Standard Operating Procedure for Environmental 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 environmental control system used in the manufacturing of ocular dosage forms to ensure a controlled environment that meets regulatory standards.
2) Scope
This SOP applies to all environmental control systems within the facility used for maintaining controlled 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 environmental control system. Quality assurance personnel are responsible for overseeing compliance with regulatory requirements and standards.
4) Procedure
4.1 Start-up and Shutdown Procedures
- Ensure all personnel are trained on start-up and shutdown procedures for the environmental control system.
- Check and verify power supply to the environmental control unit before starting.
- Follow manufacturer’s instructions for starting up and shutting down the system.
4.2 Routine Operation
- Monitor and record environmental parameters such as temperature, humidity, and pressure regularly.
- Adjust operational settings as necessary to maintain specified environmental conditions.
- Monitor alarm systems and respond promptly to any deviations or abnormalities.
4.3 Filter Replacement and Maintenance
- Schedule routine filter replacements based on manufacturer’s recommendations and facility-specific requirements.
- Verify filter integrity and seal before installation.
- Dispose
4.4 Cleaning and Sanitization
- Clean external surfaces of the environmental control unit regularly using approved cleaning agents and methods.
- Sanitize internal components of the environmental control unit as per validated procedures to prevent microbial growth.
4.5 Emergency Procedures
- Develop and maintain emergency procedures for power failures, equipment malfunctions, or other emergencies affecting the environmental control system.
- Train personnel on emergency response procedures and ensure the availability of backup systems or contingency plans.
4.6 Calibration and Validation
- Calibrate monitoring instruments used to measure temperature, humidity, and pressure.
- Validate the performance of the environmental control system periodically according to regulatory requirements and industry standards.
4.7 Documentation and Records
- Maintain records of routine operations, maintenance activities, filter replacements, and validation results.
- Document any deviations from standard procedures and corrective actions taken.
4.8 Training
- Provide training to personnel involved in the operation, maintenance, and monitoring of the environmental control system.
- Ensure personnel are aware of SOP updates and revisions related to the environmental control system.
5) Abbreviations, if any
SOP: Standard Operating Procedure
6) Documents, if any
- Environmental control system maintenance log
- Filter replacement schedule
- Validation reports
7) Reference, if any
GMP Guidelines for Pharmaceutical Manufacturing
8) SOP Version
Version 1.0
