device qualification of the finnpipette novus electronic pipette (iq

Device Qualification of the Thermo Scientific Finnpipette NovusElectronic Pipette (IQ/OQ/PQ)Irmgard Suominen, Marina Elf and Sami Koivisto, Thermo Fisher Scientific, Vantaa, Finland

IntroductionDuring device qualification, oneverifies and documents whether theequipment, in this case a pipette, isreliable and capable of fulfilling therequirements of its intended use.All qualification activities are fullydocumented according to pertinentquality and regulatory requirementsand signed by authorized personnel.

Installation Qualification (IQ)The main purpose of the InstallationQualification is to verify that thecorrect pipette has been deliveredand that the electrical connectionsconform to the manufacturer’sspecifications and requirements.

IQ includes but is not limited to:

Verifications

• The catalog number on the labelof the pipette shipping boxcorresponds to the purchase order.

• The pipette corresponds to theorder specifications (volume range,number of channels, model).

• The catalog number stated on theCalibration Report corresponds tothe purchase order.

• The serial number stated on theCalibration Report corresponds tothe serial number on the pipette.

• The Instructions for Usecorresponds to the purchasedpipette model (either singlechannel or multichannel model asappropriate). The catalog numberof the purchased model is statedin the Instructions for Use.

• The complete Thermo ScientificFinnpipette Novus product boxcontains the items stated in theInstructions for Use.

Technical Note: TIHPNovusQ10-0025

Key Words

• Thermo ScientificFinnpipette NovusElectronic Pipette

• Device Qualification

• InstallationQualification (IQ)

• OperationalQualification (OQ)

• PerformanceQualification (PQ)

• The following environmentalrecommendations apply:- Operating temperature 15–35°C- Relative humidity 40–92.5%

Actions• Confirm that the pipette chargeris compatible with the local powersupply and that the chargerspecifications correspond to thelocal power supply specifications.

• Fully charge the battery of thepipette, preferably for 2 hours, for the first charge.

• Confirm the existence of necessarySOPs (preventive maintenance,work instructions, etc.)

• Confirm that the required operatortraining has been conducted.

Operational Qualification (OQ)The OQ protocol verifies that thepipette is functioning in anacceptable manner. This includestesting the pipette to ensure that iscapable of operating in accordancewith the specifications andrequirements defined by themanufacturer.

OQ shall be performed after IQ andshall be repeated throughout the life of the pipette and after service. OQ must be included in the SOPs.

OQ includes but is not limited to:• Ensuring the pipette is operatingproperly by checking basicoperations and functions definedin the Instructions for Use, e.g. thefunction of the display, tip ejectorand menu.

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Lit. no. 151 7380

• Verifying pipette operation eitherby the end user or by an authorizedparty, e.g. the manufacturer. The Calibration Report provided with the pipette verifies the OQperformed by the manufacturer.User verification should beperformed in a controlledenvironment using water, e.g. inaccordance with ISO 8655. Werecommend that end users performthe verifications themselvesbecause pipetting results obtainedby the user may differ from thevalues stated in the CalibrationReport.

• Ensuring repeatable results, thepipette must be regularly servicedaccording to the Instructions for Use.

Performance Qualification (PQ)The purpose of the PerformanceQualification is to verify that thepipette is capable of properlyaccomplishing the task for itsintended use. PQ relates to the dailyuse of the pipette and is designed tomeasure routine performance.

Note: Prior to shipment, thepipettes are tested under factoryconditions. However, performancein a laboratory may vary due totemperature, pressure, humidity,operator, liquid, type of tip, etc.This should be taken into accountwhen verification and validationtests are performed.

PQ includes but is not limited to:• Determination by the user of theacceptance criteria required by themost critical pipette and tipapplication. Typically, this meanssetting acceptance limits forpipetting accuracy and precisionand verifying that the pipette andtip fulfill these criteria.

Because the pipette typically is partof a broad application comprised of several instruments, systemvalidation is recommended. Thisshould be done after PQ has beenperformed for each instrument. Inpractice, system validation oftenrequires the use of provencalibrators, samples or referenceliquids.

Thermo Scientific Finnpipette Novus Electronic Pipette

Example of a Calibration Report