What is HVAC?

System consists of chain of components

designed to heat, ventilate or cool a
specific area while maintaining a
defined environmental cleanliness level.

HVAC-THE FULL FORM

H-Heating (To control temperature)
V-Ventilation (To purify the Air)
AC-Air Conditioning (To control
Humidity).
Purpose of HVAC
PRODUCT SAFETY
Degradation
PERSONAL COMFORT
Contamination
GENERAL SAFETY
Fire Hazards
Major components of HVAC
Blowers
Cooling & Heating Systems
Distribution Network
Filters
Controls
 Blowers

Air moving equipment.

Blowers/fans & their design characteristics
govern the amount of air flowing through the
system and delivers the static pressure
required to overcome resistance offered by
filters, coils & ducting layouts.
Selection criteria of Blower
Volume of the controlled space
Desired air changes
Desired environmental condition
Static pressure requirements based on
specific layout.
Air cooling & heating system
Air is cooled to reduce the level of
moisture by condensation.
Air is heated to raise the temperature of
the cooled air to desired level.
Cooling and heating coils are used.
Cooling and heating system

 Selection criteria
- Desired environmental condition
- Ambient environmental condition
- Heat load of the area
- Volume of space to be conditioned
Cooling
Normally two steps of cooling used by
circulating coolant.
- Chilled water 6 to 8 ° c
- Chilled brine (–1) to (–2) ° c
Flow is controlled by two way modulating
valves.
Depending upon the requirement of RH &
other features one step cooling can be done.
 COOLING DETAILS
 An air conditioning system, or a standalone air conditioner, provides
cooling, ventilation, and humidity control for all or part of a house or
building.
 The refrigeration cycle uses four essential elements to create a cooling effect. The
system refrigerant starts its cycle in a gaseous state. The compressor pumps the
refrigerant gas up to a high pressure and temperature. From there it enters a heat
exchanger (sometimes called a "condensing coil" or condenser) where it loses
energy (heat) to the outside. In the process the refrigerant condenses into a liquid.
The liquid refrigerant is returned indoors to another heat exchanger ("evaporating
coil" or evaporator). A metering device allows the liquid to flow in at a low
pressure at the proper rate. As the liquid refrigerant evaporates it absorbs energy
(heat) from the inside air, returns to the compressor, and repeats the cycle. In the
process heat is absorbed from indoors and transferred outdoors, resulting in
cooling of the building.
 HEATING
In variable climates, the system may include a reversing
valve that automatically switches from heating in winter to
cooling in summer. By reversing the flow of refrigerant, the
heat pump refrigeration cycle is changed from cooling to
heating or vice versa. This allows a residence or facility to
be heated and cooled by a single piece of equipment, by the
same means, and with the same hardware.
Central, 'all-air' air conditioning systems (or package
systems) with a combined outdoor condenser/evaporator
unit are often installed in modern residences, offices, and
public buildings, but are difficult to retrofit (install in a
building that was not designed to receive it) because of the
bulky air ducts required to carry the needed air to heat or
cool an area. The duct system must be carefully maintained
to prevent the growth of pathogenic bacteria such as
legionella in the ducts.
Heating

After passing through cooling coils the

air temperature becomes as low as around
6°c.
Circulating hot water (55 to 60 °c) is
used to bring the temperature up to comfort
level.
Flow is controlled by three way
modulating valve.
Distribution Network

The design of the ducting system depends

upon
- Dimensional Stability
- Noise and Vibration
- Resistance to Air Flow
- Air Flow Pattern Inside the Controlled
Space
Filters

Both the outside (fresh air) and the

recirculated air contain dust & suspended
impurities.
The number and size of the particles vary
according to location, environment & the
type of the operation.
Why Filters

An average person breaths approx. 15 kg

of air per day & 60% of his energy is
derived from air.
Cleanliness of the air in a Pharma
industry is even more important.
- Clean Room Operation
- Cross Contamination
Protection to the cooling & heating coils
Type of Filter

Pre-Filters
- Sieve or screen filters
Fine Filters
HEPA Filters
Electronic Filters
Pre-Filters
Normally placed in return air line.
Protects fine and absolute filters.
Normally 10 to 20 micron of pore size at
an efficiency of 90%.
Pressure Differential
- Installation 6mm
- Disposal 12 to15mm
MOC
- Synthetic Washable Material
Fine Filters
Normally located in the AHU at the fan
discharge side.
Gives clean air & protects HEPA wherever
applicable
Efficiency of 99.9% down to 5-micron
Pressure Differential
- Installation 6mm
- Disposal 15 to 18mm
MOC
- Micro Layer Fibre Glass
HEPA Filters
Terminally fitted in the supply duct.
Clean room operation/avoid cross
contamination.
Efficiency of 99.97% down to 0.3 micron.
Pressure Differential
- Installation 25mm
- Disposal 50 to 75mm
MOC
- Micronised Glass Fibre
Electronic Filters

Not common in Pharma industry.

Electrostatic field is created to charge
the particles in the air & then through the
oppositely charged plates.
Control systems
Dampers
- Supply
- Return
Thermostat
Humidistat
Modulating motor
Few Other Controls
- Flow switch
- Manometers
- Fire Dampers
- Sequential Start
ORAL SOLID DOSAGE FORM
GMP Considerations.

Temperature and Humidity control as per the

product requirements and personnel comfort.
Dedicated Air Handling Units with 5-micron
terminal filters for different processing areas.
4-20 air changes to be maintained in the
processing areas.
Negative pressure in the processing areas with
respect to the corridor.
Particulate count complying to class 100000 at
rest for processing area.
 Potential sources of room contamination
•Outdoor make-up air.
•Process equipment/ operations.
•Room construction materials
•Floor Drains
•Failure of HVAC system with reversal of flow.
•Transportation equipment and containers.
•HVAC system components
•Personnel
•Infiltration
•Sprinkler Heads
•Multiple products/materials in the facility,
especially with potent or toxic compounds.
Equipment failure modes
Mechanical failure of a fan
Failure of all fans due to electrical
interruption
Interlocks
Special sequences of operation
Room/zone fail safe modes
User action in event of failure(especially
if power fails and critical parameters
cannot be monitored)
Critical parameters which may affect
products or materials
Temperature
Humidity
Airborne Particulates (Microbial
Contamination should be
considered)
Temperature
Room temperature may be a critical parameter
for both open and closed operations. Most
products, materials and processes can handle a
wide range in temperature.However, the width of
this range decreases as the exposure time
increases.
The contents of a large processing vessel
would typically not change temperature
measurably during typical sampling activities.
If products or material is stored or exposed for
significant periods, however, (such as in non-
temperature controlled blender) then significant
effects may occur.
Relative Humidity
Affect exposed product or materials that are
sensitive to air moisture.
Liquid product can lose moisture to a low
humidity room over an extended period.
Exposed humidity sensitive products require
humidity controlled to 30-50%.
Cooling coil type systems generate large
amounts of condensate which must be drained
properly to avoid microbial contamination .
Liquid and dry type desiccant systems should be
evaluated for potential carry over of desiccant
into the supply air stream and its effect on the
exposed product.
Airborne Particulates
No particulate classification
requirements for OSD facilities.
Cross contamination can originate from
both internal environment and outside the
OSD facility.
Filtration should be evaluated for
adequate arrestance of outdoor
particulates.
Multiple products are exposed,
dedicated air handlers and ductwork may
be more practical and cost-effective.
Non critical parameters which may
affect products or material

Air Changes
Room Pressure
Air Changes

No minimum GMP requirement for air

changes per hour.
Air change rates of between 4 and 20.
Room relative pressure
Room relative pressure may be critical
parameter if:
Airborne concentration of products, materials or
contaminants are high enough to pose an
exposure threat to operating personnel.
Air locks or buffer zones can be used to separate
production areas from adjacent common corridor/
staging areas, non-controlled areas and potent
drugs manufacturing areas.
To provide protection, when the doors are
closed, room pressure should be demonstrably
negative.
Cleaning and Maintenance of
HVAC
Potential for personnel exposure and cross-
contamination.
Contamination of product or product contact
surfaces may be caused by poor maintenance
practices. Scheduling and co-ordination of
maintenance should be addressed.
HVAC components requiring routine maintenance
should be placed outside rooms where clean or
hazardous processes occur.
Preventive Maintenance
Calibration.
 Layout of HVAC system
Exhaust vent

Blower
5 micron
Fine filter

Heating coil cv
Cooling coil cv

10 micron Pre-filter HEPA

Defumigation Controlled room

Fresh Air Machine
Figure 1. Basic HVAC System
Ventilation