Standard Operating Procedure for Differential Pressure Gauge

1) Purpose

The purpose of this SOP is to provide guidelines for the proper operation and calibration of the Differential Pressure Gauge used in the clean room environment for manufacturing ocular dosage forms.

2) Scope

This SOP applies to all Differential Pressure Gauges installed in clean rooms to monitor pressure differentials and ensure proper air balance for the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, calibration, and maintenance of the Differential Pressure Gauge. Facility engineers are responsible for following this procedure, and the maintenance team is responsible for calibration and periodic checks.

4) Procedure

4.1 Start-Up Procedure

1. Ensure the Differential Pressure Gauge is properly installed and calibrated.
2. Verify that the gauge displays zero pressure differential when no air handling equipment is operating.
3. Record the initial readings of pressure differentials for each clean room area.

4.2 Operation

1. Regularly monitor the Differential Pressure Gauge readings during operation of air handling units (AHUs) and clean room activities.
2. Ensure that pressure differentials are within specified limits as per clean room classification requirements.
3. Take immediate corrective actions if pressure differentials exceed allowable limits.

4.3 Calibration

1. Calibrate the Differential Pressure Gauge annually or as per the manufacturer’s recommended schedule.
2. Use calibrated test instruments and follow documented procedures for calibration.
3. Record calibration results and adjustments made in the calibration logbook.

4.4 Maintenance

1. Perform regular inspections to ensure the Differential Pressure Gauge is free from physical damage or obstruction.
2. Replace batteries or power supply as needed to ensure continuous operation.
3. Document any maintenance activities performed in the logbook.

5) Abbreviations, if any

None

6) Documents, if any

1. Calibration logbook
2. Maintenance records

7) Reference, if any

GMP Guidelines for pharmaceutical manufacturing facilities and clean room environmental monitoring.

8) SOP Version

Version 1.0