HVAC System: Animation, Principle, Qualification

HVAC System: 

Animation, Principle, Qualification

Heating ventilation and air conditioning system i.e. HVAC system plays a crucial part in the pharmaceutical industry. The HVAC system is required everywhere for maintaining temperature and humidity control. For eg. in the mall also an HVAC system is in use. But the use of HVAC Systems for the pharmaceutical industry that too in a sterile pharmaceutical company is critically important. The HVAC system serves as the first utility service required for maintaining temperature, relative humidity, pressure differential, and clean air in the clean rooms.

Hence it is very important to learn the HVAC system basics and HVAC system working principle, HVAC system design. As it is a critical and very huge concept, a detailed evaluation of the HVAC system will be covered in parts of the post.

First, you all see the animation of the HVAC system, where I have tried to visualize the HVAC system working principle and HVAC basic. Watch the video linked below, you will know the complete working principle and HVAC basics.

For procuring HVAC system, the first capacity of HVAC system is required to be evaluated.  It is dependent on room size where we have to maintain unidirectional laminar airflow. Based on the same, the motor (blower) size can be finalized.

1. HVAC System Operation/Animation (Air Handling Unit):

AHU (air handling unit) working principle / HVAC working principle is provided in the below animation.

2. Importance of HVAC System In Pharmaceutical Industry:

To attain the required,

• Grade of the area.
• The temperature in the area.
• Humidity in the area.
• Differential pressure in the area
• To maintain Cleanroom effectiveness

3. HVAC System Components:

For constructing an HVAC system following major parts are required but not limited to.,

• AHU cabinet-
• Ducts and ducting material (Armaflex / PUF)
• Blower (Motor)
• Filter (HEPA filter / Fresh Air Filter, Intermediate filter / Fine Filter)
• Hot water and chilled water coils
• The drain line for condensate removal
• Chilled water supply
• Risers / diffusers
• Smoke detector/fire alarm system
• Dampers
• View panels
• Magnehelic gauges for differential pressure monitoring
• Temperature and RH sensors
• BMS / SCADA system (For auto operation)

These are the most required parts. Still, more are there that I have not listed.

4. HVAC system Qualification:

A. User Requirement Specification for HVAC system:

Proposal of HVAC system shall be done through URS. Based on the required class gradation of the area and the size of the area, the AHU design varies. So before procuring, it is better to evaluate with room size, otherwise, AHU will not maintain the required class gradation of the area.

B. Design Qualification of HVAC system- 

Verification of design for ensuring variables mentioned in URS is important. During design qualification, ensure that the user requirement specification is fulfilled. Changes may happen while designing the AHU, but the impact of change shall be evaluated. 

A risk assessment tool can be utilized to evaluate the risk associated with the qualification of the HVAC system.

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C.  Installation Qualification of HVAC system– 

During Installation, all parts of the AHU are verified for their integrity, design. Sometimes during transit, the equipment parts will damage. Hence same is to be verified prior to installation. Also, during installation qualification, variables mentioned in URS and DQ need to be verified for qualification fulfillment. 

D. Operational Qualification of HVAC system– 

During the OQ phase, ensure the AHU and its parts are operational with full function. For HVAC system evaluation below mentioned tests are carried out. 

• Air changes per hour - Depends on class gradation.

• Airflow pattern - Should be laminar and unidirectional in Grade "A" maintained areas.

• Air classification- As per area requirement

• HEPA Filter integrity / PAO Test - Should be NMT 0.01% of upper aerosol concentration.

• Air velocity -Should be between 0.36 to 0.54 m/s  

• Duct leakage - Should not be more than 3%

• Temperature, RH, and pressure differential - As per area requirement

• Area recovery - Specifically for 0.5-micron particle size. Area recovery shall be done within 15 minutes.

E.Performance Qualification of HVAC system:

• Particulate count (viable and non-viable count) At selected locations

F. Handover of HVAC system

5. Conclusion on the HVAC system, AHU (Air handling unit):

As we know, complete pharmaceutical industry construction is in closed condition, to prevent the ingress of external environment contamination. Here AHU plays an important role. Hence it is recommended as per area and class gradation requirement for medicine manufacturing AHU (air handling unit / HVAC systems shall be installed, qualified, and used.

Moreover, periodic verification of HVAC system performance has to be carried out.

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Detailed evaluation will be covered in the next update. Please subscribe and share.