Standard Operating Procedure for Using Deionization Unit
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the deionization unit in the pharmaceutical manufacturing of otic dosage forms to produce high-purity water by removing ionized salts and other charged particles.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of deionization units in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the deionization 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 deionization unit in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the deionization unit for cleanliness and integrity before use.
4.1.1.2 Ensure that all ion exchange resins are properly installed and not exhausted.
4.1.1.3 Check that the control systems and gauges 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
4.2 Operation
4.2.1 Starting the Deionization Unit
4.2.1.1 Start the deionization unit by turning on the feed pump.
4.2.1.2 Monitor the process parameters such as pressure, flow rate, and conductivity continuously to ensure they remain within the specified range.
4.2.1.3 Observe the permeate (deionized water) stream to ensure proper production and quality.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling chemicals used for regeneration 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 flow rate and turn off the feed pump.
4.3.1.2 Close all valves and properly dispose of any waste water as per the facility’s waste disposal guidelines.
4.3.1.3 Regenerate the ion exchange resins as per the manufacturer’s recommendations after each use.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly regenerate the ion exchange resins using appropriate regenerants to maintain efficiency.
4.3.2.2 Replace pre-filters and post-filters as per the maintenance schedule.
4.3.2.3 Inspect the deionization 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 deionization log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Deionization log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the deionization unit
Pharmacopeial guidelines for water purification processes in pharmaceutical manufacturing
8) SOP Version
Version 1.0