Standard Operating Procedure for Decontamination 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 decontamination system used in the manufacturing of ocular dosage forms to ensure a clean and sterile environment, preventing microbial contamination.

2) Scope

This SOP applies to all decontamination 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 decontamination 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 decontamination system.
2. Check and verify power supply to the decontamination 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. Activate and monitor the decontamination cycles as per standard operating procedures.
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 decontamination 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 decontamination unit regularly using approved cleaning agents and methods.
2. Sanitize internal components of the decontamination unit as per validated procedures to maintain effectiveness.

4.5 Emergency Procedures

1. Develop and maintain emergency procedures for power failures, equipment malfunctions, or other emergencies affecting the decontamination 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.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Decontamination 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