Operational Qualification For Compressed Air System.

Equipment:
Protocol #:
Date:
Compressed Air System
U-0018-2009-01
07 September 2010
Facility:
National Institute of Health
Location:
Building 10 Pharmacy
Bethesda, MD 20892
Revision:
Title:
Operational Qualification Protocol for Compressed Air System.
Objective:
The objective of this protocol is to document the proper operation functionality of the
Compressed Air System.
Written By: Michael Molloy
Title: Consultant
Approved By: ______________________

Title: _____________________________
Signature:
Signature:
Date:
Date:
Approved By: ______________________
Approved By: ______________________
Title: _____________________________
Title: _____________________________
Signature:
Signature:
Date:
Date:
Qualification
Process
Solutions, Inc.
PROPRIETARY INFORMATION:
Unauthorized Duplication Is Prohibited
DOCUMENT NUMBER U-0018-2009-01

DATE: 07 September 2010
REVISION NUMBER Original
Author: Michael Molloy ______________________
PAGE: 1 of 23
Revision DATE: N/A
VALIDATION PROTOCOL
OPERATIONAL QUALIFICATION OF THE

COMPRESSED AIR SYSTEM
INSTALLED
AT
NATIONAL INSTITUTE OF HEALTH
BUILDING 10 ATRIUM INFILL PENTHOUSE
Bethesda, MD 20892
Qualification Process Solutions

13406 blythenia Rd
Phoenix, MD 21131
DOC. # U-0018-2009-01
OPERATIONAL QUALIFICATION
BETHESDA, MD 20892
Page 2 of 23
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 3 of 23
TABLE OF CONTENTS
1.0
OBJECTIVE ....................................................................................................................
...................... 4
2.0
SCOPE
........................................................................................................
.................................. 4
3.0
RESPONSIBILITIES .............................................................................................................
................... 4
4.0
METHODOLOGY...................................................................................................................
................. 5
5.0
TERMINOLOGY ..................................................................................................................
................... 5
6.0
DOCUMENTATION
PRACTICES ......................................................................................................... 6
7.0
EQUIPMENT/SYSTEM
DESCRIPTION ................................................................................................ 7
8.0
SIGNATURE
LOG ..........................................................................................................................
......... 8
9.0
LIST OF TEST
FUNCTIONS .................................................................................................................. 9
10.1
PROCEDURE
LIST
......................................................................................................
..................... 10
10.3
TEST INSTRUMENT CALIBRATION VERIFICATION ................................................................... 12
10.4
SYSTEM OPERATIONAL VERIFICATION .......................................................................................
14
10.5
FUNCTIONAL
VERIFICATION .......................................................................................................... 16
10.6
ALARM
VERIFICATION .................................................................................................................
.... 18
11.0
QUALIFICATION PROTOCOL NON-CONFORMANCES ................................................................ 19
12.0
OPERATIONAL QUALIFICATION PROTOCOL REVIEW .............................................................. 23
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 4 of 23
1.0
2.0
3.0
Objective
1.1
The objective of this qualification protocol is to outline a prospective test plan, via protocol, to
qualify the operational functionality of the compressed air system at National Institute of
Health, Bethesda Maryland.
1.2
Verifications/tests will be conducted within the qualification protocol designed to verify that,
when successfully executed, all required aspects of the operational functionality of the
compressed air system adhere to National Institute of Healths requirements.
Scope
2.1
The qualification protocol is limited to the operational functionality of the compressed air
system. Within the scope of this documentation are all operational and user required
parameters, including all peripheral equipment such as utilities, up to the point of use of the
utility system.
2.2
Each verification/test/challenge defined in this document is performed by an individual test
method.
Responsibilities
3.1 The protocol review and approval is the responsibility of the following functional groups:
3.1.1 National Institute of Health
3.1.2 Qualification Process Solutions, LLC
3.2 Qualification Process Solutions, LLC
3.2.1 Prepares the validation protocol according to applicable specifications, engineering details,
procedures and generally accepted industry practice.
3.2.2 Executes the protocol and any associated addendum as written.
3.2.3 Secures any test equipment required to conduct the validation.
3.2.4 Conducts the validations and arranges for all support functions (engineering/maintenance
services, start-up services by factory representatives, or other technical services).
3.2.5 Records all non-conformance observations and provides possible resolution(s).
3.2.6 Interacts with responsible mechanical contractors as required to resolve nonconformances.
3.2.7 Prepares the turnover package and summary report of the commissioning activities.
3.2.8 Approves the turnover package and summary report.

3.3 National Institute of Health
3.3.1 Reviews and approves the validation protocol including protocol addenda.
3.3.2 Reviews and approves the executed protocol and Non-Conformance Reports.
3.3.3 Interacts with responsible mechanical contractors as required to resolve nonconformances.
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 5 of 23
4.0
Methodology
The methodology used to develop this operational qualification protocol is based on NATIONAL
INSTITUTE OF HEALTHs user requirements, system specification, the manufacturers
recommendations, and current industry and/or NATIONAL INSTITUTE OF HEALTHs standards.
The purpose, procedure, and acceptance criteria for each verification/test/challenge are listed in the
individual sections. In all cases, acceptance criteria for each verification/test/challenge are based on
NATIONAL INSTITUTE OF HEALTHs system specifications/user requirement, and the
manufacturer's requirements.
The following verification/test procedures are to be performed:
4.1
Procedure List
This section verifies the existence of suitable procedures for operation and maintenance of this
equipment.
4.2
Training Verification
This section verifies that end users have been trained in the operation and maintenance of this
equipment.
4.3
Test Instrument Calibration Verification
This section verifies that all the instruments, used during execution of this protocol, are
calibrated against a NIST traceable standard and are within calibration during execution. A
copy of the calibration certificate is attached, or its location referenced.
4.7
System Operational Verification
This section verifies that the system operational sequences including startup, shutdown, and
sequential functions, operate as specified at varying operating conditions as defined by the
equipment manufacturer and design specifications.
4.8
Functional Verification
This section verifies that the system operating functions are within the specified parameters as
defined by the equipment manufacturer and design specifications.
4.9
Alarm Verification
This section verifies that the proper alarm is generated for given conditions and that the proper
alarm events occur for each alarm tested including proper alarm activation, alarm delay timing,
alarm acknowledgement and alarm clearance.
5.0
Terminology
5.1
HVAC:
Heating Ventilation and Air Conditioning
5.2
AHU:
Air Handling Unit
5.3
BAS:
Building Automation System
5.4
CFM:
Cubic Feet per Minute
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 6 of 23
6.0
Documentation Practices
6.1
Test personnel perform all verification and test procedures as outlined in the attachments. For
each attachment, the requested information is recorded in black or blue ink. Designated
personnel performing the verification testing complete all information as requested in the
attachment.
6.2
The test personnel record all test results on the protocol attachments. Use additional copies of
the protocol attachments as necessary, which the testers attach to the completed protocol. All
associated documentation and raw data is kept with the protocol or in the turnover package for
the system.
6.3
If a page is blank or information is not applicable to the equipment or system being
commissioned, the tester draws a single line through the text, writes N/A and initials and dates
the entry. If the reason for recording N/A is not readily apparent, annotate the document with a
brief justification.
6.4
The test personnel review the stated specification for each test item listed in the attachments to
determine the acceptance status of each test. Acceptance criteria are listed in the individual
tests. Test personnel record the acceptance status of the test by marking the appropriate status
and initial and date the test item.
6.4.1
All test procedures outlined in the applicable attachments are completed indicating the
test status of the test item as either acceptable or unacceptable.
6.4.2
Items that comply with the requirements and/or specifications and do not have
outstanding non-conformances are considered acceptable.
6.4.3
Test items that exhibited a non-conformance that did not fully meet all defined
acceptance criteria or that is not in compliance is considered unacceptable.
6.4.4
Test personnel initiate a non-conformance report for any item that does not meet all the
expected results and specifications listed within verification or test.
6.5
During the execution of the verification tests, additional test items may need to be added to the
testing documentation. If additional testing is required, an addendum worksheet is created
with the additional applicable testing. The executed addendum testing is then attached to this
protocol.
6.6
All personnel participating in the verification testing that perform test procedures, review
executed tests, or otherwise write on the verification protocol must complete the signature log.
This ensures traceability of documentation to the correct individuals.
6.7
When completing the attachment worksheets, utilize the following nomenclature and
abbreviations:
6.7.1
Use the following terms to identify HOW VERIFIED:
MEASUREMENT - physical measurement
VISUAL - visual inspection
DOCUMENT - Specify document name, revision, and date - as applicable

(document types: drawing, specifications or manual)
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 7 of 23
OTHER - specify the method used

Abbreviations:
N/S - not specified
N/A - not applicable
N/AC - not accessible
N/AV - not available

6.7.3
Supporting test data collected during testing is attached to the appropriate appendix of
the qualification protocol.
7.0
Equipment/System Description
7.1
Laboratory Air Compressor
The Air Compressor unit is a Quintaplex, air cooled, two stage, oil free, scroll compressor
unit. Unit is supplied with air receiver. Compressor unit is frame mounted. Unit is pre-piped
and wired providing single point connection for utilities and air piping.
The unit consists of :
Model WTR45-A Air Compressor (4 ea.)
Integral 30 diameter , 200 psi ASME coded air receiver
One set of twin tower dessicant dryers , ZEKS Model 160-200 ZPA heatless
One set of cartridge air filters, 5 micron primary and 1 micron final.
Quintaplex Controls
Pressure regulators
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 8 of 23
6.7.2
8.0
Signature Log
Individuals involved in the execution and review of this protocol complete the spaces in the table
below.
Signature Log Table
Print Name
Signature / Initials
*This page may be duplicated as needed

DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 9 of 23
9.0
List of Test Functions

9.1
Procedure List
9.2
9.3
9.4
9.5
Alarm Verification
DOC. # U-0018-2009-01

BETHESDA, MD 20892
Page 10 of 23
10.1
Procedure List
10.1.1 Purpose:
The purpose of this section is to verify and document those instructions for the use of the
equipment has been documented.
10.1.2 Test Method:
10.1.2.1
Using Section 10.1.4, Procedure Verification, verify and document the
instructions for use of the equipment are available and cover the topics listed.
10.1.2.2
Attach a copy of these documents to this protocol or reference the location of it in
the verification form.
10.1.3 Acceptance Criteria:
10.1.3.1
System use instructions are attached or their locations referenced.
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 11 of 23
10.1.4
Procedure Verification
List the operating instructions that are required for execution of this protocol.
Document
Document
Procedure Title
Initial/Date
Type
Operation of the Compressed Air System
Location
Maintenance of the Compressed Air System
Comments:
Performed By:
Reviewed By:
DOC. # U-0018-2009-01
Date:
Date:
BETHESDA, MD 20892
Page 12 of 23
10.2

10.3.1 Purpose:
The purpose of this section is to verify that all the test instruments, used during execution of
this protocol, are calibrated against a traceable standard and are within calibration during
execution.
10.3.2 Procedure:
10.3.2.1
Using Section 10.3.4, Test Instrument Calibration Verification, verify and
document the calibration information of all the test instruments used for
execution of this protocol.
10.3.2.2
The verification form may be duplicated as necessary to accommodate additional
test instruments.
10.3.2.3
Attach all test instrument calibration certificates to this protocol.
10.3.3 Acceptance Criteria:
10.3.3.1
All test instruments are calibrated against traceable standards.
10.3.3.2
All test instruments are within the current calibration period and have a
calibration sticker affixed during the execution of this protocol.
10.3.3.3
All test instrument calibration certificates are attached to this protocol.
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 13 of 23
10.3.4 Test Instrument Calibration Verification

Cal. Date/
ID No.
Calibration Sticker
Cal. Cert.
Initial /
Description
Due Date
Affixed?
Attached?
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
Date
Comments:
Performed By:
Reviewed By:
DOC. # U-0018-2009-01
Date:
Date:
BETHESDA, MD 20892
Page 14 of 23
10.3

10.4.1
Purpose:
The purpose of this section is to verify that the system operational sequences including
startup, shutdown, and sequential functions, operate as specified at varying operating
conditions as defined by the equipment manufacture and design specifications. Operational
verification is performed on the following system components:
Air Compressor
Desiccant Dryer
10.4.2
Procedure:
10.4.2.1
Using Section 10.4.4, System Operational Verification, verify and document the
operating sequences of the system.
10.4.2.2
Verify that the automatic operation of the system components follow the
sequences as specified in the procedure.
10.4.3
Acceptance Criteria:
10.4.3.1
The control sequences of the system are documented and verified to operate as
specified by the equipment manufacture and design specifications.
10.4.3.2
The system is installed, starts, and functions as specified
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 15 of 23
10.4.4

Verified
Initial /
Action
(Yes/No)
Air Compressor
The equipment operates using factory controls. Factory start-up parameters
are documented and equipment runs per factory specifications.
Pressure switch enables start / stop of pumps.
Motors in a lead / lag configuration.
Automatic low pressure cut in demonstrated.
Date
Automatic high pressure cut out demonstrated.

Air receiver charges to greater than 100 psi.
Desiccant Dryer
The equipment operates using factory controls. Factory start-up parameters
are documented and equipment runs per factory specifications.
Automatically controls air discharge to -40F pressure dewpoint.
Automatic purge and switch over of towers demonstrated.
Comments:
Performed By:
Reviewed By:
DOC. # U-0018-2009-01
Date:
Date:
BETHESDA, MD 20892
Page 16 of 23
10.4
10.5.1
Purpose:
The purpose of this section is provide documentary evidence that the compressed air system
function as specified.
10.5.2
Procedure:
10.5.2.1
Using Section 10.5.4, Functional Verification, verify and document the
operating functions of the system.
10.5.2.2
Verify that the functionalities of the system and its related components meet the
expected results.
10.5.3
10.5.3.1
The system and its related components are documented and verified to perform
to the contractual standards.
DOC. # U-0018-2009-01
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10.5.4
Description
Expected Results
Generated by oil-
Verified
Initial/
(Yes / No)
YES NO
Date
Actual Results
Compressed Air Source

less compressor
All hard piped
equipment is
Connected Equipment
supplied with
sufficient air to
operate properly.
Point of Use Compressed Air Pressure
Test Lab
25-90 psi
Wash Room Two
25-80 psi
Clean Prep Room
25-80 psi
Filling Room
NLT 30 psi
Lyo Mechanical Room
NLT 100 psi
Large Batch Room
NLT 90 psi
Blending Room
NLT 90 psi
Tablet Room
NLT 30 psi
Point of Use Compressed Air Flow
Test Lab
NLT 5 scfm
Wash Room Two
NLT 5 scfm
Clean Prep Room
NLT 5 scfm
Filling Room
NLT 5 scfm
Lyo Mechanical Room
NLT 5 scfm
Large Batch Room
NLT 5 scfm
Blending Room
NLT 5 scfm
Tablet Room
NLT 5 scfm
Comments:
YES NO
YES
YES
YES
YES
YES
YES
YES
YES
NO
NO
NO
NO
NO
NO
NO
NO
YES
YES
YES
YES
YES
YES
YES
YES
NO
NO
NO
NO
NO
NO
NO
NO
Performed By:
Reviewed By:
DOC. # U-0018-2009-01
Date:
Date:
BETHESDA, MD 20892
Page 18 of 23
10.5
Alarm Verification
10.5.1
Purpose:
The purpose of this section is to verify that the proper alarm is generated for given
conditions and that the proper alarm events occur for each alarm tested including proper
alarm activation, alarm delay timing, alarm acknowledgement and alarm clearance. Alarm
verification is performed on the following system components:
Air Compressor
Desiccant Dryer
10.5.2
Procedure:
10.6.2.1
Record the as-found process variable/setpoint for each alarm.
10.6.2.2
Record the method used to generate the alarm as follows:
10.6.2.2.1
Enter A1 if the alarm is generated by manually starting or
stopping a device
10.6.2.2.2
Enter A2 if the alarm is generated by using a signal generator or
jumper connected wiring of I/O terminals
10.6.2.3
As applicable, record the as-found alarm setpoint and the setpoint used to test
the alarm.
10.6.2.4
Verify alarm is active at the system operator interface.
10.6.2.5
Verify alarm is acknowledged at the Alarm Screen of the system operator
interface.
10.6.2.6
Clear the conditions that generated the alarm. Verify alarm is cleared at the
Alarm Screen of the system operator interface.
10.5.3
10.6.2.7
The system responds as specified to alarm verification endpoints, alarm
activation, alarm delay timing, alarm acknowledgement and alarm clearance, as
specified in the attached Alarm Verification Form.
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 19 of 23
10.5.4
Alarm Verification
As-Found
Alarm
Alarm
Alarm Test
Description
Alarm
Generation
Delay
Value
Setpoint
Method
Alarm Delay
Alarm
Timed As
Activated?
Setpoint
Specified?
Air Compressor
Yes
Compressor
Yes
No
1-5 High
No
N/A
Yes
Temp
Yes
No
No
N/A
Yes
Yes
No
No
N/A
Desiccant Dryer
Yes
Yes
No
No
N/A
Yes
Yes
No
No
Initial/ Date
N/A
Yes
Yes
No
No
N/A
Comments:
Performed By:
Reviewed By:
DOC. # U-0018-2009-01
Date:
Date:
BETHESDA, MD 20892
Page 20 of 23
11.0 Qualification Protocol Non-Conformances

11.1
Purpose:
The purpose of this section is to document all the non-conformance events encountered during
execution of this qualification protocol.
11.2
Procedure:
11.2.1 A protocol non-conformance report is generated for each non-conformance
encountered during the execution of this protocol. Non-conformance occurrences
include: failure to meet an acceptance criterion or failure to follow protocol procedure.
The protocol executor initiates a protocol non-conformance report by completing the
observation/ comments section.
11.2.2 Each protocol non-conformance report generated during the execution of this protocol
is sequentially numbered. Each protocol non-conformance report is documented in
Section 11.3, Protocol Non-Conformance Report Log, with the number and a brief
description of the non-conformance.
11.2.3 Attach all supporting information to the commissioning protocol non-conformance
report.
11.2.4 Each protocol non-commissioning report generated during the execution of this
protocol is reviewed and signed by a qualified engineering representative. If
necessary, additional personnel may be required to review and sign the protocol nonconformance report.
11.2.5 The protocol non-conformance report is completed, reviewed, and signed prior to
routing of the final package for approval.
11.2.6 All protocol non-conformance reports are attached to this protocol.
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 21 of 23
11.3
Qualification Non-Conformance Report Log
Document all non-conformances found during execution. Note: Make additional copies of this attachment as
necessary.
Number
Description
Initial/Date
Comments:
Performed By:
Reviewed By:
DOC. # U-0018-2009-01
Date:
Date:
BETHESDA, MD 20892
Page 22 of 23
Protocol #
Date Encountered:
Protocol Deviation Report (Template)

Protocol Section
Page
Executor/Discovered By
Step
Description of Deviation
Investigation / Findings
Statement of Impact
Resolution
Approvals
Role
Executor
Name (Print)
Signature
Date
Reviewer
NIH QA Officer
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 23 of 23
12.0 Operational Qualification Protocol Review
12.1
Purpose:
The purpose of this section is to document that the protocol has been reviewed.
12.2
Procedure:
12.2.1 Review this protocol and attachments for completeness.
12.2.2 Verify non-conformance reports are completed and submitted.
12.2.3 Sign the installation qualification protocol review statement.
DOC. # U-0018-2009-01
BETHESDA, MD 20892
Page 24 of 23
12.3
Operational Qualification Protocol Review Statement:
I attest that this document has been reviewed and found satisfactory.
Name (print):____________________________________________________________________
Company (Print): _________________________________________________________________
Title: ________________________________
Signature: ____________________________________________
Date: ___________________
NIH Document Review Approvals:
Approved By: ______________________
Approved By: ______________________
Title: _____________________________
Title: _____________________________
Signature:
Signature:
Date:
Date:

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Equipment:

Compressed Air System

Approved By: ______________________

Approved By: ______________________

Approved By: ______________________

DOCUMENT NUMBER U-0018-2009-01

Revision DATE: N/A

OPERATIONAL QUALIFICATION OF THE

Qualification Process Solutions

3.2.8 Approves the turnover package and summary report.

MEASUREMENT - physical measurement

VISUAL - visual inspection

DOCUMENT - Specify document name, revision, and date - as applicable

OTHER - specify the method used

N/S - not specified

N/A - not applicable

N/AC - not accessible

N/AV - not available

Model WTR45-A Air Compressor (4 ea.)

Integral 30 diameter , 200 psi ASME coded air receiver

*This page may be duplicated as needed

List of Test Functions

BUILDING 10 ATRIUM INFILL PENTHOUSE

Maintenance of the Compressed Air System

Test Instrument Calibration Verification

10.3.4 Test Instrument Calibration Verification

System Operational Verification

System Operational Verification

Automatic high pressure cut out demonstrated.

Compressed Air Source

11.0 Qualification Protocol Non-Conformances

Protocol Deviation Report (Template)

Company (Print): _________________________________________________________________

NIH Document Review Approvals:

Approved By: ______________________

Approved By: ______________________

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