SOP for Cleaning of Nebulizer Air Handling Units

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 reinstalling them to prevent mold growth.

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

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

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