Standard Operating Procedure for Water for Injection (WFI) System

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Water for Injection (WFI) System used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Water for Injection (WFI) System used in the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Water for Injection (WFI) System. The equipment operator is responsible for following the procedure, and the maintenance team is responsible for regular maintenance and calibration.

4) Procedure

4.1 Preparation

1. Ensure the Water for Injection (WFI) System and surrounding area are clean and sanitized.
2. Verify that all necessary materials (filters, piping) and equipment are available and within expiry dates.
3. Check that the WFI System is properly connected to utilities (water source, power) if required.

4.2 Operation

1. Turn on the Water for Injection (WFI) System and ensure all valves are in the correct position.
2. Initiate the purification process according to the established procedure.
3. Monitor the system parameters (temperature, conductivity) to ensure proper operation.
4. Collect samples for water quality testing at regular intervals.
5. Stop the purification process once the required volume or quality of WFI is obtained.

4.3 Post-Operation

1. Shut down the Water for Injection (WFI) System in accordance with the shutdown procedure.
2. Clean and sanitize the system components as per the cleaning procedure.
3. Record the operation details (start time, end time, quantity produced) in the logbook.

4.4 Maintenance

1. Perform routine checks and maintenance tasks as specified in the maintenance schedule.
2. Replace filters and sanitize piping as per the manufacturer’s recommendations.
3. Calibrate temperature sensors and conductivity meters periodically to ensure accuracy.
4. Address any deviations or malfunctions promptly and document corrective actions.

5) Abbreviations, if any

None

6) Documents, if any

1. Operational logbook
2. Maintenance records
3. Calibration certificates

7) Reference, if any

GMP Guidelines for pharmaceutical production and water systems.

8) SOP Version

Version 1.0