Dust Control
Ahmed Abushrida
In the pharmaceutical industry dust control is important to avoid cross
contamination and particles in parental products OR any
pharmaceutical product.
▪ Contamination
The undesired introduction of impurities of a chemical or microbiological
nature, or of foreign matter, into or onto a starting material, or
intermediate or finished product during production, sampling, packaging
or repackaging, storage or transport.
▪ Cross-contamination
Contamination of a starting material, intermediate product or finished
product with another starting material or product during production.
❖ Sources of contamination
The possible sources of contamination are:
1. Atmosphere
Small particles (0.1 to 1 µm) may be retained in the air. The rate at which dust particles
settle from the air depends on the particle size, amount of the air movement and humidity.
2. Operator
Skin, hair and cloth of the operator are potent source for particles.
3. Raw materials
Raw materials that obtained from natural sources (animals or plants) may account for a high
portion of microbial and inert particulate contamination. However, synthetic drugs are
generally free from contamination when prepared and stored properly.?????
4.. Equipment
Source of contamination depends on the design of the processing equipment.
Dust may be generated during use.
Due to sedimentation of particles or droplets, external surfaces are potential source of
contamination.
Control of Atmospheric
Contamination
Atmospheric contamination can be prevented by efficient air filtration and controlling of
the airflow.
I. Air filtration.
Types of Air filters
1. Fibrous filters
It may compose of slag of wool, long stample of cotton wool, glass wool or oil wetted
glass fiber. When it is loosely packed, it can be used for prefiltration removing 99% of
particles down to 5 µm at an average air velocity of 0.12 m. Se * c ^ - 1 When it is
compressed into felts it may be able to remove 99.9% particles down to 1 µm at the same
air velocity.
2. HEPA filter (High Efficiency Particulate Air Filter)
It is composed of various fibers (glass fiber and ceramic fiber bounded with
resin or acrylic binders). The filter consists of continuous sheet of filtration
material pleated with a corrugated separator placed between each pleat and
sealed with a rigid metal frame. Efficient gaskets are used to ensure that air
can not leak past the filter material. HEPA filter is capable of removing
99.99% of particles down to 1 um at an air velocity of 0.54 m. Se * c ^ - 1.
(Acrylic is a transparent plastic material with outstanding strength, stiffness,
and optical clarity. Acrylic sheet is easy to fabricate, bonds well with
adhesives and solvents, and is easy to thermoform.)
II. Airflow control
It helps to remove allergens, pollutants, and particles from the air, which can
enhance respiratory health and reduce allergic reactions. Additionally, a clean
filter ensures that the HVAC system operates efficiently, preventing it from
becoming clogged and potentially damaging the system.,
The typical airflow system for supplying clean air involves the following
1. Intake of fresh air:
Fresh air should be introduced through intake situated above the ground level to avoid most
pathogenic dust found at the street level and should be away from chimneys.
2. Prefiltration : It is a coarse filtration to remove coarse particles.
3. Temperature adjustment :It is conducted by passing air over coils.
4. Humidification:
The air is passed through a fine atomizer spray of demineralized water to
increase humidity level. Drying, if required can be done by passing the air
over a bed of desiccant.
5. Final filtration: It is achieved by using HEPA filter.
There are two main methods for controlling atmospheric contamination:
1. Conventional air flow (normal)
Filtered air is pumped into the room, in a turbulent fashion, through filters in the
ceiling and leaves through a carefully sited outlets fitted low down on the opposite
wall which will flush out already present particles. Pumping of filtered air into the
room produce a positive pressure (plenum completely filled) inside compared to
the outside.
2 - Laminar flow (unidirectional)
The fresh air enters the room through a bank of filters that comprises complete wall
of ceiling and exits through a bank of outlets which comprises the floor.
The total air of of the room moves ideal and with a uniform velocity.
Laminar airflow refers to the flow within an air distribution system that follows the
principle of laminar flow of air. When gas molecules travel in straight, parallel layers
without intersecting or mixing with each other, laminar conditions are formed. In an
enclosed space, the uniformity in velocity and direction due to laminar airflow
provides the opportunity for creating an efficient circulation system. The circulation of
the filtered air within a system is key to keeping a clean and contamination-free
environment.
HVAC System
The meaning is heating, ventilation and air-conditioning (HVAC)
What can HVAC do? HVAC system performs four basic functions:
1. Control airborne particles, dust and micro-organisms – Thru air filtration using
high efficiency particulate air (HEPA) filters.
2. Maintain room pressure that must remain “cleaner” than surrounding areas must
be kept under a “positive” pressurization, meaning that air flow must be from the
“cleaner” area towards the adjoining space (through doors or other openings) to
reduce the chance of airborne contamination. This is achieved by the HVAC
system providing more air into the “cleaner” space than is mechanically removed
from that same space.
3. Maintain space moisture (Relative Humidity) – Humidity is controlled by cooling
air to dew point temperatures or by using desiccant dehumidifiers. Humidity can
affect the efficacy and stability of drugs and is sometimes important to effectively
mould the tablets.
4. Maintain space temperature - Temperature can affect production directly or
indirectly by fostering the growth of microbial contaminants on workers
What HVAC can’t do?
1. HVAC can not clean up the surfaces of a contaminated surfaces, room or
equipment
2. HVAC can not compensate for workers who do not follow procedures
The air handling unit (AHU)
The easiest way to differentiate between an AHU and HVAC is to remember that an
AHU is a part of the HVAC system and adds further utility to the construction.
As a part of HVAC system an Air handling units (AHU) is an equipment used to
supply, regulate and circulate air through a building by the distribution of ductwork
system. This system consist of different equipment and devices depending on the
complexity application and requirement of the served area for the proper function
such as: blower or supply fan, heating or cooling coils (indirect coil) used with Steam
or Chilled water according to the required application, filters, dehumidifier units,
dampers, local and control instrumentation. Air handlers usually connect to a
ductwork ventilation system that distributes the conditioned air through the building
and returns it to the AHU. There are several configuration types of Air Handling Units
The air is provided by an air handling unit (AHU) which receives air from
the outside and air recirculated from the building. The outside and return air
are mixed in the mixing chamber, filtered, cooled, and delivered to occupied
areas through sheet metal ducts and usually supply by air diffusers located
on the ceiling,
An AHU (Air Handling Unit) is a device that conditions and distributes air
throughout a building. It takes fresh air from outside and then has the ability
to treat it in a number of ways: -
Clean it - Heat it - Cool it - Humidify it - Dehumidify it
What does an AHU consist of?
Dehumidifier
Thank you for being quiet,
attention and interest in
the lecture