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Sample Qualification Report

Purified Water SystemInstallation and Operational

Qualification Report

Prepared and Authored By:

Mike Turnure, Gerbig Engineering Company Validation Services


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Purified Water System Installation and Operational Qualification Report

Document Approvals

Pre-Execution Authorizations

This protocol was written by:

_________________________________ ___________________Mike Turnure DateSenior Validation SpecialistGerbig Engineering Company

The undersigned have reviewed this report, and found it to be a complete andappropriate record to support the Your Company Installation and OperationalQualification of the Purified Water System.

_________________________________ ___________________David Headguy, President Date

_________________________________ ___________________Claire Quality, Chief Technical Officer Date

Table of Contents

1. Revision History ............................................................................................................... 32. Objective .......................................................................................................................... 43. Scope ............................................................................................................................... 44. Background ...................................................................................................................... 45. Systems Description ........................................................................................................ 56. Acronyms and Definitions ................................................................................................. 57. References ....................................................................................................................... 5


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8. Acceptance Criteria .......................................................................................................... 59. Schedule .......................................................................................................................... 610. Test Plan Attachments ..................................................................................................... 6SignatureVerificationForm(Attachment#1)..................................................................................................... 6TestInstrumentDataForm(Attachment#2)..................................................................................................... 6ProtocolDeviationReportForm(Attachment#3)............................................................................................. 6NodeviationswereobservedduringIQ/OQplanexecution.............................................................................. 6PurifiedWaterSystemInspectionandTestReports(Attachment#4)............................................................... 6CarbonFilter(Attachment#5)............................................................................................................................ 7TwoBedDeionization(Attachment#6).............................................................................................................. 7MixedBedDeionization(Attachment#7).......................................................................................................... 7UltraFilters(Attachment#8).............................................................................................................................. 7RecirculationPumps(Attachment#9)................................................................................................................ 7UltravioletSanitizers(Attachment#10)............................................................................................................. 7Filters(Attachment#11)..................................................................................................................................... 7Instrumentation(Attachment#12)..................................................................................................................... 7Valves(Attachment#13)..................................................................................................................................... 8Piping(Attachment#14)..................................................................................................................................... 8Controls(Attachment#15)................................................................................................................................. 8Utilities(Attachment#16)................................................................................................................................... 8SpecificationsandPurchaseOrders(Attachment#17)...................................................................................... 8Drawings(Attachment#18)................................................................................................................................ 8Lubricants(Attachment#19).............................................................................................................................. 8SpareParts(Attachment#20)............................................................................................................................. 8EngineeringDocumentation(Attachment#21).................................................................................................. 9PurifiedWaterSystemInspectionandTestReports(Attachment#22)............................................................. 9OperatingandPreventiveMaintenanceProcedures(Attachment#23)............................................................ 9InstrumentCalibrations(Attachment#24)......................................................................................................... 9OperationVerification(Attachment#25)........................................................................................................... 9PurifiedWaterSystemOperation(Attachment#26)......................................................................................... 9PurifiedWaterSystemController(Attachment#27)......................................................................................... 9Autosentinal(Attachment#28).......................................................................................................................... 9ChemicalandBiologicalTestingofPurifiedWaterSystem (Attachment#29)............................................... 10PowerFailureShutdownandStartup(Attachment#11)................................................................................. 10Attachments...................................................................................................................................................... 10

11. End of document ............................................................................................................ 11

1. Revision History

Revision Description of Change

0 Initial Release


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2. ObjectiveThe purpose of this Installation/Operational Qualification report (IQ/OQ) is to confirmthat the installation and operation qualification requirements and acceptance criteria forthe Purified Water System located at Gerbig Engineering Company in Burnsville,Minnesota, USA have been successfully me. Successful completion of these validationrequirements provides assurance that the system was installed and operates inconformance with engineering design and construction specifications, and meets thecurrent Good Manufacturing Practices (cGMP), regulatory, and quality obligations.

All acceptance criteria established in the IQ/OQ Protocol have been met, and theinstallation and operation of Purified Water System is considered qualified.

3. Scope

This Installation/Operational Qualification report confirms the installation andoperational qualification requirements and acceptance criteria for the Purified WaterSystem located at the Gerbig Engineering, Burnsville, MN, USA. This plan includes thefollowing systems:

Purified Water System Purified Water System use points Purified Water Distribution Piping

The system, new piping and use points have been qualified as part of the PurifiedWater System Installation/Operational Qualification (IQ/OQ) prior to the system beingput into use.

This IQ/OQ is intended to be used as a plan to define the installation qualificationrequirements and acceptance criteria for the Purified Water System. The PurifiedWater System IQ/OQ has been be executed and results compiled in accordance withthe IQ/OQ protocol.

All validation work has been performed as defined in the approved protocol. Alldocumentation required for the protocol is contained in the executed protocol and thisreport, or the storage location identified. Any deviation or variation observed during the

execution of the plan has been documented with resolution and approval. No deviationwas observed during protocol execution.

4. BackgroundThe Purified Water System has been installed to meet the needs of the lab at GerbigEngineering Company. The DI water system consists of two main components, the DIwater source and the DI water distribution system. The DI water system has a capacityof 15 GPM.


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The DI water system IQ portion of the protocol has been performed to verify anddocument installation in accordance with manufacturers specifications and specificrequirements.

The DI water system OQ potion of the protocol has been performed to verify anddocument that the system meets acceptable operational requirements. The OQ willinclude the following tests:

Bioburden Endotoxin TOC Resistivity/Conductivity Alarms testing Controller verification

Due to the nature of the labs being serviced by this water system, there are no limitsfor bioburden, endotoxin, TOC, and resistivity/conductivity tests and the data has beencollected for informational purposes only.

5. Systems DescriptionThe Purified Water System is a new 15 GPM skid provided by Smith Engineering.

The Purified Water System will be designed to meet the lab water purity requirementson a continuous basis and to supply purified water to the use points on an on-demandbasis. The purified water will be continuously circulated via distribution loops, except to

perform preventive maintenance and sanitizing procedures.

A complete systems description is included in the DI IQ/OQ Protocol.

6. Acronyms and DefinitionsPertinent terms and acronyms are defined in the DI IQ/OQ Protocol.

7. References

References are defined in the DI IQ/OQ Protocol.

8. Acceptance CriteriaThe acceptance criteria for the IQ/OQ protocol are listed in Section 12 of the DI IQ/OQProtocol. Installation and operation of the Purified Water System conforms to designcriteria specified in drawings and specifications.


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All relevant information has been recorded in the executed IQ/OQ protocol and anyadditional information is attached. No deviations were observed during IQ/OQ planexecution.

This IQ/OQ report, the completed IQ/OQ protocol and any additional informationattached will be used as the acceptance report for the Installation/OperationalQualification of Purified Water System after review and acceptance.

This IQ/OQ report must be reviewed and approved by the individuals listed on the frontof this protocol for the Installation/Operational Qualification to be consideredacceptable.

9. Schedule

Installation/Operational Qualification of the new Purified Water System and piping anduse points occurred in November 2008. The system has been documented accordingto the IQ/OQ protocol and the final report issued for complete systeminstallation/operation qualification acceptance.

10. Test Plan Attachments

Signature Verification Form (Attachment #1)All persons involved with the execution of this Installation Qualification protocol have

completed a line of the Signature Verification Form Attachment #1.

Test Instrument Data Form (Attachment #2)All test instruments used during protocol execution are listed on the Test InstrumentData Sheet, Attachment #2 of the Installation Qualification document, including themanufacturer, model number, serial number, date of calibration and calibration duedate. Copies of NIST traceable calibration certificates for each test instrument areincluded in Attachment #2.

Protocol Deviation Report Form (Attachment #3)

No deviations were observed during IQ/OQ plan execution.

Purified Water System Inspection and Test Reports (Attachment #4)Any inspection, start-up, or other test reports associated with the Cleanroom PurifiedWater System have been identified and documented in Attachment #4. The start upconducted by Smith Engineering is documented in this Attachment.


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Carbon Filter (Attachment #5)The carbon filter installation has been inspected and documented in Attachment #5.The carbon filter has been installed in accordance with specifications and isacceptable.

Two Bed Deionization (Attachment #6)The two bed deionization installation has been inspected and documented inAttachment #6. The 4 sets of 2 tanks are documented in this Attachment. The twobed deionization installation is acceptable.

Mixed Bed Deionization (Attachment #7)The mixed bed deionization installation has been inspected and documented inAttachment #7. The two tank installation is documented in this Attachment. The mixed

bed deionization installation is acceptable.

Ultra Filters (Attachment #8)The three single element Desal ultrafilters have been inspected and documented inAttachment #8. The ultrafilter installation is acceptable.

Recirculation Pumps (Attachment #9)The recirculation pumps have been inspected and documented in Attachment #9. The HP two bed unit and the 1 HP mixed bed unit are installed in accordance withspecifications. The recirculation pump installation is acceptable

Ultraviolet Sanitizers (Attachment #10)The two ultraviolet sterilization lightsfor the Purified Water System have beeninspected and documented in Attachment #10. One UV light is installed after the twobed DI bed and one after the mixed bed before the ultrafilters in the distribution loop.The ultraviolet sterilizer installation is acceptable.

Filters (Attachment #11)The single 5 micron two bed post filter and the three 0.45 micron mixed bed post filters

for the Purified Water System have been inspected and documented in Attachment#11. The filter installation is acceptable.

Instrumentation (Attachment #12)All instrumentation associated withthe Purified Water System has been inspected anddocumented in Attachment #12. Instrumentation consists of pressure gauges, flowcontroller, flow meters, and resistivity monitors. All instruments have been installed asspecified and the instrumentation installation is acceptable


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Valves (Attachment #13)Valves associated with the System are documented in Attachment #13. All valves onthe purified water skid are documented, as well as the use point valves which are zerodead leg. All valves are appropriate for their intended use.

Piping (Attachment #14)Piping which is part of the System is documented in Attachment #14. All piping hasbeen inspected, is installed according to specifications, and meets the acceptancecriteria in this protocol. All piping is Sani-tech polypropylene. Piping has been tested atrated flow and pressure visually for leaks. Piping is labeled.

Controls (Attachment #15)Controls associated with the Water System have been inspected and documented in

Attachment #15. The primary control system consists of a GE Fanuc Versamaxcontroller. The installed controller is adequate for their intended purposes.

Utilities (Attachment #16)Utilities required for the operation of the Purified Water System have been identified,and are documented in Attachment #16. All utilities have been verified as meetingspecifications. As specified 480 VAC electrical is installed for the pumps, and 120 VACelectricity is installed for the controllers and UV sterilizers. The skid connects to 480VAC and features transformers for lower voltages required by various components.Potable source water and compressed air for tank exchange are also installed as

specified.

Specifications and Purchase Orders (Attachment #17)Specifications and purchase orders associated with the Purified Water System havebeen documented in Attachment #17. The specifications for clean water aredocumented in this Attachment.

Drawings (Attachment #18)Drawings documenting the Purified Water System have been reviewed. Drawings areidentified in Attachment #18, and their storage location noted. Any inaccuracies havebeen redlined on the original drawing to reflect the actual facility as built.

Lubricants (Attachment #19)Any lubricants in use in the Cleanroom Purified Water System are documented inAttachment #19. No lubricants are specified or were observed in use.

Spare Parts (Attachment #20)Spare parts lists for the Purified Water System are documented in Attachment #20.Spare parts lists are contained in the Smith Engineering O & M manual.


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Engineering Documentation (Attachment #21)Engineering documentation such as operation and maintenance manuals, technicalbulletins, etc. are listed in Attachment #21. The manuals provided by SmithEngineering are documented here.

Purified Water System Inspection and Test Reports (Attachment #22)Any inspection, start-up, or other test reports associated with System have beenidentified and documented in Attachment #22. The start up conducted by SmithEngineering is documented in this Attachment.

Operating and Preventive Maintenance Procedures (Attachment #23)Operating and preventive maintenance procedures are documented in Attachment#23. The SOP for operation and maintenance of the system is documented in this

Attachment.

Instrument Calibrations (Attachment #24)System instrumentation identified as requiring calibration is documented in Attachment#24. Two conductivity cells which display on one conductivity meter are documentedwith calibration certificates attached.

Operation Verification (Attachment #25)The carbon filter backwash cycle operation was verified and is documented inAttachment #25. The carbon filter backwash cycle operates as intended and is

acceptable. No free chlorine can be detected at Valve #2 following backwash.

Purified Water System Operation (Attachment #26)The Purified Water System operation was verified and is documented in Attachment#26. The Purified Water System operates as intended and is acceptable. Completeddaily logs are attached in this section.

Purified Water System Controller (Attachment #27)The Purified Water System GE Fanuc Controller operation has been verified anddocumented in Attachment #27. The controller operates as intended and is

acceptable. The function of the two-bed water quality, mixed bed water quality, twobed pump, mixed bed pump, and lead two bed quality lights have all been verified andfound to meet the acceptance criteria in the OQ protocol.

Autosentinal (Attachment #28)The Autosentinal and Autodialer alarm and normal operations functions have beenverified and documented in Attachment #28. The Autosentinal operates as intendedand is acceptable. Call logs to Smith Engineering are attached.


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Chemical and Biological Testing of Purified Water System(Attachment #29)

Attachment #29 provides a summary of key water use point test results. CFU, EU,TOC, and resistivity results are all included in this attachment. All microbial tests wereconducted on all System use points for three consecutive days. TOC and conductivitywas measured on one day at the distribution loop piping return to the skid. All testingwas carried out in accordance with the IQ/OQ protocol and results met therequirements of the protocol which is for information only.

Microbial samples were taken at all accessible Purified Water System use points.Microbial Colony Forming Units (CFU) counts ranged from 0 to 74CFU per ml of watersampled. These results meet the protocol acceptance criteria of Information OnlyCFU/ ml. All test results are included in Attachment #29.

Endotoxin results were all 1.0); 30-18 (0.01); and 30-26 (0.166) which meets the acceptancecriteria of for information only.

Total Organic Carbon (TOC) results were determined by an inline meter connected todistribution loop return to skid at valve #50. All results for TOC met the acceptancecriteria of information only. Results were 6 ppb.

Resistivity results were determined by samples taken with the inline TOC meter alongwith TOC readings. Results for resistivity met the acceptance criteria of information

only. Results were 16.7 Mohm/cm.

Power Failure Shutdown and Startup (Attachment #30)

Power failure shutdown and startup was performed on November 12, 2008. All resultsmet the acceptance criteria. The system shut down with no damage when power wasinterrupted, and started up normally upon restoring power.

Attachments

Attachment #1 Signature Verification Form

Attachment #2 Test Instrument Data FormAttachment #3 Protocol Deviation Report FormAttachment #4 Inspection and Test ReportsAttachment #5 Carbon FilterAttachment #6 Two Bed DeionizationAttachment #7 Mixed Bed DeionizationAttachment #8 Ultra FiltersAttachment #9 Distribution PumpsAttachment #10 Ultraviolet SanitizersAttachment #11 Filters


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Attachment #12 InstrumentationAttachment #13 ValvesAttachment #14 Distribution Loop Piping

Attachment #15 ControlsAttachment #16 UtilitiesAttachment #17 Specifications and Purchase OrdersAttachment #18 DrawingsAttachment #19 LubricantsAttachment #20 Spare Parts ListAttachment #21 Engineering DocumentationAttachment #22 Start Up ReportsAttachment #23 Operating and Preventive Maintenance ProceduresAttachment #24 Instrument CalibrationAttachment #25 Carbon Filter Backwash

Attachment #26 Purified Water SystemAttachment #27 GE Fanuc ControllerAttachment #28 Auto Sentinel / Auto DialerAttachment #29 Biological and Chemical TestingAttachment #30 Power Failure Shutdown and Startup

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