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 HVAC System
Page 1 of 24
Document No.
PERFORMANCE QUALIFICATIONPROTOCOL
FOR
HVAC SYSTEM
 
Signing of this Performance Qualification Protocol indicates agreement with the Validation Master Planapproach of the equipment. Further if any changes in this protocol are required, protocol will be revisedand duly approved.
 
 HVAC System
Page 2 of 24
Document No.
PREPARED BY:Company Name Signature DateWritten By:
ABB
ReviewedBy:
Jacobs Engineering
CHECKED BY:OrganizationName Designation Signature Date
AbcPharmaceuticals(User Dept.)AbcPharmaceuticals(Engg. Dept.)AbcPharmaceuticals(QA Dept.)
APPROVED BY:
 
OrganizationNameDesignationSignature Date
AbcPharmaceuticals(HOD QA Dept.)AbcPharmaceuticals(Plant Head)
 
 HVAC System
Page 3 of 24
Document No.
TABLE OF CONTENTS
1
 
OBJECTIVE ................................................................................................................................................. 5
 
2
 
SCOPE .......................................................................................................................................................... 5
 
3
 
RESPONSIBILITIES .................................................................................................................................. 5
 
4
 
SYSTEM DESCRIPTION ........................................................................................................................... 6
 
5
 
DOCUMENTATION REQUIREMENTS ................................................................................................. 9
 
6
 
DATA COLLECTION ................................................................................................................................ 9
 
7
 
CHANGE CONTROL ............................................................................................................................... 10
 
8
 
PRE-QUALIFICATION REQUIREMENTS .......................................................................................... 10
 8.1 System Pre-requisites ............................................................................................................. 118.2 Test Equipment Calibration ................................................................................................... 12
9
 
TESTS AND CHECKS .............................................................................................................................. 13
 9.1 Differential Pressure Monitoring ........................................................................................... 13
9.1.1
 
Objective ........................................................................................................................ 13
 
9.1.2
 
Test Method .................................................................................................................... 13
 
9.1.3
 
 Acceptance Criteria ....................................................................................................... 13
 
9.1.4
 
Test Material/Equipment ................................................................................................ 13
 9.2 Temperature and Humidity monitoring ................................................................................. 13
9.2.1
 
Objective ........................................................................................................................ 13
 
9.2.2
 
Test Method .................................................................................................................... 13
 
9.2.3
 
 Acceptance Criteria ....................................................................................................... 13
 
9.2.4
 
Test Material/Equipment ................................................................................................ 14
 9.3 Airborne Particulate Testing .................................................................................................. 14
9.3.1
 
Objective ........................................................................................................................ 14
 
9.3.2
 
Test Method .................................................................................................................... 14
 
9.3.3
 
 Acceptance Criteria ....................................................................................................... 14
 
9.3.4
 
Test Material/Equipment ................................................................................................ 14
 9.4 Microbiological Environmental Monitoring .......................................................................... 15
9.4.1
 
Objective ........................................................................................................................ 15
 
9.4.2
 
Test Method .................................................................................................................... 15
 
9.4.3
 
 Acceptance Criteria ....................................................................................................... 15
 
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