Air Handling unit

A brief description on AHU

Air handling unit is a device used to condition and circulate air as part of a heating, ventilating, and
air-conditioning (HVAC) system. An air handler is usually a large metal box containing a blower,
heating or cooling elements filter racks or chambers, sound attenuators, and dampers. Air handlers
usually connect to a ductwork ventilation system that distributes the conditioned air through the
building and returns it to the AHU. Sometimes AHUs discharge (supply) and admit (return) air
directly to and from the space served without ductwork.

Small air handlers, for local use, are called terminal units, and may only include an air filter, coil, and
blower; these simple terminal units are called blower coils or fan coil units. A larger air handler that
conditions 100% outside air, and no recalculated air, is known as a makeup air unit (MAU). An air
handler designed for outdoor use, typically on roofs, is known as a packaged unit (PU) or rooftop
unit (RTU).

The design, installation, commissioning and qualification of clean rooms heating, ventilation and air
conditioning (HVAC) systems are often one of the largest considerations in the design of a new
pharmaceutical or biotechnology manufacturing facility. With high running costs (energy associated
with the movement, cooling, and heating of air) and the potential to impact upon safety and product
quality, getting them right is important for business, safety, and good manufacturing practice (GMP)
criticality.

The design of the HVAC system will be based upon the clean room suite that it serves, and will be
affected by factors such as the number of rooms served, the layout of the rooms, the equipment within
the rooms and, most critically from a qualification perspective, the environmental conditions that the
rooms must achieve.

The air handling unit helps maintain each room's clean environment by providing an appropriate
volume of clean air to each room at the correct temperature and humidity.

The air is filtered by pleated paper filters called high-efficiency particulate air (HEPA) filters which,
depending upon the classification of the rooms, are located either within the air handling unit or where
the air enters each room. Cooling and heating coils are also located within the air handling unit,
increasing or decreasing the air temperature to ensure that the room temperatures remain within
specification.
Reliable operation of the air handling unit within established limits is critical, not only to prevent
product quality from being compromised by poor air conditioning but also for the following reasons:

- To prevent cross contamination of products to maintain operator safety,

- where the HVAC is being used for this purpose to maintain product safety,
- where the HVAC is being used for this purpose.

Whereas other services and utilities can be (relatively) easily moved within a building's framework
once the building work has been completed, the HVAC is much more integral with the building's
fabric, making retrospective modifications much more time consuming and expensive.

What are the problems If the design phase is completed without considering the compliance aspects of
the clean rooms, then there is a high likelihood of incurring significant time delays and costs during
the validation period, as a result of having to make mechanical changes to the installation or revisiting
some of the commissioning work?

Some typical examples of areas where problems can occur as a result of not designing for compliance
are highlighted below, together with suggested actions to try to avoid these problems from occurring.
Operating tolerances Design, commissioning, and validation criteria must be determined for GMP-
critical parameters such as air change rates, room differential pressures, temperature, and humidity.
For example, different tolerances may need to be applied at commissioning and validation to ensure
that the facility will operate reliably within the validation acceptance criteria limits.

The level of air filtration will vary depending upon the classification of the clean rooms being served.
For example, an ISO Class 5 room (Class 100) will require terminal HEPA filters, whereas an ISO
Class 8 environment (Class 100000) may be achieved by using a high-grade (non-HEPA) filter within
the air handling unit. To avoid failures during validation integrity testing it is important for the
validation and design teams to discuss the in situ test requirements, and to agree upon appropriate
grades of air filtration.

Criteria for validation:

During AHU validation, following tests shall be carried out-

Filter efficiency test,
Air velocity & number of air changes,
Air flow pattern (visualization),
Differential pressure, temperature, and RH,
Static condition area qualification,
Dynamic condition qualification,
Non-viable count,
Microbial monitoring,
Area recovery and power failure study.

Why re-validation?

AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU shall be
revalidated in following cases also.

When basic design of AHU is changed,

When clean room volume is changed,
When new equipment is installed,
When a construction is carried out, that calls for reconstruction of AHU system.