Standard Operating Procedure for Adjusting Filling Nozzles for Precise Cream Dispensing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/104/2025 |
| Supersedes | SOP/CRM/104/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
The purpose of this SOP is to define the procedure for adjusting filling nozzles used in cream dispensing. Proper adjustment of the filling nozzles ensures accurate and uniform dispensing of cream products, which is essential for meeting product specifications and maintaining packaging consistency.
2. Scope
This SOP applies to all filling nozzles used in the Creams Department for dispensing cream products into containers. It covers the procedures for adjusting, calibrating, and ensuring precise filling of containers during the packaging process.
3. Responsibilities
- Production Team: Responsible for adjusting the filling nozzles according to this SOP and ensuring that the cream is dispensed accurately into the containers.
- Maintenance Team: Responsible for inspecting and maintaining the filling nozzles and ensuring they are in good working condition for precise dispensing.
- Quality Control (QC): Ensures that the cream dispensed from the nozzles meets the required quantity and packaging standards.
4. Accountability
The Production Supervisor is accountable for ensuring that the filling nozzles are adjusted properly according to this SOP. The Maintenance Manager is responsible for the maintenance and repair of filling nozzles and related equipment to ensure their proper functioning.
5. Procedure
5.1 Pre-Operation Setup
- Before starting the filling process, ensure that the filling nozzles are clean and free of any previous cream residue. Follow the cleaning SOP for filling nozzles to ensure they are sanitized.
- Verify that the nozzles are securely attached to the filling machine and are positioned correctly for dispensing into the containers.
- Check the filling machine’s settings, including the filling speed, nozzle height, and nozzle width, to ensure they align with the specifications for the batch.
- Verify that the cream consistency is correct for dispensing, as thicker creams may require nozzle adjustments for better flow and precision.
5.2 Adjusting the Nozzle Height
- Adjust the height of the filling nozzles to ensure that they are positioned just above the containers to prevent splashing or overfilling.
- The nozzle height should be adjusted according to the size and type of the container to be filled. Ensure that the nozzles do not touch the containers, as this may cause contamination.
- For containers with varying sizes, adjust the nozzle height to suit the specific container, ensuring uniform filling of each container.
5.3 Adjusting the Filling Speed
- Adjust the filling speed based on the viscosity of the cream and the type of container being used. Thicker creams may require slower filling speeds to prevent splashing and ensure accuracy.
- If the filling machine allows, fine-tune the speed settings to ensure that the cream is dispensed at a consistent rate and fills each container to the correct level.
- Monitor the speed during the production run and make adjustments as needed to accommodate any changes in cream consistency or container sizes.
5.4 Calibrating the Nozzles
- Calibrate the filling nozzles by measuring the amount of cream dispensed into a container. Compare this measurement with the required fill weight or volume for the container.
- If the amount dispensed is incorrect, adjust the nozzle calibration to increase or decrease the volume of cream dispensed per cycle.
- Use calibrated measuring equipment, such as a scale or volumetric measurement tool, to verify the correct fill level. Record the calibration details in the Nozzle Calibration Log (Annexure-1).
5.5 Testing for Accurate Dispensing
- Perform a test run to check the accuracy of the adjusted filling nozzles. Fill a batch of containers and check that each container is filled to the correct level and meets the weight or volume specifications.
- If any discrepancies are found, make further adjustments to the nozzles and repeat the test until the desired dispensing accuracy is achieved.
- Ensure that any product that does not meet the required specifications is discarded and not used for sale.
5.6 Post-Operation Shutdown
- After the production run, ensure that the filling nozzles are cleaned and properly shut down. Follow the cleaning SOP to ensure that the nozzles are free from cream residues, which could lead to cross-contamination during subsequent runs.
- Inspect the nozzles for any signs of wear, clogging, or damage. If any issues are identified, report them to the Maintenance Team for repair or replacement.
5.7 Documentation
- Record all adjustments made to the filling nozzles in the Nozzle Adjustment Log (Annexure-2). This includes nozzle height, filling speed, and calibration details.
- Ensure that all calibration results, test runs, and corrective actions are documented in the Nozzle Calibration Log (Annexure-1).
- Review and approve all documentation to ensure accuracy and compliance with the required filling standards.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Nozzle Calibration Log
- Annexure-2: Nozzle Adjustment 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
- Filling Equipment Manufacturer’s Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Nozzle Calibration Log
| Batch Number | Calibration Date | Operator | Calibration Results | Comments |
|---|---|---|---|---|
| 12345 | 21/01/2026 | John Doe | Accurate to within 0.5 ml | No issues, calibration successful |
Annexure-2: Nozzle Adjustment Log
| Batch Number | Adjustment Date | Adjusted Parameters | Operator | Comments |
|---|---|---|---|---|
| 12345 | 21/01/2026 | Height: 5 cm, Speed: 80 RPM | Jane Smith | Successful adjustments made |
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 |