Standard Operating Procedure for Calibration of Flow Meters in Cream Manufacturing Equipment
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/108/2025 |
| Supersedes | SOP/CRM/108/2022 |
| 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 establish a procedure for the calibration of flow meters used in cream manufacturing equipment. Proper calibration ensures accurate measurement of cream flow, which is critical for maintaining product consistency and meeting production specifications.
2. Scope
This SOP applies to all flow meters used in the cream manufacturing equipment for measuring the flow rate of ingredients during production. It covers the procedures for setting, verifying, and recalibrating flow meters to ensure their accuracy and compliance with product requirements.
3. Responsibilities
- Production Team: Responsible for ensuring that the flow meters are operating within the specified parameters and reporting any discrepancies to the Maintenance Team.
- Maintenance Team: Responsible for the calibration, verification, and regular maintenance of the flow meters.
- Quality Control (QC): Ensures that the calibrated flow meters meet the required specifications for accuracy and that the product meets the expected flow rates during production.
4. Accountability
The Production Supervisor is accountable for ensuring that flow meters are calibrated and maintained according to this SOP. The Maintenance Manager is responsible for overseeing the calibration and repair of flow meters, ensuring they operate accurately.
5. Procedure
5.1 Pre-Calibration Setup
- Ensure that the flow meter is clean and free from any obstructions or residues that could affect the flow measurement. If necessary, follow the equipment cleaning SOP before beginning calibration.
- Check the equipment settings and confirm that the flow meter is installed correctly and securely in the cream manufacturing line.
- Ensure that the environment, including temperature and pressure, is stable and within the acceptable operating range for the calibration process.
- Verify that the flow meter model and specifications match the requirements for the current batch of cream production.
5.2 Calibration of the Flow Meter
- Follow the manufacturer’s instructions for calibrating the flow meter. Typically, this involves introducing a known flow of cream through the meter and adjusting the meter’s reading to match the actual flow rate.
- Use a calibrated flow reference device, such as a graduated cylinder or volumetric flow standard, to measure the actual flow rate of cream.
- Adjust the flow meter’s settings (e.g., calibration factor or zero point) to match the measured flow rate. Ensure that the flow meter’s reading aligns with the reference measurement within an acceptable tolerance.
- Document the calibration parameters, including the reference flow rate, meter readings, and any adjustments made, in the Flow Meter Calibration Log (Annexure-1).
5.3 Verification of Calibration
- After calibration, verify the accuracy of the flow meter by running the system and checking that the flow meter reading matches the expected value based on the production specifications.
- If discrepancies are observed, repeat the calibration process and make necessary adjustments until the flow meter’s reading aligns with the expected value.
- Record the results of the verification in the Flow Meter Calibration Log (Annexure-1) for traceability.
5.4 Post-Calibration Operation
- Once the flow meter has been calibrated and verified, resume the cream production process. Monitor the flow rate during production to ensure it stays within the required specifications.
- Regularly check the flow meter during production runs to confirm that it continues to operate accurately. Make adjustments as necessary to maintain consistency in the cream manufacturing process.
- Document any adjustments made during production in the Flow Meter Monitoring Log (Annexure-2).
5.5 Calibration Frequency
- Calibration of flow meters should be performed on a routine basis as per the maintenance schedule. Additionally, calibration should be performed if there is any suspicion of inaccurate readings or after maintenance and repair activities.
- Ensure that all calibration records are reviewed periodically by the QA team to ensure compliance with the required accuracy standards.
5.6 Documentation
- Record all calibration activities, including the calibration settings, test results, and any issues encountered, in the Flow Meter Calibration Log (Annexure-1).
- Maintain records of all calibration verifications and adjustments in the Flow Meter Monitoring Log (Annexure-2).
- Ensure that all records are reviewed and approved by the Quality Assurance (QA) team to ensure compliance with GMP and product specifications.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Flow Meter Calibration Log
- Annexure-2: Flow Meter Monitoring 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
- Flow Meter 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: Flow Meter Calibration Log
| Batch Number | Calibration Date | Calibration Method | Operator | Calibration Results | Comments |
|---|---|---|---|---|---|
| 12345 | 21/01/2026 | Standard Volumetric Method | John Doe | Accurate within ±2% | Calibration successful, no issues |
Annexure-2: Flow Meter Monitoring Log
| Batch Number | Start Time | End Time | Flow Rate (L/min) | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | 08:00 AM | 04:00 PM | 3.5 L/min | Jane Smith | Consistent flow rate, no deviations |
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 |