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Advanced Validation SystemKaye Validator AVSTurn thepage to theNext Generation.

Advanced Validation TechnologyThe Kaye Validator AVS (Advanced Validation System) is a state of the art validation systemdesigned to meet current regulatory requirements for Thermal Validation and Data Integrity.The Validator AVS combines high accuracy measurements, automated sensor calibration, intuitivemetro style user interface, and extensive reporting to simplify the complete validation process.The Validator AVS is the successor of the widely recognized Kaye Validator 2000, the acceptedstandard in wired validations systems for over 20 years. Hardened, Dedicated Validation Console Asset Centric Data Management Concept Intuitive Metro-Style User Interface Enhanced Connectivity Increased Scan Speed2 Kaye Validator AVS

Lifting Validation to the Next LevelThe Kaye Validator AVS System is a unique design and concept combining a stand-aloneValidator AVS along with a Validator AVS Console. The AVS console is a rugged hardened consolededicated to interfacing with your Kaye Validator AVS. It is pre-loaded with the Kaye AVS softwareand a core load that is dedicated to Validation tasks only. This concept greatly simplifies softwarevalidation and dependency on continuously changing PC’s, Operating Systems, and core loads.The Kaye Validator AVS offers easy, dedicated and reliable validation. The AVS is intuitive,efficient, and easy to operate - allowing you to focus on the validation, not the technology. Portable Validation Console Pre-loaded Software Dedicated to Validation Tasks Simplified Compliance andEasy Validation Data Integrity and 21 CFR Part11 Compliant Direct connection viadocking mechanism / WiFi and Ethernet Console Can be Used toInterface with MultipleAVS Units Stand-Alone Operation Reliable Data Safety bySmart RedundancyConcept Battery Backup 3 HoursAdvanced Validation Technology 3

Applications - Challenges - SolutionsApplications Steam Sterilizers (Autoclaves) Dry Heat Sterilizers Steam in Place (SIP) Water Cascade/Fall Sterilizers Incubators Stability Chambers Freezers Freeze Dryer/Lyophilisation VesselsChallenges Pharmaceutical industries are faced w IT Environment Increased IT security and lock dow Continually changing operation sy- Hardware compatibility- Complex software operation Validation Diverse evolution of technologies i- Data backward compatibility Complex and time consuming data- Cost and time of validation and4 Kaye Validator AVS

Solutions Kaye Validator AVS Console dedicated forvalidation OS and Hardware controlled and validated byKaye Eliminates IT control Intuitive metro-style touch screen interface Simplified Validation Asset Centric Data Management concept Data Integrity / 21 CFR part 11 compliantwith increasing operational challengeswn on portable dataystemsin validationa organizationre-validationAdvanced Validation Technology 5

Kaye Validator AVSAVS SystemA Kaye Validator AVS system consists of theValidator AVS and the Validation Console. Theconsole can be docked directly to the ValidatorAVS and is used as the operator interface tothe Validator AVS.Selectable input capacity (1 to 4 SIMs) up to 48total inputs.Robust Design Robust industrial design with two handles IPL55 rating, chemical resistant ABS housing Dedicated Validation Console for improveduser interface On-board docking station for Kaye ValidationConsole Battery backup with field replaceable batterypack (3 hours)Data Security via Smart RedundancyConcept Standalone operation of Validator AVS –console connection not needed Validator AVS Internal Memory Second independent mirrored memory cardfor data redundancy Data download to validation console Manual download of study and audit data toUSB Backup and restore – synchronization ofconsole data with server and other consoles6 Kaye Validator AVSButton forData DumpUSB forThumb Drive

Hardware ConnectivityThe Kaye Validator AVS comes completewith improved robust connections for IRTDand Calibration Baths. The Validator AVS isbackward compatible with all existing IRTD andKaye Baths for Automatic Calibration. Two relayoutputs are also available to be activated viaQualification events.Min Din Ports forIRTD & BathUSB / EthernetUSB / EthernetRelay PortsUSB Device for ICALOn / Off SwitchAC Power InputThe Validator has 4 slots on the back of the unit foreasy plug-in of SIMsSensor Inputs Up to 4 SIMs 48 channel capacity Scan speed of 48 channels per second SIMs for TCs, 4-20mA, 0-10V and RTDs Improved Sensor Connectivity (quick-fix &lock connectors) Accepts a wide range of thermocouple types(T, T premium, J, K, E, B, R, N, S)Advanced Validation Technology 7

Kaye Validation ConsoleA New Flexible Approach to ValidationThe Kaye Validator AVS Console is a state-of-the-art,portable and rugged console dedicated to the programming,displaying, reporting, and storage of Validator AVS data. TheConsole comes pre-loaded and configured with the KayeAVS software and is customized to specific Validation tasks.The Console offers direct docking and Wi-Fi connectivitywith the Validator AVS; it brings about a new approach totackling your Software Validation.Validation Console SpecificationsIntel Core ProcessorSeparate Docking StationAvailableDurabilityI/O PortsIP54 rated- Water, Dust and Splash resistantDocking ConnectorProcessor - Durable Gorilla GlassUSB 3.0 port with rubberizedcover- Rubberized for shock dampeningEmbedded I/O- Molded Handle to prevent dropsDisplayOn-Board Camera capabilityof taking pictures withConsole10.4“ Display with ProjectiveCapacitive Dual Touch Gorilla GlassDimensions / WeightSystem Storage10.0“ x 10.0“ x .95“(256mm x 256mm x 24.3mm)mSATA Solid State Drive (SSD)3.3 lbs (1,50 kg) 1Integrated CommunicationsBatteryIntel Centrino Advanced-N 6235Battery life up to 6 hours 2IEEE 802.11a/b/g/n Wi-Fi 1. Weight represents approximate system weight measured with a 40WHr battery. Actual system weight may vary depending on component andmanufacturing variability.2. Battery life varies by configuration, applications in use, utilized features and operating conditions. Maximum battery capacity decreases with time and use.8 Kaye Validator AVS

Two ways to Connect the Validation Consoleto the Kaye Validator AVS1Docking Mode(Standalone)The console sits in the dockingstation of the Validator AVS andconnects directly.The Validator AVS offers a fullyfunctional docking station withdirect access to the ports locatedon rear of the unit.2Network ModeThe Validator AVS and the consolecan connect to a local network byusing Ethernet or Wi-Fi connection.One validation console can handlemultiple Kaye Validator AVS‘s simultaneously.Console battery is charged whiledocked.The Kaye Validator AVS system can establish wireless connections* by utilizing any kind ofavailable Wi-Fi infrastructure like in-house Wi-Fi access points or simply set up a smartphone asa hotspot. This feature simplifies your daily routine work. You can access the live data wirelesslyon the console screen while the Validator is wired on the other side of the autoclave. You canstart or stop studies and read the live data from a Kaye Validator AVS in a cleanroom withoutentering the room.* This feature is not available in some countries. Please contact your local Kaye support for details.Advanced Validation Technology 9

Kaye Validator AVS SoftwareAsset Centric Data ManagementThe Kaye Validator AVS includes an intuitive Asset Centric Data Management concept (patentpending) which allows you to store and access your data faster and more efficiently.Each individual process that you validate whether an autoclave or freezer etc. can be setup anddefined as an asset. All files and data related to this asset, like setups, calibrations, or study files,are organized and accessedin one single screen aroundthe basic asset data. It is evenpossible to upload additionaldocuments like standardoperation procedures orcertificates and associate it withthe asset. Assets can be sortedand searched by type, location,manufacturer etc. for easyaccess. Organized Study Data Simplified Data SearchEquipment AssetsThe Kaye Validator AVS also allows you to define assets for each piece of Kaye Validationequipment. Data such as serial number, calibration due dates can be defined. The software willautomatically notify user when calibrations are due.The equipment search functionuses the Kaye serial number, thatis automatically retrieved as part ofthe study file*, to find related files.With just one fingertip you get a listof qualification studies, where theequipment asset was used.* not for Temperature bath product line10 Kaye Validator AVS

Sensor CalibrationKaye the original creator of the Automatic Sensor Calibration feature has included enhancementseliminating manual methods of sensor calibration resulting in better accuracy. The Kaye ValidatorAVS is backward compatible to existing Kaye IRTD and Calibration baths. The AutomaticCalibration feature minimizes training and ensure accurate, and repeatable calibrations optimizedfor your Kaye calibration equipmentSelect only the sensors you want to calibrate. Defining acalibration set lets you calibrate any number of sensorsamong all those wired to the system.Set the criteria for a sensor calibration - low, high and checkpoint for the actual calibration.The Console shows the entire calibration process on onescreen. Data fields change color to show the progress ofstability and deviation for each sensor. A status screen listseach step and indicates where the system is in the process.HardwareThe Kaye Validation console can connect to a Validator AVS directly through the docking port ofthe AVS or any network based connection available. It enables the user to transfer setups, startstudies and monitor live data or read finished studies. After the start a study, the Validator AVSruns the tasks independently. One Kaye Validation console can control several Validator AVS inparallel and one Validator AVS can handle several consoles. That means you can disconnect andwork with a different Validator AVS.While connected to the ValidatorAVS the user can see the livedata in List or or Layout view,group based calculation andevent messages. Any connectedhardware is displayed withserial number. Simple colorcode informs the operator of thecalibration status of his sensorsand sensor input modules.Advanced Validation Technology 11

Wiring DiagramKaye AVSReporting ToolDocument Critical Validation StudiesThe Kaye Validator AVS Console includes an extensiveand flexible Reporting Tool used to analyze and documentyour critical Validation studies. The AVS Reporting Tool is aseparate application which is seamlessly integrated into theAVS software. It can be used to documnet your Validationstudies, as well as provide Pass/Fail Criteria analysis tosave hours of manual efforts.While offering several new features and enhancements,the Reporting Tool is designed to ensure that the provenand accepted formats of the Validator 2000: Summary,Detailed Interval and Calibration reports are maintained,and Calibration formats are maintained.Detailed Lethality ReportEnhancements to Graphing reports, Set-up reports, as wellas new reports such as Pass/Fail Criteria Report, providefaster and more detailed ways of analyzing your data.Reports can be previewed, printed, saved as a PDF orexported in CSV format.Configuration ChoicesPrior to generating reports the AVS Reporting Toolprovides a host of configuration choices: Sensors Included in Report Sensors Separated by Groups Sensor Placement and Description Define Cycles ( Qualification, Exposure, etc) Calculations (Statistical, Lethality, Saturation, MKT etc) Header / Footers Graphing Templates with Pass / Fail Criteria analysisThese features provide maximum flexibility to ensure youget the data and calculations you need in the format youneed to meet your Validation reporting needs.12 Kaye Validator AVSCalibration Report

Graph ReportReportingGraph Lethality Report AVS Wiring Layout Setup Report Calibration Report Graph Report Detailed Report:- StatisticalPass / Fail Report- Lethality- Saturation- MKT Summary Report Verification Report Pass / Fail Criteria ReportQualification Report Audit Trail ReportAdvanced Validation Technology 13

Data Integrity / 21 CFR Part 11ComplianceThe Validator AVS was designed to meet the current regulatory guidelines for Data Integrity and 21CFR Part 11. From the design of the Validation Console which minimizes operator access to filesto the automated Sync functions to provide secure back up of the files. The system was designedto provide ease of use while in the background providing the data management and security tomeet regulatory guidelines. All of these functionalities are fully documented in our Data Integrityand 21 CFR Part 11 Assesment documents.User ManagementPoliciesData Integrity ComplianceAudit Trail ReportThe Kaye Validator AVS is specifically designed to enable compliance with FDA 21 CFR Part11. All recorded data, including calibration offsets, set-up parameters, and administrativetasks are saved in secure, encrypted, tamper-proof electronic records in a format accessibleonly through the system software. In addition to pre-configured privilege levels, it is possibleto explicitly set permissions for each user.With data synchronization to a shared folder it is possible to exchange configuration and datafiles like your assets, setups and study files with other Kaye Validation consoles. It also allowsto synchronize the user database but also merging the audit trails of several consoles enablingsorting, searching and printing of department-wide audit trails, for example, a list of all failedlogin attempts within a specified time period across all synchronized Kaye Validation consoles.Every console has a unique but customizable machine ID for identification.14 Kaye Validator AVS

Calibration / VerificationHigh Accuracy ReferencingFast/Accurate ReferencesKaye’s temperature calibration equipment isdesigned specifically to maximize overall systemaccuracy. Calibration equipment includestemperature references with superior uniformityfor sensors, traceable intelligent RTD standards,and validation software to communicate with thehardware.One temperature reference covers the temperaturerange for the high and low calibration point used fora typical validation study. Choose the model thatbest fits your need from the chart below.Temperature dry wells employ unique inserts thatminimize cooling of the thermocouple tips due tostem conduction. Without proper inserts, transferuncertainty in excess of 0.5 C can occur with 22gage, type T thermocouples. Amphenol units provide an uncertainty of 0.1 C.Intelligent RTD StandardThe IRTD Temperature Standard (IRTD-400) is aNIST-traceable instrument that is calibrated over therange of -195 C to 420 C. It is accurate to 0.025 Cover the entire operating range.The IRTD-400 is a completely self-containedmeasurement system, containing the electronics forcalibration and temperature conversion.Communicating directly with the Validatorsoftware, the IRTD-400 eliminates the potentialfor human error, assuring accurate and traceablemeasurements.Calibrating over a more limited range will alsoincrease accuracy. Since regulations require calibration for the temperature range of a process,an autoclave, for example, can be calibrated from90 C to 125 C. This method reduces the error fromthermocouple characteristics to less than 0.05 C—atwo-fold improvement over a calibration at 0 C and125 C.The temperature bath, CTR-80, provides very fastresponse (90 minutes from ambient to -80 C) andquiet operation. Rugged casters allow this unit to bemoved with little effort. A specially designed coversupports two IRTD standards and all thermocouplesfrom the Kaye Validator AVS.CTR-40CTR-80Temperature Range-40 to 150 C-80 to100 CTemperature Stability 0.005 C to -40 C (ethanol) 0.005 C to 25 C (eau) 0.007 C to 150 C (huile5012) 0.03 CTemperature Uniformity 0.01 C 0.03 CHTR 400LTR -25/140LTR-40/140LTR-9025 C above ambientto 400 C–25 C to140 C–40 C to140 C–95 C to140 CAmbient Operating Range5 C to 50 C5 C to 50 C5 C to 50 C5 C to 50 CSet-Point Accuracy0.2 C to 300 C0.3 C to 400 C0.2 C0.2 C0.2 CTemperature Stability0.02 C to 300 C0.05 C to 400 C0.02 C0.02 C0.02 CTemperature RangeAdvanced Validation Technology 15

AccessoriesThe Kaye product range including moisture meters, testers and sensors are designed to meet the mostdemanding industrial requirements for process improvement, thermal validation and reporting. Specializingin providing turnkey system solutions and supporting them with unmatched technical service, we offer acomplete range of temperature standards, baths, thermocouples and fittings, all designed to provide themost accurate process measurement available.The Kaye product range is relied upon by the world’s leading pharmaceutical and biotechnology companiesto validate and monitor critical sterilization processes as required by governing regulatory bodies. Thermocouples for Autoclaves Thermocouples: Stainless Steel Thermocouples for Dry Heat Tunnels Thermocouples with Stainless Steel TipThermocouplesKaye thermocouple wire is manufactured with the highest purity and uniformityavailable to the industry. Quality control and testing of every wire spool andthermocouple probe ensures consistent measurement results. Each spool of wireincludes a Certificate of Conformance — your guarantee that it meets the accuracyspecifications. Each Teflon Thermocouple is leakage vacuum tested.Feed-thru for Autoclave ApplicationsEasy way to seal the autoclave port when introducing thermocouples into thechamber. Standard 1.5” TRI-CLAMP process connection. Installation is simplewith out the need of any tools, fitted with safety release mechanism.Pressure Transducer for AutoclavesComply with current standards to measure pressure in parallel to temperature when qualifying autoclaves. The pressure sensor is optimized to workwith autoclaves and the Validator AVS.Shipping CaseProtect your Validator AVS during transfer and shipping and store itsafely when not being used.Cables16 Kaye Validator AVS

System DocumentationQuality Control DocumentsKaye’s quality policy, the ISO 9001 implementation and certificate, and document control standardoperating procedures (SOPs)Development ProceduresDesign control and project management SOPs, and functional specificationsQuality Assurance ProceduresTest plan and test case proceduresRelease DocumentsQuality assurance certification and product release noticesQuality Assurance Test DocumentationQuality assurance test plan and test casesIQ/OQ ProtocolThe Installation Qualification/Operational Qualification Protocol defines a set of proceduresto ensure that the Kaye Validator AVS system is properly installed and operated according toAmphenol recommendations, and is adequately documented and controlled according to cGMPrequirements. The documents are provided in hard copy and on CD, allowing users to modify thedocumentation to suit specific organizational requirements.The IQ/OQ Protocol includes the following: Installation Qualification document Operational Qualification document - AVS Operational Qualification document – AVS Report Standard Operating Procedures documentIf you prefer to have IQ/OQ executed by qualified Kayetechnicians we also provide Validation IQ/OQ On-Site Execution.Validation ReferenceThe Kaye Validator AVS system is supported with documentation that verifies a fully validatedsystem, including software, hardware and firmware. The Validation Reference Binder provides acomprehensive overview of the Amphenol Quality Policy, description of ISO 9001 implementationand support procedures, and standards for the development, testing, and maintenance ofhardware and software. Quality Control documents, Development procedures, Quality Assuranceprocedures, Release documents, and Quality Assurance test documentation are all included.The Validation Reference is a serialized document, ensuring that registered users automaticallyreceive notification and updates to keep documentation current. The result is a summary ofinformation you would obtain by conducting an audit at Amphenol’s facility—complete, wellorganized, neatly packaged, and immediately accessible.Advanced Validation Technology 17

Additional Services Factory / On-Site System Calibration Annual Service Contract RentalsSystem SpecificationsTotal System SpecificationsWhen you use specifications to compare equipment, be sure to establish an error budget thataccounts for all possible measurement uncertainty. Sensor calibration is an integral part ofvalidation, and total system accuracy should include potential error from the recorder, as well asthe temperature reference and traceable standard.Since all component errors are additive to the total system, every potential error is significant. Asummary of the error budget for an Amphenol validation system after sensor calibration with typeT thermocouples, used at steam and dry heat, is listed below. These specifications are guaranteedunder worst case conditions. Under typical operating conditions, you can expect significantlybetter accuracy.Kaye Validator AVS (resolution and short term stability)0.017 Ck 1IRTD Temperature Standard0.01 Ck 1Temperature Reference0.051 Ck 1Total System Uncertainty0.078 Ck 118 Kaye Validator AVS

Kaye Validation SpecificationsAnalog InputUp to 48ThermocouplesType T, J, K,E,B,R,N,S: 0.1 C; T limited range 0.01 C resolutionScanning Speed48 channels / secInternal Memory4 gb for data collectionInput Impedance10KΩ. Source greater than 10KΩ produces open circuit indication160 db (8 inputs/sec) @ line frequencyCommon Mode Rejection145 db (12 inputs/sec) @ line frequency140 db @ DCMax. Common Mode Voltage100V pk ch-to-ch350V pk ch-to ch to frame groundNormal Mode Rejection82 db @ 60 Hz (8 inputs/sec)69 db @ 60 Hz (12 inputs/sec)Voltage Input0 to 10 VDCResolution1:72,000Voltage Input Accuracy30 days: (0.003% of reading 2 counts 4 microvolts)1 year: (0.006% of reading 2 counts 4 microvolts)Sensitivity0.5 microvolts/count on most sensitive rangeVoltage Temp. Coef. (0.1 microvolts 0.001% reading)/ CCompensator Temp. Coef. 0.01 C per CInput Terminal TemperatureNon-uniformity 0.1 C from calibrated terminalInput Ranges-6 to 30mV, -12 to 60mV, -60 to 300mV, -2 to 10VEnvironmentalTemperature: 0 to 50 C (32 to 122 F)Relative humidity: 95% non-condensingPower90 to 250 VAC, 50/60 HzFuse Rating4A Slow BlowSize190H X 411W X 381 mm D (457 mm with SIM)7.5 in H x 16.2 in W x 15 in D (18 in with SIM)Weight10.60 kg (23.4 lbs)BatteryLithium ion with minimum 3 hours of battery backupAdvanced Validation Technology 19

Europe/AsiaUSAAmphenol Advanced Sensors GermanyGmbHSinsheimerstr 675179 PforzheimGermanyAmphenol Thermometrics Inc.967 Windfall RdSt. Marys, PA 15857T: 1 814-834-9140F: 1 814-781-7969T: 49 (0) 7231 14335 0F: 49 (0) 7212-14335 29Warranty and disclaimer:The information mentioned on documents are based on our current tests, knowledge and experience. Because of the effect of possible influences in anapplication of the product, they do not exempt the user from their own tests, checks and trials. A guarantee of certain properties or a guarantee for the propersuitability of the product for a specific, especially permanent application cannot be derived from our data. Liability is therefore excluded to that extent permittedby law. Any proprietary rights of third parties as well as existing laws and regulations must be observed by the recipient of the product on his own nstruments.com 2020 Amphenol Corporation. All Rights Reserved. Specifications are subject tochange without notice.Other company names and product names used in this document are the registeredtrademarks of their respective owners.AAS-BR-220B04/2020

The Validator AVS is the successor of the widely recognized Kaye Validator 2000, the accepted standard in wired validations systems for over 20 years. 2 Kaye Validator AVS Enhanced Connectivity Increased Scan Speed Hardened, Dedicated Validation Console Asset Centric Data Management Concept Intuitive Metro-Style User Interface