Standard Operating Procedure for Aseptic 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 aseptic control system used in the manufacturing of ocular dosage forms to ensure a sterile environment free from contamination.

2) Scope

This SOP applies to all aseptic control systems within the facility used for maintaining aseptic conditions 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 aseptic 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 aseptic control system.
2. Check and verify power supply to the aseptic 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 environmental conditions regularly using calibrated instruments.
2. Adjust operational settings as necessary to maintain specified aseptic 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 aseptic control instruments through regular calibration.
3. Replace or