5. FUNDAMENTAL OF HVAC
HVAC is an acronym that
stands for “heating,
ventilating and air-
conditioning” system .
This system generally
includes a variety of active
mechanical or electrical
systems employed to
provide thermal control in
buildings.
Fig: HVAC System
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6. FUNDAMENTAL OF HVAC
An air-conditioning system by ASHRAE (American Society of
Heating, Refrigerating and Air-Conditioning Engineers) definition
is a system that must accomplish four objectives simultaneously.
These objectives are to:
Control air temperature
Control air humidity
Control air circulation and
Control air quality.
6
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7. FUNDAMENTAL OF HVAC
“H” in HVAC
A heating system (“H” in HVAC) is designed to add
thermal energy to a space or building in order to
maintain some selected air temperature that would
otherwise not be achieved due to heat flows (heat
loss) to the exterior environment.
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8. FUNDAMENTAL OF HVAC
Heating a system contains :
Boiler
Furnace or
Heat pump to heat water, steam and air
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9. FUNDAMENTAL OF HVAC
“V” in HVAC
A ventilating system (“V”) is intended to introduce air to
or remove air from a space to move air without changing
its temperature.
Ventilating systems may be used to improve indoor air
quality or to improve thermal comfort.
Methods for ventilating a building may be divided into :
1.Mechanical forced and
2.Natural types ventilation
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10. FUNDAMENTAL OF HVAC
Mechanical or forced ventilation
Mechanical ventilation is provided by an air handler and used to
control indoor air quality.
Excess humidity ,odors and contaminants can often be
controlled via dilution or replacement with outside air.
In pharmaceutical Company normally use this type of
ventilation system.
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11. FUNDAMENTAL OF HVAC
Natural ventilation
Natural ventilation is the ventilation of a building
with outside air without the mechanical system.
It can be achieved with open able windows or trickle
vents.
11
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12. FUNDAMENTAL OF HVAC
“AC” in HVAC
Cooling systems are normally considered as part of the “AC”
in HVAC.AC stands for air-conditioning.
A cooling system is designed to remove thermal energy
from a space or building to maintain some selected air
temperature.
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13. FUNDAMENTAL OF
HVAC
“AC” in HVAC
Air conditioning and refrigeration are provided through the
removal of heat.
The definition of cold is the absence of heat and all air
conditioning systems work on this basic principle.
Heat can be removed through radiation, convection and by
heat pump systems through a process called the
refrigeration cycle.
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14. FUNDAMENTAL OF HVAC
The Refrigeration
Cycle
The Compressor
The Condensing
Coil
The Metering
Device
The Evaporator
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16. FUNDAMENTAL OF HVAC
First Condition:
• The temperature is constant, but the quantity of
water vapor is increasing.
• If the temperature remains constant, then, as the
quantity of water vapor in the air increases, the
humidity increases.
To understand the relationship between water vapor,
air, and temperature, we will consider two conditions.
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17. FUNDAMENTAL OF HVAC
Second Condition:
The temperature is dropping, but the quantity of
water vapor is constant. If the air is cooled
sufficiently, it reaches the saturation line.
If it is cooled even more, moisture will condense out
and dew forms.
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18. FUNDAMENTAL OF HVAC
Relative Huminity
The percentage of amount moisture present in a
certain area in a certain temperature .
Saturation line
The curved “maximum water vapor line” is called the
“saturation line.
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19. Types of HVAC
System
HVAC systems come in a broad range of sizes and complexity. The most commonly used types
of HVAC systems are listed here.
1.Single Zone
3.Multiple Zone
2.Constant Volume
4.Variable Air Volume(VAV)
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20. Single Zone
A single air handling unit can only serve more than one
building area if the areas served have similar heating,
cooling, and ventilation requirements.
Single-zone systems can satisfy all HVAC functions
efficiently.
But contemporary single-zone HVAC equipment performs
poorly because of flaws in design and equipment
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21. Multiple Zone
Multiple zone systems can provide each zone with air at a
different temperature by heating or cooling the air stream
in each zone.
Multiple-zone air handling systems inherently cannot
perform all HVAC functions and operate efficiently.So, they
must be abandoned.
Alternative design strategies involve delivering air at a
constant temperature while varying the volume of airflow
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22. Constant Volume
Constant volume systems generally deliver a constant
airflow to each space.
These systems often operate with a fixed minimum
percentage of outdoor air.
Changes in space temperatures are made by heating
or cooling the air or switching the air handling unit on
and off, not by modulating the volume of air supplied.
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23. Variable Air Volume
Variable Air Volume
Variable air volume systems maintain thermal comfort by varying
the amount of heated or cooled air delivered to each space, rather
than by changing the air temperature.
Overcooling or overheating can occur within a given zone if the
system is not adjusted to respond to the load.
Fig: Variable Air Volume (VAV) System
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24. HVAC
HVAC
Components
Components
HVAC system components may be grouped into
three functional categories:
1.Source components :
Source components provide or remove heat or moisture.
2.Distribution components :
Distribution components convey a heating or cooling
medium from a source location to portions of a building
that require conditioning.
3.Delivery components :
Delivery components serve as an interface between the
distribution system and occupied spaces.
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26. Source components
Space heat may be added or removed by an electro-
mechanical system which is termed an active
systems.
Space heat may be added or removed by a system
designed to make use of naturally occurring
environmental forces. Such a system is termed a
passive system.
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27. Source components
Basic sources for building heat:
A. On-site combustion : Heat may be generated by the combustion of
some flammable material (a fuel) such as coal or natural gas.
B .Electric resistance: Electricity may be converted to heat through
the process of electric resistance.
C. Solar collector on roof to furnace: Solar radiation or other
renewable energy resources may be collected on site and converted
to heat.
D.Heat pump in furnace: Heat may be removed from some material
on site and transferred into a building.
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28. Source components
The choice of a heat source is usually based
upon.
Required HVAC System
Source availability
Required system capacity
Equipment and
Fuel costs.
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30. BOILER
A boiler is a closed vessel in which water or other fluid is
heated and produced steam.
Boiler is a heating system component designed to heat
water for distribution to various building space.
The heated or vaporized fluid exits the boiler for use in
various processes or heating applications.
Boilers are only used in central systems where hot water
is circulated to delivery devices ( air-handling units).
Worked at low to medium pressure (1–300 psi/0.069–
20.684 bar; 6.895–2,068.427 kP).
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31. BOILER
Materials of Boiler:
Stainless steel is virtually prohibited for use in wetted parts of
modern boilers
In live steam models, copper or brass is often used because it
is more easily fabricated in smaller size boilers.
Highest grade of iron is used.
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32. BOILER
Fuel of Boiler:
Wood
Coal
Oil or
Natural gas.
Nuclear fission is also used as a heat source for
generating steam.
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33. BOILER
Boilers can be classified into the following
configurations:
Pot boiler
Fire-tube boiler
Water-tube boiler.
Flash boiler
Fire-tube boiler with Water-tube firebox.
Sectional boiler.
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35. BOILER
Fire-tube boiler
A boiler in which hot gases from a fire pass
through one or more tubes running through a
sealed container of water.
The heat of the gases is transferred through the
walls of the tubes by thermal conduction heating
the water and ultimately creating steam.
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38. BOILER
water tube boiler
A water tube boiler is a type of boiler in
which water circulates in tubes heated
externally by the fire.
In a pharmaceutical company mostly used
this type of boiler.
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40. Chiller
A chiller is a machine that removes heat from a liquid or water
via a vapor-compression or absorption refrigeration cycle.
This liquid can then be circulated through a heat exchanger to
cool air or equipment as required.
Chiller produce chilled water(cool water) that is used in
commercial building or in pharmaceuticals.
Chilled water temperatures can range from 35 to 45 degrees
Fahrenheit (1.5 to 7 degrees Celsius) depending upon
application requirements.
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41. Chiller
Chillers may operate on either the vapor compression
principle
or the absorption principle.
Vapor-Compression Chiller Technology
Absorption Chiller Technology
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42. Chiller
vapor compression chillers
There are basically four different types of compressors used in vapor
compression chillers:
Reciprocating compression
Scroll compression
Screw-driven compression and
Centrifugal compression.
All mechanical machines that can be powered by electric motors,
steam, or gas turbines. They produce their cooling effect via the
"reverse-Rankine cycle, also known as vapor-compression.
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43. Chiller
vapor compression chillers
Their coefficients-of-performance (COPs)
are very high.
In recent years, Variable Speed Drive
(VSD) technology has increased
efficiencies of vapor compression chillers.
VSDs are being applied to rotary screw
and scroll technology compressors.
43 Fig: VSD
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44. Chiller
Absorption Chiller Technology
Absorption chillers use heat instead of mechanical energy to provide cooling.
A thermal compressor consists of an absorber, a generator, a pump, and a
throttling device, and replaces the mechanical vapor compressor.
The two most common refrigerant/ absorbent mixtures used in absorption
chillers are water/lithium bromide and ammonia/water.
Compared with mechanical chillers, absorption chillers have a low coefficient
of performance (COP = chiller load/heat input).
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45. Chiller
Absorption chillers come in two commercially available designs:
single-effect and double-effect.
Single-effect
A single-effect absorption machine means all condensing heat cools
and condenses in the condenser is released to the cooling water.
Single-effect machines provide a thermal COP of 0.7 & require
about 18 pounds of 15-pound-per-square-inch-gauge (psig) steam
per ton-hour of cooling.
Double-effect
A double-effect machine adopts a higher heat efficiency of
condensation and divides the generator into a high-temperature
and a low-temperature generator. Double-effect machines are
about 40% more efficient.
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47. Cooling Tower
A cooling tower is a heat rejection device installed outside of
the building envelope, through which condenser water is
circulated.
A cooling tower is a latent heat exchanger.
Heat rejected from the refrigerant increases the temperature of
the condenser water.
The condenser water is circulated to the cooling tower where
evaporative cooling causes heat to be removed from the water
and added to the outside air.
The cooled condenser water is then piped back to the condenser
of the chiller.
47
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48. Cooling Tower
The towers vary in size from small roof-
top units to very large up to 200 metres
tall and 100 metres in diameter
Rectangular structures that can be over
40 metres tall and 80 metres long.
48
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49. Cooling Tower
Classification Cooling Tower by use:
HVAC: Chillers
Industrial cooling towers: Machinery or heated process material.
Classification Cooling Tower by build:
Package Type: Hospitals, hotels, malls, chemical processing plants.
Field Erected Type: Power plants, steel processing plants, petroleum
refineries.
49
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55. Distribution components
A central system will always require distribution
components to convey the heating or cooling effect
from the source to the conditioned locations.
Hot water and steam can be used as heating media.
Cold water can used cooling medium.
55
56. Distribution components
PIPE SYSTEM
In a water-based central system pipes are used to convey
water from the source to the final delivery components.
A minimum of two pipes is necessary one for supply water and
one for return water to establish a distribution loop.
When both heating and cooling are required in a building, 3-
pipe and 4-pipe distribution systems may be used to increase
system flexibility.
56
57. Distribution components
A 2-pipe system can only heat or cool, simultaneous heating
and cooling not an uncommon requirement in large buildings
is not possible with a 2-pipe system.
A 3-pipe system has two supply pipes (hot and cold water) and
a single return. The mixing of heating and cooling water in a
single return is not energy efficient and is not recommended.
A 4-pipe distribution system has two supply pipes and two
separate return pipes (hot and cold). The 4-pipe arrangement
provides the greatest control flexibility in the most energy-
efficient manner.
57
58. Distribution components
Several piping materials are used in HVAC
distribution systems.
Steel pipes are most commonly used, although copper
may be used when economic or environmental conditions
dictate.
Hot and cold (chilled) water pipes in HVAC distribution
systems are normally insulated.
Yellow color pipe chilled water supply and green color pipe
for return chilled water.
60. Distribution components
Valve
Valves are used to control water flow as a means of
adjusting system heating or cooling capacity to the
demands of the building thermal zones.
Valves are also used to shut off water flow so that
equipment may be maintained.
60
62. Distribution components
Gauge
A range gauges is used to
balance system flows and
verify temperature and
pressure conditions.
62
Fig: Gauges for HVAC
applications.
63. Distribution components
The typical central HVAC system
may require the use of several
pumps: for hot water, for chilled
water, and often for condenser
water.
Pumps come in a variety of designs
and capacities and can be driven by
electric motors, combustion
engines, or steam. Electric motor
driven centrifugal pumps.
63
Fi
Centrifugal pumps
64. Air Handling Unit(AHU)
Air Handling
System
Production Room
With
Defined
Requirements
Supply
Air
Outlet
Air
66. Distribution components
Air Handling Unit(AHU):
AHU is a device used to condition and circulate air as part of a
HVAC system.
AHU is to suck air from the rooms and fresh air let it pass
through chilled water cooling coils and then discharging the
cooled air back to the rooms.
Air handlers usually connect to ductwork that distributes the
conditioned air through the building and returns it to the AHU.
A certain amount of fresh air(20%) and (80%) recirculated air
introduced at the suction duct of the AHU that balance the
oxygen & carbon dioxide in the room for comforting.
66
67. Distribution components
Some Air handler components
Mixed (recirculated 80%+ outside20%)
air duct
Filter compartment
Cooling coil
Heating Coil
Vibration isolator ('flex joint')
Fan compartment
Final filtr
Supply duct
67
68. Distribution components
Mixed (recirculated 80%+ outside20%) air duct.
The 80% recirculated air is enter the mixing box
section and mixed with 20% fresh air.
Recirculated air is come from the HVAC controlling
room by return pipe.
By filtering fresh air is come from Fan Coil Unit (FCU)
68
69. Distribution components
Pre filter:
Panel filter used in HVAC applications as
a coarse dust filter or pre-filter.
Filtering the mixed air by pre-filter-G4
(averrage arrestance <35%.
Medium Filter
Then again filtering the pre-filtrated air
by medium filter F-7 (Efficiency 85%)
69
71. Distribution components
Cooling Coil Section
Large commercial air handling units
contain coils that circulate chilled water
for cooling the air.
Coils are typically manufactured from
copper for the tubes with copper or
aluminum fins to aid heat transfer.
Cooling coils will also employ eliminator
plates to remove and drain condensate.
The chilled water is provided by a central
chiller.
71
72. Distribution components
Heating Coil Section
Air handling units contain
coils that circulate hot
water or steam for heating
The hot water or steam is
provided by a central boiler.
72
73. Distribution components
Vibration isolator ('flex joint')
The blowers in AHU can create substantial vibration and duct system would
transmit this noise and vibration to the occupants of the building.
To avoid this, vibration isolators (flexible sections) are normally inserted into the
duct immediately before and after the air handler and often also between the fan
compartment and the rest of the AHU.
.
73
74. Distribution components
Fan compartment
Multiple blowers present in large commercial AHU.
They are typically placed at the end of the AHU and
the beginning of the supply ductwork (therefore also
called "supply fans").
They are often augmented by fans in the return air
duct ("return fans") pushing the air into the AHU.
74
76. Distribution components
Supply duct:
At the ending of AHU the controlled air is supply to the
various room.
Final filter:
Before supplying the conditioned air to room filtering the
air by final filter. Normally High Efficiency Particulate Air
(HEPA) filter (Efficiency is 99.997%) is used
76
77. Distribution components
High Efficiency Particulate Air (HEPA) filter
A high efficiency particulate air (HEPA) filter is a type of air filter
that satisfies certain standards of efficiency such as those set by
the United States Department of Energy (DOE).
HEPA filters are composed of a mat of randomly arranged fibres.
The fibres are typically composed of fiberglass and possess
diameters between 0.5 and 2.0 micrometer.
Larger particles(>.2micron) can not pass the filter.
77
79. Specifications of HEPA filter
79
E 10 >85 …
E 11 >95 …
E12 >99.5 …
H 13 >99.95 >99.75
H 14 >99.995 >99.975
U 15 >99.9995 >99.9975
U 16 >99.99995 99.99975
U 17 >99.999995 >99.9999
HEPA class Retention
(total%)
Retention (local
%)
83. HVAC Thermostat wire color code
83
Wire Color code Description
Red R 24VAC Control Power
Green G Fan
Yellow Y Cooling
White W Heating
Orange O Cooling Aux (reversing
valve fail to heat)
Blue B Heating Aux (reversing
valve fail to cool)
84. Distribution components
HVAC Duct Design
In an air-based central system, ducts (ductwork) are used
to convey air from a primary or secondary source to the
final delivery components.
Typically two duct paths are necessary one for supply air
and one for return air.
84
93. DELIVERY COMPONENTS
The heating or cooling effect produced at a source and
distributed by a central system to spaces throughout a
building needs to be properly delivered to each space to
promote comfort.
In air-based systems, heated or cooled air could
theoretically just be dumped into each space.
In water-based systems, the heated or cooled media (water
or steam) can not just be dumped into a space.
Distribution components are collectively termed delivery
devices.
93
94. DELIVERY COMPONENTS
Diffuser
A diffuser is a device designed specifically
to introduce supply air into a space, to
provide good mixing of the supply air with
the room air, to minimize drafts that
would discomfort occupants.
Diffusers are intended for ceiling
installation and are available in many
shapes, sizes, styles, finishes, and
capacities.
94
Figure . Common diffuser
designs.
95. DELIVERY COMPONENTS
Register:
Used for floor air supply
and
Side wall air supply
applications or as return
air inlets.
95
Fig : Common
register designs
96. DELIVERY COMPONENTS
Grille
Grilles are simply decorative
covers for
return air inlets.
They are used to block
sightlines.
96
Figure . A typical
grille.
98. DELIVERY COMPONENTS
Production floor in the Granulation ,Blending ,Encapsulation,dry syrup
filling maintain 23 to 25 Celsius and RH is 40 to 45%.
In Dispensing,weighing materials store,Blister packaging,Corridor
bottle drying area maintain 23 to 25 Celsius and RH 45 to 50%.
In cold room maintain 2 to 8 Celsius.
All process room maintain negetive pressure.
In sterile manufacturing room maintain positive pressure.
98
100. 100
Test
Parameter
Objective Maximum
time interval
Test
procedure*
and key
aspects
Filter leakage Verify filter
integrity
12 months Filter media and
filter seal
integrity
Recovery (time) Verify clean-up
time
12 months Time taken
maximum 15
minutes
Airflow
visualization
Verify required
airflow patterns
12 months Airflow direction,
documented
evidence
101. 101
Test ParameterObjective Maximum time
interval
Test
procedure*
and key
aspects
Air pressure
difference
Absence of cross-
contamination
12 months Measure pressure
difference
Airflow volume Verify air change
rates
12 months Measure supply
and return air,
calculate air
change rate
Airflow velocity Verify
unidirectional
airflow and or
containment
condition
12 months Velocity
measurement
105. 105
1. Water for Injections – PFW & WFI
2. Softened Water
3. Water for Final Rinse
4. Pure, or Clean Steam
5. Purified Water
6. Water for Cooling Autoclaves
Types of water used in
pharmaceutical processes
106. purified water
106
1.The most common type of water in use in a
pharmaceutical factory is purified water. This is
used as an ingredient for manufacture of non-
sterile pharmaceuticals.
107. Water For Injections.
107
2.The highest quality is Water For Injections.Water
for Injections is used in parenteral products.
•In bulk, this type of water is also called Pyrogen Free
Water, or PFW, and if sterilized, it is called Sterilized
Water for Injections. For other purposes, other
types of water may also be used.
108. .“Water for Final Rinse
108
3.“Water for Final Rinse” is used for rinsing equipment
after washing. It must be of the same quality as the
water used for manufacturing the product. In some
countries this can be prepared using different
equipment to the ingredient water. For example, ultra-
filtered water may be used for rinsing equipment for
parenteral use, but WFI must be used as the parenteral
ingredient.
109. potable water
4. Besides potable water, there is softened water,
which has had its Calcium and Magnesium
removed. Such a water can be used e.g. for first
washing steps. Certain processes require special
well-defined qualities of water.
109
110. Steam, and Water for Cooling
Autoclaves
110
4.Pure, pyrogen-free steam (called Clean Steam) is
needed for sterilization, if the steam comes into
contact with parenteral product or equipment that
is going to be used for preparing parenteral
products.
5. Steam, and Water for Cooling Autoclaves, are
also used and must be properly prepared if they
have the potential to come into contact with sterile
or non-sterile product.
111. 111
Water hardness
Water hardness mg/L or ppm
Classification as CaCO3
S
o
f
t 0
-
6
0
M
o
d
e
ra
t
e 6
1
-
1
2
0
H
a
rd 1
2
1
-
1
8
0
112. 112
Raw water storage
May be required prior to pre-treatment
according to local circumstances
Check material of construction
- Concrete, steel are acceptable
but check corrosion
- Plastics or plastic linings may
leach
113. 113
Why purify raw water?
1. Although reasonably pure, it is always
variable
2. Seasonal variations may occur in water
3. Some regions have very poor quality
water
4. Must remove impurities to prevent
product contamination.
5. Control microbes to avoid contaminating
products
114. 114
Contaminants of water (1)
There is no pure water in nature, as it can contain
up to 90 possible unacceptable contaminants
Contaminant groups:
1. Inorganic compounds
2. Organic compounds
3. Solids
4. Gases
5. Micro-organisms
115. 115
Contaminants of water (2)
Treatment depends on water’s chemistry and
contaminants, influenced by:
1. Rainfall 5. Evaporation
2. Erosion 6. Sedimentation
3. Pollution 7. Decomposition
4. Dissolution
116. 116
Contaminants of water (3)
Problem minerals
1. Calcium and magnesium
2. Iron and manganese
3. Silicates
4. Carbon dioxide
5. Hydrogen sulfide
6. Phosphates
117. 117
Further problem minerals
1. Copper
2. Aluminium
3. Heavy metals
– Arsenic, lead, cadmium
1. Nitrates
Contaminants of water (4)
121. raw water in
« S” trap to sewer
Water is kept
circulating
To water
softener &
DI plant
Pretreatment –schematicdrawing
cartridge
filter
5 micrometers
activated
carbon
filter
spray ball
break tank
air break to drain
centrifugal pump
air filter
float
operated
valve
sand filter
excess water recycled
from deioniser
122. Plumbing
chlorination
S S S S
Pre-treatment Distillation
Holding
Take
≥ 80o
c
S
Pump
S
S
S
Source water
* S: Sampling
.
1.Filtration
-Sand filter
-Charcoal filter
-Cartridge filter
2. Primary water treatment
-Water solftener
-Deionizer
-Reverse Osmosis
123. brine and salt tank
brine
"hard" water
in
zeolite water softener
-exchanges
-Ca and Mg for Na
drain
"soft" water to deioniser
by pass valve
Water Softener – schematic drawing
129. Ultrafiltration
Can be used for WFI or for Water For Final
Rinsing for parenteral manufacturing (if
permitted)
Removes organic contaminants, such as
endotoxins
Operation at 80°C, and sterilization at 121 °C
129
131. 131
Branch
Branch
2nd stage buffer tank
Cartridge
filter 1 µm
Second stage RO cartridge
First stage filtrate feeds second stage RO
with excess back to 1st stage buffer tank
.
1st
stage
reject
concentrate
Air break
to sewer
Second stage reject water goes back to first stage buffer tank
Second stage RO water
meets Pharmacopoeia
standards Outlets or storage
1st stage buffer tank
1st stage buffer tank
Water from softener or de-ioniser
Water returns to 1st stage buffer tank
Typical 2-stage RO schematic
Hygienic pump
First stage RO cartridge
High pressure
pump
Water from softener or de-ioniser
132. 132
Water for Injections
International pharmacopoeia requirements
for WFI are those for purified water plus
it must be free from pyrogens.
Usually prepared by distillation.
Storage time should be less than 24 hours.
Microbial limits must be specified.
133. 133
Pyrogens and endotoxins
Any compound injected into mammals which gives rise to fever is a “Pyrogen”.
Endotoxins are pyrogenic, come from Gram negative bacterial cell wall
fragments
134. Pyrogens and endotoxins
134
Detect endotoxins using a test for
lipopolysaccharides (LPS)
– rabbit test detects pyrogens
– LAL test detects endotoxins
Ultrafiltration, distillation, & RO may remove
pyrogens
135. Water for Injection (WFI)
USP: “. . .distillation or a purification process that is equivalent of superior to
distillation”
Conductivity ≤ 1.3 µS/cm @ 25º C
Total Organic Carbon (TOC) ≤ 500 ppb
Microbial ≤ 10 cfu / 100 ml
Endotoxin requirement < 0.25 EU/ml
– EP: “. . .distillation”
– JP: “. . .distillation. . .or by the Reverse Osmosis Ultrafiltration of Purified
Water”
135
136. Water for Injection (WFI) Distillation
Techniques
Steam in subsequent Effect Multi-
Effect Still (MES)
Uses Plant Steam to convert
feedwater to pure steam
Separators allow impurities to
drop out of the pure steam
Pure steam from first effect used to
convert feedwater to pure steam
136
137. Water for Injection (WFI) Distillation
Techniques
– Vapor Compression (VC)
Uses plant steam to convert
initial feedwater to vapor (pure
steam)
Pure steam is compressed,
elevating temperature
Compressed vapor is used to
evaporate new feedwater, giving
up latent heat and condensing as
WFI
Higher electrical demand, but
lower steam demand
137
139. Typical water storage and
distribution schematic
139
Water
must be
kept
circulatin
g
Spray ball
Cartridge
filter 1 µm
Air break
to drain
Outlets
Hygienic pump
Optional
in-line filter
0,2 µm
UV light
Feed Water
from
DI or RO
Heat Exchanger
Ozone Generator
Hydrophobic air filter
& burst disc
140. Suggested bacterial limits
(CFU /mL)
140
Sampling location Target Alert
Action
200
100
100
50
20
10
1
300
300
300
300
200
50
10
500
500
500
500
500
100
100
Raw water
Post multimedia filter
Post softener
Post activated carbon filter
Feed to RO
RO permeate
Points of Use
142. 142
Inspection plan
Water quality manual
- water system drawing
- validation
- sampling procedures, location and plan
- records of testing
- sanitation and maintenance
- schedules of maintenance
143. 143
Review water quality manual
A water quality manual is advisable.
A brief description of water systems
is required.
Include drawings of the purification,
storage distribution system.
144. 144
The manual should contain
Chemical and microbiological
specifications
Sampling instructions
Test procedures
Responsible persons
Training requirements
146. 146
Phase 1
Investigational phase (2-4 weeks)
- DQ, IQ and OQ
- Develop
- operational parameters
- cleaning and sanitization
procedures and frequencies
- Sample daily at each point of use
-End of phase 1, develop SOPs for the
water system
147. 147
Phase 2
Verifying control (4- 5 weeks)
- Demonstrate the system is in
control
-Sampling as in phase 1
148. 148
Phase 3
Verifying long- term control ( 1 year)
- Demonstrate the system in control over
a long period of time
-Weekly sampling
149. Conducting the inspection
Take the drawing and walk around the entire system
Check:
- dead legs - pumps
-filter - UV light
-pipe and fittings - sample points
-DI - RO
-storage tank - non return valves
-by –pass lines- heat exchangers
150. Conducting the inspection
150
Check pipes and pumps
– hygienic couplings
– welded pipes
– hygienic pumps
– hygienic
sampling points
– acceptable floor
– no leaks
151. Conducting the inspection
151
Check condition of equipment
Staining on water storage tanks
Corrosion on plates of
heat exchangers
indicates possible
contamination
152. 152
Check:
- air filter
- integrity testing, sterilization
- replacement frequency
- burst discs
