Standard Operating Procedure for Maintaining Air Filtration Systems in Nebulizer Production Areas
1) Purpose
The purpose of this SOP is to provide a standardized procedure for maintaining air filtration systems in nebulizer manufacturing areas to ensure optimal air quality and compliance with regulatory standards.
2) Scope
This SOP applies to all air filtration systems, including HEPA filters, HVAC systems, and pre-filters, in the nebulizer production facility.
3) Responsibilities
Operators: Perform daily checks and report any abnormalities in the air filtration systems.
Maintenance Team: Conduct scheduled maintenance, cleaning, and replacement of air filters.
Quality Assurance (QA): Monitor air quality and validate the effectiveness of the filtration system.
4) Procedure
4.1 Daily Checks
- Inspect the air filtration systems for visible damage or blockages.
- Monitor the airflow rates and ensure they are within the specified range for the production area.
- Check the pressure differential across the filters using installed gauges and record the values.
- Report any abnormalities, such as unusual noises or reduced airflow, to the maintenance team.
4.2 Monthly Maintenance
- Shut down the air filtration system following the lockout/tagout (LOTO) procedure.
- Remove pre-filters and clean them using approved cleaning methods, such as vacuuming or washing with water and detergent.
- Inspect the HEPA filters for any signs of damage or contamination.
- Replace pre-filters if they show excessive wear or reduced performance.
- Reassemble the system and perform a functional test to verify proper operation.
4.3 Quarterly Maintenance
- Calibrate the pressure differential gauges to ensure accurate readings.
- Inspect the HVAC ducts and clean them to remove dust and particulate buildup.
- Conduct airflow validation tests using particle counters to ensure compliance with air quality standards.
- Replace HEPA filters if pressure differential readings exceed the specified limit or as per the replacement schedule.
4.4 Post-Maintenance Activities
- Document all maintenance activities, including cleaning, repairs, and replacements, in the Air Filtration Maintenance Log.
- Perform a final inspection of the system and ensure it is functioning correctly.
- Submit the maintenance records to the QA team for review and approval.
4.5 Emergency Maintenance
- In case of system failure, immediately shut down the filtration system and isolate the affected area.
- Notify the maintenance team for immediate troubleshooting and repairs.
- Resume operations only after the system has been repaired and validated by the QA team.
5) Abbreviations
- QA: Quality Assurance
- HEPA: High-Efficiency Particulate Air
- HVAC: Heating, Ventilation, and Air Conditioning
- LOTO: Lockout/Tagout
6) Documents
The following documents should be maintained:
- Air Filtration Maintenance Log
- Pressure Differential Records
- Airflow Validation Report
7) References
Relevant regulatory guidelines and references include:
- ISO 14644: Cleanrooms and Associated Controlled Environments
- Good Manufacturing Practices (GMP) Guidelines
- Equipment Manufacturer’s Manual
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Air Filtration Maintenance Log
| Date | System ID | Maintenance Type | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | System Identifier | Daily/Monthly/Quarterly | Maintenance Personnel | QA Name | Details of maintenance |
Annexure Title: Pressure Differential Records
| Date | Filter ID | Pressure Differential | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Filter Identifier | Pressure (Pa) | Operator Name | QA Name | Details of reading |
Annexure Title: Airflow Validation Report
| Date | System ID | Airflow Validation Result | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | System Identifier | Pass/Fail | Maintenance Personnel | QA Name | Details of validation |