Standard Operating Procedure for Maintenance of Cleanroom Facilities
1) Purpose
This SOP outlines the procedures for maintaining cleanroom facilities used in the production of nasal formulations. Cleanroom maintenance is critical for controlling contamination and maintaining air quality within the facility.
2) Scope
This SOP applies to all personnel responsible for maintaining the cleanliness, safety, and operational standards of cleanroom facilities at [Company Name].
3) Responsibilities
- Cleanroom Operators: Responsible for cleaning and maintaining the cleanroom, including floors, walls, and equipment surfaces.
- Quality Assurance (QA): Ensures that cleanroom environmental conditions, including air quality and surface cleanliness, meet the required specifications.
- Maintenance Team: Responsible for maintaining HVAC systems, cleanroom integrity, and cleanliness monitoring systems.
4) Procedure
4.1 Daily Cleanroom Maintenance
4.1.1 Surface Cleaning
- At the start of each shift, clean all surfaces, including floors, walls, and equipment surfaces, using an approved disinfectant solution. Follow a systematic cleaning pattern from the cleanest areas to the dirtiest.
- Ensure that no dust, debris, or spilled liquids remain on any surface. Record the cleaning activities in the cleanroom cleaning log.
4.1.2 Equipment Cleaning
- Disassemble any removable equipment parts, such as filters and
seals, and clean them with an approved cleaning agent. Rinse with sterile water and dry using lint-free wipes.
Inspect all cleaned equipment to ensure it is free from contamination and ready for use. Document the cleaning process in the equipment cleaning log.
4.2 Weekly Cleanroom Maintenance
4.2.1 Airflow and Pressure Testing
- Test the air pressure differentials between the cleanroom and adjacent areas weekly. Verify that the airflow is laminar and that the cleanroom maintains the required positive pressure differential.
- Record the results of airflow and pressure tests in the cleanroom environmental monitoring log. Notify the maintenance team if any deviations are detected.
4.2.2 HEPA Filter Inspection
- Inspect the HEPA filters in the HVAC system weekly for any blockages or signs of wear. Replace filters if the pressure differential exceeds acceptable limits or if filters appear damaged.
- Document the filter inspection in the maintenance log and submit for QA review.
4.3 Monthly Cleanroom Maintenance
4.3.1 Deep Cleaning of Surfaces
- Conduct a deep cleaning of all surfaces in the cleanroom at least once per month, using stronger disinfectant solutions. Pay special attention to hard-to-reach areas and clean beneath and behind equipment.
- Ensure that all cleanroom fixtures, such as lighting and HVAC ducts, are cleaned thoroughly during deep cleaning. Record the deep cleaning in the cleanroom cleaning log.
4.3.2 Monitoring Particle Counts
- Measure particle counts in the cleanroom monthly using an approved particle counter. Compare the results with the specified limits for the cleanroom classification (e.g., ISO Class 5).
- Document the particle count results in the environmental monitoring log and submit for QA approval.
4.4 Annual Cleanroom Certification
4.4.1 Full HVAC System Maintenance
- Once per year, perform full maintenance on the cleanroom HVAC system, including duct cleaning, HEPA filter replacement, and recalibration of pressure control systems.
- Document the HVAC system maintenance and submit the report for QA review.
4.4.2 Cleanroom Recertification
- Contract a certified cleanroom validation company annually to perform recertification of the cleanroom according to regulatory guidelines (e.g., ISO standards). Ensure that the cleanroom passes particle count, airflow, and microbial contamination tests.
- Submit the cleanroom recertification report to QA for approval and archiving.
5) Abbreviations, if any
- HVAC: Heating, Ventilation, and Air Conditioning
- QA: Quality Assurance
6) Documents, if any
- Cleanroom Cleaning Log
- Equipment Cleaning Log
- Environmental Monitoring Log
- Maintenance Log
7) References, if any
- ISO 14644-1: Cleanrooms and associated controlled environments
- Internal SOP for HVAC system maintenance
8) SOP Version
Version 1.0
Annexure
1. Cleanroom Cleaning Log Template
| Date | Room ID | Surface Cleaned | Disinfectant Used | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Room Identifier | Surface Cleaned | Disinfectant Name | Operator Name | QA Name |