Standard Operating Procedure for Sterile Transfer Pump

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Sterile Transfer Pump used in the pharmaceutical manufacturing of otic dosage forms to ensure sterile transfer of liquids without contamination.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the Sterile Transfer Pump in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the Sterile Transfer Pump as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying the integrity of the sterile transfer process.
Maintenance Personnel: Responsible for maintaining the Sterile Transfer Pump in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Sterile Transfer Pump for cleanliness and integrity before use.
4.1.1.2 Ensure that all connections, seals, and filters are intact and functional.
4.1.1.3 Verify that the pump is calibrated and operating within specified parameters.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the external surfaces of the pump and surrounding area.
4.1.2.2 Check and prepare all materials and containers needed for sterile transfer.
4.1.2.3 Ensure that the pump is primed and ready for operation according to manufacturer’s instructions.

4.2 Operation
4.2.1 Sterile Transfer Process
4.2.1.1 Power on the Sterile Transfer Pump and set the appropriate flow rate.
4.2.1.2 Connect the sterile transfer tubing to the pump and the receiving container.
4.2.1.3 Initiate the transfer process, ensuring that all connections remain sterile and sealed throughout.

4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE, including gloves and face mask, when handling sterile transfer operations.
4.2.2.2 Maintain aseptic technique throughout the transfer process to prevent contamination.
4.2.2.3 Monitor the transfer process continuously to ensure smooth operation and detect any abnormalities.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the transfer process and disconnect the sterile transfer tubing.
4.3.1.2 Clean and sanitize the pump and all transfer equipment according to approved procedures.
4.3.1.3 Perform post-transfer checks to ensure no leaks or contamination issues.

4.3.2 Maintenance
4.3.2.1 Regularly inspect and clean the pump components, including filters and seals.
4.3.2.2 Replace worn-out or damaged parts as per manufacturer’s recommendations.
4.3.2.3 Keep maintenance records and document any issues or repairs performed.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment

6) Documents, if any

Maintenance records
Sterile transfer logs
Calibration records for the Sterile Transfer Pump

7) Reference, if any

Manufacturer’s manual for the Sterile Transfer Pump
Pharmacopeial guidelines for aseptic processing in pharmaceutical manufacturing

8) SOP Version

Version 1.0