Operation and Maintenance of Suppository Transfer Pump
1) Purpose
The purpose of this SOP is to outline the procedures for operating and maintaining the suppository transfer pump to ensure efficient and safe transfer of suppository mass.
2) Scope
This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the suppository transfer pump in the manufacturing facility.
3) Responsibilities
It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the suppository transfer pump.
4) Procedure
4.1 Preparation
- Ensure the work area and equipment are clean and sanitized before starting the transfer process.
- Verify the availability and integrity of suppository mass ready for transfer.
- Inspect the suppository transfer pump, including hoses and seals, to ensure they are clean and in good condition.
4.2 Transfer Process
- Connect the inlet and outlet hoses of the transfer pump to the respective containers.
- Start the pump and adjust the flow rate according to the viscosity and volume of suppository mass being transferred.
- Monitor the transfer process to ensure complete and accurate transfer of suppository mass.
4.3 Cleaning and Maintenance
- Stop the transfer pump after completing the transfer operation.
- Flush the pump and hoses with appropriate cleaning solutions to remove any residue.
- Perform routine
maintenance tasks such as checking pump seals, lubricating moving parts, and inspecting motor performance.
5) Abbreviations, if any
N/A
6) Documents, if any
Batch production record, Cleaning log, Suppository transfer pump specifications
7) Reference, if any
GMP guidelines, Manufacturer’s operating manual for suppository transfer pump
8) SOP Version
Version 1.0