Catalog excerpts
Advanced Validation Technology The Kaye Validator AVS (Advanced Validation System) is a state-of-the-art validation system designed to meet current regulatory requirements for Thermal Validation and Data Integrity. The Validator AVS combines high accuracy measurements, automated sensor calibration, intuitive metro 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 accepted standard in wired validations systems for over 20 years. ∙ Hardened, dedicated validation...
Open the catalog to page 2Applications – Challenges – Solutions APPLICATIONS ∙ Steam Sterilizers (Autoclaves) ∙ Dry Heat Sterilizers ∙ Steam in Place (SIP) ∙ Water Cascade / Fall Sterilizers ∙ Incubators ∙ Stability Chambers ∙ Freezers ∙ Freeze Dryer / Lyophilization ∙ Vessels CHALLENGES ∙ Pharmaceutical industries are faced with increasing operational challenges ∙ IT environment ∙ Increased IT security and lock down on portable data ∙ Continually changing operation systems: Hardware compatibility and complex software operation ∙ Validation ∙ Diverse evolution of technologies in validation: Data backward...
Open the catalog to page 3AVS SYSTEM A Kaye Validator AVS system consists of the Validator AVS and the Validation Console. The console can be docked directly to the Validator AVS and is used as the operator interface to the Validator AVS. Selectable input capacity (1 to 4 SIMs) up to 48 total inputs. ROBUST DESIGN ∙ Robust industrial design with two handles ∙ IP55 rating, chemical resistant ABS housing ∙ Dedicated Validation Console for improved user interface ∙ On-board docking station for Kaye Validation Console ∙ Battery backup with field replaceable battery pack (3 hours) DATA SECURITY VIA SMART REDUNDANCY...
Open the catalog to page 4HARDWARE CONNECTIVITY The Kaye Validator AVS comes complete with improved robust connections for IRTD and calibration baths. The Validator AVS is backward compatible with all existing IRTD and Kaye baths for automatic calibration. Two relay outputs are also available to be activated via qualification events. Mini Din Ports for IRTD & Bath USB / Ethernet AVS USB / Ethernet AVS Console Relay Posts USB Device for ICAL On / OFF Switch SENSOR 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...
Open the catalog to page 5Kaye Validation Console A NEW FLEXIBLE APPROACH TO VALIDATION The 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. The console comes pre-loaded and configured with the Kaye AVS software and is customized to specific validation tasks. The console offers direct docking and Wi-Fi connectivity with the Validator AVS; it brings about a new approach to tackling your software validation. VALIDATION CONSOLE SPECIFICATIONS Operating System / Processor / Memory ∙ Microsoft Windows 10...
Open the catalog to page 6Two ways to Connect the Validation Console to the Validator AVS DOCKING MODE (STAND-ALONE) NETWORK MODE The console sits in the docking station of the Validator AVS and connects directly. The Validator AVS offers a fully functional docking station with direct access to the ports located on rear of the unit. Console battery is charged while docked. The Validator AVS and the console can connect to a local network by using ethernet or Wi-Fi connection. The Validation Console can be used to communicate to any connected AVS. The Kaye Validator AVS system can establish wireless connections* by...
Open the catalog to page 7ASSET CENTRIC DATA MANAGEMENT The Kaye Validator AVS includes an intuitive Asset Centric Data Management concept 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 and defined as an asset. All files and data related to this asset, like setups, calibrations, or study files, are organized and accessed in one single screen around the basic asset data. It is even possible to upload additional documents like standard operation procedures or certificates and associate it with the...
Open the catalog to page 8SENSOR CALIBRATION / VERIFICATION Kaye, the original creator of the Automatic Sensor Calibration / Verification feature has included enhancements eliminating manual methods of sensor calibration / verification resulting in better accuracy. The Kaye Validator AVS is backward compatible to existing Kaye IRTD and calibration baths. The automatic calibration / verification feature minimizes training and ensures accurate, and repeatable calibrations optimized for your Kaye calibration equipment. Define the temperature setpoint as well as criteria for stability and deviation. QUALIFICATION...
Open the catalog to page 9AVS Reporting Tool DOCUMENT CRITICAL VALIDATION STUDIES The Kaye Validator AVS Console includes an extensive and flexible Reporting Tool used to analyze and document your critical validation studies. The AVS Reporting Tool is a separate application which is seamlessly integrated into the AVS software. It can be used to document your Validation studies, as well as provide pass / fail criteria analysis to save hours of manual efforts. ∙ AVS Wiring Layout ∙ Setup Report ∙ Calibration Report ∙ Verification Report ∙ Graph Report ∙ Summary Report While offering several new features and...
Open the catalog to page 10Wiring Diagram Graph Report Detailed Lethality Report Pass / Fail Report Graph Lethality Repo
Open the catalog to page 11Pass / Fail Report When performing a qualification study and collecting raw data, one of the most time consuming tasks is the post-analysis of the data to ensure the study meets all of the required criteria. After the parameters are defined, you can save it as a template, saving you time in your future studies. Multiple templates can be set up and saved for different processes and applications. For many customers this entails exporting the raw data to excel and using customized pivot tables or macros to analyze the data and create the final report. While this method has been widely used for...
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