Recommended Air Handling Unit Specifications for ISO Class 8 Cleanrooms and Biosafety Level 2 Labs

For an Air Handling Unit (AHU) designed to meet ISO Class 8 cleanroom requirements and Biosafety Level 2 (BSL-2) standards, several key factors must be considered:

 ISO Class 8 Cleanroom Requirements

1.   Air Changes per Hour (ACH):   For ISO Class 8, the typical air change rate is 20-30 air changes per hour.

2.   Filtration:   

   -   Pre-Filters:   Typically MERV 7-13 (or equivalent) to remove larger particles.

   -   HEPA Filters:   High-efficiency particulate air (HEPA) filters with at least 99.97% efficiency for particles of 0.3 microns. These are generally required for final filtration to meet ISO Class 8 standards.

3.   Airflow Patterns:   Generally, a turbulent airflow pattern is acceptable for ISO Class 8 cleanrooms.

4.   Environmental Control:   Temperature and humidity control are important. Typically, temperature is maintained between 20-22°C, and humidity between 40-60%.

Biosafety Level 2 (BSL-2) Requirements

1.   Containment:   BSL-2 labs require containment equipment like biosafety cabinets (Class II), which must be ventilated and properly exhausted to prevent contamination.

2.   Airflow:   The AHU must maintain negative pressure relative to adjacent areas to contain any hazardous particles. This prevents contaminants from escaping the lab.

3.   Exhaust Air:   The exhaust air from a BSL-2 lab should be HEPA filtered before being released into the environment. It is also recommended that the exhaust system is separate from other building systems.

4.   Redundancy:   Critical components such as fans, filters, and control systems should have redundancy to ensure continuous operation in case of failure.

 Recommended Features for an AHU

1.   Multiple Stages of Filtration:   Ensure the AHU includes pre-filters, secondary filters, and HEPA filters to meet both ISO Class 8 and BSL-2 standards.

2.   Pressure Monitoring:   Install differential pressure sensors and alarms to monitor and maintain the required pressure gradients.

3.   Control Systems:   Advanced control systems for precise temperature, humidity, and pressure control.

4.   Redundancy:   Incorporate redundant fans and filtration systems for reliability.

5.   UV Germicidal Irradiation (UVGI):   Consider UVGI systems to provide additional disinfection within the AHU.

6.   Noise and Vibration Control:   Design to minimize noise and vibration, ensuring a stable environment for sensitive processes.

 Maintenance and Validation

1.   Regular Maintenance:   Schedule regular maintenance to check and replace filters, and inspect the overall condition of the AHU.

2.   Validation:   Regularly validate the cleanroom and BSL-2 lab to ensure compliance with ISO and biosafety standards. This includes particle count tests, airflow velocity measurements, and pressure differential checks.

 Example Specifications

1.   Air Changes per Hour (ACH):   20-30 ACH

2.   Pre-Filters:   MERV 13

3.   Secondary Filters:   MERV 16 or higher

4.   Final Filters:   HEPA filters (99.97% efficiency at 0.3 microns)

5.   Temperature Control:   20-22°C

6.   Humidity Control:   40-60%

7.   Pressure Differential:   Negative pressure for BSL-2 areas relative to surrounding areas

8.   Exhaust Filtration:   HEPA filtered exhaust

 These recommendations will help ensure that the AHU meets both ISO Class 8 and BSL-2 requirements, providing a safe and controlled environment for your applications.

                                                         END OF THE DOCUMENT

You may like to read these links: 

1. Understanding Clean Room Standards: ISO, FS209, and EU GMP Explained

2. Key Considerations in Cleanroom HVAC Design: Ensuring Optimal Air Quality and Contamination Control

3. Understanding Puff Panels: Types, Uses, Benefits, and Requirements for Clean Rooms and Laboratory Buildings

4. Key Considerations for HVAC Systems in Small Animal Laboratories with Room-Specific Air Change and Pressure Requirements

5. Optimizing HVAC System Design for Small Animal Facilities in India's Diverse Climate

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