Standard Operating Procedure for Use of Vacuum Transfer Systems in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/104/2025 |
| Supersedes | SOP/ELX/104/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for the proper operation, monitoring, and cleaning of vacuum transfer systems used for the hygienic and efficient transfer of liquids and powders in elixir manufacturing.
2. Scope
This SOP applies to all vacuum-based transfer systems used in the Elixir Department for transferring raw materials or final product between vessels, tanks, or containers under closed-loop conditions.
3. Responsibilities
- Production Operator:
- Set up and operate the vacuum transfer system as per instructions.
- Record transfer parameters and any observations.
- Production Supervisor:
- Ensure vacuum transfer is carried out according to protocol.
- Verify and sign documentation.
- QA Officer:
- Confirm system cleanliness and approve transfers when required.
4. Accountability
The Head of Production is accountable for the correct usage, maintenance, and cleaning validation of vacuum transfer systems as per GMP standards.
5. Procedure
5.1
Pre-Operation Checks
- Verify that the vacuum transfer system is labeled “CLEANED” and ready for use.
- Check the integrity of gaskets, seals, hoses, and clamps.
- Ensure that vacuum pump oil level and filters are within operational range.
- Verify that the source and receiving vessels are clean and labeled correctly.
5.2 Setup of System
- Connect the suction line to the source tank/container and ensure airtight connection.
- Connect the discharge line to the receiving vessel.
- Start the vacuum pump using the control panel and set the pressure according to product requirement (as per BMR).
5.3 Transfer Operation
- Initiate the transfer by opening the inlet valve of the source vessel slowly to allow controlled suction.
- Monitor the level indicator or sight glass during transfer.
- Adjust the vacuum level if the flow rate is too high or low.
- Once desired quantity is transferred, close inlet and outlet valves.
- Stop the vacuum pump and release residual vacuum using vent valve.
5.4 Post-Transfer Activities
- Disconnect hoses and lines using clean gloves.
- Transfer equipment to the wash area and clean as per cleaning SOP.
- Label the system as “TO BE CLEANED” until cleaning is complete.
- Record all observations in the Vacuum Transfer Log (Annexure-1).
5.5 Cleaning and Storage
- Clean all product contact surfaces using validated cleaning agents.
- Dry the system thoroughly and store in designated clean area with “CLEANED” status label.
- QA to inspect and verify before reuse.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Vacuum Transfer Log (Annexure-1)
- Equipment Cleaning Log
- Batch Manufacturing Record (BMR)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ISPE Good Practice Guide – Process Equipment Cleaning
- 21 CFR Part 211.65 – Equipment Construction
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Vacuum Transfer Log
| Date | Batch No. | Material Transferred | Quantity (L) | Vacuum Level (mbar) | Operator | Supervisor Verified |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1043 | Sugar Syrup | 250 | 450 | Rajesh Kumar | Sunita Reddy |
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 | Included additional verification steps and cleaning storage | GMP Compliance Update | QA Head |