Standard Operating Procedure for Stability Chamber

1) Purpose

The purpose of this SOP is to outline the procedures for the operation and monitoring of the Stability Chamber used in the pharmaceutical manufacturing facility for stability testing of ocular dosage forms.

2) Scope

This SOP applies to all Stability Chambers used for stability testing of ocular dosage forms, ensuring that environmental conditions are controlled and maintained within specified parameters.

3) Responsibilities

The responsibilities include the operation, monitoring, and maintenance of the Stability Chamber. Quality control personnel 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 Stability Chamber is clean and free from any previous samples or contaminants.
2. Verify that all required sensors (temperature, humidity, light) are functioning properly.
3. Set the Stability Chamber to the specified testing conditions as per the stability protocol.

4.2 Operation

1. Monitor and record temperature, humidity, and any other specified parameters regularly according to the stability testing schedule.
2. Check for any deviations from the specified conditions and take corrective actions as necessary.
3. Ensure that the Stability Chamber remains operational throughout the stability testing period.

4.3 Shutdown Procedure

1. Complete the stability testing as per the designated time period in the stability protocol.
2. Remove samples from the Stability Chamber carefully, following established procedures.
3. Clean the Stability Chamber and reset it for the next stability testing cycle.

4.4 Maintenance

1. Perform regular preventive maintenance on the Stability Chamber as per the maintenance schedule.
2. Calibrate temperature and humidity sensors annually or as per the manufacturer’s recommendations.
3. Document all maintenance and calibration activities in the logbook.

5) Abbreviations, if any

None

6) Documents, if any

1. Stability testing protocol
2. Maintenance records
3. Calibration certificates

7) Reference, if any

GMP Guidelines for stability testing of pharmaceutical products.

8) SOP Version

Version 1.0