hvac system in pharmaceutical industry
TRANSCRIPT
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ENVIRONMENTAL CONTROL
Air Handling, Air Conditioning and Refrigeration
Compiled & delivered by,
Mr. N. G. ShindeAssistant Professor,
Department of Pharmaceutics,
Satara College of Pharmacy, Satara.2015-2016
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Factors contributing to quality products
Starting materials
Personnel
Procedures
Validated processes
Equipment
Premises
Environment
Packing materials
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The manufacturing environment is critical for product quality1. 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
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What are contaminants ?Contaminants are1. Products or substances other than product
manufactured 2. Foreign products3. Particulate matter4. Micro-organisms5. Endotoxins (degraded micro-organisms)
Cross-contamination is a particular case of contamination
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Cross-Contamination
What is Cross-Contamination ?
Contamination of a starting material, intermediate product, or finished product with another starting material or product during production.
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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
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Contamination
Contaminant from
EnvironmentOperators
Contaminant from
Equipment
CrossContamination
Productfrom
EnvironmentOperators
Productfrom
Equipment
Cross-Contamination
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Cross-Contamination
Cross-contamination can be minimized by:1. Personnel procedures2. Adequate premises3. Use of closed production systems4. Adequate, validated cleaning
procedures5. Appropriate levels of protection of
product6. Correct air pressure cascade
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“CLEANLINESS, CLEANLINESS and CLEANLINESS”
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A Heating system (“H” in HVAC) A Ventilating system (“V” in HVAC)
A Cooling system (“AC" in HVAC)
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HVAC
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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
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What can HVAC do?
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Control airborne particles, dust and
micro-organisms
Maintain room pressure (delta P)
Maintain space moisture (Relative
Humidity)
Maintain space temperature
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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
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Block Diagram
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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
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Components Of HVAC System
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Clean RoomClass
Class Limits "not to exceed" particles percu ft for particle sizes shown
0.1m 0.2m 0.3m 0.5m 5m
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
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HEPA FILTER : At Glance
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High Efficiency Particulate Air capture a minimum of 99.97% of contaminants at 0.3 microns in size.
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Monitoring and Testing of HVAC Clean Room
PhysicalAir borne particulate matterHEPA integrityAir Changes per hourFlow pattern in roomPressure Diff across filterTemperature and Humidity
MicrobiologicalSettling PlateSlit PlateSurface Sampling
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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
Daily24
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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.
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Uni-directional / laminardisplacement of dirty air
Turbulent dilution of dirty air
0,30 m/s
Air flow patterns
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PrefilterAir flow patterns
AHU
Main filter
Uni-directional TurbulentTurbulent
1 2 3
Annex 1, 17.3
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Workbench (vertical) Cabin/ booth Ceiling
Air flow patterns
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Positioning of filters
Filter in terminal position AHU mounted final filter
Production Room
+
Production Room
HEPA Filter
HEPA Filter
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AHUPrefilter
Final filter
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Positioning of filters
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Air re-circulation
The filtered air entering a production room can be
100% exhausted or a proportion re-circulated
GMP aspect economical reasons
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Ventilation with 100% fresh air (no air re-circulation)
W
Washer (optional)
Central Air Handling Unit
Production Rooms
Exhaust Unit
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Ventilation with re-circulated air + make-up air
Central Air Handling Unit
Return air
Exhaust Unit
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Air conditioningIt 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
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Types of equipment
1.Self contained air conditioner/ Unitary/ Packaged2.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.
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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.
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Definitions Humidity:The amount of water vapour present in moist air per unit mass of thedry 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 errorfree temperature measuring device.
Wet bulb temperature:Dynamic equilibrium temperature attained by a water surface when exposed to air under adiabatic conditions.
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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.
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Psychrometric methods
Determination of wet bulb and dry bulb temperatures.
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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.
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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.
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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.
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Dehumidifier
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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
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Thank you