Standard Operating Procedure for Cleaning Nebulizer Air Handling Units (AHUs)
1) Purpose
The purpose of this SOP is to establish a standardized procedure for cleaning air handling units (AHUs) used in nebulizer manufacturing areas to ensure optimal performance and maintain air quality.
2) Scope
This SOP applies to all AHUs installed in nebulizer production, storage, and quality control areas within the facility.
3) Responsibilities
Operators: Perform routine cleaning tasks and monitor AHU performance.
Maintenance Team: Conduct thorough cleaning and ensure proper functioning of AHUs.
Quality Assurance (QA): Inspect and validate the cleaning process and approve records.
4) Procedure
4.1 Pre-Cleaning Preparation
- Ensure the AHU is turned off and isolated from the power supply before cleaning.
- Wear appropriate personal protective equipment (PPE), including gloves, goggles, and dust masks.
- Inspect the AHU for visible dirt, dust, or contamination.
- Assemble all required cleaning tools and materials, such as soft brushes, vacuum cleaners, and cleaning solutions.
4.2 Cleaning Filters
- Remove pre-filters, fine filters, and HEPA filters carefully, following the manufacturer’s instructions.
- Clean pre-filters and fine filters using a vacuum cleaner or wash them with water if permitted.
- Inspect HEPA filters for dirt or damage; replace them if necessary as per the maintenance schedule.
- Dry the filters thoroughly before
4.3 Cleaning Internal Components
- Vacuum and wipe down the blower fans, dampers, and ductwork to remove accumulated dust and debris.
- Inspect and clean cooling and heating coils using an approved coil cleaner and a soft brush.
- Clean condensate drain pans and ensure they are free of water or microbial growth.
- Check for rust or corrosion on internal components and treat them using appropriate anti-corrosion solutions.
4.4 External Cleaning
- Wipe down the external surfaces of the AHU using a damp cloth and mild detergent.
- Inspect the external panels and ensure they are securely fastened.
4.5 Reassembly and Testing
- Reinstall all cleaned and dried filters in their respective positions.
- Reconnect the power supply and turn on the AHU.
- Monitor AHU performance, such as airflow and temperature, to ensure it is functioning optimally.
- Record the cleaning process details in the AHU Cleaning Log.
4.6 Frequency of Cleaning
- Daily: Visual inspection of filters and removal of surface dust.
- Weekly: Cleaning of pre-filters and inspection of other components.
- Monthly: Comprehensive cleaning of all components and replacement of worn-out parts.
4.7 Safety Precautions
- Handle cleaning chemicals as per their Material Safety Data Sheets (MSDS).
- Avoid direct contact with electrical components during cleaning.
- Ensure proper ventilation during cleaning to avoid inhaling dust or fumes.
5) Abbreviations
- QA: Quality Assurance
- AHU: Air Handling Unit
- HEPA: High-Efficiency Particulate Air
- PPE: Personal Protective Equipment
- MSDS: Material Safety Data Sheet
6) Documents
The following documents should be maintained:
- AHU Cleaning Log
- Filter Replacement Report
- AHU Performance Monitoring Log
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Good Manufacturing Practices (GMP) Guidelines
- Equipment Manufacturer’s Manual
8) SOP Version
Version: 1.0
Annexure
Annexure Title: AHU Cleaning Log
| Date | AHU ID | Components Cleaned | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | AHU Identifier | Details of components | Technician Name | QA Name | Details of activity |
Annexure Title: Filter Replacement Report
| Date | AHU ID | Filter Type | Replaced By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | AHU Identifier | Pre-Filter/Fine Filter/HEPA | Technician Name | QA Name | Details of replacement |
Annexure Title: AHU Performance Monitoring Log
| Date | AHU ID | Airflow (CFM) | Temperature (°C) | Humidity (%) | Performed By |
|---|---|---|---|---|---|
| DD/MM/YYYY | AHU Identifier | Measured Airflow | Measured Temperature | Measured Humidity | Technician Name |