Barnstead | D11911 | DIamond™ Ultrapure Water System

Installation/Operational
Qualification Protocol
______________________________________________________________________________
IQ/OQ DOCUMENT
REV. NO. 0
Barnstead
Thermolyne
NANOpure
 DIamond™ Ultrapure Water
System
*Models D11901, D11911, D11921, D11931
IQ/OQ
Approved by: _____________________________ Date: ________________
Manager, QA
Approved by: ______________________________Date:________________
Owner
Barnstead
Thermolyne
2555 Kerper Blvd.
Dubuque, IA 52001 USA
Phone: 1-800-446-6060 Fax: 319-589-0516
Mkt@barnstead.com
SSL2030
Title
T Protocol
B
T Revision
B
Equipment ID
Customer ID
BarnsteadThermolyne
BT.001.01.A
0
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Customer
Protocol
Customer
Revision
Qualification
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
___________
Protocol # ___________ Revision # _______________ Equipment ID __________
Customer ______________________________
INDEX
Introduction
Scope
Responsibilities
Procedure
System Product Water Quality
Section
A
Title
Installation Qualification
1. Unit Location/Installation
2. Feed Water
3. Supplied Power
4. Controller Module
5. Spare Parts
6. Documentation
7. General Comments
B
Operation Qualification
1. Power Switch
2. System Configuration
3. Normal Operation
4. Optional Pressure or Float Switch
5. Controller
6. Power Failure Recovery
7. General Comments
C
Attachments
1. Purchase Order Verification
2. Acceptance Criteria
BT.001.01.A
09262000
Page 2 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Introduction
The purpose of this installation and operational qualification is to provide
documented evidence that the BarnsteadThermolyne NANOpure
DIamond™ Ultrapure Water System is installed properly and performs as
intended throughout the operating ranges specified by the owner.
Scope
The equipment to be validated is one of the following:
BarnsteadThermolyne Model D11901, D11911, D11921, or D11931 (NANOpure
DIamond™ Ultrapure Water System)
Model:
Serial Number:
___________
located in the:
______________________________________________________________________________
used to:
______________________________________________________________________________
Date:____________________________
BT.001.01.A
09262000
Completed by: ___________________________
Page 3 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Responsibilities
The responsibilities of the validation services personnel include:
Execution of this protocol
Providing test data for review upon request by customer personnel
Analysis and compilation of data into the summary report package
The responsibilities of the owner include:
Supplying all relevant documentation, procedures, manuals and
drawings necessary for the completion of this protocol
Providing personnel when necessary to assist in operation of the
NANOpure DIamond™ Ultrapure Water System as necessary for
the completion of this protocol
This protocol is to be completed after the water system has been installed in
accordance with the operation manual.
Procedure
The installation and operation qualifications will be conducted by physically
observing and operating the NANOpure DIamond™ Ultrapure Water System
and any associated equipment, comparing it to relevant documentation for
appropriate function, and documenting results on the attached data sheets for
future change control.
Date:____________________________
BT.001.01.A
09262000
Completed by: ___________________________
Page 4 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Procedure continued
Any performance qualification (PQ) will be the responsibility of the owner, which
may be performed by the ongoing monitoring of water quality under various
operations, including but not limited to worst case conditions.
NOTE: Acceptance criteria apply equally to all NANOpure DIamond™
Ultrapure Water System configurations (see section on Acceptance Criteria).
System Product Water Quality
Configuration
Analytical
UF
UV
Life Science
(UV/UF)
Flow
Up to 1.5
liter/min.
Up to 1.5
liter/min.
Up to 1.5
liter/min.
Up to 1.5
liter/min.
Resistivity
Up to 18.2 MΩ
Up to 18.2 MΩ
Up to 18.2 MΩ
Up to 18.2 MΩ
Date:____________________________
BT.001.01.A
09262000
TOC
Less than 10.0
ppb
Less than 10.0
ppb
Less than 3.0
ppb
Less than 5.0
ppb
Endotoxin
N/A
Less than 0.02
EU/ml
N/A
Less than 0.02
EU/ml
Completed by: ___________________________
Page 5 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Section A
Installation Qualification
1. Unit Location/Installation
2. Feed Water
3. Supplied Power
4. Controller Module
5. Spare Parts
6. Documentation
7. General Comments
BT.001.01.A
09262000
Page 6 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
A. Installation Qualification
Step
Description
Specification or Acceptance
Criteria
1
Unit Location/
Installation
Is the NANOpure DIamond™
Ultrapure Water System located on
a level surface or securely wallmounted?
Y
N
Has the minimum clearance,
9”(23cm) each sides, 3” (8cm)on
top, 4.75” (12cm)in front been
provided?
Y
N
Is unit mounted away from
electrical equipment or
combustible materials?
Y
N
Has the water inlet piping
connection been made?
Y
N
Has a manual shutoff valve been
installed between the main water
supply and the NANOpure
DIamond™ Ultrapure Water
System?
Y
N
BT.001.01.A
09262000
Page 7 of 21
Actual Result
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
1
Unit Location/
Installation
continued
Model D11921 & D11931
Has the UF (ultrafilter) been
installed?
Y
N
N/A
Model D11911 & D11931 has the UV
(ultraviolet) lamp been installed?
Y
N
N/A
Has the float switch (P/N D8964)
been installed? (optional)
Y
N
N/A
Has the pressure switch (P/N D2706)
been installed? (optional)
Y
N
N/A
Has the cartridge pack been
installed?
Y
N
Has initial sanitization of the unit
been performed?
Y
N
(If not, sanitization must be
completed before proceeding with
IQ procedure:
refer to Initial sanitization procedure
in operating manuals)
BT.001.01.A
09262000
Page 8 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Unit Location/
Installation
Continued
2
Feed Water
Has initial rinse-up been performed?
If not, see manual for initial rinse
instructions.
Has the final 0.2 micron filter been
installed?
Supplied feed water must be
reverse osmosis, deionized or
distilled,
<70 ppm total dissolved solids (TDS).
Record actual TDS.
Y
N
Y
N
__________ ppm
What is the TOC (total organic
carbon) level of the feed water
(ppm) provided to the unit?
(required value is <1.0 ppm)
Record actual TOC
___________ ppm
What is the turbidity level of the
feed water (as measured in NTU)
provided to the unit?
(required value is <=1.0 NTU)
Record actual turbidity
___________ NTU
What is the pressure of the feed
water (as measured in psig)
provided to the unit?
(required value is <=100 psig)
Record actual pressure
BT.001.01.A
09262000
Page 9 of 21
___________ psig
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
2
Feed water
continued
What is the flow rate of the feed
water?
Record actual flow rate
________ ml/min
What is the temperature of the feed
water provided to the unit?
(required value is 4 - 40°C (40104°F))
Record actual temperature
3
Supplied Power
__________ °C/°F
Describe supplied electrical power:
Required:
100-240 VAC
100 Watts
47-63 Hz
1 phase
Verify amperage of installed fuses:
__________ VAC
_________ Watts
________ Hz
________ Phase
________ Amps
Record circuit number, if
applicable, and amperage of
circuit breaker
BT.001.01.A
09262000
Page 10 of 21
Circuit #
________________
_________ Amps
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
4
Controller
Module
BT.001.01.A
09262000
After switching power switch to ON
does initial display indicate correct
configuration?
__Analytical
__UV
__UF
__UV/UF
Y
N
Does initial display indicate the
following:
1) BARNSTEADTHERMOLYNE……..
2) UNIT INITIALIZING…………………...
3) SELF TEST……………………………...
4) NANOpure DIamond(tm) IDLE…..
Y
Y
Y
Y
N
N
N
N
Does pressing “UP” arrow key
access Operations menus?
SANITIZE UNIT?…………………………
NIST CALIBRATE?………………………
RESET TIMERS?…………………………
ADVANCED MENU?………………….
DIAGNOSTIC MENU?…………………
Y
Y
Y
Y
Y
N
N
N
N
N
Does pressing “BACK” key return
display to IDLE?
Y
N
Page 11 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
5
Spare parts
Recommended spare parts:
Stocked on site?
D3750, Final filter
FZX47, Main fuse (120 v.)
FZX54, Main fuse (230 v.)
AZ9027, Main transformer fuse
CMX25, Sanitization Solution
Y
Y
Y
Y
Y
N
N
N
N
N
D11911 & D11931 only
LMX13, UV Lamp
Y
N
N/A
N/A
N/A
Describe the types and quantities of
additional spare parts stocked onsite, if any. List storage locations of
spare parts, if applicable.
6
Documentation
BT.001.01.A
09262000
Determine if any service
agreements are applicable.
Agreement #
_______________
Verify accuracy of:
Customer specification(s)
Purchase orders/invoices, etc.
Y
Y
Page 12 of 21
N
N
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
6
Documentation
continued
Verify NANOpure DIamond™
Ultrapure Water System installation
and operation manual dates and
storage locations.
Serial number:
________________
Manual Date:
________________
Location:
________________
Review that any in-house Standard
Operating Procedures are in
agreement with
Barnstead/Thermolyne
documentation, including;
Use
Maintenance and Service
Cleaning/Disinfection
Safety precautions
Maintenance procedures
7
Discrepancies/
General
Comments
N
Y
Y
Y
N
N
N
General Comments:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
Installation Qualification
Date:____________________________
BT.001.01.A
09262000
Y
Completed by: ___________________________
Page 13 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Section B
Operation Qualification
BT.001.01.A
09262000
1.
Power Switch
2.
System Configuration
3.
Normal Operation
4.
Optional Pressure or Float Switch
5.
Controller
6.
Power Failure Recovery
7.
General Comments
Page 14 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
B. Operational qualification
Step
Test or Control
Device
Specification or Acceptance
Criteria
1
Power switch
NANOpure Diamond™ Ultrapure
Water System is receiving power.
Control panel LCD is lit.
2
Configuration
Normal
Operation
Does pressing the Start/Stop key
start the pump? Unit displays
***MΩ-cm
Does pressing Start/Stop key again
stop pump? (Unit returns to IDLE)
Press the Start/Stop key to start unit.
Does pressing Standby key stop
pump, and display “Standby?”
BT.001.01.A
09262000
Y
N
Y
N
Y
Y
Y
Y
N
N
N
N
Y
N
Y
N
Y
N
Greeting displays correct model
when power switch is activated.
Analytical
UV
UF
UV/UF
3
Actual Result
Page 15 of 21
N/A
N/A
N/A
N/A
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
3
Normal
Operation
Continued
Does pressing Start/Stop key re-start
pump and change display to
*** MΩ-cm
Y
N
Y
Y
Y
Y
Y
N
N
N
N
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
In IDLE mode, press up or down
arrows to scroll through the
following menus
•
•
•
•
•
Sanitize unit?……………………….
NIST calibrate?…………………….
Reset timers?………………………
Advance menu?………………….
Diagnostic menu?………………..
To access resistivity setpoint, put
unit in IDLE mode. Press up arrow
to “Advanced menu?”. Press enter.
Continue pressing enter to scroll
through the following parameters:
Printer Attached?……………………..
Remote Gun?………………………….
Date Format?………………………….
Set Date?……………………………….
Set Time?………………………………..
Set Cell Constant?…………………….
Set Display Brightness?……………….
Adjust Set Point?, Push arrow so
display reads “YES” and then push
BT.001.01.A
09262000
Page 16 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
3
Normal
Operation
Continued
“Enter”
Modify set point with up- and
down-arrow if necessary and press
Enter.
Document the programmed
setpoint.
4
Pressure or Float
Switch (optional)
Controller
5
6
Power Failure
Recovery
Reduce inlet water pressure and/or
volume.
Verify that pump shuts down and
displays “Check Inlet”.
Y
N
Maintains resistivity above
programmed set point.
Y
N
Y
N
Press BACK key two times to return
to IDLE mode.
Turn main circuit breaker for
DIamond(tm) off and then back on
to simulate a power failure
followed by a restoration of power.
Verify that the controller returns to
normal operation upon restoration
of power by depressing the
START/STOP button.
Discrepancies/
BT.001.01.A
09262000
_______MΩ-cm
List all discrepancies between specifications and
Page 17 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
7
General
Comments
actual conditions. All discrepancies must be
presented to authorized customer company
personnel for resolution and/or statement of
acceptability.
General Comments:
__________________________________________________
__________________________________________________
__________________________________________________
__________________________________________________
__________________________________________________
Operation Qualification
Date:____________________________
Completed by: ___________________________
The installation and operational qualifications will be performed as stated in this
protocol and all raw data sheets will be completed concurrently with the
execution of the protocol.
All documentation (approved protocol, completed data sheets, lab reports) will
be maintained in a single Validation Project File. Upon completion of the
protocol, the data will be analyzed and presented, along with substantiating
documentation, in a summary report to be reviewed and approved by
designated _____________ personnel.
Any modifications to the NANOpure DIamond™ Ultrapure Water System made
during the course of the protocol execution will be documented as per
__________________change control standard operating procedure. An
assessment will be made after the change to determine if re-validation is
required. All change control forms should be filed and reviewed at least yearly
to determine if re-validation is required.
BT.001.01.A
09262000
Page 18 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Section C
Attachments
1. Purchase Order Verification
2. Acceptance Criteria
BT.001.01.A
09262000
Page 19 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Purchase Order Certification
We certify to the best of our knowledge that the BarnsteadThermolyne NANOpure ®
DIamond™ water purification system, Model number ____________, which was purchased and
installed, is in compliance with the following purchase order.
P.O. Number __________________________
Date: ______________________
Comments: ____________________________________________________________
Reviewed by: ______________________________________
Date: ______________
BT.001.01.A
09262000
Page 20 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
Acceptance Criteria
Instruments used to generate all data must be calibrated according to
approved procedures and be traceable to NIST standards.
Barnstead/Thermolyne recommends the use of the NIST calibration module, P/N
E896X5, for the system’s electronics calibration.
The NANOpure DIamond™ Ultrapure Water System must perform as specified
by Barnstead/Thermolyne.
Thermolyne NANOpure
 DIamond™ Ultrapure
Barnstead
Water System
Installation/Operational Qualification Acceptance
Approved by
_____________________________________ Date: _______________
Manager, QA
Approved by
_____________________________________ Date:________________
Owner
BT.001.01.A
09262000
Page 21 of 21
Title
Protocol
Revision
Equipment ID
Customer
BarnsteadThermolyne
BT.001.01.A
0
Customer
Protocol
Customer
Revision
NANOpure®
DIamond™
Ultrapure
Water
System 1
____________
____________
____________
____________
____________
____________
____________
NANOpure® DIamond™
Ultrapure Water System
Installation/Operation
Qualification
BT.001.01.A
09262000
Page 22 of 21
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