correct parameters.
5.3. Handling Deviations in Temperature and Pressure
- If the temperature exceeds the upper limit or falls below the lower limit, adjust the heating or cooling mechanisms accordingly. Ensure that the temperature returns to the acceptable range before resuming the filling process.
- If the pressure exceeds the upper limit or drops below the lower limit, check for potential issues such as leaks, pressure valve malfunctions, or improper equipment settings. Adjust the pressure control system to restore the correct pressure levels.
- If the deviation cannot be resolved quickly, stop the filling process and notify the maintenance team to troubleshoot and resolve the issue before restarting the process.
- Record all deviations, adjustments, and corrective actions taken in the Deviation Log (Annexure-3), including the batch number, the cause of the deviation, and the actions taken to correct it.
5.4. Post-Filling Temperature and Pressure Verification
- After the filling process is complete, conduct a final check to ensure that the temperature and pressure are within the acceptable range for the next stage of production (e.g., sealing, packaging).
- If necessary, verify the temperature and pressure settings before transferring the filled cans to the next stage. Ensure that all cans are sealed properly and that no pressure-related issues will affect the final product.
5.5. Documentation and Record-Keeping
- Ensure that all temperature and pressure readings, including initial settings, deviations, and corrective actions, are documented in the Temperature and Pressure Monitoring Log (Annexure-2).
- Document any deviations and corrective actions taken in the Deviation Log (Annexure-3), ensuring that all records are complete and accurate.
- Store all records according to the company’s document retention policy and ensure they are available for future audits or inspections.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- CAPA: Corrective and Preventive Actions
- PPE: Personal Protective Equipment
- R&D: Research and Development
7. Documents
- Process Monitoring Log (Annexure-1)
- Temperature and Pressure Monitoring Log (Annexure-2)
- Deviation Log (Annexure-3)
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
- International Pharmacopoeia (Ph. Int.) – Aerosol Delivery
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Process Monitoring Log
| Batch No. | Temperature | Pressure | Time | Operator Name |
|---|---|---|---|---|
| 12345 | 22°C | 150 psi | 06/02/2025 | Rajesh Patel |
Annexure-2: Temperature and Pressure Monitoring Log
| Batch No. | Temperature | Pressure | Time | Operator Name |
|---|---|---|---|---|
| 12345 | 22°C | 150 psi | 06/02/2025 | Rajesh Patel |
Annexure-3: Deviation Log
| Batch No. | Deviation Description | Action Taken | Operator Name |
|---|---|---|---|
| 12345 | High pressure during filling | Adjusted pressure valve | Rajesh Patel |
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 temperature and pressure procedures | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |