Standard Operating Procedure for Filtration Unit

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Filtration Unit used in the pharmaceutical manufacturing of otic dosage forms to ensure efficient filtration of materials.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the Filtration Unit as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of filtration.
Maintenance Personnel: Responsible for maintaining the Filtration Unit in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Filtration Unit for cleanliness and integrity before use.
4.1.1.2 Ensure that all filters, hoses, and connections are clean and in good condition.
4.1.1.3 Verify that the filtration parameters are set according to the batch requirements.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Filtration Unit and surrounding area.
4.1.2.2 Check and prepare all materials and equipment required for filtration.
4.1.2.3 Ensure that the Filtration Unit is properly connected to utilities and ready for operation.

4.2 Operation
4.2.1 Filtration Process
4.2.1.1 Power on the Filtration Unit and initiate the filtration process.
4.2.1.2 Load materials into the filtration system as per the batch requirements.
4.2.1.3 Monitor the filtration process to ensure proper flow and filtration efficiency.

4.2.2 Monitoring
4.2.2.1 Monitor pressure differentials and flow rates during the filtration process.
4.2.2.2 Adjust filtration parameters as necessary to optimize filtration performance.
4.2.2.3 Record all critical parameters during the filtration process.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the filtration process and transfer filtered materials to designated containers.
4.3.1.2 Clean and sanitize the Filtration Unit and associated equipment thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual material in the filtration system.

4.3.2 Maintenance
4.3.2.1 Regularly inspect and replace filters as per maintenance schedule.
4.3.2.2 Perform preventive maintenance tasks as recommended by the manufacturer.
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

6) Documents, if any

Maintenance records
Batch records for each filtration process
Calibration records for the Filtration Unit

7) Reference, if any

Manufacturer’s manual for the Filtration Unit
Pharmacopeial guidelines for pharmaceutical filtration processes

8) SOP Version

Version 1.0