Validation / Monitoring Solutions to Meet your Needs SOLUTIONS FOR PHARMACEUTICAL & BIOTECHNOLOGY INDUSTRIE

Pharma Line Card | 2 Wired Process Validation PRODUCT Wired Thermal Validation utilizing thermocouples ∙ Stand-alone Validation Console dedicated for validation tasks ∙ Asset Centric Data Management software concept ∙ 21 CFR/Data Integrity compliant ∙ Scan time 1/sec for 48 inputs (EN285/ISO17665) ∙ Accuracy up to 0.1°C (after TC Cal) ∙ Auto Calibration and Verification ∙ Enhanced data handling and redundancy (4-levels) ∙ 6hr battery backup ∙ Extensive calculation/reporting capability (Pass/Fail) ∙ Steam Sterilizers ∙ Autoclaves ∙ Dry Heat Tunnels/Ovens ∙ Freeze Dryers ∙ SIP Steam in Place ∙...

Pharma Line Card | 3 Real-Time Wireless Process Validation PRODUCT Real-Time In Situ RF Loggers for Validation of Harsh environments: ∙ Real-Time RF data under harsh conditions for validation study ∙ RF-Range up to 150 meters ∙ Temperature Range -85 to 400°C ∙ 100,000 samples per sensor ∙ Scan rate down to 1 second ∙ ValProbe RT system capacity 25 loggers/50 sensors ∙ Accuracy up to 0.1°C ∙ Unmatched battery life ∙ Choice of rigid, bendable, and flexible loggers ∙ Single, Dual, 5 channel loggers ∙ Measurands: Temp, Pressure, and Humidity ∙ Stand-alone Validation Console dedicated for validation...

Pharma Line Card | 4 Temperature Calibration PRODUCT The IRTD is a precise secondary standard used for Calibration/ Verification of Kaye products. The IRTD can also be used standalone with windows provided software for calibrations or high accuracy measurements. ∙ Temp range -196 to 420°C ∙ Accuracy over range ±0.025°C ∙ Resolution 0.001°C ∙ Traceability to NIST or PTB. ∙ Ambient temperature range 0 to 60°C (32 to 140°F) High Temperature Dry Block Calibrator can be used for temperature calibrations/ verifications of: ∙ Temp range of 30 to 420°C with temp stability of 0.01°C and uniformity of...

Pharma Line Card | 5 LTR150 Multi-purpose Temperature Calibrator can be used for temperature calibrations/ verifications of: ∙ Temp range of -30 to 150°C with temp stability of +/- 0.01°C and uniformity of 0.1°C ∙ Ability to be used as Dry Block, Liquid Bath & Surface Calibrator ∙ Easy to use color touch screen ∙ Calibration of up to 48 T/C’s ∙ Thermocouple fixture for easy handling of up to 48 T/C’s ∙ Optional Liquid micro bath, sensor cage and magnetic stirrer can be used for special probes or loggers ∙ Fast Heating and Cooling ∙ Software support for all existing Kaye products to support Automatic/Manual...

Pharma Line Card | 6 Portable Liquid Calibration Bath can be used for temperature calibrations/verifications of: ∙ Temp range -25°C to 140°C with temp stability of 0.01°C and uniformity of up to 0.02°C ∙ Compact, portable design for carrying (20kg/44lbs) ∙ Compressor free unit – using Peltier Technology ∙ Large 2.5L tank with up to 6” (15.24 cm) depth for use with wide range of sensor types ∙ Special fixture holds 10 Kaye stainless loggers and one IRTD ∙ Thermocouples ∙ RTD’s ∙ ValProbe RT rigid, bendable or flexible loggers (fully submersed) ∙ ValProbe rigid, bendable, or flexible loggers (fully...

Pharma Line Card | 7 Validation Accessories PRODUCT Kaye Feedthru used for insertion of thermocouples into pressure vessels such as: ∙ Accommodates from 1 to 18 T/C’s of any diameter ∙ No hole plugs required for unused T/C ports ∙ Accepts labeled T/C’s ∙ High Quality silicone rubber sealing gaskets ∙ 1.5" tri-clamp connection ∙ Easily installed with no tools required ∙ Autoclaves ∙ Freeze dryers ∙ Pressure chambers Kaye Feedthru High performance pressure transducer designed for the harsh environment applications such as: ∙ Connects to 1.5 triclover flange ∙ ISO-17025 traceable calibration ∙ 0...

Pharma Line Card | 8 Calibration / Service Contracts / Rental / IQ-OQ Execution Kaye offers a comprehensive range of products for short- and long-term rentals with the latest updates all guaranteed and supported by of specialists in tech support. ∙ Large inventory of systems ∙ Systems maintained with up-todate upgrades ∙ ‘As Found’ certificates provide on rental return. ∙ Backed by expertise only the manufacturer can provide ∙ Systems reset & data cleared to ensure user confidentiality Kaye offers ISO 17025-2018 factory calibration and repair service worldwide. ∙ 5 Direct Service Centers – Europe,...

Pharma Line Card | 9 Kaye offers customizable service contracts covering calibration and/ or extended warranties. (Gold/Silver) ∙ Annual/semi-annual factory or onsite calibrations ∙ Extended warranty on products ∙ Quantity pricing ∙ Lock in pricing up to 3 years ∙ Simplified RMA process Kaye offers IQ/OQ Protocols as well as factory or onsite executions. ∙ Detailed IQ/OQ protocols for all Validation systems. ∙ Execution services offered onsite or at Kaye factory ∙ Execution performed by Kaye certified field service team Service Contracts IQ/OQ Documentati

Pharma Line Card | 10 Facility / Stability Monitoring Labwatch IoT is a web based Centralized monitoring, alarming and reporting system ∙ Web based hosted operation eliminates costs and local support of site-based servers ∙ Secure and redundant data storage using AWS GxP Cloud ∙ Scalable from 5 – 25,000 sensors ∙ Wired/wireless hardware ∙ 21 CFR Part 11 and Data Integrity compliant ∙ Accessible via standard browser on any platform -desktop or mobile ∙ Provides historical collection and analysis of data ∙ Extensive alarm monitoring and notifications via mobile APP, email, SMS ∙ Complete Audit...

Pharma Line Card | 11 Cold Chain Monitoring During Transport Kaye Log – All in one solution for traceable transportation of temperature sensitive products. ∙ Fast and secure data transfer with any NFC mobile device ∙ Temp range -40°C to 60°C ∙ Accuracy 0.2 °C to 0.5°C ∙ Logger models ranging from 36 days to 1 year ∙ Only 2.5 mm thick, easily integrates into any packaging. ∙ Label can be programmed with any shipment and product information ∙ Internal Battery 1 year ∙ Quick and easy installation ∙ Encrypted data transfer to secure cloud ∙ Resistant to mechanical damage IP67 ∙ Cold chain ∙ Transportation...