Procedure for Operating Filling Machines
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/043 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for operating filling machines during ointment production. Proper operation ensures accurate filling, minimizes wastage, and maintains product integrity.
2. Scope
This SOP applies to all personnel involved in handling, operating, and maintaining filling machines in the ointment manufacturing facility.
3. Responsibilities
- Production Supervisor: Ensures filling operations comply with batch requirements.
- Machine Operator: Operates and monitors the filling machine.
- Quality Assurance (QA) Personnel: Conducts in-process checks to confirm filling accuracy.
- Engineering Technician: Maintains and calibrates the filling machine.
4. Accountability
The Production and QA Managers are accountable for ensuring that the filling operation follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Operational Checks
- Ensure the filling machine is clean and sanitized.
- Verify the calibration of volume control settings.
- Check that all connections, hoses, and nozzles are securely attached.
- Ensure that the batch is approved for filling.
5.2 Loading the Product into the Filling Machine
- Transfer the ointment from the storage tank to the hopper.
- Ensure the transfer is done under controlled conditions to prevent contamination.
- Maintain the product at the required temperature for proper flowability.
5.3
Setting Up the Machine for Filling
- Adjust the volume settings as per batch specifications.
- Set the speed and pressure to ensure uniform filling.
- Run a test fill to confirm accuracy before starting full-scale production.
5.4 Filling Process
- Start the filling machine and monitor the initial output.
- Ensure that each container is filled to the correct volume.
- Check for leaks, air bubbles, or uneven filling.
- Maintain a steady pace to prevent fluctuations in filling levels.
5.5 Monitoring During Filling
- Conduct periodic weight checks to ensure consistency.
- Monitor for any signs of nozzle clogging or product overflow.
- Ensure the temperature remains within the specified range.
5.6 Completion of Filling
- Stop the machine after the last batch is filled.
- Check all filled containers for uniformity.
- Record the batch details and verify compliance before sealing.
5.7 Cleaning and Shutdown
- Flush the filling machine with an approved cleaning solution.
- Sanitize all contact surfaces to prevent cross-contamination.
- Document the cleaning process in the Equipment Cleaning Log.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- RPM – Revolutions Per Minute
- BMR – Batch Manufacturing Record
7. Documents
- Filling Log (Annexure-1)
- Equipment Cleaning Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- Equipment Manufacturer Guidelines
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 Log
| Date | Batch Number | Container Size (g/ml) | Target Volume | Actual Volume | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | 50g | 50g | 50.2g | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | 100g | 100g | 99.8g | QA Officer |
Annexure-2: Equipment Cleaning Log
| Date | Filling Machine ID | Cleaning Agent Used | Sanitization Method | Verified By |
|---|---|---|---|---|
| 01/02/2025 | FM-101 | Sodium Hypochlorite | Rinsed and Dried | QA Head |
| 02/02/2025 | FM-102 | Ethyl Alcohol | Wiped and Flushed | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |