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

Protocol Reviewed By:

Name/Title Signature Date

Protocol Technical Reviewed By:

Name/Title Signature Date

Protocol Approved By:

Name/Title Signature Date

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 Operation Qualification Protocol Protocol No.
Effective Date
Title: HVAC
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

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 Operation Qualification Protocol Protocol No.
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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

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 Operation Qualification Protocol Protocol No.
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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”.

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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 Supply air to all applicable pneumatic
valves on the AHU-6
Compressed Instrument Air Inlet at respective valve Supply air to all applicable pneumatic
valves on the MAU-1.
Low Pressure Steam Inlet at respective valve Supply to appropriate inlets of H-1
Compressed Instrument Air Inlet at respective valve Supply air to all applicable pneumatic
valves on all VAV boxes: 1-9,19-21.
Chilled Water In-AHU-6 CHWS-18 Supply to Cooling Coil-
Chilled Water Out-AHU-6 CHWR-19 Return from Cooling Coil
Low Pressure Steam Out- To Be Field Verified Return from steam reheat coil
MAU-1
Low Pressure Steam In- To Be Field Verified Supply to steam reheat coil-
MAU-1
Chilled Water Out-MAU-1 To Be Field Verified Return from cooling coil
Hot Water In-RHC-1 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-1 To Be Field Verified Return from hot water coil
Hot Water In-RHC-2 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-2 To Be Field Verified Return from hot water coil
Hot Water In-RHC-3 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-3 To Be Field Verified Return from hot water coil
Hot Water In-RHC-4 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-4 To Be Field Verified Return from hot water coil
Hot Water In-RHC-5 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-5 To Be Field Verified Return from hot water coil
Hot Water In-RHC-6 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-6 To Be Field Verified Return from hot water coil
Hot Water In-RHC-7 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-7 To Be Field Verified Return from hot water coil
Hot Water In-RHC-8 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-8 To Be Field Verified Return from hot water coil
Hot Water In-RHC-9 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-9 To Be Field Verified Return from hot water coil

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Supplied Utilities ID Number Description

Hot Water In-RHC-19 To Be Field Verified Supply to hot water coil

Hot Water Out-RHC-19 To Be Field Verified Return from hot water coil
Hot Water In-RHC-20 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-20 To Be Field Verified Return from hot water coil
Hot Water In-RHC-21 To Be Field Verified Supply to hot water coil
Hot Water Out-RHC-21 To Be Field Verified Return from hot water coil
Chiller-1 To Be Field Verified Outlet to respective Valve
Chiller-2 To Be Field Verified Outlet to respective Valve
Chiller-3 To Be Field Verified Outlet to respective Valve
Hot Water Boilers (7) To Be Field Verified Outlet to respective Valves
Low pressure Steam Boilers To Be Field Verified Outlet to respective Valves
(10)
Electrical AHU-6 Main Breaker Supply to Unit
Electrical MAU-1 Main Breaker Supply to Unit

3.0 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”.

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6.0 RESPONSIBILITY

6.1 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.

6.2 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.

6.3 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.

6.4 Engineering and/or Facilities Department:

6.4.1 Review and approve the test protocol content.

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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.

6.5 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.

6.0 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 Air Handling Unit
AL Airlock
CGMP current Good Manufacturing Practice
CPH Changes per hour
CAV Control Air Volume Boxes
EWT Entering Water Temperature
GPM Gallons Per Minute
HEPA High Efficiency Particulate Air
HVAC Heating, Ventilating, and Air Conditioning
IWG Inches of Water Gage
LAT Leaving Air Temperature
LWT Leaving Water Temperature
MAU Make-Up Air Unit
NEBB National Environmental Balancing Bureau
NLT Not Less Than

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NMT Not More Than

IQ Installation Qualification
PSI Pound per Square Inch
PM Preventive Maintenance
P&ID Piping and Instrumentation Diagram
RPM Revolutions Per Minute
SOP’s Standard operating Procedures
RHC Re Heat Coils
TAB Testing, Adjusting, and Balancing
VAV Variable Air Volume (Dampers or Boxes)

9.0 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 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.

10.2 Test Equipment Identification/Calibration

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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.

10.3 Test Equipment Operation

10.3.1 Document on Attachment 3 the SOPs and/or Operation Manuals that are required for the
test equipment used in the execution of this protocol.

10.4 Protocol Corrections

10.4.1 Protocol corrections must be documented by the issuance of a protocol amendment

providing the correct information.

10.5 Raw Data Corrections

10.5.1 Corrections to the raw data must be performed using a single line cross out and
explanation with the person’s initials and date.

10.6 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.

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10.7 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.

11.0 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.

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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 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients,
August 2001.
13.7 Standard Operating Procedures

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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:
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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 Initials Date

Reviewed by: Date:

QA Approval: Date:
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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

Last Cal Cal Due Initials
Description Model # Serial # Tag #
Date Date Date

Criteria Met? Initials

Acceptance Criteria
(Yes/No/NA) Date
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:
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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.

Current and
Effective
Document # Title Documented? Initial/Date
Date
(Yes/No)

Completed by: Date:

Reviewed by: Date:

QA Approval: Date:
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ATTACHMENT 4 - TESTING, ADJUSTING AND BALANCING (TAB) VERIFICATION

Document the testing, adjusting and balancing (TAB) performed meet the design specifications.

Yes/No 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 Actual Initial/Date

Testing performed by:
Location of Original Report (s)

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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:
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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.

Procedure Initials
SOP Title Effective Date
Number Date

Acceptance Criteria Criteria Met? Initials

(Yes, No, NA) Date
SOPs are approved and current.

Comments:

Completed by: Date:

Reviewed by: Date:

QA Approval: Date:
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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
Last Cal Cal Due Initials
Instrument Model # Serial # Tag #
Date Date Date

Criteria Met? Initials

Acceptance Criteria
(Yes, No, NA) Date
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:
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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

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 Actual Initial/Date

Testing performed by:

Location of Original Report (s)

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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:
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Completed by: Date:

Reviewed by: Date:

QA Approval: Date:
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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 Actual Results Pass Initial/

Results (Yes/No) Date

Revolutions (RPM) 2252 ± 10%

Nominal Voltage (V) 120 ± 10%
Full Load Amperage (FLA) Not Specified
Total Static pressure (I.W.) 1.5± 10%

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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:
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ATTACHMENT 9 – VERIFICATION OF OPERATION – PUMPS / MOTORS

Chillers # 1
Pump #12
Expected Values Actual values Initials/Dates
Pump Manufacturer: Not Specified
Series: Not Specified
Flow Rate: 270 GPM
Head: 92 FT
Motor Manufacturer Not Specified
HP: 10HP
Voltage: 460
Phases: 3
Hertz: 60
Motor NEMA Not Specified
Classification:

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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 Actual Results Initial/Date

EWT NMT 180°F
LAT 75°F

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
 Operation Qualification Protocol Protocol No. MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
Issue No. Revision # 1

ATTACHMENT 11 – Verification of Operation – Variable Air Volume Box

Document the mechanical condition of the Variable Air Volume Box.

Initial/Date
Dampers Physical/Mechanical Condition Operation*
Supply Air Opens (Yes/No):______
Closes (Yes/No:_______
*Operation may involve two positions, Normally Open (NO) and Normally Closed (NC), and floating or proportioning
(modulating).

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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 Initial/

(Yes/No) Date

Place the machine in Upon sensing smoke the

operation and simulate a Smoke Sensor Inlet (DH-
smoke condition inside the 51) shall stop the AHU-6
duct. and trigger the alarm
condition at the fire alarm
panel.

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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 26
 Operation Qualification Protocol Protocol No. MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
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

Step Action Step Yes/No Initial/Date
No.
Points of Operation
Is there a guard or safety device provided for each point-of-operation of
1. the machine?
Do these guards allow the operators' hand, arms, or other body parts
2.
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
3.
them ineffective (at the time of this review)?
Are the guards firmly secured and not easily removed (fasteners should
4.
require the use of hand tools for removal)?
Power Transmission Apparatus
Are there any unguarded gears, sprockets, pulleys, flywheels, shafts,
1.
belts, couplings, or chain drives on the equipment?
Do power transmission guards allow the operator’s hands, arm or other
2.
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.?
3.
Are guards in good condition and firmly secured (fasteners should
4.
require the use of hand tools for removal)?
Are starting and stopping controls within easy reach of the operator?
5.
If there is more than one operator station, are separate controls so located
6.
that the operators can see the entire operation?
Are controls, including foot controls, guarded against accidental
7.
activation?
Are controls labeled to identify their functions?
8.
Are controls similar in type and arrangement to other similar machines
9.
in the plant?
Are emergency stop controls easily accessible and clearly identified?
10.
11. 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:
12.
Concurrent use of both hands _______Anti-repeat ______Anti-hold-
down

Completed by: Date:

Reviewed by: Date:

QA Approval: Date:
Page 27
 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 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? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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
Actual as
Alarm Test Procedure Expected Results expected? Initials/Date
(Yes/No)
AHU-6- Using the Metacomm station The RHC-1, RHC-2 and
Temperature increase the temperature VAV-A will increase and
Control setpoint for each room (123- maintain temperature in rooms
125). 123 and 125 at the new
setpoint.
The alarm condition will be
indicated in the printed report.

AHU-6 Using the Metacomm station The RHC-1, RHC-2 and

Temperature decrease the temperature VAV-A will decrease and
Control setpoint for each room (123- maintain temperature in rooms
125). 123-125 at the new setpoint.
The alarm condition will be
indicated in the printed report.

AHU-6-Supply Test the smoke detection. AHU-6 will shut down

Smoke Alarms Using smoke sticks, simulate
smoke detection by the The alarm condition will be
smoke detector in the AHU- indicated in the printed report.
6.

AHU-6-Return Test the smoke detection. AHU-6 will shut down

Smoke Alarms Using smoke sticks, simulate
smoke detection by the The alarm condition will be
smoke detector in the AHU- indicated in the printed report.
6.

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
All actual results conform to expected results.
Written justifications are provided for actual results that could not be field verified.

Comments Expected results provided by Company XFacilities Department.

Completed by: Date:

Reviewed by: Date:

QA Approval: Date:
Page 30
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
Actual as
Alarm Test Procedure Expected Results expected? Initials/Date
(Yes/No)
MAU-1-Smoke Test the smoke detection. MAU-1 will shut down
Alarm Using smoke sticks, simulate The alarm condition will be
smoke detection by the indicated in the printed
smoke detector in the MAU- report.
1.
MAU-1-Low Check the low temperature Fan shuts down.
Temperature detection thermostat. Outside damper closed
Detection Simulate an air temperature
below the low temperature Chilled water valve closed
detection thermostat setpoint.
The alarm condition will be
indicated in the printed report.
MAU-1-Room Using the Metacomm station The RHC-3-9, 19-21 and
Temperature increase the temperature VAV-B-H, J-L will increase
Control 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.
MAU-1-Room Using the Metacomm station The RHC-3-9, 19-21 and
Temperature decrease the temperature VAV-B-H, J-L will decrease
Control 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? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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
Actual as
Alarm Test Procedure Expected Results expected? Initials/Date
(Yes/No)
EF-1 Shut off power to Exhaust Fan shuts down.
Fan –EF-1 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-2 Shut off power to Exhaust Fan shuts down.
Fan –EF-2 by cutting off the The alarm condition will be
appropriate Electrical indicated in the printed report.
Breaker Switch.
EF-3 Shut off power to Exhaust Fan shuts down.
Fan –EF-3 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-4 Shut off power to Exhaust Fan shuts down.
Fan –EF-4 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-5 Shut off power to Exhaust Fan shuts down.
Fan –EF-5 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-6 Shut off power to Exhaust Fan shuts down.
Fan –EF-6 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-7 Shut off power to Exhaust Fan shuts down.
Fan –EF-7 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-8 Shut off power to Exhaust Fan shuts down.
Fan –EF-8 by cutting off the The alarm condition will be
appropriate Electrical indicated in the printed report.
Breaker Switch.
EF-9 Shut off power to Exhaust Fan shuts down.
Fan –EF-9 by cutting off the
appropriate Electrical
The alarm condition will be
Breaker Switch.
indicated in the printed report.

Completed by: Date:

Reviewed by: Date:

QA Approval: Date:
Page 32
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
Actual as
Alarm Test Procedure Expected Results expected? Initials/Date
(Yes/No)
EF-10 Shut off power to Exhaust Fan shuts down.
Fan –EF-10 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-11 Shut off power to Exhaust Fan shuts down.
Fan –EF-11 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-12 Shut off power to Exhaust Fan shuts down.
Fan –EF-12 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-16 Shut off power to Exhaust Fan shuts down.
Fan –EF-16 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.
EF-17 Shut off power to Exhaust Fan shuts down.
Fan –EF-17 by cutting off the
appropriate Electrical The alarm condition will be
Breaker Switch. indicated in the printed report.

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
 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
Actual as
Alarm Test Procedure Expected Results expected? Initials/Date
(Yes/No)
Hot Water Shut off power to supply The alarm condition will
pumps by cutting off the be indicated in the
appropriate Electrical printed report.
Breaker Switch.

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
 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
%RH T(°F) Pass/Fail Initial/Date
ID. No.
1
2
3
4
5

Test Stage Date Hour

Beginning
End

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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
%RH T(°F) Pass/Fail Initial/Date
ID. No.
1
2
3
4
5

Test Stage Date Hour

Beginning
End

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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
%RH T(°F) Pass/Fail Initial/Date
ID. No.
1
2
3
4
5

Test Stage Date Hour

Beginning
End

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
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
%RH T(°F) Pass/Fail Initial/Date
ID. No.
1
2
3
4
5

Test Stage Date Hour

Beginning
End

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date

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
 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: Design Actual Pass Initial/Date
(Yes/No)
Mechanical Corridor 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 = Room air changes per hour as per Avecia’s specifications
Nactual = Actual room’s air changes per hour
Qexhaust = Total air exhaust from room (CFM)
Vol. = 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? Initial/

cceptance Criteria
(Yes/No/NA) Date
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
 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? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
 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: 3,520,000 particles/m³ of 0.5µ and 29,300 particles/m³ of 5.0µ

Data Room 111 Non Viable Particle Count (As Found Results) Pass/Fail
Initial/
Point
0.5 µ 5.0µ Date
ID. No.
1
2
3
4
5

Criteria Met? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
 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.

Time EWT (oF) Initial/Date

Expected Results 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? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
 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.

Time EWT (oF) Initial/Date

Expected Results 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? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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
 Operation Qualification Protocol Protocol No. MF/VAL/OQ/013/PRO
Effective Date
Title: HVAC AHU-6 and MAU-1
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? Initial/

Acceptance Criteria
(Yes/No/NA) Date
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