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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

Factors contributing to quality products

Starting materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing materials

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

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

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

EnvironmentOperators

Contaminant from

Equipment

CrossContamination

Productfrom

EnvironmentOperators

Productfrom

Equipment

Cross-Contamination

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

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

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

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

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

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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.

Uni-directional / laminardisplacement of dirty air

Turbulent dilution of dirty air

0,30 m/s

Air flow patterns

PrefilterAir flow patterns

AHU

Main filter

Uni-directional TurbulentTurbulent

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

AHUPrefilter

Final filter

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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

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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

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