Standard Operating Procedure for Microbial Control System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the operation, monitoring, and maintenance of the microbial control system used in the manufacturing of ocular dosage forms to ensure a controlled environment free from microbial contamination.

2) Scope

This SOP applies to all microbial control systems within the facility used for maintaining controlled microbial levels in the manufacturing areas for ocular dosage forms.

3) Responsibilities

Facility management and maintenance personnel are responsible for the operation, monitoring, and maintenance of the microbial control system. Quality assurance personnel are responsible for overseeing compliance with regulatory requirements and standards.

4) Procedure

4.1 Start-up and Shutdown Procedures

1. Ensure all personnel are trained on start-up and shutdown procedures for the microbial control system.
2. Check and verify power supply to the microbial control unit before starting.
3. Follow manufacturer’s instructions for starting up and shutting down the system.

4.2 Routine Operation

1. Monitor and record microbial levels regularly using calibrated instruments.
2. Adjust operational settings as necessary to maintain specified microbial control conditions.
3. Monitor alarm systems and respond promptly to any deviations or abnormalities.

4.3 Maintenance and Calibration

1. Schedule routine maintenance activities based on manufacturer’s recommendations and facility-specific requirements.
2. Verify the accuracy of microbial control instruments through regular