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ENVIRONMENTAL CONTROL
Air Handling, Air Conditioning and
Refrigeration
Compiled & delivered by,
Mr. N. G. Shinde
Assistant Professor,
Department of Pharmaceutics,
Satara College of Pharmacy, Satara.
2015-2016
Factors contributing to quality products
Starting materials
Personnel
Procedures
Validated processes
Equipment
Premises
Environment
Packing materials
The manufacturing environment is critical for
product quality
1. Light
2. Temperature
3. Humidity
4. Air movement
5. Microbial contamination
6. Particulate contamination
7. Uncontrolled environment can lead to product degradation
product contamination
loss of product and profit
What are contaminants ?
Contaminants are
1. Products or substances other than product
manufactured
2. Foreign products
3. Particulate matter
4. Micro-organisms
5. Endotoxins (degraded micro-organisms)
Cross-contamination is a particular case of contamination
Cross-Contamination
What is Cross-Contamination ?
Contamination of a starting material, intermediate
product, or finished product with another starting
material or product during production.
Cross-Contamination
From where does Cross-Contamination originate?
1. Poorly designed air handling systems and dust extraction
systems
2. Poorly operated and maintained air handling systems and
dust extraction systems
3. Inadequate procedures for personnel and equipment
4. Insufficiently cleaned equipment
Contamination
Contaminant
from
Environment
Operators
Contaminant
from
Equipment
Cross
Contamination
Product
from
Environment
Operators
Product
from
Equipment
Cross-Contamination
Cross-Contamination
Cross-contamination can be minimized by:
1. Personnel procedures
2. Adequate premises
3. Use of closed production systems
4. Adequate, validated cleaning procedures
5. Appropriate levels of protection of product
6. Correct air pressure cascade
9
“CLEANLINESS, CLEANLINESS and
CLEANLINESS”
10
11
12
13
A Heating system (“H” in HVAC)
A Ventilating system (“V” in HVAC)
A Cooling system (“AC" in HVAC)
14
15
HVAC
16
HVAC – Heating, Ventilation, Air-conditioning
Temperature
Humidity
Pressure
Ventilation
68°F (20°C) and 75°F (25°C)
30% relative humidity (RH) and 60% RH
A slightly positive pressure to reduce
outside air infiltration.
Rooms typically have several
complete air changes per hour
What can HVAC do?
17
Control airborne particles, dust and micro-
organisms
Maintain room pressure (delta P)
Maintain space moisture (Relative Humidity)
Maintain space temperature
What HVAC can’t do?
1. HVAC can not clean up the surfaces of a
contaminated places, room or equipment
2. HVAC can not compensate for workers who do not
follow procedures
18
Block Diagram
19
Local heating systems
heat source, distributors, and Portable electric heaters, built-in
electric resistance heaters, infrared heaters and wood stoves
Local cooling systems
Air circulation devices, such as paddle or desk fans
Local ventilating systems
Local air-conditioning systems
20
Components Of HVAC System
21
Clean Room
Class
Class Limits "not to exceed" particles per
cu ft for particle sizes shown
0.1∝m 0.2∝m 0.3∝m 0.5∝m 5 ∝m
1 35.0 7.50 3.0 1.0 --
10 350 75.0 30.0 10.0 --
100 -- 750 300 100 --
1000 -- -- -- 1000 7.0
10000 -- -- -- 10000 70.0
10000 -- -- -- 100000 700
Classification Of Clean Room :
REGULATORY POINT OF VIEW
US Federal Standard 209E
HEPA FILTER : At Glance
22
High Efficiency Particulate Air capture a minimum of
99.97% of contaminants at 0.3 microns in size.
:
Monitoring and Testing of HVAC Clean
Room
Physical
Air borne particulate matter
HEPA integrity
Air Changes per hour
Flow pattern in room
Pressure Diff across filter
Temperature and Humidity
Microbiological
Settling Plate
Slit Plate
Surface Sampling
Parameter Test Frequency
Particulate monitoring in air

HEPA filter integrity testing
(DOP testing
Air change rates
Air pressure differentials
Microbiological monitoring
by settle plates
Temperature and humidity
6 Monthly
Yearly
6 Monthly
Daily
Daily
Daily
24
Air flow patterns
Filtered air entering a production room or
covering a process can be
turbulent
uni-directional (laminar)
GMP aspect
economical aspect
New technologies: barrier technology/isolator technology.
Uni-directional / laminar
displacement of dirty air
Turbulent
dilution of dirty air
0,30 m/s
Air flow patterns
Prefilter
Air flow patterns
AHU
Main filter
Uni-directional Turbulent
Turbulent
1 2 3
Annex 1, 17.3
Workbench (vertical) Cabin/ booth Ceiling
Air flow patterns
Positioning of filters
Filter in terminal position
AHU mounted final filter
Production Room
+
Production Room
HEPA Filter
HEPA
Filter
AHU
Prefilter
Final filter
2
1
Positioning of filters
Air re-circulation
The filtered air entering a production room can be
100% exhausted or
a proportion re-circulated
GMP aspect
economical reasons
Ventilation with 100% fresh air (no air re-circulation)
W
Washer (optional)
Central Air Handling Unit
Production Rooms
Exhaust Unit
Ventilation with re-circulated air + make-up air
Central Air Handling Unit
Return air
Exhaust Unit
34
35
36
37
Air conditioning
It is the process of treating the air so as to control its temp.,
humidity, cleanliness and distribution simultaneously to meet
the requirements of the conditioned space.
Applications:
Promoting the human comfort
Maintenance of proper conditions for manufacture, processing and
preserving of material and equipment.
Environmental test chamber
Maintenance of animal and equipment
38
Types of equipment
1.Self contained air conditioner/ Unitary/ Packaged
2.Central air conditioner/ Field erected
1.Self contained air conditioner/ Unitary/ Packaged
These system include window mounted or wall bracket conditioners.
Most of this units are air cooled through water cooled type.
Room air enters the casing at the front panel. It is mixed with part of
the outdoor air and this mixture is forced over a cooling coils by a
centrifugal fans.
39
Central air conditioning system
In this system one or several areas are air conditioned by duct
network.
Air cleaning is done by filters.
Cooling is achieved by using water or by direct expansion in
refrigerated coils or air washers.
Heating is achieved by using steam or hot water coils.
40
41
42
43
Definitions
Humidity:
The amount of water vapour present in moist air per unit mass of the
dry air in given volume.
Dew point:
The temperature at which the liquid droplets just appear when the
moist air is cooled continuously.
Dry bulb temperature:
The actual temperature of gas or mixture of gases indicated by an error
free temperature measuring device.
Wet bulb temperature:
Dynamic equilibrium temperature attained by a water surface when
exposed to air under adiabatic conditions.
44
Measurement of humidity
Direct method
A known volume of air is drawn through phosphorus pentoxide.
The moisture present in the air get absorbed and determined by
chemical or gravimetric method.
From the difference of initial and final masses humidity is
estimated.
45
Psychrometric methods
Determination of wet bulb and dry bulb temperatures.
46
Dew point method
In this method formation of mist and disappearance of
mist is considered and dew point is calculated.
A cooled and polished disk is placed in vessel
containing the gas whose humidity is to be determined.
The temp. of the disk is gradually lowered using liquid
air or liquid carbon dioxide or ether.
Soon mist condenses on polished surface.
The temperature at which mist just appeared is noted.
The temp. of disk is slowly increased and disappearance
of mist is observed and temp. is noted.
The average of these two temperatures represent
accurate dew point.
47
Humidification
The process of increasing the moisture in the air.
Approaches:
The air may be brought in contact with water in
such a way that only a part of the water is
evaporated.
Cooling towers are utilized.
The incoming air is heated to higher temp. then
cooled adiabatically with water to achieve desired
humidity.
The air may be mixed with stream of air of higher
humidity.
48
49
Dehumidification
Removal of moisture from the air.
Dehumidification is achieved by bringing the moist air in
contact with cold surface (solid/liquid).
In pharmaceutical industry many operations are carried out at
stated temperature and humidity to get optimum results.
In many parts of India (Bengal, Kerala) air is very humid so it
becomes very difficult to carryon operations with hygroscopic
substances even in AC room. Hence, dehumidifiers are installed
for such operations.
50
Dehumidifier
Air handling systems:
Play a major role in the quality of pharmaceuticals
Must be designed properly, by professionals
Must be treated as a critical system
Conclusion
52
Thank you

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What is hvac

  • 1. 1 ENVIRONMENTAL CONTROL Air Handling, Air Conditioning and Refrigeration Compiled & delivered by, Mr. N. G. Shinde Assistant Professor, Department of Pharmaceutics, Satara College of Pharmacy, Satara. 2015-2016
  • 2. Factors contributing to quality products Starting materials Personnel Procedures Validated processes Equipment Premises Environment Packing materials
  • 3. The manufacturing environment is critical for product quality 1. Light 2. Temperature 3. Humidity 4. Air movement 5. Microbial contamination 6. Particulate contamination 7. Uncontrolled environment can lead to product degradation product contamination loss of product and profit
  • 4. What are contaminants ? Contaminants are 1. Products or substances other than product manufactured 2. Foreign products 3. Particulate matter 4. Micro-organisms 5. Endotoxins (degraded micro-organisms) Cross-contamination is a particular case of contamination
  • 5. Cross-Contamination What is Cross-Contamination ? Contamination of a starting material, intermediate product, or finished product with another starting material or product during production.
  • 6. Cross-Contamination From where does Cross-Contamination originate? 1. Poorly designed air handling systems and dust extraction systems 2. Poorly operated and maintained air handling systems and dust extraction systems 3. Inadequate procedures for personnel and equipment 4. Insufficiently cleaned equipment
  • 8. Cross-Contamination Cross-contamination can be minimized by: 1. Personnel procedures 2. Adequate premises 3. Use of closed production systems 4. Adequate, validated cleaning procedures 5. Appropriate levels of protection of product 6. Correct air pressure cascade
  • 10. 10
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  • 12. 12
  • 13. 13 A Heating system (“H” in HVAC) A Ventilating system (“V” in HVAC) A Cooling system (“AC" in HVAC)
  • 14. 14
  • 15. 15
  • 16. HVAC 16 HVAC – Heating, Ventilation, Air-conditioning Temperature Humidity Pressure Ventilation 68°F (20°C) and 75°F (25°C) 30% relative humidity (RH) and 60% RH A slightly positive pressure to reduce outside air infiltration. Rooms typically have several complete air changes per hour
  • 17. What can HVAC do? 17 Control airborne particles, dust and micro- organisms Maintain room pressure (delta P) Maintain space moisture (Relative Humidity) Maintain space temperature
  • 18. What HVAC can’t do? 1. HVAC can not clean up the surfaces of a contaminated places, room or equipment 2. HVAC can not compensate for workers who do not follow procedures 18
  • 20. Local heating systems heat source, distributors, and Portable electric heaters, built-in electric resistance heaters, infrared heaters and wood stoves Local cooling systems Air circulation devices, such as paddle or desk fans Local ventilating systems Local air-conditioning systems 20 Components Of HVAC System
  • 21. 21 Clean Room Class Class Limits "not to exceed" particles per cu ft for particle sizes shown 0.1∝m 0.2∝m 0.3∝m 0.5∝m 5 ∝m 1 35.0 7.50 3.0 1.0 -- 10 350 75.0 30.0 10.0 -- 100 -- 750 300 100 -- 1000 -- -- -- 1000 7.0 10000 -- -- -- 10000 70.0 10000 -- -- -- 100000 700 Classification Of Clean Room : REGULATORY POINT OF VIEW US Federal Standard 209E
  • 22. HEPA FILTER : At Glance 22 High Efficiency Particulate Air capture a minimum of 99.97% of contaminants at 0.3 microns in size.
  • 23. : Monitoring and Testing of HVAC Clean Room Physical Air borne particulate matter HEPA integrity Air Changes per hour Flow pattern in room Pressure Diff across filter Temperature and Humidity Microbiological Settling Plate Slit Plate Surface Sampling
  • 24. Parameter Test Frequency Particulate monitoring in air  HEPA filter integrity testing (DOP testing Air change rates Air pressure differentials Microbiological monitoring by settle plates Temperature and humidity 6 Monthly Yearly 6 Monthly Daily Daily Daily 24
  • 25. Air flow patterns Filtered air entering a production room or covering a process can be turbulent uni-directional (laminar) GMP aspect economical aspect New technologies: barrier technology/isolator technology.
  • 26. Uni-directional / laminar displacement of dirty air Turbulent dilution of dirty air 0,30 m/s Air flow patterns
  • 27. Prefilter Air flow patterns AHU Main filter Uni-directional Turbulent Turbulent 1 2 3 Annex 1, 17.3
  • 28. Workbench (vertical) Cabin/ booth Ceiling Air flow patterns
  • 29. Positioning of filters Filter in terminal position AHU mounted final filter Production Room + Production Room HEPA Filter HEPA Filter
  • 31. Air re-circulation The filtered air entering a production room can be 100% exhausted or a proportion re-circulated GMP aspect economical reasons
  • 32. Ventilation with 100% fresh air (no air re-circulation) W Washer (optional) Central Air Handling Unit Production Rooms Exhaust Unit
  • 33. Ventilation with re-circulated air + make-up air Central Air Handling Unit Return air Exhaust Unit
  • 34. 34
  • 35. 35
  • 36. 36
  • 37. 37 Air conditioning It is the process of treating the air so as to control its temp., humidity, cleanliness and distribution simultaneously to meet the requirements of the conditioned space. Applications: Promoting the human comfort Maintenance of proper conditions for manufacture, processing and preserving of material and equipment. Environmental test chamber Maintenance of animal and equipment
  • 38. 38 Types of equipment 1.Self contained air conditioner/ Unitary/ Packaged 2.Central air conditioner/ Field erected 1.Self contained air conditioner/ Unitary/ Packaged These system include window mounted or wall bracket conditioners. Most of this units are air cooled through water cooled type. Room air enters the casing at the front panel. It is mixed with part of the outdoor air and this mixture is forced over a cooling coils by a centrifugal fans.
  • 39. 39 Central air conditioning system In this system one or several areas are air conditioned by duct network. Air cleaning is done by filters. Cooling is achieved by using water or by direct expansion in refrigerated coils or air washers. Heating is achieved by using steam or hot water coils.
  • 40. 40
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  • 42. 42
  • 43. 43 Definitions Humidity: The amount of water vapour present in moist air per unit mass of the dry air in given volume. Dew point: The temperature at which the liquid droplets just appear when the moist air is cooled continuously. Dry bulb temperature: The actual temperature of gas or mixture of gases indicated by an error free temperature measuring device. Wet bulb temperature: Dynamic equilibrium temperature attained by a water surface when exposed to air under adiabatic conditions.
  • 44. 44 Measurement of humidity Direct method A known volume of air is drawn through phosphorus pentoxide. The moisture present in the air get absorbed and determined by chemical or gravimetric method. From the difference of initial and final masses humidity is estimated.
  • 45. 45 Psychrometric methods Determination of wet bulb and dry bulb temperatures.
  • 46. 46 Dew point method In this method formation of mist and disappearance of mist is considered and dew point is calculated. A cooled and polished disk is placed in vessel containing the gas whose humidity is to be determined. The temp. of the disk is gradually lowered using liquid air or liquid carbon dioxide or ether. Soon mist condenses on polished surface. The temperature at which mist just appeared is noted. The temp. of disk is slowly increased and disappearance of mist is observed and temp. is noted. The average of these two temperatures represent accurate dew point.
  • 47. 47 Humidification The process of increasing the moisture in the air. Approaches: The air may be brought in contact with water in such a way that only a part of the water is evaporated. Cooling towers are utilized. The incoming air is heated to higher temp. then cooled adiabatically with water to achieve desired humidity. The air may be mixed with stream of air of higher humidity.
  • 48. 48
  • 49. 49 Dehumidification Removal of moisture from the air. Dehumidification is achieved by bringing the moist air in contact with cold surface (solid/liquid). In pharmaceutical industry many operations are carried out at stated temperature and humidity to get optimum results. In many parts of India (Bengal, Kerala) air is very humid so it becomes very difficult to carryon operations with hygroscopic substances even in AC room. Hence, dehumidifiers are installed for such operations.
  • 51. Air handling systems: Play a major role in the quality of pharmaceuticals Must be designed properly, by professionals Must be treated as a critical system Conclusion