Standard Operating Procedure for Use of Volumetric Filling Machine in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/132/2025 |
| Supersedes | SOP/ELX/132/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the standard procedure for the setup, operation, and cleaning of volumetric filling machines used for accurate filling of elixir formulations into primary containers such as bottles and jars under controlled conditions.
2. Scope
This SOP applies to all volumetric filling machines used in the Elixir Department for batch-wise filling of oral liquid products including sugar-based, alcohol-based, and aqueous elixirs.
3. Responsibilities
- Production Operator:
- Set up, operate, monitor, and clean the filling machine.
- Production Supervisor:
- Verify volume accuracy, oversee line clearance, and maintain records.
- Engineering Department:
- Perform preventive maintenance, servicing, and calibration.
- QA Officer:
- Verify cleanliness, review BMR entries, and ensure GMP compliance.
4. Accountability
The Production Head is accountable for machine operation and documentation. The Engineering Head is responsible for equipment upkeep and calibration.
5. Procedure
5.1 Pre-Operation Checks
- Ensure
the machine is labeled “CLEANED” and released by QA.
Check that the volumetric pistons, cylinders, valves, and nozzles are properly assembled and clean.
Verify calibration status of the machine and ensure it is within the due date.
Ensure containers (e.g., bottles) are clean and ready for filling.
5.2 Setup and Trial Run
- Connect the inlet to the bulk tank or storage vessel using sanitized hoses.
- Set the desired filling volume using the control panel or manual dial (e.g., 100 mL, 200 mL).
- Perform trial fills on 10 containers and weigh the filled volume using a calibrated balance.
- If variation is within ±2% of target volume, proceed with batch filling. If not, readjust settings.
- Record trial run results in the Filling Machine Calibration Log (Annexure-1).
5.3 Batch Filling Operation
- Start the filling process and monitor container placement, nozzle movement, and volume consistency.
- Collect filled containers onto the conveyor or collection tray for capping.
- Continuously check 1 container every 15 minutes or 1000 units for volume verification.
- Document all observations in the BMR and Filling Activity Log (Annexure-2).
5.4 Post-Filling Cleaning
- Switch off the machine and disconnect hoses.
- Drain remaining liquid from the machine into a recovery container.
- Disassemble filling nozzles, pistons, and valves.
- Clean all parts using validated cleaning solutions, rinse with purified water, and dry.
- Reassemble and label the machine “TO BE CLEANED” or “CLEANED.”
5.5 Safety and Precautions
- Ensure machine guards and covers are in place during operation.
- Do not attempt to adjust pistons or remove nozzles while the machine is running.
- Wear gloves, mask, and eye protection when handling filled products or cleaning solutions.
- Do not bypass safety interlocks or sensors.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- GMP: Good Manufacturing Practice
7. Documents
- Filling Machine Calibration Log (Annexure-1)
- Filling Activity Log (Annexure-2)
- BMR/Batch Sheet
8. References
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
- WHO TRS 986 – GMP Equipment Guidelines
- ICH Q8 – Pharmaceutical Development
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Filling Machine Calibration Log
| Date | Machine ID | Set Volume (mL) | Avg. Actual Volume (mL) | Deviation (%) | Status | Checked By |
|---|---|---|---|---|---|---|
| 11/04/2025 | VMF-03 | 100 | 99.6 | -0.4% | Pass | Sunita Reddy |
Annexure-2: Filling Activity Log
| Date | Batch No. | Start Time | End Time | Volume/Container | No. of Containers | Operator | Remarks |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1062 | 09:00 | 10:20 | 100 mL | 5000 | Rajesh Kumar | Operation Normal |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added trial fill verification and cleaning steps | Process Standardization | QA Head |