Standard Operating Procedure for Vacuum Pump

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Vacuum Pump used in the pharmaceutical manufacturing of otic dosage forms to ensure efficient and reliable performance.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the Vacuum Pump as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the performance of the Vacuum Pump.
Maintenance Personnel: Responsible for maintaining the Vacuum Pump in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Vacuum Pump for cleanliness and integrity before use.
4.1.1.2 Ensure all connections, hoses, and fittings are secure and functional.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Vacuum Pump and surrounding area.
4.1.2.2 Check the oil level and refill if necessary.
4.1.2.3 Ensure the pump is properly connected to the power supply and vacuum system.

4.2 Operation
4.2.1 Starting the Pump
4.2.1.1 Turn on the power switch and allow the pump to warm up.
4.2.1.2 Check for any unusual noises or vibrations during startup.
4.2.1.3 Monitor the vacuum gauge to ensure the pump is achieving the required vacuum level.

4.2.2 Operating the Pump
4.2.2.1 Ensure continuous monitoring of the vacuum level during operation.
4.2.2.2 Adjust the pump settings as necessary to maintain the required vacuum.
4.2.2.3 Record the vacuum levels and any observations in the logbook.

4.2.3 Stopping the Pump
4.2.3.1 Turn off the power switch and allow the pump to cool down.
4.2.3.2 Disconnect the pump from the vacuum system.
4.2.3.3 Clean and sanitize the pump and surrounding area after use.

4.3 Post-operation
4.3.1 Maintenance
4.3.1.1 Perform routine maintenance as per the manufacturer’s guidelines.
4.3.1.2 Check and replace the oil regularly.
4.3.1.3 Inspect and clean the air filters periodically.
4.3.1.4 Document all maintenance activities and update maintenance records accordingly.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Batch records for each operation batch
Maintenance records
Calibration records for vacuum levels

7) Reference, if any

Manufacturer’s manual for the Vacuum Pump
Pharmacopeial guidelines for pharmaceutical vacuum processes

8) SOP Version

Version 1.0