HVAC stands for Heating, Ventilation, and Air Conditioning. HVAC system helps control factors: temperature, humidity, particle limit, infection limit, and pressure in industrial complexes, apartment buildings, hospitals, clean rooms, ... or general areas that need to control air quality and microbiology.
An HVAC system created to provide control of heat and circulation in the home is designed around the principles of thermodynamics, fluid mechanics, and heat transfer.
Components in the HVAC system
Inlet air cluster: Prevents insects, rain, and dirt.
Silencer: Reduces operating noise
Air regulating valve: Adjust airflow to control flow, pressure
Control valve: adjust the amount of air
Heating Coil: Heats the air to the right temperature.
Cold coil: cools the air to the required temperature, the amount of moisture in the cold air condenses to help separate moisture and reduce the humidity of the fresh air stream entering the clean room.
Humidifier cluster: If the air humidity is too low compared to the humidity in the clean room, the humidifying cluster will increase the air humidity accordingly.
Membrane (industrial dust bag): Removes particles of predetermined size and/or microorganisms.
Pre-filter VAF: the filter of the AHU device, which helps to remove large particles
Fine filter VAF: helps to remove smaller particles, protects & increases the life of HEPA filter
HEPA filter VAF: includes HEPA filter H13, and HEPA filter H14 to help remove small particles and/or microorganisms.
Air duct: conducts air in the system
Working principle of HVAC system
Fresh air is taken from the air, passes through the inlet gas cluster, then passes through the AHU to adjust the humidity and pressure as well as pre-filter a large number of particles in the fresh air. The amount of fresh air supplied is controlled by the air valve.
Fresh air after passing through the AHU is adjusted to the temperature by the heater.
Finally, the fresh air is filtered through a HEPA VAF filter to remove small particles and bacteria
90% of the air in the room is returned to the AHU (return gas) and supplied to the clean room, the remaining 10% of the air before being discharged into the environment must be treated to avoid causing environmental pollution.
Role and application of HVAC system in GMP EU
The EU GMP standard helps to strictly manage and evaluate the factory cleaning process. Requires laboratory space, drug production, finished product packaging ... to be cleaned of bacteria, free of contaminated ingredients, increasing the risk of cross-contamination, negatively affecting drug quality.
Air is a large environment, directly affecting the factory space and clean room for research and drug production. Bacteria can enter through the air, bringing potential pollutants into the factory, and contaminating the space that has been cleaned and disinfected.
HVAC in GMP EU will control factors: temperature, humidity, dust concentration, number of microorganisms, and pressure inside the workshop space. This plays an important role in the cleaning process of the factory, minimizing the effects of pollution on factory equipment, raw materials, and medicinal products.
Depending on the drug, the manufacturing process in the EU GMP will have its requirements for the level of cleanliness in the room (For example, infusion drugs require a level A cleanroom, and the production of oral tablets requires Class D cleanroom requirements).
Notes when designing HVAC system in GMP
The HVAC system plays an important role, helping to control the cleanliness of the environment inside the production area. HVAC system design in GMP EU includes AHU air handler, air conditioning system - CDU outdoor unit, ventilation control system - adjustment valve, sound absorber, HEPA VAF filter with levels Different filters for each area.
Enterprises that design HVAC in GMP EU standards need to know the acceptable standards of the system of production plants corresponding to each specific field.