Standard Operating Procedure for Sterile 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 sterile control system used in the manufacturing of ocular dosage forms to ensure a sterile environment and prevent microbial contamination.

2) Scope

This SOP applies to all sterile control systems within the facility used for maintaining sterile 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 sterile 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 sterile control system.
2. Check and verify power supply to the sterile 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 sterile 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 sterile control instruments through regular calibration.
3. Replace or repair any malfunctioning components to ensure optimal performance.

4.4 Cleaning and Sanitization

1. Clean external surfaces of the sterile control unit regularly using approved cleaning agents and methods.
2. Sanitize internal components of the sterile control unit as per validated procedures to prevent contamination.

4.5 Emergency Procedures

1. Develop and maintain emergency procedures for power failures, equipment malfunctions, or other emergencies affecting the sterile control system.
2. Train personnel on emergency response procedures and ensure the availability of backup systems or contingency plans.

4.6 Documentation and Records

1. Maintain records of routine operations, maintenance activities, and calibration results.
2. Document any deviations from standard procedures and corrective actions taken.

4.7 Training

1. Provide training to personnel involved in the operation, maintenance, and monitoring of the sterile control system.
2. Ensure personnel are aware of SOP updates and revisions related to the sterile control system.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Sterile control system maintenance log
2. Calibration certificates
3. Emergency response plan

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0