Validation ServicesSeamless Integration of Validation &Product Support

Turn key solutions

We offer the most precise and in-depth validationresources specific to Panasonic laboratory products. Whatever your validation needs are, Panasonic provides comprehensive expertise inlaboratory equipment to meet your exact compliance needs.

ValidationAs a leader in commercial, refrigeration, energy andenvironmental products, Panasonic offers a robustsource of proven technologies and technical servicesdeployed throughout a range of biomedical andmedical research products. Pioneering developmentsin consumer and industrial products are applied to allPanasonic products through the development modelof Vertical Component Integration. Because many ofour key component parts are designed and built byPanasonic, we offer onlythe most precise and in-depth validation resourcesspecific to Panasoniclaboratory products.

Detailed Validation Support PackagePanasonic also offer detailed protocols including allrequired specifications, servicing manuals andsupport documents. This package will assist yourvalidation team in the qualification process, greatlyreducing the time required to complete the entirevalidation. Panasonic validation instruments arecalibrated and maintained to the highest qualitystandards, while providing and retaining detailedrecords for all tested equipment.As the manufacturer we are the most knowledgeableon our equipment. We offer validation services forPanasonic equipment and a total solution in fulfillingother regulatory requirement.

Complete validation & qualificationsolutions for laboratory equipment(turn key solutions)

Panasonic is a vertical componentmanufacturer that can provide turn-keysolutions for validation and qualification inaccordance with all current GMPs, GLPs,GCPs, 21 CFR Part 11, PAT, ISO and specificcustomer requirements and applications.Because many of our key component partsare designed and built by Panasonic, we offerthe most precise and in-depth validationresources specific to Panasonic laboratoryproducts. Whatever your validation needsare, Panasonic provides comprehensiveexpertise in laboratory equipment to meetyour exact compliance needs. Panasonicvalidation systems employ advancedtechnology coupled with the latest trends toinsure compliance with accurate and timeefficient completion.

l IOQ (formerly IQ/OQ/PQ)l Factory acceptance testingl Independent temperature mapping servicel Qualification of critical utilitiesl National/international traceable calibrationl Customised validation protocolsl Onsite protocol executionl Commissioning of equipmentl Panasonic warranty service coverage

Validation SolutionsTurn Key Solutions available for:l Ultra low freezersl Cryogenic freezersl Medical Freezersl Pharmaceutical refrigeratorsl Incubatorsl Ovensl Autoclavesl Environmental test chambers

Panasonic can assist throughout the entire processfrom helping you to select the best suited product(s)through the extended warranty and service contractoptions to keep your equipment running. We help youmatch the appropriate equipment to yourrequirements (DQ) as well as arranging insidedelivery and setup (commissioning) of the equipment.

Installation and OperationalQualification IOQPanasonic offer onsite validation of Panasonicsupplied equipment via Installation and OperationalQualification Protocol IOQ.Installation Qualification (IQ) Verifies and documentsthe equipment installation is compliant with themanufacturers requirements and specifications.Operational Qualification (OQ) Verifies anddocuments the full functional operation of theinstalled equipment (as specified by Panasonic orother OEM supplied equipment). Temperatureperformance will be mapped over a continuous 24hrperiod; also a short open door test included towardthe end of this period. Data produced will becompared with manufacturers published equipmentspecification. Product specific parameters such asCO2/O2, %RH etc. are included within the relevantequipment IOQ protocol. Additional options: Additional temperature sensorpositions, extended logging period 48/72hrs,simulated customer loaded mapping, powerfail/recovery performance tests. Door open recovery performance test.

Panasonic validation solutions

PQ Ensures User requirements

are met

OQ Verifies Manufacturer

specs

IQ Verifies Proper Setup

Validation solutions thermal validation

User Requirement

Manufacturer specs DQ(select equipment)

PQ OQ IQ

Process Qualification (PQ) is usually conducted andperformed by customer/end-user as the equipmentwill be in a environment where specific user conditionsand actual product is loaded, stored and accessed e.g.the customers actual production or product processingarea. The PQ will probably make reference to customerspecific Standard Operating Procedures documents(SOPs). Example: product identification and specificstorage requirements; loading patterns etc. thereforemaking the PQ a unique and customer specificdocument. Panasonic however will provide assistanceto customers where required in either the preparationor assisted execution of the Process Qualification.Panasonic is also able to offer a “TemperatureMapping Service” for customers wishing to verifyactual equipment performance as installed, thisservice is also available for all NON Panasonicequipment

Factory AccceptanceWe offer in depth factory acceptance testing coveringalarms as well as temperature/ CO2 stability andrecovery. This service can also be customised to yourSOPs.

In-House Third party ManufacturerEquipment experience Broad based Broad based Most Panasonic specific experienceUp to date technical info General knowledge General knowledge Direct updatesUnexpected service issues Must be certified Must be certified Immediate solutionsTime consuming More prep. time More prep. time Most experienceKnowledge of industry standards Insufficient resources Broad based Best applicable knowledge

Commissioning

Thermal ValidationPanasonic provides a thermal validation solutionspecifically designed to conform with new FDA dataprotection guidelines (21 CFR Part 11) and meetinternational and European cGMP requirements forinspection of pharmaceutical, biotechnology andmedical device (EN285, EN554) manufacturing.Panasonic simplifies the entire validation process byreducing setup time and minimizing sensorhandling, automating sensor calibration,systematically organizing study data and generatingrequired regulatory reports.

Panasonic implements a wired process validationsystem designed around the measurement andreporting requirements of the most intenselyregulated industries. Our system meets thestandards for cGMP regulated industries forthermalvalidation and has broad regulatorycompliance.

We offer a complete package of thermalmanagement including simulations andmeasurement:l Measurement of temperature profiles, CO2, O2, %RH, lighting and pressure

l Data analysisl System design

Equipment Operation & InstallmentIn this area, we also offer support that is exactlytailored to your requirements:l General handling of the unitl Functions of the unit and its componentsl Safety instructions for operation of the unitl Aspects of starting, operation, applications andmaintenance.

In order to trace and keep intact accuracy andperformances of your laboratory equipment a regularschedule of calibration and preventive maintenance isneeded. Our objective is to provide confidence that thetested equipment meets the performance andcompliance requirements of our customers. Theacceptance phase may also act as the final qualitygateway, where any quality defects not previouslydetected may be uncovered.

Commissioning your equipment involves the following tasks:l Ensure unit meets all user requirements l Setting up the equipment l Installation of all necessary accessoriesl Calibrationl Test operation of equipment.

Equipment setup

Panasonic validation services by model

Validation by Model 4

MDF-150ºC Freezers 4

MDF-86ºC Freezers 4

MDF-30ºC Freezers 4

MBR Blood Bank 4Refrigerators

MPR Pharmaceutical 4Refrigerators

MIR Incubator Series 4 4

MCO O2/CO2 Incubators 4 4 4 4

MLS Top Loading Autoclaves 4 4

MLR Environmental Test 4 4 4Chamber

CBS Isothermal Freezers 4

CBS Standard LN2 Freezers 4

Temp. CO2 O2 %RH Lighting Pressure(Lux/Par)

Calibration

Onsite protocol execution

Immediate warranty solutions

Factory Acceptance Testing

Commisioning

Custom Validation Protocols

Panasonic Biomedical Sales Europe B.V.Head officeNijverheidsweg 1204879 AZ Etten LeurThe Netherlands

Tel: +31 (0)76 543 38 33Fax: +31 (0)76 541 37 32Email: biomedical.service.nl@eu.panasonic.comWeb: www.biomedical.panasonic.eu