Protocol # ___________ Revision # _______________ Equipment ID __________
Customer ______________________________INDEX
IntroductionScope
ResponsibilitiesProcedure
System Product Water QualitySection TitleA Installation Qualification
1. Unit Location/Installation2. Feed Water3. Supplied Power4. Controller Module5. Spare Parts6. Documentation7. General Comments
B Operation Qualification1. Power Switch2. System Configuration3. Normal Operation4. Optional Pressure or Float Switch5. Controller6. Power Failure Recovery7. General Comments
C Attachments1. Purchase Order Verification2. Acceptance Criteria
The purpose of this installation and operational qualification is to providedocumented evidence that the Barnstead Thermolyne NANOpureDIamond™ Ultrapure Water System is installed properly and performs asintended 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 (NANOpureDIamond™ Ultrapure Water System)
ResponsibilitiesThe responsibilities of the validation services personnel include:
Execution of this protocolProviding test data for review upon request by customer personnelAnalysis and compilation of data into the summary report package
The responsibilities of the owner include:Supplying all relevant documentation, procedures, manuals anddrawings necessary for the completion of this protocol
Providing personnel when necessary to assist in operation of theNANOpure DIamond™ Ultrapure Water System as necessary forthe completion of this protocol
This protocol is to be completed after the water system has been installed inaccordance with the operation manual.
Procedure
The installation and operation qualifications will be conducted by physicallyobserving and operating the NANOpure DIamond™ Ultrapure Water Systemand any associated equipment, comparing it to relevant documentation forappropriate function, and documenting results on the attached data sheets forfuture change control.
Any performance qualification (PQ) will be the responsibility of the owner, whichmay be performed by the ongoing monitoring of water quality under variousoperations, 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 QualityConfiguration Flow Resistivity TOC Endotoxin
Verify NANOpure DIamond™Ultrapure Water System installationand operation manual dates andstorage locations.
Review that any in-house StandardOperating Procedures are inagreement withBarnstead/Thermolynedocumentation, including; Use Maintenance and Service Cleaning/Disinfection Safety precautions Maintenance procedures
Serial number:________________
Manual Date:________________
Location:________________
Y N
Y NY NY N
7 Discrepancies/GeneralComments
General Comments:____________________________________________________________________________________________________________________________________________________________________________________________________________________
To access resistivity setpoint, putunit in IDLE mode. Press up arrowto “Advanced menu?”. Press enter.Continue pressing enter to scrollthrough the following parameters:
Printer Attached?……………………..Remote Gun?………………………….Date Format?………………………….Set Date?……………………………….Set Time?………………………………..Set Cell Constant?…………………….Set Display Brightness?……………….Adjust Set Point?, Push arrow sodisplay reads “YES” and then push
“Enter” Modify set point with up- anddown-arrow if necessary and pressEnter.
Document the programmedsetpoint.
_______MΩ-cm
4 Pressure or FloatSwitch (optional)
Reduce inlet water pressure and/orvolume.Verify that pump shuts down anddisplays “Check Inlet”. Y N
5 Controller Maintains resistivity aboveprogrammed set point. Y N
6 Power FailureRecovery
Press BACK key two times to returnto IDLE mode.Turn main circuit breaker forDIamond(tm) off and then back onto simulate a power failurefollowed by a restoration of power.
Verify that the controller returns tonormal operation upon restorationof power by depressing theSTART/STOP button.
Y N
Discrepancies/ List all discrepancies between specifications and
actual conditions. All discrepancies must bepresented to authorized customer companypersonnel for resolution and/or statement ofacceptability.
General Comments:__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
The installation and operational qualifications will be performed as stated in thisprotocol and all raw data sheets will be completed concurrently with theexecution of the protocol.
All documentation (approved protocol, completed data sheets, lab reports) willbe maintained in a single Validation Project File. Upon completion of theprotocol, the data will be analyzed and presented, along with substantiatingdocumentation, in a summary report to be reviewed and approved bydesignated _____________ personnel.
Any modifications to the NANOpure DIamond™ Ultrapure Water System madeduring the course of the protocol execution will be documented as per__________________change control standard operating procedure. Anassessment will be made after the change to determine if re-validation isrequired. All change control forms should be filed and reviewed at least yearlyto determine if re-validation is required.
We certify to the best of our knowledge that the Barnstead Thermolyne NANOpure ®DIamond™ water purification system, Model number ____________, which was purchased andinstalled, is in compliance with the following purchase order.
P.O. Number __________________________ Date: ______________________
Instruments used to generate all data must be calibrated according toapproved procedures and be traceable to NIST standards. Barnstead/Thermolyne recommends the use of the NIST calibration module, P/NE896X5, for the system’s electronics calibration.
The NANOpure DIamond™ Ultrapure Water System must perform as specifiedby Barnstead/Thermolyne.
Barnstead Thermolyne NANOpure DIamond™ UltrapureWater System
Installation/Operational Qualification Acceptance
Approved by _____________________________________ Date: _______________Manager, QA
Approved by _____________________________________ Date:________________Owner
