Standard Operating Procedure for Using Reverse Osmosis Unit

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the reverse osmosis (RO) unit in the pharmaceutical manufacturing of otic dosage forms to purify water by removing dissolved salts and other impurities.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the reverse osmosis unit as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the water quality and ensuring it meets the required standards.
Maintenance Personnel: Responsible for maintaining the reverse osmosis unit in proper working condition.

4) Procedure

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

4.1.2 Preparation
4.1.2.1 Ensure the feed water tank is filled with water that meets the required pre-treatment specifications.
4.1.2.2 Verify that all connections and valves are secure and properly aligned.

4.2 Operation
4.2.1 Starting the Reverse Osmosis Unit
4.2.1.1 Start the reverse osmosis unit by turning on the feed pump.
4.2.1.2 Gradually increase the pressure to the recommended operating level.
4.2.1.3 Monitor the process parameters such as pressure, flow rate, and conductivity continuously to ensure they remain within the specified range.
4.2.1.4 Observe the permeate and concentrate streams to ensure proper separation and collection.

4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling chemicals used for cleaning and maintenance.
4.2.2.2 Avoid contact with high-pressure water streams unless necessary and 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 Gradually reduce the pressure and turn off the feed pump.
4.3.1.2 Close all valves and properly dispose of any concentrate as per the facility’s waste disposal guidelines.
4.3.1.3 Clean the reverse osmosis unit as per the manufacturer’s recommendations after each use.

4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the RO membranes using appropriate cleaning agents to prevent fouling.
4.3.2.2 Replace pre-filters and post-filters as per the maintenance schedule.
4.3.2.3 Inspect the RO unit for any signs of wear or damage and repair or replace components as necessary.
4.3.2.4 Document all cleaning and maintenance activities in the reverse osmosis log.

5) Abbreviations, if any

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

6) Documents, if any

Reverse osmosis log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the reverse osmosis unit
Pharmacopeial guidelines for water purification processes in pharmaceutical manufacturing

8) SOP Version

Version 1.0