Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
APPROVAL PAGE
System
HVAC
Location
Protocol Prepared By:
Name/Title
Signature
Date
Signature
Date
Protocol Reviewed By:
Name/Title
Protocol Technical Reviewed By:
Name/Title
Signature
Date
Signature
Date
Protocol Approved By:
Name/Title
Page 1
Operation Qualification Protocol
Title: HVAC
Protocol No.
Effective Date
Issue No.
Revision # 1
Company X
Table Of Contents
1.0
SYSTEM OVERVIEW .................................................................................................................................... 4
2.0
SYSTEM BOUNDARY ................................................................................................................................... 5
3.0
OBJECTIVE ..................................................................................................................................................... 6
4.0
SCOPE .............................................................................................................................................................. 6
5.0
QUALIFICATION STUDY OVERVIEW .................................................................................................... 6
6.0
RESPONSIBILITY .......................................................................................................................................... 7
7.0
PREREQUSITES ............................................................................................................................................. 8
8.0
ACRONYMS .................................................................................................................................................... 8
9.0
DEFINITIONS ................................................................................................................................................. 9
10.0
GENERAL DOCUMENTATION REQUIREMENTS ................................................................................ 9
11.0
DATA COLLECTION AND DOCUMENTATION PROCEDURES ...................................................... 11
12.0
OPERATION QUALIFICATION TEST REQUIREMENTS .................................................................. 12
13.0
REFERENCES ............................................................................................................................................... 12
Page 2
Operation Qualification Protocol
Title: HVAC
Protocol No.
Effective Date
Issue No.
Revision # 1
Company X
Index Of Attachments
General Data Worksheet .............................................................................................................................................. 13
ATTACHMENT 1 - Personnel Identification List ...................................................................................................... 14
ATTACHMENT 2 - Test Equipment Identification/Calibration ................................................................................. 15
ATTACHMENT 3 – Test Equipment Operation ......................................................................................................... 16
ATTACHMENT 4 - Testing, Adjusting and Balancing (TAB) Verification .............................................................. 17
ATTACHMENT 5 - Operation, Maintenance and Calibration SOPs.......................................................................... 18
ATTACHMENT 6 – Calibration Verification (Instruments) ...................................................................................... 19
ATTACHMENT 7 – HEPA Filter Integrity Test Verification Using.......................................................................... 20
ATTACHMENT 8 – Verification of Operation – Exhaust Fan / Motor...................................................................... 22
ATTACHMENT 9 – Verification of Operation – Pumps / Motors ............................................................................. 23
ATTACHMENT 9 – Verification of Operation – Pumps / Motors ............................................................................. 23
ATTACHMENT 10 – Verification of Operation – Cooling / Reheating Coils ........................................................... 24
ATTACHMENT 11 – Verification of Operation – Variable Air Volume Box ........................................................... 25
ATTACHMENT 12 – Verification of Operation – Smoke Sensor.............................................................................. 26
ATTACHMENT 13 – Safety Device(s)-Machine Guarding Checklist ....................................................................... 27
ATTACHMENT 14 – Verification of Operation – Interlocks..................................................................................... 28
ATTACHMENT 15– Verification of Operation – Alarms .......................................................................................... 30
ATTACHMENT 16 – Environmental Conditions Verification – Static Conditions ................................................... 35
ATTACHMENT 17 –Differential Pressure Verification – Static Conditions ............................................................. 39
ATTACHMENT 18 – Air Changes Verification ......................................................................................................... 40
ATTACHMENT 19 – Power Loss and Recovery ....................................................................................................... 41
ATTACHMENT 20 – Non-Viable Particle Count Test .............................................................................................. 42
ATTACHMENT 21 Support Utilities Verification-Chilled Water ............................................................................. 43
ATTACHMENT 22 Support Utilities Verification-Hot Water ................................................................................... 44
ATTACHMENT 23 Support Utilities Verification-Compressed Air .......................................................................... 45
Page 3
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
1.0
SYSTEM OVERVIEW
History
The AHU-6 and MAU-1 HVAC system includes Air Handling Unit (AHU-6) and Make Up Air Unit
(MAU-1). AHU-6 was purchased from York International in October 1994. AHU-6 was designed and
installed to supply recirculating air to rooms: 123–125. MAU-1 was purchased as part of the building and
operated to supply make up air to the AHU-6 and rooms 120-125, 111, 113, 114, 117, 118,and both service
corridors. .
Description
The major equipment / components of the AHU-6 and MAU-1 HVAC system include Air Handler Unit
AHU-6, Make Up Air Unit MAU-1, Humidifier H-1, twelve (12) reheat coils RHC-1-RHC-9 and RHC-19
– RHC-21 and fourteen (14) exhaust fans EF-1 - EF-12, and EF-15 - EF-17.
AHU–6 is a recirculating air handling unit, which provides a constant volume of airflow to rooms 123,124,
and 125. It is equipped with a Pre Cooling coil, Preheat coil and 65% efficiency air filters. AHU-6
provides airflow using outside air from MAU-1 mixed with return air.
MAU-1 provides conditioned air to rooms 111, 113, 114, 117, 118, and 120-125 utilizing 100% outside air.
It is equipped with one (1) reheat coil and two (2) cooling coils. It has 35% efficiency pre-filters and 95%
efficiency bag filters, it also utilizes eleven (11) Variable Air Volume controllers VAV-A, B, C, D, E, F, G,
H, J, K and L. one (1) Steam Humidifier H-1 located in the supply air duct downstream from MAU-1
provides humidification.
The operation of AHU-6 and MAU-1 are controlled by Johnson Controls’ Metasys Air Handling Unit
Controllers with sensors monitoring air/water temperature, humidity and air/water pressure. The operation
is monitored through the use of the Metacomm system as a Building Management System (BMS). Metasys
VAV Controllers are provided for the control of each VAV box.
The HVAC system will be qualified to provide personnel comfort. Performance criteria for the system are:
Temperature:
70°F ± 5°F
Humidity:
20-80% R.H.
Rationale
This protocol will be executed in compliance as per the requirements in 21CFR 210 & 211, ICH Q-7A
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001.
Upon final approval of this Protocol and Summary Report the system will be placed under formal change
control in accordance with Company X Change Control Program summarized in Standard Operating
Procedure DNAP/QM/012 entitled “Change Control System”.
Page 4
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
2.0
SYSTEM BOUNDARY
The system boundary is defined as the supply utility service first point of contact with the
system/equipment being installation qualified. In most cases this is interpreted as the first inlet manual
valve or motor control/electrical panel providing supply of said utility.
Supplied Utilities
ID Number
Description
Compressed Instrument Air
Inlet at respective valve
Compressed Instrument Air
Inlet at respective valve
Low Pressure Steam
Compressed Instrument Air
Inlet at respective valve
Inlet at respective valve
Chilled Water In-AHU-6
Chilled Water Out-AHU-6
Low Pressure Steam OutMAU-1
Low Pressure Steam InMAU-1
Chilled Water Out-MAU-1
Hot Water In-RHC-1
Hot Water Out-RHC-1
Hot Water In-RHC-2
Hot Water Out-RHC-2
Hot Water In-RHC-3
Hot Water Out-RHC-3
Hot Water In-RHC-4
Hot Water Out-RHC-4
Hot Water In-RHC-5
Hot Water Out-RHC-5
Hot Water In-RHC-6
Hot Water Out-RHC-6
Hot Water In-RHC-7
Hot Water Out-RHC-7
Hot Water In-RHC-8
Hot Water Out-RHC-8
Hot Water In-RHC-9
Hot Water Out-RHC-9
CHWS-18
CHWR-19
To Be Field Verified
Supply air to all applicable pneumatic
valves on the AHU-6
Supply air to all applicable pneumatic
valves on the MAU-1.
Supply to appropriate inlets of H-1
Supply air to all applicable pneumatic
valves on all VAV boxes: 1-9,19-21.
Supply to Cooling CoilReturn from Cooling Coil
Return from steam reheat coil
To Be Field Verified
Supply to steam reheat coil-
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
Return from cooling coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Page 5
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
Supplied Utilities
Hot Water In-RHC-19
Hot Water Out-RHC-19
Hot Water In-RHC-20
Hot Water Out-RHC-20
Hot Water In-RHC-21
Hot Water Out-RHC-21
Chiller-1
Chiller-2
Chiller-3
Hot Water Boilers (7)
Low pressure Steam Boilers
(10)
Electrical
Electrical
3.0
ID Number
Description
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Supply to hot water coil
Return from hot water coil
Outlet to respective Valve
Outlet to respective Valve
Outlet to respective Valve
Outlet to respective Valves
Outlet to respective Valves
AHU-6
MAU-1
Main Breaker Supply to Unit
Main Breaker Supply to Unit
OBJECTIVE
The objective of the Operational Qualification (OQ) Protocol is to verify and document that the AHU-6 and
MAU-1, HVAC system perform as intended throughout all operating ranges under at rest (static)
conditions. Dynamic conditions will be evaluated in the Performance Qualification (PQ) Protocol.
The execution of the OQ protocol determines if the AHU-6 and MAU-1, HVAC system consistently
operates in accordance with the design specifications, NEBB and SMACNA standards and intended
performance. The operation of the AHU-6 and MAU-1, HVAC system will be verified and documented by
executing the qualification test cases and recording the results in the corresponding test case forms.
4.0
SCOPE
This protocol will be limited to the HVAC AHU-6 & MAU-1 System at Company X, Inc., Address01757.
5.0
QUALIFICATION STUDY OVERVIEW
During the execution of this protocol, determination of the operational ranges, calibration frequencies and
formalized procedures will be provided to AAC Consulting Group, Inc.(AAC) by Company X, Inc.
Company X will ensure that all instrumentation requiring calibration is calibrated with traceability to NIST.
Certificates of calibration provided to AAC for inclusion in this protocol.
The BMS control system will be qualified in a separate protocol, as part of the Computer System
Validation (CSV).
The Installation Qualification of this system was performed as per protocol # MF/VAL/IQ/013/PRO
entitled “Installation Qualification of HVAC AHU-6 and MAU-1 System”. The Performance Qualification
of this system will be performed in accordance with protocol entitled “Performance Qualification of HVAC
AHU-6 and MAU-1 System”.
Page 6
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
6.0
RESPONSIBILITY
6.1
6.2
6.3
6.4
Validation Department:
6.1.1
Prepare and submit the protocol for approval in accordance with current industry
standards, regulatory requirements, and approved Standard Operating Procedures.
6.1.2
Perform and coordinate the execution of the protocol and recording of all raw data.
6.1.3
Review deviations and support the preparation of all corrective action reports that may be
required to resolve discrepant situations.
6.1.4
Prepare and/or coordinate the preparation of a final test report analyzing and
summarizing the data and submit for review and approval.
AAC Consulting Group:
6.2.1
Provide technical input into the preparation of the test protocol in accordance with
cGMPs, industry, USFDA standards and guidelines, and Company Xapproved Standard
Operating Procedures. Provide expert review of the finished protocol and procedures.
6.2.2
Assist in the performance of the execution of the test protocol and recording/analysis of
the test results.
6.2.3
Assist in the preparation of deviation reports and recommend corrective actions to resolve
discrepant situations that may arise during execution of the test protocol.
6.2.4
Assist in the preparation of a final report and provide input as to the conclusions
summarizing the study and submit to Company Xmanagement for review and approval.
Manufacturing Department:
6.3.1
Review and approve the test protocol content.
6.3.2
Provide qualified personnel to assist with the execution of the protocol and the collection
of samples.
6.3.3
Assist in preparation of deviation reports and recommend corrective action to resolve
discrepant situations that may arise during execution of the protocol.
6.3.4
Review and approve the final report.
Engineering and/or Facilities Department:
6.4.1
Review and approve the test protocol content.
Page 7
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
6.5
6.0
6.4.2
Provide documentation required for the generation and execution of the protocol.
6.4.3
Provide equipment that has been commissioned and functional as specified by Site
Acceptance Test Report.
6.4.4
Provide assistance in evaluating and resolving equipment malfunctions that may be
encountered during execution of the protocol.
Quality Assurance Department:
6.5.1
Review and approve the test protocol content in accordance with the approved SOPs,
cGMPs, and current industry guidelines.
6.5.2
Review deviations and support preparation of corrective action reports that may be
required to resolve discrepant situations.
6.5.3
Review and approve the final report.
PREREQUSITES
All Standard Operating Procedures required for the execution of this OQ such as operation, maintenance
and calibration of the equipment undergoing OQ must be approved before the approval of the OQ Final
Report.
This section lists acronyms and definitions specific to this document.
8.0
ACRONYMS
AHU
AL
CGMP
CPH
CAV
Air Handling Unit
Airlock
current Good Manufacturing Practice
Changes per hour
Control Air Volume Boxes
EWT
GPM
HEPA
HVAC
IWG
LAT
LWT
MAU
NEBB
NLT
Entering Water Temperature
Gallons Per Minute
High Efficiency Particulate Air
Heating, Ventilating, and Air Conditioning
Inches of Water Gage
Leaving Air Temperature
Leaving Water Temperature
Make-Up Air Unit
National Environmental Balancing Bureau
Not Less Than
Page 8
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
NMT
IQ
PSI
PM
P&ID
RPM
SOP’s
RHC
TAB
VAV
9.0
Not More Than
Installation Qualification
Pound per Square Inch
Preventive Maintenance
Piping and Instrumentation Diagram
Revolutions Per Minute
Standard operating Procedures
Re Heat Coils
Testing, Adjusting, and Balancing
Variable Air Volume (Dampers or Boxes)
DEFINITIONS
9.1
Acceptance Criteria
The system specifications and accept/reject criteria that is necessary for making a decision to
accept or reject the system and/or component being qualified.
9.2
Summary of Results
A written summary of the qualification policies, procedures, and results that may include graphs
and tables to support conclusions and final acceptance. Also included in this summary would be
documentation of deviations, their investigation, and final corrective action implemented to
provide final closure.
9.3
System
The term “system” as used in this protocol refers to the series of components, measuring or control
devices and/or equipment, that when working together perform a function considered critical to the
manufacturing of a product intended for medicinal use. Within the scope of this procedure, the
term “system” equally applies to computerized systems, process control systems, utilities, services,
and equipment set-ups (e.g., a reactor-condenser-motor-agitator set-up).
10.0
GENERAL DOCUMENTATION REQUIREMENTS
10.1
10.2
Personnel Identification List
10.1.1
All personnel involved in the execution of the protocol must review and complete
Attachment 1.
10.1.2
Curriculum Vitae for all contract personnel have been submitted to the Validation
Department, documented in the Approved Personnel List maintained by the Document
Control Department at Company X, Inc.
Test Equipment Identification/Calibration
Page 9
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
10.3
10.2.1
Document on Attachment 2 the test equipment that is used during execution of this
protocol.
10.2.2
All test equipment descriptions have been submitted to the Validation Department,
documented in the approved Test Instrument List maintained by the Document Control
Department at Company X, Inc.
10.2.3
All test equipment must be calibrated against standards that are NIST traceable. Copies of
all calibration certificates for the test equipment must be included in this attachment.
Test Equipment Operation
10.3.1
10.4
Protocol Corrections
10.4.1
10.5
Protocol corrections must be documented by the issuance of a protocol amendment
providing the correct information.
Raw Data Corrections
10.5.1
10.6
Document on Attachment 3 the SOPs and/or Operation Manuals that are required for the
test equipment used in the execution of this protocol.
Corrections to the raw data must be performed using a single line cross out and
explanation with the person’s initials and date.
Protocol Deviations
10.6.1
A protocol deviation indicates the discovery of discrepant results, methods, information,
or procedures resulting from the execution of this protocol.
10.6.2
All protocol deviations must be documented in accordance with the current Company X
Standard Operating Procedure # MF/SOP/097, entitled “SOP for Reporting and
Investigation of Incidents, Discrepancies, and Deviations”. Each deviation must be
documented on the Deviation Report found MF/SOP/097.
10.6.3
Document all protocol deviations that may occur during the execution of this OQ on the
protocol deviation report log found in MF/SOP/097.
Page 10
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
10.7
11.0
Worksheets
10.7.1
Data, other than laboratory data, must be documented on one of the following types of
worksheets during the execution of the protocol:
10.7.2
Protocol specific data worksheets, provided in the attachments, will be used to record
data as required.
10.7.3
The General Data Worksheet provided in the attachments, may be customized for
additional data collection or clarification.
10.7.4
Copies of raw data from notebook pages or laboratory test results shall be attached to the
summary package.
DATA COLLECTION AND DOCUMENTATION PROCEDURES
11.1
Operation Qualification Worksheets
11.1.1
Each OQ worksheet must be completed as directed on the individual worksheet.
11.1.2
The executed OQ worksheet raw data should be compared against the acceptance criteria,
evaluated, and initialed/dated. In the event the acceptance criteria are not met, a deviation
report must be prepared, reviewed and approved, and recorded on the deviation report log
for each occurrence.
11.1.3
All data and results are to be recorded on approved copies of OQ worksheets.
11.1.4
Initial and date each entry and sign and date each worksheet.
11.1.5
Each page of any attachments to the protocol must reference the protocol #, section and
page #, and must be initialed and dated.
11.1.6
A summary of results reflecting conclusions for all verifications should be prepared and
this document inserted at the beginning of the data package.
11.1.7
The acceptance criteria as indicated for each OQ worksheet must be met.
11.1.8
All specified data available at the time of protocol generation should be entered on each
worksheet prior to approval of the protocol. The source of each specified value entered
should be referenced in the comment section of each OQ worksheet. All specified data
that cannot be determined at the time of protocol generation would be recorded as “Not
specified” and the actual value from field verification will be recorded. In the event a
specified cannot be field verified a reason should be entered in the comment section of
the form.
Page 11
Operation Qualification Protocol
Protocol No.
Effective Date
Title: HVAC
Issue No.
Revision # 1
Company X
12.0
OPERATION QUALIFICATION TEST REQUIREMENTS
12.1
Objective
12.1.1 To verify that the HVAC system and its components have been operated in accordance
with the requirements as indicated in the system designs.
12.2
Acceptance Criteria
12.2.1 The acceptance criteria as indicated on each protocol attachment must be met or written
explanation providing resolution must be documented.
12.3
Procedure
12.3.1 Complete each protocol attachment as directed on the individual attachment making sure
all required data is properly recorded, initialed, and dated.
12.4
Methods of Data Analysis
12.4.1 Review all completed attachments and compare against the acceptance criteria to assure
that all criteria have been met.
13.0
REFERENCES
13.1
ISO-14644-1,
Cleanrooms and Associated Controlled Environments, Part 1: Classification of
Air Cleanliness, First Edition, 1999-05-01.
13.2
ISO-14644-2,
Cleanrooms and Associated Controlled Environments, Part 2: Specifications for
Testing and Monitoring to Prove Compliance with ISO 14644-1 , First Edition, 2000-09-15.
13.3
ISO-14644-4,
Cleanrooms and Associated Controlled Environments, Part 4: Design,
Construction, and Start-up, First Edition, 2000-04-01.
13.4
ISO-14644-7,
Cleanrooms and Associated Controlled Environments, Part 7: Separative
Enclosures (Clean Air Hoods, Gloveboxes, Isolators, Mini-Environments, Draft.
13.5
Title 21,
Code of Federal Regulations, Parts 210 and 211
13.6
ICH, Q7A
August 2001.
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients,
13.7
Standard Operating Procedures
Page 12
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
GENERAL DATA WORKSHEET
Attachment #
Page 1 of 1
Use this worksheet for additional data gathering or data clarification. Include in applicable section of summary package.
NOTE: Make copies of this worksheet as necessary.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 13
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 1 - Personnel Identification List
Page 1 of 1
Each person who will be executing the protocol must complete an entry on this page. Signatures signify that they have
been trained in the protocol and understand the protocol requirements. NOTE: Make copies of this attachment as
necessary.
Name
Title
Signatures
Reviewed by:
Date:
QA Approval:
Date:
Page 14
Initials
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 2 - Test Equipment Identification/Calibration
Page 1 of 1
Document test equipment not installed on the equipment/system being qualified that are required for execution of this
protocol. NOTE: Make copies of this attachment as necessary.
Test Equipment Calibration
Description
Model #
Serial #
Tag #
Last Cal
Date
Cal Due
Date
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
The test equipment is calibrated and the calibration is current.
The calibration standards are traceable to NIST.
A copy of the calibration certification(s) for the test equipment used is attached.
Comments:
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 15
Initials
Date
Initials
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 3 – Test Equipment Operation
Page 1 of 1
Document SOPs and/or Operation Manuals that are required for operation of the test equipment used in the execution
of this protocol and verify they are current. NOTE: Make copies of this attachment as necessary.
Document #
Effective
Date
Title
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 16
Current and
Documented?
(Yes/No)
Initial/Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
ATTACHMENT 4 - TESTING, ADJUSTING AND BALANCING (TAB) VERIFICATION
Document the testing, adjusting and balancing (TAB) performed meet the design specifications.
Yes/No
Initial/Date
Actual
Initial/Date
Was the testing adjusting and balancing conducted?
Did the system comply with specifications?
Was the TAB Test Report Generated?
Is the firm’s current NEBB certification current ?
Description
Testing performed by:
Location of Original Report (s)
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All TAB Testing for room 111 meets the design specifications
A copy of the firm’s NEBB certification attached.
A copy of the current TAB test report is attached or location where it can be found is
referenced.
Written justifications are provided for documents that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 17
Initial/
Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
ATTACHMENT 5 - OPERATION, MAINTENANCE AND CALIBRATION SOPS
Page ______ of _______
List and verify the SOPs that relate to the operation, maintenance and calibration of the system. Also include any
additional SOPs required for execution of this protocol.
SOP Title
Procedure
Number
Effective Date
Criteria Met?
(Yes, No, NA)
Acceptance Criteria
SOPs are approved and current.
Comments:
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 18
Initials
Date
Initials
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 6 – CALIBRATION VERIFICATION (INSTRUMENTS)
Page ______ of _______
List the calibrated instruments and verify their calibration status during the execution of this protocol. Include a copy
of the calibration certifications with this protocol.
Instruments Calibration
Instrument
Model #
Serial #
Tag #
Last Cal
Date
Cal Due
Date
Criteria Met?
(Yes, No, NA)
Acceptance Criteria
The calibrated instruments are entered into a calibration program.
The calibrated instruments have a current calibration sticker that is visible.
The calibration standards are traceable to NIST.
A copy of the calibration certification(s) for each instrument is attached.
Comments:
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 19
Initials
Date
Initials
Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
ATTACHMENT 7 – HEPA FILTER INTEGRITY TEST VERIFICATION
Document if the HEPA filter integrity testing performed meet the design specifications.
Room 111 and MAU-1
Yes/No
Initial/Date
Actual
Initial/Date
Are copies of the Vendor testing report attached?
Are the serial numbers documented in the report correct?
Have any significant leaks been found and corrected?
Do any corrections made using caulking silicone sealant exceed
5% of the filter area?
Instrument used to perform the test is calibrated to NIST
traceable standards?
Description
Testing performed by:
Location of Original Report (s)
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All required documents are provided.
Written justifications are provided for documents that could not be field verified.
Comments
Reference: FARR Clean Room Products
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 20
Initial/
Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 21
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 8 – Verification of Operation – Exhaust Fan / Motor
Verify and document the following information from the motor and Exhaust Fan :
• Fan’s speed.
• Motor’s supply voltage is within the motor specifications when operating under load.
• Motor’s current draw is less than the motor full load amps when operating under load.
• Fan’s Total Static Pressure.
Parameters
Expected
Results
Revolutions (RPM)
2252 ± 10%
Nominal Voltage (V)
120 ± 10%
Full Load Amperage (FLA)
Not Specified
Total Static pressure (I.W.)
1.5± 10%
Actual Results
Initial/
Date
Pass
(Yes/No)
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Justifications are provided for actual results that could not be field verified.
The Fan’s speed is within ± 10% of the specified speed.
The motor supply voltage is within ± 10% of the nominal when the voltage is
operating under load.
The motor current is less than the motor full load amps when operating under load.
The total static pressure is within ± 10% of the specified total static pressure.
Comments
Reference: Raytheon Engineers & Constructors Dwg.No.H-02, rev –2,8/17/94
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 22
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 9 – VERIFICATION OF OPERATION – PUMPS / MOTORS
Pump #12
Pump Manufacturer:
Expected Values
Not Specified
Chillers # 1
Actual values
Initials/Dates
Not Specified
Series:
270 GPM
Flow Rate:
92 FT
Head:
Motor Manufacturer
Not Specified
10HP
HP:
460
Voltage:
3
Phases:
Hertz:
Motor NEMA
Classification:
60
Not Specified
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Justifications are provided for actual results that could not be field verified.
The motor supply voltage is within ± 10% of the nominal when the voltage is
operating under load.
The motor current is less than the motor full load amps when operating under load.
Comments
Reference: Raytheon Engineers & Constructors Dwg.No.H-02, rev –2,8/17/94.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 23
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 10 – Verification of Operation – Cooling / Reheating Coils
Verify and document the following information from the Reheating Coil:
•
•
Enter Water Temperature (EWT).
Leaving Air Temperature (LAT).
Parameters
Expected Results
EWT
NMT 180°F
LAT
75°F
Actual Results
Initial/Date
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Justifications are provided for actual results that could not be field verified.
Comments
Reference: Raytheon Engineers & Constructors Dwg.No.H-02, rev –2,8/17/94.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 24
Initial/
Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
ATTACHMENT 11 – Verification of Operation – Variable Air Volume Box
Document the mechanical condition of the Variable Air Volume Box.
Dampers
Physical/Mechanical Condition
Supply Air
Opens (Yes/No):______
Initial/Date
Operation*
Closes (Yes/No:_______
*Operation may involve two positions, Normally Open (NO) and Normally Closed (NC), and floating or proportioning
(modulating).
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
The mechanical condition of the Variable Air Volume Box (VAV-A).
Written justification is provided for actual results that could not be field verified.
Comments
Reference: Raytheon Engineers & Constructors Dwg.No.H-02, rev –2,8/17/94.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 25
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 12 – VERIFICATION OF OPERATION – SMOKE SENSOR
Verify and document that the Smoke Sensor Inlet (DH-51), operates as specified (shuts off the supply air
fan’s motor and trigger the alarm conditions at the fire alarm panel, when the presence of smoke is detected).
Action Step
Expected Results
Actual Results
Pass
(Yes/No)
Place the machine in
operation and simulate a
smoke condition inside the
duct.
Upon sensing smoke the
Smoke Sensor Inlet (DH51) shall stop the AHU-6
and trigger the alarm
condition at the fire alarm
panel.
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Initial/
Date
Reference:
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 26
Initial/
Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
ATTACHMENT 13 – SAFETY DEVICE(S)
Verify and document the guarding requirements of the AHU-6 and MAU-1.
AHU-6 - SPECIFIC GUARDING REQUIREMENTS
Action Step
Yes/No
Step
No.
1.
2.
3.
4.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Points of Operation
Is there a guard or safety device provided for each point-of-operation of
the machine?
Do these guards allow the operators' hand, arms, or other body parts
from making contact with hazardous machine parts by reaching over,
under, around, or through the guard?
Is there evidence that guards have been tampered with or bypass to make
them ineffective (at the time of this review)?
Are the guards firmly secured and not easily removed (fasteners should
require the use of hand tools for removal)?
Power Transmission Apparatus
Are there any unguarded gears, sprockets, pulleys, flywheels, shafts,
belts, couplings, or chain drives on the equipment?
Do power transmission guards allow the operator’s hands, arm or other
body parts to make contact with dangerous moving parts by reaching
over, under, around, or through the guard?
Are there any exposed sets of screws, keyways, collars, etc.?
Are guards in good condition and firmly secured (fasteners should
require the use of hand tools for removal)?
Are starting and stopping controls within easy reach of the operator?
If there is more than one operator station, are separate controls so located
that the operators can see the entire operation?
Are controls, including foot controls, guarded against accidental
activation?
Are controls labeled to identify their functions?
Are controls similar in type and arrangement to other similar machines
in the plant?
Are emergency stop controls easily accessible and clearly identified?
Is wired so that it must be manually re started if power is interrupted
and then reapplied?
Are two hands controls electrically wired to include the following:
Concurrent use of both hands _______Anti-repeat ______Anti-holddown
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 27
Initial/Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
ATTACHMENT 14 – VERIFICATION OF OPERATION – INTERLOCKS
Page 1 of 2
Verify and document that each interlock shuts off AHU-6 and MAU-1. Verify that the AHU-6 and MAU-1can not be
turned on with interlock open, verify on closure that machine must be reset.
AHU-6
Interlock List
Action Step
Shuts Off (Yes/No)
Verified By/ Date
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 28
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 14 – Verification of Operation – Interlocks
Page 2 of 2
MAU-1
Interlock List
Action Step
Shuts Off (Yes/No)
Verified By/ Date
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 29
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 15– VERIFICATION OF OPERATION – ALARMS
Page 1 of 5
Verify and document the operational condition of each alarm in the AHU-6, MAU-1, Exhaust Fans and Utilities.
AHU-6
Alarm
Test Procedure
Expected Results
AHU-6Temperature
Control
Using the Metacomm station
increase the temperature
setpoint for each room (123125).
The RHC-1, RHC-2 and
VAV-A will increase and
maintain temperature in rooms
123 and 125 at the new
setpoint.
The alarm condition will be
indicated in the printed report.
AHU-6
Temperature
Control
Using the Metacomm station
decrease the temperature
setpoint for each room (123125).
The RHC-1, RHC-2 and
VAV-A will decrease and
maintain temperature in rooms
123-125 at the new setpoint.
The alarm condition will be
indicated in the printed report.
AHU-6-Supply
Smoke Alarms
Test the smoke detection.
Using smoke sticks, simulate
smoke detection by the
smoke detector in the AHU6.
AHU-6 will shut down
Test the smoke detection.
Using smoke sticks, simulate
smoke detection by the
smoke detector in the AHU6.
AHU-6 will shut down
AHU-6-Return
Smoke Alarms
Initials/Date
The alarm condition will be
indicated in the printed report.
The alarm condition will be
indicated in the printed report.
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Actual as
expected?
(Yes/No)
Expected results provided by Company XFacilities Department.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 30
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 15 – Verification of Operation – Alarms
Page 2 of 5
MAU-1
Alarm
Test Procedure
MAU-1-Smoke
Alarm
Test the smoke detection.
Using smoke sticks, simulate
smoke detection by the
smoke detector in the MAU1.
MAU-1 will shut down
The alarm condition will be
indicated in the printed
report.
MAU-1-Low
Temperature
Detection
Check the low temperature
detection thermostat.
Simulate an air temperature
below the low temperature
detection thermostat setpoint.
Fan shuts down.
Outside damper closed
MAU-1-Room
Temperature
Control
MAU-1-Room
Temperature
Control
Expected Results
Actual as
expected?
(Yes/No)
Initials/Date
Chilled water valve closed
The alarm condition will be
indicated in the printed report.
Using the Metacomm station
The RHC-3-9, 19-21 and
increase the temperature
VAV-B-H, J-L will increase
setpoint for each room:
and maintain temperature in
(120,121,122,113,114,111,118 rooms (120,121,122,113,114,
,117,119).
111,118,117,119) at the new
setpoint.
The alarm condition will be
indicated in the printed report.
Using the Metacomm station
The RHC-3-9, 19-21 and
decrease the temperature
VAV-B-H, J-L will decrease
setpoint for each room:
and maintain temperature in
(120,121,122,113,114,111,118 rooms (120,121,122,113,114,
,117,119).
111,118,117,119) at the new
setpoint.
The alarm condition will be
indicated in the printed report.
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 31
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 15 – Verification of Operation – Alarms
Page 3 of 5
EXHAUST FANS
Alarm
Test Procedure
Actual as
expected?
(Yes/No)
Expected Results
Shut off power to Exhaust
Fan –EF-1 by cutting off the
appropriate Electrical
Breaker Switch.
Fan shuts down.
EF-2
Shut off power to Exhaust
Fan –EF-2 by cutting off the
appropriate Electrical
Breaker Switch.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
EF-3
Shut off power to Exhaust
Fan –EF-3 by cutting off the
appropriate Electrical
Breaker Switch.
Fan shuts down.
EF-1
EF-4
EF-5
EF-6
EF-7
EF-8
EF-9
Shut off power to Exhaust
Fan –EF-4 by cutting off the
appropriate Electrical
Breaker Switch.
Shut off power to Exhaust
Fan –EF-5 by cutting off the
appropriate Electrical
Breaker Switch.
Shut off power to Exhaust
Fan –EF-6 by cutting off the
appropriate Electrical
Breaker Switch.
Shut off power to Exhaust
Fan –EF-7 by cutting off the
appropriate Electrical
Breaker Switch.
Shut off power to Exhaust
Fan –EF-8 by cutting off the
appropriate Electrical
Breaker Switch.
Shut off power to Exhaust
Fan –EF-9 by cutting off the
appropriate Electrical
Breaker Switch.
The alarm condition will be
indicated in the printed report.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 32
Initials/Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 15 – Verification of Operation – Alarms
Page 4 of 5
EXHAUST FANS
Alarm
EF-10
Test Procedure
Shut off power to Exhaust
Fan –EF-10 by cutting off the
appropriate Electrical
Breaker Switch.
EF-11
Shut off power to Exhaust
Fan –EF-11 by cutting off the
appropriate Electrical
Breaker Switch.
EF-12
Shut off power to Exhaust
Fan –EF-12 by cutting off the
appropriate Electrical
Breaker Switch.
EF-16
Shut off power to Exhaust
Fan –EF-16 by cutting off the
appropriate Electrical
Breaker Switch.
EF-17
Shut off power to Exhaust
Fan –EF-17 by cutting off the
appropriate Electrical
Breaker Switch.
Actual as
expected?
(Yes/No)
Expected Results
Initials/Date
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Fan shuts down.
The alarm condition will be
indicated in the printed report.
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 33
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 15 – Verification of Operation – Alarms – Utilities Services
Page 5 of 5
UTILITIES SERVICES
Alarm
Hot Water
Test Procedure
Shut off power to supply
pumps by cutting off the
appropriate Electrical
Breaker Switch.
Expected Results
Actual as
expected?
(Yes/No)
Initials/Date
The alarm condition will
be indicated in the
printed report.
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Justifications are provided for actual results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 34
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 16 – ENVIRONMENTAL CONDITIONS VERIFICATION – STATIC CONDITIONS
Temperature and Relative Humidity (T&RH) data collection points will be distributed inside the controlled space.
Points distribution will be based upon the presence of heat sources, heat sinks, and the location of manufacturing
equipment. T&RH data collection points will follow the numerical sequence and/or identification per area, specified
in Attachment 1.
Procedure:
T&RH readings will be taken in designated points at work levels heights (4 to 5 feet). For this
purpose, portable T&RH probe(s) will be used to obtain simultaneous readings of temperature and relative humidity at
each predetermined location. The data acquisition will be performed at 6:00AM, 12:00PM, 6:00PM and 12:00AM
with a time tolerance of plus/minus one hour per area, for three (3) consecutive days (the time intervals have been
chosen considering general perceptive environmental changes of temperature and humidity). (Make copies of test
form as needed.)
Acceptance Criteria:
Temperature and humidity are maintained within the specified design ranges (70oF ± 5oF
and 20-80% RH) throughout the test period.
Table 1: Temperature and relative humidity periodic readings recording
Room 111 1st data collection
Data Point
ID. No.
%RH
T(°F)
Initial/Date
Pass/Fail
1
2
3
4
5
Test Stage
Beginning
End
Date
Hour
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All field verified results conform to system operating specified conditions..
Written justifications are provided for results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 35
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
TACHMENT 16 – Environmental Conditions Verification – Static Conditions
Table 2: Temperature and relative humidity periodic readings recording
Room 111 2nd data collection
Data Point
ID. No.
%RH
T(°F)
Pass/Fail
Initial/Date
1
2
3
4
5
Test Stage
Beginning
End
Date
Hour
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All field verified results conform to system operating specified conditions..
Written justifications are provided for results that could not be field verified.
Comments
Reference
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 36
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 16 – Environmental Conditions Verification – Static Conditions
Page 3 of 40
Table 3: Temperature and relative humidity periodic readings recording
Room 111 3rd data collection
Data Point
ID. No.
%RH
T(°F)
Pass/Fail
Initial/Date
1
2
3
4
5
Test Stage
Beginning
End
Date
Hour
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Reference
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 37
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 16 – Environmental Conditions Verification – Static Conditions
Page 4 of 40
Table 4: Temperature and relative humidity periodic readings recording
Room 111 4th data collection
Data Point
ID. No.
%RH
T(°F)
Pass/Fail
Initial/Date
1
2
3
4
5
Test Stage
Beginning
End
Date
Hour
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Reference
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 38
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 17 –DIFFERENTIAL PRESSURE VERIFICATION – STATIC CONDITIONS
Page 1 of 1
To verify that the AHU-6 and MAU-1 maintain differential pressures where designed. Testing shall be performed in
accordance with the NEBB requirements for “Enclosure Pressurization and Integrity Testing” as defined in Procedural
Standards for Certified Testing of Cleanrooms.
Acceptance Criteria:
Operational Differential Pressure with all doors closed meets requirements for
environmental performance qualification in Avecia’s facility.
Procedure:
Room differential pressures will be recorded from differential pressure monitors once a day under
static conditions, with all doors closed, to ensure compliance with the design specifications. Verify and document that
the AHU-6 and MAU-1 will maintain the differential pressure within Avecia’s specified operating ranges under static
conditions.
Room 111
Note: Not Less Than 0.005” W.C. in the specified direction
With Respect To:
Mechanical Corridor
Design
Actual
Pass
(Yes/No)
Initial/Date
0.005” W.C.
Acceptance Criteria
Initial/Date
All actual values conform to design results.
Written justifications are provided for actual results that could not be field verified.
Comments
Reference: NEBB requirements for “Enclosure Pressurization and Integrity Testing
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 39
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 18 – AIR CHANGES VERIFICATION
Page 1 of 1
To verify that the operation of the AHU-6 and MAU-1 conform to design specifications for air changes per hour.
Procedure:
Testing and reporting shall be performed in accordance with the NEBB Standard Procedures.
Acceptance Criteria:
Air Change Rate meets requirements for environmental performance qualification in
Avecia’s facility. These requirements are at least twenty (20) air changes per hour (CPH) for each room. Airflow
readings should be taken from the Testing and Adjusting Balancing (TAB) Report, generated by a NEBB certified
firm during the installation qualification. The TAB Report must be attached to the OQ Protocol. To verify and
document that the operation of the AHU-6 and MAU-1 conforms to design specifications for air changes per hour.
Equation
Nactual = Qexhaust x 60
Vol.
Where:
Nrequired =
Nactual =
Qexhaust =
Vol. =
Room air changes per hour as per Avecia’s specifications
Actual room’s air changes per hour
Total air exhaust from room (CFM)
Room’s volume (ft3)
Air Changes for Room 111
Nrequired
Qexhaust
(CFM)
Vol
(ft3)
Nactual (CPH)
Pass or Fail
Verified By/ Date
Nactual ≥ _____
Criteria Met?
(Yes/No/NA)
cceptance Criteria
All actual results conform to specified results.
Written justifications are provided for actual results that could not be field verified.
Comments
Reference: Air Balance Report
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 40
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 19 – POWER LOSS AND RECOVERY
Recovery of Environmental Conditions: To verify and document the response of the AHU-6 and MAU-1, when
simulating a failure in the Chilled Water support utility.
Procedure:
Prior to power failure, record the set points in the table provided on the next page. Simulate power
failure and record conditions until the readings of temperature and relative humidity are out of parameters, then restore
power and continue recording until conditions returns to operational parameters. On the columns designated for In
and Out Parameters Audit, write IN or OUT when the temperature and the humidity are in or out of parameters,
respectively. During the power failure, field devices will be observed. In addition, the time elapsed for full restoration
will be documented.
Acceptance Criteria:
On power failure, AHU-6 and MAU-1 goes to power off conditions. On power restoration,
the AHU-6 and MAU-1 should pass the challenges stated on the test case form.
In or Out of Parameters Audit
Min/Max Readings
%RH=20% to 80%, T= 70oF ± 5oF
Time
%RH
T
%RH
T
Min.
Max.
Min.
Max.
Min.
Max.
Min.
Max.
Condition Before Power Failure
N/A
Condition During Power Failure
10 min.
20 min.
30 min.
40 min.
50 min.
60 min.
Condition After Power Failure
10 min.
20 min.
30 min.
40 min.
50 min.
60 min.
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 41
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 20 – NON-VIABLE PARTICLE COUNT TEST
Page 1 of 1
Verify and document that the MAU-1 and AHU-6 maintain the design non-viable particle count for controlled room
environment area.
Procedure: To ensure that the controlled manufacturing environments comply with the requirements stated in the
engineering specifications and current revision of ISO-14644-1, “Classification of Air Cleanliness”. Non-viable
particle counts will be taken for each room on each predetermined locations (see room Reference Attachment 1) for
one (1) day under static conditions using a Met-One Particle Counter.
Avecia’s Criteria:
Data
Point
3,520,000 particles/m³ of 0.5µ and 29,300 particles/m³ of 5.0µ
Room 111 Non Viable Particle Count (As Found Results)
0.5 µ
ID. No.
Pass/Fail
5.0µ
Initial/
Date
1
2
3
4
5
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All data points results conform to expected results based on room classification..
Written justifications are provided for actual results that could not be field verified.
Comments
Reference:ISO14644-1
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 42
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 21 SUPPORT UTILITIES VERIFICATION-CHILLED WATER
Page 1 of 1
Test Objective: To verify that the operating chilled water inlet temperature meets design conditions.
procedure:
Chilled water coil temperatures shall be measured with a calibrated instrument and recorded a
minimum of once every eight (8) hours over a period of three (3) consecutive days (shall be performed in conjunction
with Environmental Verification at Dynamic Conditions).
Acceptance Criteria:
Chilled water coil inlet temperature meets design conditions (36 -48 oF) throughout the test
period.
EWT (oF)
Time
Expected Results
Initial/Date
As Found Results
36 – 48°F
36 – 48°F
36 – 48°F
36 – 48°F
36 – 48°F
36 – 48°F
36 – 48°F
36 – 48°F
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All results conform to design results.
Written justifications are provided for actual results that could not be field verified.
Comments
Make copies of test form as required.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 43
Initial/
Date
Operation Qualification Protocol
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No.
Revision # 1
ATTACHMENT 22 SUPPORT UTILITIES VERIFICATION-HOT WATER
Page 1 of 1
Test Objective: To verify that the operating hot water inlet temperature meets design conditions.
Procedure:
Hot water coil temperatures shall be measured with a calibrated instrument and recorded a minimum
of once every eight (8) hours over a period of three (3) consecutive days (shall be performed in conjunction with
Environmental Verification at Dynamic Conditions).
Acceptance Criteria:
Hot water coil inlet temperature meets design conditions (150-170oF ) throughout the test
period.
EWT (oF)
Time
Expected Results
Initial/Date
As Found Results
150 - 170°F
150 - 170°F
150 - 170°F
150 - 170°F
150 - 170°F
150 - 170°F
150 - 170°F
150 - 170°F
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All results conform to design results.
Written justifications are provided for actual results that could not be field verified.
Comments
Make copies of test form as required.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 44
Initial/
Date
Operation Qualification Protocol
Title: HVAC AHU-6 and MAU-1
Protocol No.
MF/VAL/OQ/013/PRO
Effective Date
Issue No.
Revision # 1
ATTACHMENT 23 SUPPORT UTILITIES VERIFICATION-COMPRESSED AIR
Page 1 of 1
To verify that the compressed air inlet pressure meets control and equipment’s requirements.
Procedure:
Compressed air pressure shall be measured at system’s air pressure regulator valve’s inlet and
recorded a minimum of once reading every eight (8) hours over a period of three (3) consecutive days (shall be
performed in conjunction with Environmental Verification at Dynamic Conditions).
Acceptance Criteria:
Compressed air pressure meets control and equipment’s requirements (90-110 PSIG)
throughout the test period.
Time
Pressure inlet (PSIG)
Initial/Date
Expected Results
As Found Results
90-110 PSIG
90-110 PSIG
90-110 PSIG
90-110 PSIG
90-110 PSIG
90-110 PSIG
90-110 PSIG
90-110 PSIG
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
All actual results conform to design results.
Written justifications are provided for actual results that could not be field verified.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Page 45
Initial/
Date