Sample Qualification Report

Purified Water System Installation 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 Senior Validation Specialist Gerbig Engineering Company

___________________ Date

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

_________________________________ David Headguy, President

___________________ Date

_________________________________ Claire Quality, Chief Technical Officer

___________________ Date

Table of Contents
1. 2. 3. 4. 5. 6. 7. Revision History ............................................................................................................... 3 Objective .......................................................................................................................... 4 Scope ............................................................................................................................... 4 Background ...................................................................................................................... 4 Systems Description ........................................................................................................ 5 Acronyms and Definitions................................................................................................. 5 References ....................................................................................................................... 5

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

1. Revision History
Revision 0 Description of Change Initial Release

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Purified Water System Installation and Operational Qualification Report

2. Objective
The purpose of this Installation/Operational Qualification report (IQ/OQ) is to confirm that the installation and operation qualification requirements and acceptance criteria for the Purified Water System located at Gerbig Engineering Company in Burnsville, Minnesota, USA have been successfully me. Successful completion of these validation requirements provides assurance that the system was installed and operates in conformance with engineering design and construction specifications, and meets the current Good Manufacturing Practices (cGMP), regulatory, and quality obligations. All acceptance criteria established in the IQ/OQ Protocol have been met, and the installation and operation of Purified Water System is considered qualified.

3. Scope
This Installation/Operational Qualification report confirms the installation and operational qualification requirements and acceptance criteria for the Purified Water System located at the Gerbig Engineering, Burnsville, MN, USA. This plan includes the following 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 Purified Water System Installation/Operational Qualification (IQ/OQ) prior to the system being put into use. This IQ/OQ is intended to be used as a plan to define the installation qualification requirements and acceptance criteria for the Purified Water System. The Purified Water System IQ/OQ has been be executed and results compiled in accordance with the IQ/OQ protocol. All validation work has been performed as defined in the approved protocol. All documentation required for the protocol is contained in the executed protocol and this report, or the storage location identified. Any deviation or variation observed during the execution of the plan has been documented with resolution and approval. No deviation was observed during protocol execution.

4. Background
The Purified Water System has been installed to meet the needs of the lab at Gerbig Engineering Company. The DI water system consists of two main components, the DI water source and the DI water distribution system. The DI water system has a capacity of 15 GPM.

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Purified Water System Installation and Operational Qualification Report The DI water system IQ portion of the protocol has been performed to verify and document installation in accordance with manufacturers specifications and specific requirements. The DI water system OQ potion of the protocol has been performed to verify and document that the system meets acceptable operational requirements. The OQ will include 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 limits for bioburden, endotoxin, TOC, and resistivity/conductivity tests and the data has been collected for informational purposes only.

5. Systems Description
The 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 requirements on a continuous basis and to supply purified water to the use points on an on-demand basis. 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 Definitions

Pertinent terms and acronyms are defined in the DI IQ/OQ Protocol.

7. References
References are defined in the DI IQ/OQ Protocol.

8.

Acceptance Criteria
The acceptance criteria for the IQ/OQ protocol are listed in Section 12 of the DI IQ/OQ Protocol. Installation and operation of the Purified Water System conforms to design criteria specified in drawings and specifications.

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Purified Water System Installation and Operational Qualification Report All relevant information has been recorded in the executed IQ/OQ protocol and any additional information is attached. No deviations were observed during IQ/OQ plan execution. This IQ/OQ report, the completed IQ/OQ protocol and any additional information attached will be used as the acceptance report for the Installation/Operational Qualification of Purified Water System after review and acceptance. This IQ/OQ report must be reviewed and approved by the individuals listed on the front of this protocol for the Installation/Operational Qualification to be considered acceptable.

9.

Schedule
Installation/Operational Qualification of the new Purified Water System and piping and use points occurred in November 2008. The system has been documented according to the IQ/OQ protocol and the final report issued for complete system installation/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 Instrument Data Sheet, Attachment #2 of the Installation Qualification document, including the manufacturer, model number, serial number, date of calibration and calibration due date. Copies of NIST traceable calibration certificates for each test instrument are included 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 Purified Water System have been identified and documented in Attachment #4. The start up conducted 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 is acceptable.

Two Bed Deionization (Attachment #6)

The two bed deionization installation has been inspected and documented in Attachment #6. The 4 sets of 2 tanks are documented in this Attachment. The two bed deionization installation is acceptable.

Mixed Bed Deionization (Attachment #7)

The mixed bed deionization installation has been inspected and documented in Attachment #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 in Attachment #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 with specifications. The recirculation pump installation is acceptable

Ultraviolet Sanitizers (Attachment #10)

The two ultraviolet sterilization lights for the Purified Water System have been inspected and documented in Attachment #10. One UV light is installed after the two bed 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 with the Purified Water System has been inspected and documented in Attachment #12. Instrumentation consists of pressure gauges, flow controller, flow meters, and resistivity monitors. All instruments have been installed as specified 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 on the purified water skid are documented, as well as the use point valves which are zero dead 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 has been inspected, is installed according to specifications, and meets the acceptance criteria in this protocol. All piping is Sani-tech polypropylene. Piping has been tested at rated 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 Versamax controller. 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 meeting specifications. As specified 480 VAC electrical is installed for the pumps, and 120 VAC electricity is installed for the controllers and UV sterilizers. The skid connects to 480 VAC 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 have been documented in Attachment #17. The specifications for clean water are documented in this Attachment.

Drawings (Attachment #18)

Drawings documenting the Purified Water System have been reviewed. Drawings are identified in Attachment #18, and their storage location noted. Any inaccuracies have been 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 in Attachment #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, technical bulletins, etc. are listed in Attachment #21. The manuals provided by Smith Engineering are documented here.

Purified Water System Inspection and Test Reports (Attachment #22)

Any inspection, start-up, or other test reports associated with System have been identified and documented in Attachment #22. The start up conducted by Smith Engineering 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 documented with calibration certificates attached.

Operation Verification (Attachment #25)

The carbon filter backwash cycle operation was verified and is documented in Attachment #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. Completed daily logs are attached in this section.

Purified Water System Controller (Attachment #27)

The Purified Water System GE Fanuc Controller operation has been verified and documented in Attachment # 27. The controller operates as intended and is acceptable. The function of the two-bed water quality, mixed bed water quality, two bed pump, mixed bed pump, and lead two bed quality lights have all been verified and found to meet the acceptance criteria in the OQ protocol.

Autosentinal (Attachment #28)

The Autosentinal and Autodialer alarm and normal operations functions have been verified and documented in Attachment # 28. The Autosentinal operates as intended and 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 were conducted on all System use points for three consecutive days. TOC and conductivity was measured on one day at the distribution loop piping return to the skid. All testing was carried out in accordance with the IQ/OQ protocol and results met the requirements 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 74 CFU per ml of water sampled. These results meet the protocol acceptance criteria of Information Only CFU/ ml. All test results are included in Attachment #29. Endotoxin results were all <0.01 EU/ml except for results from day three of testing at use points 30-19 (>1.0); 30-18 (0.01); and 30-26 (0.166) which meets the acceptance criteria of for information only. Total Organic Carbon (TOC) results were determined by an inline meter connected to distribution loop return to skid at valve #50. All results for TOC met the acceptance criteria of information only. Results were 6 ppb. Resistivity results were determined by samples taken with the inline TOC meter along with 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 results met the acceptance criteria. The system shut down with no damage when power was interrupted, and started up normally upon restoring power.

Attachments
Attachment #1 Attachment #2 Attachment #3 Attachment #4 Attachment #5 Attachment #6 Attachment #7 Attachment #8 Attachment #9 Attachment #10 Attachment #11 Signature Verification Form Test Instrument Data Form Protocol Deviation Report Form Inspection and Test Reports Carbon Filter Two Bed Deionization Mixed Bed Deionization Ultra Filters Distribution Pumps Ultraviolet Sanitizers Filters

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Purified Water System Installation and Operational Qualification Report Attachment #12 Attachment #13 Attachment #14 Attachment #15 Attachment #16 Attachment #17 Attachment #18 Attachment #19 Attachment #20 Attachment #21 Attachment #22 Attachment #23 Attachment #24 Attachment #25 Attachment #26 Attachment #27 Attachment #28 Attachment #29 Attachment #30 Instrumentation Valves Distribution Loop Piping Controls Utilities Specifications and Purchase Orders Drawings Lubricants Spare Parts List Engineering Documentation Start Up Reports Operating and Preventive Maintenance Procedures Instrument Calibration Carbon Filter Backwash Purified Water System GE Fanuc Controller Auto Sentinel / Auto Dialer Biological and Chemical Testing Power Failure Shutdown and Startup

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