Standard Operating Procedure for Operating Cream-Filling Machines
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/083/2025 |
| Supersedes | SOP/CRM/083/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
This SOP outlines the procedure for operating cream-filling machines during the packaging process. The purpose is to ensure that the filling process is performed accurately, efficiently, and in compliance with product specifications.
2. Scope
This SOP applies to the operation of all cream-filling machines in the Creams Department. It covers the setup, operation, monitoring, and maintenance of filling machines used for packaging cream products.
3. Responsibilities
- Production Team: Responsible for setting up, operating, and monitoring the filling machine to ensure proper filling of cream products.
- Quality Control (QC): Ensures that the filled products meet the required volume, weight, and quality standards.
- Maintenance Team: Ensures that the filling machines are properly maintained, calibrated, and cleaned after each use.
4. Accountability
The Head of Production is accountable for ensuring that the filling machines are operated according to this SOP. The QA Manager is responsible for reviewing product quality and ensuring that filled products comply with specifications.
5. Procedure
5.1 Pre-Operation Setup
- Ensure the cream-filling machine is clean and free of any contaminants. Perform cleaning and sanitization procedures as per the cleaning SOP.
- Check the filling machine for any visible wear or damage. Ensure that all parts (e.g., nozzles, valves, and hoses) are correctly fitted and functioning.
- Verify that the correct type of containers (e.g., jars, tubes, or bottles) are available and ready for filling. Ensure that containers are free of defects.
- Set up the machine with the appropriate settings, such as filling volume, speed, and temperature, according to the batch record.
5.2 Operating the Filling Machine
- Start the filling machine and allow it to reach the desired operating speed and pressure.
- Verify that the cream is flowing smoothly through the filling nozzles and filling containers consistently.
- Monitor the filling volume for each container to ensure it meets the specified weight or volume as per the product requirements. Use the automatic sensors or manual checks to verify accuracy.
- If a deviation from the set filling volume or weight is observed, stop the machine immediately and identify the cause (e.g., nozzle blockage, underfilled container).
5.3 Monitoring During Operation
- Continuously monitor the filling machine for any issues such as overfilling, underfilling, leakage, or abnormal noises.
- Ensure that the cream flows evenly into each container without splashing or spilling.
- Periodically check filled containers for consistency in fill level and product appearance.
- In case of underfilling or overfilling, adjust the filling machine settings accordingly and document the corrective action in the Batch Production Record (Annexure-1).
5.4 Post-Operation Checks
- Once the filling process is completed, verify the final product by inspecting the filled containers for proper sealing and labeling.
- Ensure that all containers are properly closed, sealed, and labeled with the correct batch number, expiration date, and product information.
- Record the amount of product filled and any discrepancies or deviations in the Batch Production Record (Annexure-1).
5.5 Maintenance and Cleaning
- After completing the filling process, immediately clean the machine to prevent contamination between batches. Follow the equipment cleaning SOP for proper cleaning and sanitization.
- Perform routine maintenance checks to ensure that the machine components are in good working condition. Schedule regular calibration and servicing as required.
- Document the cleaning and maintenance activities in the Equipment Cleaning Log (Annexure-2).
5.6 Documentation
- Record all relevant details in the Batch Production Record (Annexure-1), including the filled product quantity, any discrepancies in filling volume, and maintenance activities.
- Complete the Equipment Cleaning Log (Annexure-2) after each filling operation, ensuring that all maintenance and cleaning activities are documented.
5.7 Final Approval
- The QA team must review the records of the filling operation, including product fill levels and any deviations, before approving the filled products for further processing or packaging.
- Ensure that all filled products meet the required quality standards for appearance, consistency, and packaging integrity.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Batch Production Record
- Annexure-2: Equipment Cleaning Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Guidelines for Cosmetics Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Production Record
| Batch Number | Production Date | Filling Volume | Operator | Comments |
|---|---|---|---|---|
| 12345 | 21/01/2026 | 5000 L | Jane Smith | Completed without issues |
Annexure-2: Equipment Cleaning Log
| Equipment | Cleaning Date | Cleaning Method | Operator | Comments |
|---|---|---|---|---|
| Cream Filling Machine | 21/01/2026 | Rinsed and cleaned with detergent | John Doe | Cleaned after every batch |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |