FORM-943 IQ OQ Miris Ultrasonic Processor

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic ProcessorFigure 1. The Miris Ultrasonic Processor1. Sound reducing cabinet2. Power supply unitCOMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 1 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic ProcessorTable of contentsGeneralities . 31.Objectives . 32.References . 33.Definitions, Terms and Abbreviations . 34.Signature table . 4Installation qualification (IQ) . 55.Objective . 56.Scope . 57.Equipment origin and identification . 58.Equipment delivery . 69.Environment and siting . 710.Equipment safety . 711.Installation . 812.IQ summary report . 10Operational Qualification (OQ). 1113.Objective . 1114.Scope . 1115.Functional tests . 1116.Training . 1217.OQ summary report . 13COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 2 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic ProcessorGeneralities1. ObjectivesThe objectives of the IQ are to ensure that equipment documentation, delivery and installation conformto the manufacturer’s literature, and to confirm the reference information of the equipment.The objectives of the OQ are to determine that the equipment operates according to specifications, andto record all relevant information and data to demonstrate it functions as expected according to themanufacturer’s specifications.When IQ/OQ protocol is approved after execution, the Miris Ultrasonic Processor will be ready for usein non-critical applications and for further testing.2. References2.1 The following documents are referred to within the IQ/OQ protocolNo Document titleDocument IDCommentsDOC-8651 Miris Ultrasonic Processor User Manual3. Definitions, Terms and Abbreviations3.1 criptionInstallation Qualification / Operational QualificationFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 3 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic Processor4. Signature tableAll the trained personnel who have been working on the protocol must fill the information required in thelist below and put down their signatures.5.1 M-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorTrainedaccording to [1]Version: 1InitialsPage 4 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic ProcessorInstallation qualification (IQ)5. ObjectiveThe objectives of the IQ are to ensure that equipment documentation, delivery and installation conformto the manufacturer’s literature, and to confirm the reference information of the equipment.6. ScopeIQ should be performed at the time of installation, modification, or relocation. The Miris UltrasonicProcessor shall be in power-off during the execution of the IQ protocol.7. Equipment origin and identification7.1 Equipment referencesEquipment nameMiris Ultrasonic ProcessorEquipment descriptionMiris Ultrasonic Processor reduces the particle size distribution inmilk. This device is intended for use in laboratories by laboratorypersonnel.ManufacturerService contactEquipmentMiris ABDanmarksgatan 26753 23 UPPSALASWEDENwww.MirisSolutions.comTel: 46 18 14 69 07e-mail: support@MirisSolutions.comserial numberproduct numberDate receivedCondition when receivedNew Serviced Location installedVerified by:Date and signature:COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 5 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic Processor8. Equipment deliveryUnpack and check the contents of the equipment package. Please note that when a MirisUltrasonic Processor is returned after a repair or service, all items listed here may not beincluded.8.1 Are any of the standard items missing?ItemSound reducing cabinet (Figure 1)Power supply unit (Figure 2)Convertor housing with probe (Figure 2)Tube holderPower cable (Figure 3)Emery cloth 3 pcsRubber carpetMiris Ultrasonic Processor User ManualPresent Figure 2. Power supply unit and Convertor housing with probe on topManufacturer informed of any missing itemsYes Missing Figure 3. Power cableNo Comments and follow-upVerified by:Date and signature:COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 6 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic Processor8.2 Are there any damages to the equipment or accessories?No Yes If yes, name the item anddescribe the damageCorrective actionManufacturer informedYes No Verified by:Date and signature:9. Environment and siting9.1 Verify that the operating environment of the equipment meets the below requirementsConditionOperating parameter Spec ified rangeDeviationmetInput voltage 110/230 V,Power supply 50/60 Hz, 2.3ACommentsVerified by:Date and signature:10. Equipment safety10.1 Verify that the Manufacturer’s safety recommendations are metConditionVerifiedPlace on a level, stable surface Place in an area free from dust, dirt, explosives,corrosive fumes, and extremes of temperature and humidityPlace to avoid draft and vibrations Ensure correct power supply In case of unstable power supply,N/A use an UPS (uninterruptible power supply)Read the User Manual before use CommentFurther comments and follow-upVerified by:Date and signature:COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 7 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic Processor11. Installation11.1 The installation is performed by:user specialised technician/engineer 11.2 Perform/verify the following installation procedureItemUnpack the equipment (see chapter 8. Equipment delivery)OKDeviation Control of the environment and equipment placement (see chapter 9.Environment and siting and chapter 10. Equipment safety) Place the Power supply unit inside the bottom compartment of the Soundreducing cabinet. Mount Convertor housing accordingly: Place the Convertor housing with probe in the laboratory standclamp inside the cabinet. You may need to loosen the heightadjustment knob and lower the clamp to do soSecure the clamp to the upper section of the converter housingonlyPut the Convertor housing cable through the hole on the upperpart of the Sound reducing cabinetFigure 4. Convertor housing placed in the laboratorystand inside the cabinet. Cable is directed through thehole in the upper part of the cabinet.COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 8 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic ProcessorPlug the Convertor housing cable into the socket at the back of the Powersupply unit. Figure 5. Back of Power supply unit where the circleindicates the socket where the Convertor housing cableshould be plugged in.Connect the Power cable into the Power socket at the back of the Powersupply unit.Figure 6. Back of the Power supply unit where the circleindicates the socket where the Power cable should beplugged in.Connect the Power cable to a power supplyComments including any deviationsVerified by:Date and signature:COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 9 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic Processor12. IQ summary reportEquipment: Miris Ultrasonic ProcessorManufacturer: Miris AB12.1 Assessment of complete Installation Qualification:No deviations 12.2 IQ deviationsDeviation DeviationNoDeviations (list below) Impact on operationJustification foracceptanceCompletion of the preceding protocol indicates that this Miris Ultrasonic Processor has been adequatelydelivered and installed. The Installation Qualification has been passed and the equipment may besubmitted for Operational Qualification.Deviations approved by:Date:IQ approved by:Date:COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 10 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic ProcessorOperational Qualification (OQ)13. ObjectiveObjectives of the OQ is to determine that the equipment operates according to specifications, and torecord all relevant information and data to demonstrate it functions as expected according to themanufacturer’s specifications.14. ScopeOQ should be performed after installation, modification or relocation, and after the InstallationQualification has been approved.15. Functional tests15.1 Perform the following tests and checks sequentiallyActionTurn on the Miris UltrasonicProcessor by pressing (I)Refer toUser Manual Chapter 3,Operating the MirisUltrasonic ProcessorAcceptance criteriaDisplay illuminatesPassFail Make sure the probe is notin contact with any surface.Set the timer on the MirisUltrasonic Processor to 3seconds.Set the amplitude to 100%.Start the sonicatingprocess.User Manual Chapter 3,Operating the MirisUltrasonic ProcessorThe sonication processstarts with a high pitchsoundProbe output powerindicator does not exceed10%CommentsVerified by:Date and signature:If any of the functional tests fails, contact Miris AB or your distributor.COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 11 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic Processor16. Training16.1 Training verificationTrained operatorsRead theUserManualWatched altraining AuthorisingsignatureCommentsVerified by:Date and signature:COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 12 of 13

IQ OQDocument titleInstallation Qualification and Operational Qualification Miris Ultrasonic Processor17. OQ summary reportEquipment: Miris Ultrasonic ProcessorManufacturer: Miris AB17.1 Assessment of complete Operational Qualification:No deviations 17.2 OQ deviationsDeviation DeviationNoDeviations (list below) Impact on operationJustification foracceptanceCompletion of the preceding activities and checks indicates that this equipment is operating satisfactorilyfollowing delivery and installation. The instrument has passed the Operational Qualification procedureand may now be released for use in non-critical applications and further testing.Deviations approved by:Date:OQ approved by:Date:COMPANYCONFIDENTIALFORM-943 Installation Qualification and OperationalQualification Miris Ultrasonic ProcessorVersion: 1Page 13 of 13

Installation Qualification and Operational Qualification Miris Ultrasonic Processor COMPANY CONFIDENTIAL FORM-943 Installation Qualification and Operational Qualification Miris Ultrasonic Processor Version: 1 Page 1 of 13 Figure 1. The Miris Ultrasonic Processor 1. Sound reducing cabinet 2. Power supply unit