Standard Operating Procedure for Cleanroom Maintenance
1) Purpose
The purpose of this SOP is to establish procedures for the maintenance of cleanrooms used in the manufacturing of dental dosage forms to ensure cleanliness and compliance with regulatory standards.
2) Scope
This SOP applies to all cleanrooms where dental pastes, gels, and mouthwashes are manufactured within the pharmaceutical industry.
3) Responsibilities
The Facilities Management Department is responsible for cleanroom maintenance. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Routine Cleaning
4.1.1 Develop a schedule for routine cleaning activities based on cleanroom classification and regulatory requirements.
4.1.2 Clean floors, walls, and ceilings using approved disinfectants and cleaning agents.
4.1.3 Clean and disinfect all surfaces, including equipment and furniture, within the cleanroom.
4.2 Monitoring and Control
4.2.1 Monitor temperature, humidity, and differential pressure within the cleanroom as per specifications.
4.2.2 Calibrate monitoring instruments regularly as per calibration schedule.
4.3 Filter Replacement
4.3.1 Replace HEPA (High Efficiency Particulate Air) filters and pre-filters at specified intervals or as needed based on monitoring results.
4.3.2 Perform filter integrity testing after replacement to ensure proper functioning.
4.4 Emergency Response
4.4.1 Respond promptly to cleanroom contamination events or equipment malfunctions.
4.4.2 Implement corrective actions and document all emergency response activities.
4.5 Record Keeping
4.5.1 Maintain records of all cleanroom maintenance activities, including cleaning schedules, filter replacements, and monitoring results.
4.5.2 Document any deviations from maintenance procedures and corrective actions taken.
4.6 Validation and Verification
4.6.1 Validate cleanroom performance through periodic environmental monitoring and particle count testing.
4.6.2 Verify cleanliness levels and compliance with regulatory standards.
5) Abbreviations, if any
QA – Quality Assurance
HEPA – High Efficiency Particulate Air
6) Documents, if any
Cleanroom Maintenance Log
Filter Replacement Records
Environmental Monitoring Reports
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
ISO 14644 – Cleanrooms and associated controlled environments
8) SOP Version
Version 1.0
