Validation of HVAC

VAL ALID IDA ATI TION ON OF HV HVAC AC SYSTEM Prepared By:

Bilal Tahir Ph.D Pharmaceutics Roll no: 7

Submitted to:

Dr. Nasir Abbas

University of the Punjab.

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Introduction •

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Is the science and practice of controlling indoor climate to provide healthy and comfortable interior conditions in a well designed environment environment HVAC role in pharmace!ical in"s!r# Heating, ventilation and air conditioning play an important role in ensuring the manufacture of quality pharmaceutical products. A well designed HVAC system will also provide comfortable conditions for operators. HVAC system plays a role in product protection, personnel protection, and environmental protection.

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Introduction •

• •

•

•

Is the science and practice of controlling indoor climate to provide healthy and comfortable interior conditions in a well designed environment environment HVAC role in pharmace!ical in"s!r# Heating, ventilation and air conditioning play an important role in ensuring the manufacture of quality pharmaceutical products. A well designed HVAC system will also provide comfortable conditions for operators. HVAC system plays a role in product protection, personnel protection, and environmental protection.

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INT$OD%CTION HVAC consis!s o&' 1. Air conditioner . AH!s ". #ehumidi$er % Heater &. 'ilters ()re * H+)A -. #ust +tractors /. #ucting ('or delivery of controlled air 0. upply 'ans 2. mo3e #etector 4. #ampers 15.Humidity 15. Humidity % 6emperature % )ressure sensors 11.7ag 11. 7ag 'ilters 1.Heating 1. Heating % Cooling Coils

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INT$OD%CTION

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INT$OD%CTION  Area - 1

 Area - 3

I M P U R E

 Area - 4

A I R

 Area - 2

Impure Air 

HVAC

Pure Air 

 Return Air 

Impure Air  5

Exhaust

HVAC (%ALIFICATION  6o

ensure that equipment is designed as per requirement, installed properly. Action of proving that any equipment wor3s correctly and leads to the epected results.

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HVAC (%ALIFICATION

    N    O     I     T    A    C     I     F     I     L     U    Q 

Validation 8aster )lan !ser 9equirement peci$cation #esign :uali$cation Installation :uali$cation ;peration :uali$cation )erformance :uali$cation 9e< :uali$cation.

VALIDATION

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THE VALIDATION MASTE$ )LAN This "ocmen! shol" con!ain •

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Validation policy ;rgani=ational structure of validation activities ummary of facilities, systems, equipment and processes to be validated #ocumentation format to be used for protocols and reports )lanning and scheduling Change control

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%SE$ $E(%I$EMENT S)ECIFICATION

I! mainl# re*ires+ 9oom temperatures and relative humidities Clean room classi$cations for the areas i.e. 7. C. or #. ingle pass or re 9oom pressures % Air ?ow directions @8) requirements.

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%SE$ $E(%I$EMENT S)ECIFICATION

Capaci!# o& HVAC "epen"s on' 1. . ". &. -. /.

9oom Volume. o. of Air Changes 9equired. )roduction % Consumption #ata easonal ?uctuation. Air Classi$cation of 9ooms. 'uture #evelopment. 10

%SE$ $E(%I$EMENT S)ECIFICATION )arame!ers !o be "e,ne" in Le-els o& )ro!ec!ion +

Air 1. . ". &. -.

cleanliness requirements $lters type and position, air changes, air ?ow patterns, pressure diBerentials, contamination levels by particulate matter * micro