Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Mr. N. G. Shinde
Assistant Professor,
Department of Pharmaceutics,
Satara College of Pharmacy, Satara.
2015-2016
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Factors contributing to quality products
Personnel
Validated processes
Procedures
Starting materials
Equipment
Packing materials
Premises
Environment
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 ?
Contaminant
Contaminant
from
Contamination from
Environment
Equipment
Operators
Product
Product
from Cross
from
Environment Contamination
Equipment
Operators
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
“CLEANLINESS, CLEANLINESS and
CLEANLINESS”
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A Heating system (“H” in HVAC)
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HVAC
HVAC – Heating, Ventilation, Air-conditioning
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What can HVAC do?
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
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Block Diagram
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Components Of HVAC System
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
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Classification Of Clean Room :
REGULATORY POINT OF VIEW
US Federal Standard 209E
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HEPA FILTER : At Glance
Microbiological
Settling Plate
Slit Plate
Surface Sampling
Parameter Test Frequency
Particulate monitoring in air 6 Monthly
HEPA filter integrity testing Yearly
(DOP testing
0,30 m/s
Air flow patterns Prefilter
Annex 1, 17.3
AHU
Main filter
1 2 3
Production Room
Production Room
HEPA Filter
Positioning of filters
Final filter
AHU
Prefilter
1 2
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)
Washer (optional)
Exhaust Unit
Production Rooms
Ventilation with re-circulated air + make-up air
Exhaust Unit
Return air
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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
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Types of equipment
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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.
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Measurement of humidity
Direct method
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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. 47
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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.
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Dehumidifier
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Conclusion
Air handling systems:
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