Procedure for Transferring Ointments to Filling Machines
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/027 |
| 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 standardized process for transferring ointments from the manufacturing vessel to the filling machine. Proper transfer ensures product integrity, prevents contamination, and maintains consistency in filling operations.
2. Scope
This SOP applies to all personnel involved in the transfer of ointments from storage tanks or processing vessels to automatic or semi-automatic filling machines in the production area.
3. Responsibilities
- Production Supervisor: Oversees the transfer process and ensures compliance with SOP guidelines.
- Machine Operator: Operates and monitors the transfer equipment.
- Quality Assurance (QA) Personnel: Verifies product integrity and ensures compliance with GMP standards.
- Engineering Technician: Maintains and troubleshoots the transfer system.
4. Accountability
The Production and QA Managers are accountable for ensuring that the ointment transfer process is conducted as per GMP standards and properly documented.
5. Procedure
5.1 Pre-Transfer Preparations
- Ensure that the filling machine, transfer hoses, and storage tanks are clean and sanitized.
- Verify that the ointment batch has been approved for filling by the QA department.
- Check the temperature of the ointment to ensure it is within the
specified range for transfer.
Ensure that all valves, pumps, and transfer lines are correctly assembled.
5.2 Selection of Transfer Method
- Gravity Transfer: Used for small-scale manual filling.
- Pneumatic Transfer: Utilizes compressed air to push the product through transfer lines.
- Positive Displacement Pump Transfer: Ensures uniform flow to the filling machine.
5.3 Transferring the Ointment
- Connect the transfer hoses securely to prevent leaks.
- Activate the transfer system and monitor the flow rate.
- Ensure there are no air bubbles or interruptions in the transfer process.
- Maintain constant agitation (if required) to prevent phase separation.
5.4 Monitoring During Transfer
- Observe the transfer for any signs of clogging or foaming.
- Ensure that all connections remain sealed to avoid contamination.
- Check that the transfer rate is consistent with the filling machine’s capacity.
5.5 Completion of Transfer
- Shut off the transfer system once the required volume has been transferred.
- Disconnect and flush the transfer lines with an approved cleaning solution.
- Perform a final weight verification of the transferred batch.
5.6 Documentation and Approval
- Record all process parameters in the Ointment Transfer Log.
- QA must verify and approve the transferred batch before filling begins.
- Label the filled machine hopper as “Ready for Filling.”
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- R&D – Research and Development
- BMR – Batch Manufacturing Record
7. Documents
- Ointment Transfer Log (Annexure-1)
- In-Process Quality Control Report (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: Ointment Transfer Log
| Date | Batch Number | Transfer Method | Temperature (°C) | Transfer Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Pneumatic | 55°C | 20 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Gravity | 50°C | 15 | QA Officer |
Annexure-2: In-Process Quality Control Report
| Date | Batch Number | Test Parameter | Specification | Result | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Temperature | 50-60°C | 55°C | Pass |
| 02/02/2025 | SOP/Ointment/002 | Transfer Efficiency | ≥98% | 99% | Pass |
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 |