BTF3373

PROCESS UTILITY SYSTEMS

Dr Nadiya binti Hj Abd Halim
CHAPTER OUTLINE
01 02 03
Generation of purified Heating, ventilation,
Types of utilities water (PW) and water and air conditioning
for injection (WFI) (HVAC) system

04 05
Dust collection
system Compressed air
 03
Heating, ventilation, and
air conditioning (HVAC)
system
 OBJECTIVES
● To understand the need for an HVAC system in the pharmaceutical
industry
● The technical requirements for air handling system
● Different types of air handling system
● Monitoring and maintenance
 INTRODUCTION
WHAT IS AN AIR HANDLING SYSTEM
● Air handling system is regarded as HVAC and refers to Systems which
are mechanical arrangements that treat outside air to produce cleaned
(from dust and microbes) conditioned air (temperature and humidity)
which is circulated or re-circulated for use in controlled and critical
areas within the pharmaceutical manufacturing space
OR
● Can be simply said to be a utility system used to provide air ventilation,
heating, cooling, and air conditioning services to a building or a
pharmaceutical space for drug manufacturing
● The Acronym HVAC means: H= Heating, V= Ventilation; A= Air; C=
Conditioning
 INTRODUCTION
● HVAC system plays a major role in the quality of pharmaceutical product
manufacturing (all types)
● It is the technology of indoor and manufacturing space environmental
control and or comfort
● It is regarded as one of the most important utility in drug product
manufacturing (a critical system)
● The manufacturing environment or space is very critical to product quality
and is premised/dependent on the air handling system which controls the
level of containment (pressurization)and cleanliness (room classification)
 INTRODUCTION
● The uncontrolled environment can lead to product degradation, loss of
product, and economic issue-profit, product contamination/cross-
contamination
● The manufacturing environment is critical for products and considers these
factors(GMP environment): light, temperature, humidity, air movement,
microbial contamination, particulate contamination,
● Air handling system to satisfy GMP/regulatory requirements must be
suitably designed, installed, qualified/Validated, monitored, and maintained
by professionals ( GEP)
 INTRODUCTION
WHY HVAC IN PHARMACEUTICAL MANUFACTURING
● Needed to condition and provide the ideal GMP environment or air space
cleanliness needed for the various pharmaceutical processes and controls in
manufacturing.
● A critical factor of Quality Assurance for pharmaceutical products (Clean
areas/space for manufacturing)
● Issue of personnel comfort, satisfaction, and safety
● As a means of containment control (airborne particulate)and preventing
contamination and cross-contamination
● Avoid product rejection
 APPLICATIONS OF HVAC SYSTEM
An ideal cGMP environment for manufacturing (HVAC system) should provide:
● Product protection:
Protect from contamination, and cross-contamination, prevent contamination by
operatives, and correct conditions of humidity and temperature.
● Personnel protection:
Prevent contact with dust, prevent contact with fumes, good comfort condition
● Environment protection:
No dust discharge, no fumes discharge, no effluent discharge
● Preservation of materials and equipment
Handling, holding, and storage
● Maintenance of animals and equipment
● The GMP environment is only possible with an HVAC System
 HVAC SYSTEM
● HVAC system comprises of Air Handling Unit (AHU) connected to a ductwork
ventilation system that distributes the conditioned air through the building
and returns it to the air handler(AHU).
● AHU is a device used to condition and circulate air as a part of HVAC.
● It is usually a large metal box containing a blower, heating or cooling
elements, filter racks or chambers, sound attenuators, and dampers
 AIR HANDLING UNIT
AIR HANDLING SYSTEM/HVAC COMPONENTS
● Ducting ( for delivery of controlled air)
● Fan component
● Vibration isolator (flex joint)
● Heating and /or cooling coil
● Filter compartment ( houses pre and post-filters)
● HEPA Filter
● Mixed (re-circulated + outside ) air duct
● Louvers ( Weather)
● Damper ( fixed adjustment of the volume of air)
● Dehumidifiers
● Flow rate controller
● Humidity, Temperature, Pressure sensors, alarms, and audit log system
● Dust extractors
AIR HANDLING UNIT
INSIDE AN AIR HANDLING UNIT (AHU)
AIR HANDLING UNIT
SCHEMATIC OF AIR HANDLING UNIT (AHU)

AHU SECTION
AIR HANDLING UNIT
AIR HANDLING UNIT
TYPICAL INSTALLATION OF AHU UNIT (VISUAL)
 AIR HANDLING UNIT
HVAC MAIN SUBSYSTEMS
Exhaust air treatment

Fresh air treatment

(make-up air) Terminal air treatment
+
at production room level

Production Room
Central air handling unit
 AIR HANDLING UNIT
OVERVIEW OF HVAC COMPONENTS

Silence Flow rate controller Fan Filter

r

Weather louvre Control damper

Fresh air treatment
(make-up air) +
Prefilter Humidifier Terminal filter

Cooling Production Room

coil
with
Heating
droplet
coil
separator
 AIR HANDLING UNIT
Air-handling unit

AHU with fan

Control damper for airflow Variable Speed
Controller

Adsorber wheel
Humid room air Filter Pressure
Gauges

Regeneration air Humid room air

Air heater
 AIR HANDLING UNIT
CHARACTERISTICS OF AIR HANDLING SYSTEM/HVAC
● Turbulent airflow (airflow pattern)
● Unidirectional airflow (airflow pattern)
● Filter position (Terminal Position, air recirculation system)
● Fresh air (100%)/Once through/external air
● Air re-circulation
● Return air systems (positions low wall air return)
● Overpressure requirements
● Local extraction system(deduster, canister)
 AIR HANDLING UNIT
FUNCTIONS OF AIR HANDLING SYSTEM (HVAC)
● Control airborne particulate, dust, and micro-organisms through air
filtration using HEPA filters
● Maintains room pressures (in areas that must remain cleaner than
surrounding areas (+ve)
● Reduces contamination by airflow from cleaner areas toward adjoining
space through doors, and ceiling openings (reduces chances of
contamination)
● Maintains space moisture RH (by cooling to due point temperature and
using desiccant dehumidifiers)
● Maintains space temperature (can affect product directly or indirectly)
All to minimize and prevent contamination and cross-contamination
 AIR HANDLING UNIT
WHAT CAN AN AIR HANDLING SYSTEM NOT DO
● Cannot clean up contaminated surfaces, room or equipment
● Do not compensate for workers who do not follow procedures

QUALITIES AND ATTRIBUTES OF A GOOD HVAC SYSTEM

● Suitably designed, installed, Qualified / validated and maintained (GEP) to
meet GMP requirements for the intended purpose
● Reliable and economical to run
● Supported by appropriate documentation (lay outs, SOPs, reports of
commissioning, qualification and validation, monitoring and maintenance
records etc
 AIR HANDLING UNIT
CLEAN AIR SUPPLY CONCEPTS
There are two basic concepts of clean air delivery for pharmaceutical
production:
● Full Fresh air or Makeup air
● Recirculation or Return air
All to provide the need for conditioned clean air for the intended
clean room required for manufacturing areas.
What is a clean area/room/space?
● A closed room supplied with filtered ( purified air ) in which the
particulate and microbial contamination load is below a specified
level. And is used in such a way to minimize the introduction,
generation, and retention of contaminants
 AIR HANDLING UNIT
CLEAN AREA/ROOM CONSIDERATIONS
● All pharmaceutical facilities belong to one/ certain or other class of clean rooms
● Facility classification is based on clean air supply that matches the requirement for
the manufacturing process/product
● Clean rooms classification differs for sterile and non-sterile and can be classified as
such:
 Non-sterile operations/controlled or non-aseptic
 Sterile operation/critical areas/aseptic applications
 Examples of clean room requirements for some product lines: e.g.
o tablets class D (10,000)
o topical and oral liquids belong to class C (10,000)
o sterile preparations/injectable – class A or B (100)
 AIR HANDLING UNIT
CLEAN AREA CLASSIFICATION CONSIDERATIONS
● Clean Room Classification is defined in the state of “as-built”, “at rest,” or “in
operation”
● Clean rooms are also Categorized by the way in which supply air is distributed:
Generally two air configurations:
 Unidirectional - UDAF (Laminar) LAF or RLAF). This is achieved by Vertical down
displacement of room air or by horizontal laminar flow) – defined air velocity
 Non –Unidirectional airflow
● EU classification is based on the alphabet system A, B, C, and D;
● FDA numerical e.g. class 100; 1000; 10,000; and 100,000
 AIR HANDLING UNIT
DEFINITIONS OF ROOM CONDITION

as built at rest in operation

air air air

 AIR HANDLING UNIT
AIR FILTRATION AND CONTROL OF CONTAMINANTS

● External Air contaminants are removed by filtration

● Internal contaminants are controlled by dilution and flushing or by
displacement airflow
● Airborne particulates and level of filtration are considered critical in the Air
Handling system
● The filtered air entering a production room can be derivable from:
 100% fresh air/external air or
 a proportion re-circulated (Mixed with external/fresh air)
● New technologies: barrier technology/isolator technology
 AIR HANDLING UNIT
Types of air encountered in an HVAC system: fresh air, supply air, recirculated and exhaust air

Air types

Fresh air
(make-up + Exhaust
Supply air
air)
air

Production Room
Return air
(recirculated)
 AIR HANDLING UNIT
FRESH AIR ( 100%)/ONCE-THROUGH SYSTEM

● Applicable to factory dealing with toxic products

● Low risk of cross-contamination
● Provides:
 The exhaust air filtration depends on the degree of contaminants and
local environmental regulations
 Offers abundant oxygen-rich fresh air for dilution of contaminants
 Air leakage between the supply and exhaust air should be prevented,
supply air pressure should be higher than the exhaust air pressure
 Exhaust fan may be located remote from the AHU making ducting simpler
 AIR HANDLING UNIT
FRESH AIR ( 100%)/ONCE-THROUGH SYSTEM

● Usually more expensive to run (heating and cooling demand)

● High filter loading resulting in frequent filters replacement
● Additional requirement for air treatment (scrubber, dust collectors)
● Applicable in laboratory hood, API plant handling highly inflammable
materials, oral solid dosage plant( OSD) where potent /product/materials are
exposed.
 AIR HANDLING UNIT
VENTILATION WITH 100% FRESH AIR (no air re-circulation)

Washer (optional)
Exhaust Unit

Central Air Handling Unit

 AIR HANDLING UNIT
RECIRCULATION SYSTEM

● A proportion or % of re-circulated air mixed with fresh air/external air

● Requires installation of HEPA filters in the supply air stream to remove
contaminants that may be placed terminally or in AHU (H13 HEPA filter
recommended)
● Single product facility may not require HEPA
● Not suitable for fumes or dust from highly toxic processes
 AIR HANDLING UNIT
RECIRCULATION SYSTEM

● Proportioning of fresh (external air) to re-circulated air can be fixed or variable

air volumes (temperature and no of operatives)
● Less air filter loading–lower maintenance cost (variable airflow)
● Energy saving/cost
● Complex design and high level of automation
● Chances of cross-contamination from system failures
● Applicable for oral solid dosage manufacturing, sterile operations, final bulk
APIs
 AIR HANDLING UNIT
VENTILATION WITH RECIRCULATED AIR + MAKE UP AIR
Exhaust Unit

Central Air Handling Unit

Return air
 AIR HANDLING UNIT
AIR FLOW PATTERN

Turbulent Uni-directional / laminar

dilution of dirty air displacement of dirty air

0,30 m/s
 AIR HANDLING UNIT
AIR FLOW PATTERN
Prefilter

AHU

Main filter
Ceiling
exhausts

1 2 3

Low level exhausts

 AIR FLOW PATTERN
Workbench (vertical) Cabin/ booth Ceiling

• A vertical air flow pattern is typically • The air flow pattern is typically The air flow pattern can vary depending on the
used to provide localized ventilation designed to ensure that the air ventilation system in place.
at the work surface. inside the cabin or booth is being It can be designed:
• Involve the use of an exhaust hood exchanged with fresh outside air. • to bring in fresh air from the top and distribute it
or fan to remove contaminants and • Involve the use of supply and throughout the space
fumes generated by the work being exhaust air ducts or vents to bring in • to exhaust contaminated air out through the
performed, while also introducing fresh air and remove contaminated ceiling
fresh air to the work area. air. • to be mixed-mode, where the fresh air is mixed
• The air flow should also be designed with the recirculated air, and then distributed
to minimize the potential for cross- throughout the space
contamination between different • to be unidirectional, where the fresh air is
areas within the cabin or booth. delivered at one end of the space and exhausted
at the other end.
 TYPES OF AIR FILTERS
Filters are of various types, specifications, and classes:

Ultra Low Particulate Air filter (ULPA): These filters are extremely efficient at removing particles from the air,
with a minimum efficiency rating of 99.999%. They are often used in cleanrooms and other environments
where very high levels of air purity are required.

High-Efficiency particulate air filter (HEPA): These filters are also highly efficient at removing particles from the
air, with a minimum efficiency rating of 99.97%. They are commonly used in hospitals, laboratories, and
other environments where air purity is important.

Packed towers: These filters use a combination of different media, such as activated carbon or catalysts, to
remove pollutants and odors from the air. They are often used in industrial settings or in environments
where there are high levels of chemical pollutants.

Membrane filter cartridges: These filters use a porous membrane to remove particles and other contaminants
from the air. They are often used in laboratory settings or in environments where high levels of air purity
are required.

Hydrophobic filters: These filters use a hydrophobic membrane to remove water vapor and other contaminants
from the air. They are often used in industrial settings where high humidity is a concern.
 AIR HANDLING UNIT
POSITIONING OR LOCATION OF FILTER IN AHU

• The required cleanliness or purity of air

can be achieved with effective cleaning
of the external air or recirculated air
through correctly designed and
installed filters to meet the
specifications or requirements for the
intended activity or manufacturing
operation.

TERMINAL (AHU OR ROOM SUPPLY VENT)

 WHAT TO MONITOR
● Temperature: The temperature of the air passing through the filters should be monitored to ensure that it
is within the appropriate range for the specific type of filter being used. Some filters may have specific
temperature requirements that must be met in order to function properly.

● Humidity: The humidity of the air passing through the filters should be monitored to ensure that it is within
the appropriate range for the specific type of filter being used. Some filters may have specific humidity
requirements that must be met in order to function properly.

● Pressure (pressure differential): The pressure differential across the filter should be monitored to ensure
that it is within the appropriate range for the specific type of filter being used. A high-pressure differential
can indicate that the filter is becoming clogged and needs to be replaced.

● Particulate: The level of particulate matter in the air should be monitored before and after the filters to
ensure that the filters are effectively removing the desired level of particulate matter.

● Microbial or Biological load: The level of microbial or biological contaminants in the air should be
monitored before and after the filters to ensure that the filters are effectively removing these types of
contaminants.
 AIR HANDLING UNIT
WHERE TO MONITOR

● All production areas (including corridors and airlock)

● Storage areas for products, intermediates, and raw materials (especially if
affected by environmental conditions, in critical areas near the doors, and
ceiling)
● Clean rooms and laminar flow hoods
● Critical surfaces
● Environmentally controlled rooms and chambers
● Freezers, refrigerators, incubators
 AIR HANDLING UNIT
POSSIBLE PROBLEMS THAT CAN OCCUR IN AHU

Problem with controller : Blockage

Control damper : Poorly adjusted, bad pressure differential system
Humidifier : Bad water/steam quality poor drainage
Cooling battery : No elimination of condensed water/poor drainage
Filters : Incorrect retention rate/damage/badly installed
Duct : Inappropriate material internal insulator leakage
 AIR HANDLING UNIT
CLEAN ROOM MONITORING
Clean rooms should be monitored for microorganisms and particles

air

Sampling point
 AIR HANDLING UNIT
CLEAN ROOM MONITORING

● There should be a routine monitoring program as part of quality assurance

● Additional monitoring and triggers
 Shutdown

 Replacement of filter elements

 Maintenance of air handling systems

 Exceeding established limits

 AIR HANDLING UNIT
HVAC PARAMETER MONITORING AND FREQUENCY
Serial PARAMETER FREQUENCY
No
1 HEPA Filter Integrity ( Annual / Yearly ( 12
DOP testing) monthly)
2 Air Change rate Every 6 months(
biennially)
3 Air pressure Daily
differential
4 Microbial load ( settle Daily
plate & Swabs)
5 Temperature Daily

6 Humidity ( Relative Daily

Humidity)
 AIR HANDLING UNIT
CONECRNS FOR PRODUCT PROTECTION IN MANUFACTURING

Include contamination/cross-contamination of products that could

result from:
● Non-reliable and poorly designed air handling s/ dust extraction system
● Poor operation and no maintenance
● Inadequate procedures for equipment and personnel
● Improperly cleaned equipment
 AIR HANDLING UNIT
CONECRNS FOR PRODUCT PROTECTION IN MANUFACTURING
Product protection can be archived through controls:
 filtration of particulates from incoming air to remove external contaminants and
 Air dilution and displacement to control internal contaminants/ local extraction (point
of use)
 Local air supply or extraction e.g. isolators and barrier systems
 Maintaining sufficient air supply velocity and volume to flush unwanted dust from
work areas.
 Air lock system used to limit or minimize migration of contaminants
 Airlock system can be cascade, bubble, or sink type
 Pressurizing helps to prevent cross-contamination between areas, ingress of
materials from outside, separate areas of different cleanliness
 AIR HANDLING UNIT
SOME DESIGN FEATURES OF AIR HADNLING SYSTEM

● Airlocks
● Pressurization
● Supply air diffuser
● Gauges, alarm, and warning system
 AIR HANDLING UNIT
SOME DESIGN FEATURES OF AIR HANDLING SYSTEM

AIRLOCK SYSTEM
● Small room with controlled air flow acting as a barrier between
spaces, minimizes the volume of contaminated air that is
introduced into the cleaner area when the door is opened
● Air lock should open and close fast (minimize the time of
contamination
● No simultaneous opening of both doors
● High air change rate and smaller airlock ensure faster recovery time
● Three types: cascade, sink, and bubble airlock. The airlock should
open to the higher pressure side
 AIR HANDLING UNIT
AIRLOCK SYSTEM
1. Cascade
● High pressure on one side of the airlock and low pressure on the other side. They are
very common.
● Outward for sterile operations and inward d for toxic or hazardous materials
● Pressure differential range from 10-15pa and is measured across the airlock and not the
single doors
● Used in dispensary layout must be designed to be adequate for the purpose
2. Sink
● Low pressure inside the airlock and high pressure on both outer sides
● Usually designed 5-8pa below the smaller of the two classes pressure
● Designed for dirty operations like gowning, decontamination/exit
● Used when there are requirements for both area and classification and product
containment
3. Bubble
● High pressure inside and low pressure on both outer sides
● Used for clean operations like gowning and Material entry airlock
● Used when there are requirements for both area and product containment
 AIR HANDLING UNIT
THREE TYPES OF AIRLOCKS IN USE IN THE PHARMACEUTICAL INDUSTRY
 AIR HANDLING UNIT
PRESSURIZATION

● Pressure gradient maintained between adjacent rooms

● Net airflow from aseptic to the non-aseptic areas
● Air flow from high pressure to the low-pressure zone
● Pressure between two-room is pressured differential
measured
● Air locks are used when there is a requirement for
pressure demarcations.
● Alarms for pressure drops and failures required
 DIFFUSERS
● Used to create air supply pattern in the room
● Types include induction diffusers, perforated plate diffusers, swirl diffusers
● Caution should be precluded non-usage of high induction diffusers in clean areas
because of induction of air, instead non-induction type should be used so as to
maximize flushing effects

Swirl Type air diffusers with terminal filters

High induction office type Low induction swirl diffusor
diffusor (avoid) (preferred)
 AIR HANDLING UNIT
REGULATION OF ROOM PRESSURE – pressure differentials concept

The room pressure indication panel

Room pressure
gauges
 AIR HANDLING UNIT
HOW MANY HVAC SHOULD BE USED
● HVAC are of simple or small unit (Modular) or Large Single Unit (Central Unit)
● The use of multiple small units (modular) improves reliability (impossible for all
units to fail)
● Air balancing is easier with multiple small units
● They require smaller distribution ductwork and are easier to route through the
ceiling void
● It is easier to make modification to parts and upgrade as compared to large single
units (Central unit)
● Allows for easier separation of areas within multi-products concurrent
manufacturing facility or plant
 04
Dust collection system
 INTRODUCTION
• Design of the tablet manufacturing area is complicated by the variety in size of
manufacturing departments, process operations, types of products handled, and
production throughput.
• Acceptable dust levels, cross-contamination limits, dust extraction, and monitoring
also play a vital role in system design.
• A dust collector is a system used to enhance the quality of air released from
industrial and commercial processes by collecting dust and other impurities from air
or gas.
 INTRODUCTION
• The removal of airborne particles in any pharmaceutical facility is essential for a
variety of reasons:
They present health hazards
They contaminate the local environment and/or other products
They can be highly toxic
They are potential sources of explosions
Dust particles that create most problems lie in the 0.2 to 5.0μm size range.
• Thus, a collection system should be designed to handle these particles
 INTRODUCTION
• Each system must be fitted with explosion venting that is specific to the materials
that are being processed.
• In the installation of a dust collection, the following factors should be addressed:
The dust collection must keep the area free of particles. This will depend on
the classification of the area
The system must contain all the material collected
The filter media and pore size must be carefully selected
If the range of particles’ size is wide, two-stage filtration is necessary – the
secondary filter will remove particles with 50 μm and above and the finer
filter will remove any particles with lower sizes.
HEPA filter is necessary to ensure complete entrapment
 DESIGN
 Designed to handle high-volume dust loads, a dust
collector system consists of a blower, dust filter, a filter-
cleaning system, and a dust receptacle or dust removal
system.
 Dust collectors may be of single unit construction, or a
collection of devices used to separate particulate matter
from the process air.
 They are often used as an air pollution control device to
maintain or improve air quality.
 DUST COLLECTORS
USES:
 Dust collectors are used in many processes to either recover valuable granular
solid or powder from process streams or to remove granular solid pollutants
from exhaust gases prior to venting to the atmosphere.
 They are often used as an air pollution control device to maintain or
improve air quality.

Identification and removal of dust have had a profound effect on plant

layout as well as on the design and construction of the production area.
 DUST COLLECTION CHALLENGES
The pharmaceutical industries face several challenges when it comes to dust control. The exact risks
and challenges depend on the ingredients and processes used.

1. Nuisance dust:
 Many of the dust created in the production of vitamins, protein powders, and other
nutraceuticals are not especially toxic or dangerous, but that doesn’t mean dust control isn’t
important.
 Nutraceutical dust can still create health problems—such as lung irritation and aggravation of
asthma symptoms—when inhaled.
 Some nutraceuticals can also trigger allergic reactions in susceptible employees, which can get
worse over time with continued exposure.
 Uncontrolled dust of any type is also a housekeeping and sanitation consideration.
 DUST COLLECTION CHALLENGES
2. Hazardous/high-potency pharmaceutical dust:
 If manufacturing processes create dust with APIs, more stringent controls will be needed to
prevent workers from being exposed.
 Many pharmaceutical dusts are toxic when inhaled, even in small quantities.
 And any exposure to medications outside of the normal doctor-prescribed channels is a health
concern for employees.
 Employees exposed to uncontrolled pharmaceutical dusts may have significant side effects,
interactions with drugs they are taking, or dangerous allergic reactions.
 High-potency drugs may require extra-special care to prevent both inhalation and exposure to skin
and mucus membranes, even in small amounts.
3. Water vapor or solvents:
 Some pharmaceutical compounding and manufacturing processes create water vapor, solvent
vapor or moisture-laden dusts.
 his can create special challenges in dust collection.
 Hygroscopic dusts absorb moisture in the air that makes them heavier and stickier.
 These dusts are harder to pulse off of filters and can cause excessive filter clogging.
 DUST COLLECTION CHALLENGES
4. Combustible dusts:
 Many of the dusts created by pharmaceutical production are highly combustible.
 That means they can generate an explosion when allowed to concentrate in the air or inside a
dust collection machine.
 Special care must be taken when collecting combustible dusts to minimize the risks of an
explosion inside the dust collector.
5. Cross-contamination concerns:
 Cross-contamination is a particular concern in the pharmaceutical industries.
 Dust that is not properly controlled may escape enclosures and contaminate other
production lines.
 This can lead to sanitation and safety concerns, including the risk of dangerous allergic
reactions from cross-contamination.
 CONSIDERATIONS IN SELECTING A DUST CONTROL SOLUTION
FOR PHARMACEUTICAL DUST
• Engineering control: source capture of dust, industrial ventilation, negative-pressure cabinets and
rooms, and other systems to reduce exposure to airborne dusts.
• Personal Protective Equipment (PPE): for workers handling or otherwise directly exposed to
hazardous substances, including dusts with APIs. PPE may include face masks or respirators, face
shields, gloves, aprons and/or full-body protective gear, depending on the level of hazard.
• Housekeeping and work processes: to prevent accumulation of dust and reduce exposure, i.e.,
high-potency pharmaceutical dust may require the use of high-vacuum equipment with HEPA
filtration for housekeeping and a “bag-in/bag-out” (BIBO) filter change process for the dust
collector to prevent dust from escaping during filter changes.
 DUST COLLECTORS
TYPES OF DUST COLLECTORS
 Although many types of dust collectors are available.
 The selection of equipment should be based primarily on its intended application.
 The types of dust collectors suitable for the pharmaceutical industry are:
1. Cyclone collectors
2. Wet collectors
 Wet scrubber
 Rotoclone
3. Replaceable filter
4. Cloth bag
5. HEPA
 DUST COLLECTORS
CYCLONE DUST COLLECTOR

 Cyclone dust collector is efficient to dust removing

equipment.
 It greatly helps in reducing the dust inside the workshop
and in the exhaust.
 Cyclones use centrifugal force to separate particulate out
of the airstream.
 There are no moving parts inside a cyclone body and no
filter media.
 Used in pharmaceutical pill and tablet manufacturing.
 DUST COLLECTORS
WET COLLECTOR
There are two types of wet collectors:

 Wet scrubber
• Effective air pollution control devices for removing particles and/or
gases from industrial exhaust streams.
• Wet Scrubbers are common in many industrial applications including
pollutant reduction at petroleum refineries, chemical processes, acid
manufacturing plants, and steel making.

• Cleans the air by the combined action of centrifugal force and a violent
 Rotoclone inter-mixing of water and dust-laden air.
• The dust is separated from the gas stream by means of water and by
the high-velocity flow of air past a stationary impeller.
• This high-velocity flow carries water with it in a heavy turbulent sheet.
• This type of scrubber is efficient and uses a minimal amount of water.
 JET DUST COLLECTORS
• Jet dust collectors are one of the most widely used types of
dust collecting systems because they require little
maintenance, can clean high-density dust, and offer excellent
filter efficiency.
• A jet dust collector is a suction filtration unit that pulls dust
ladened air into a filtration system that collects particulate
matter and releases clean air.
• Jet dust collectors take up more space than most other types
of dust collectors, often requiring outdoor installation.
• Ideal applications for jet dust collectors include product
recovery, dust capturing, separating and filtering explosive
media, metalworking chips, toxic media, central vacuum
cleaning, and pneumatic conveying.
 HEPA DUST COLLECTORS
 A HEPA filter is used in an air purifier to help filter harmful pollutants and allergens
out of the air.
 This technology was developed by the U.S. Atomic Energy Commission to remove
the airborne radioactive particles from the air it has to be able to remove 99.7%
of the particles as small as 0.3 microns from the air.
 It works by circulating the air to purify it.
 05
Compressed Air
FUNCTION Compressed Air in Pharmaceutical Production Use
Compressed air is used in various stages of the pharmaceutical production process, including the
manufacturing, packaging, and sterilization of drugs.

In manufacturing: compressed air is used to operate pneumatic valves, cylinders, and other
equipment used to mix and transfer ingredients. It is also used to provide the necessary force for
the production of tablets, capsules, and other solid dosage forms.

In packaging: compressed air is used to operate air-jetting and air-blowing equipment which is
used to fill, seal and package tablets, capsules, and other solid dosage forms. It is also used to
operate the machines that assemble and package medical devices such as inhalers.

In sterilization: compressed air is used to operate equipment such as sterilizers, autoclaves and
depyrogenation tunnels that are used to sterilize the equipment and materials used in the
production process. Compressed air is also used to operate the equipment that is used to dry and
sterilize the final products.
 COMPRESSED AIR QUALITY
• The compressed air quality must comply with the relevant ISO 8573-1
standard, quality class 1 for particles and oil residues (aerosol, liquid, and
vapor), quality class 2 for humidity & liquid water (class 1.2.1)
• Quality requirements should be updated and revised if quality
requirements are requested to higher standards.
 CONSTRUCTION REQUIREMENTS
• The Compressed Air Generation and Distribution/ Piping Systems should be
constructed according to GMP requirements.
• Dead legs/zones after sterile filters should be avoided.
• Appropriate materials of manufacture must be selected and specified in
accordance with GMP regulations depending on the specific application
and process requirements.
• All materials, instruments, and instrument enclosure materials shall be of
durable type.
• Compressed air contact parts should be made from FDA accepted materials
(food grade standard)
 CONSTRUCTION REQUIREMENTS
• Surface finish on compressed air contact parts should be such that
adherence of particles or liquids is minimized.
• Join materials, then it should be crevice-free and flush with the adjacent
material.
• The surface finish shall be the same standard as the adjacent material.
• Non-compressed air contact parts should be made of FDA accepted
materials.
• The surface finish on non-product contact parts should be such that
cleaning of the surface made easy (easily cleaning)
• All pipes should be complete drainable and possible to sanitize
 CONSTRUCTION REQUIREMENTS
• The piping must be passivated in a factory with adequate passivation solutions and should be re-
passivation after completely installed
• Compressed Air Generation and Distribution shall operate in such a way that the compressed air
produced flows smoothly through the pipe works to the point of use.
• Stable pressure compressed air at all points of use (looped system preferable)

CLEANABILITY and IDENTIFICATION

• The outer surface of the Compressed Air Generation and Distribution Piping System should be easy
to clean.
• Identification and flow direction should be available (marked)
 Test 2
FRIDAY,
20 January 2022
10am - 12pm
WDK-05