Standard Operating Procedure for Using Ultrafiltration Unit

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the ultrafiltration unit in the pharmaceutical manufacturing of otic dosage forms to concentrate and purify solutions by removing contaminants of high molecular weight.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the ultrafiltration unit as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the ultrafiltration process and verifying product quality.
Maintenance Personnel: Responsible for maintaining the ultrafiltration unit in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the ultrafiltration unit for cleanliness and integrity before use.
4.1.1.2 Ensure that all filters and membranes are properly installed and not damaged.
4.1.1.3 Check that the pumps and control systems are operational.

4.1.2 Preparation
4.1.2.1 Prepare the solution to be filtered, ensuring it is free from large particulates that could clog the unit.
4.1.2.2 Fill the feed tank with the solution and ensure all connections are secure.

4.2 Operation
4.2.1 Starting the Ultrafiltration
4.2.1.1 Start the ultrafiltration unit and set the parameters such as pressure, flow rate, and temperature as per the protocol.
4.2.1.2 Monitor the process parameters continuously to ensure they remain within the specified range.
4.2.1.3 Observe the filtrate and retentate streams to ensure proper separation and collection.

4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling solutions and operating the unit.
4.2.2.2 Avoid contact with any chemical solutions or filtrates unless properly trained.
4.2.2.3 Follow all safety protocols to prevent spills or leaks.

4.3 Post-operation
4.3.1 Shutdown Procedure
4.3.1.1 After completion of the ultrafiltration process, stop the unit and close all valves.
4.3.1.2 Carefully remove the filtrate and retentate containers for further processing or disposal.

4.3.2 Cleaning and Maintenance
4.3.2.1 Clean the ultrafiltration unit thoroughly after each use to prevent contamination or clogging.
4.3.2.2 Flush the system with appropriate cleaning agents as per the manufacturer’s recommendations.
4.3.2.3 Inspect and replace filters and membranes regularly to maintain efficiency and performance.
4.3.2.4 Document all cleaning and maintenance activities in the ultrafiltration log.

5) Abbreviations, if any

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

6) Documents, if any

Ultrafiltration log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the ultrafiltration unit
Pharmacopeial guidelines for ultrafiltration processes in pharmaceutical manufacturing

8) SOP Version

Version 1.0