Kaye Validator 2000
The Kaye Validator 2000® is a stand-alone validation system for life science industries — pharmaceuticals, medical devices, and biotechnology — and other regulated and non-regulated applications where precise mapping can affect the quality of product development and storage.
If you have a fixed-scope project that doesn’t require the full investment of purchasing your own Validator 2000, or temporarily need additional systems for increased productivity, Masy BioServices can rent a Kaye validation system to you for as long as you need. Your Kaye Validator and related instruments will arrive calibrated from our NVLAP-accredited metrology laboratory, so you can be confident in the accuracy of your mapping results.
Complete turn-key validator rental packages typically include:
- Kaye Validator 2000
- Laptop with validator software
- Sensor input modules (SIM)
- Application-specific sensors:
- Relative humidity sensors
- CO2 sensors
- Pressure sensors
- Temperature standard (if applicable)
- Temperature reference bath (if applicable)
- Uninterruptable power supply (UPS) for extra security and protection
Kaye Validator 2000 Benefits
Simple, Precise Thermal Validation
The Validator 2000 simplifies the entire validation process by
- Reducing set-up time through seamless integration of temperature standards, reference baths, and data loggers
- Minimizing sensor handling with automated sensor calibration
- Presenting critical study data in easily-customized reports
Fast, Accurate Temperature Measurement & Reporting
- Three sensor input modules (SIMs) can receive data from up to 36 sensors (temperature, relative humidity, CO2, or pressure)
- Masy BioServices offers thermocouples, relative humidity sensors, CO2 sensors, and pressure sensors that connect to the standard Kaye SIM
- Fully automated sensor calibration for precise readings
- Qualification reports present raw data per sensor; summary reports present group and cycle readings; and a new graphing utility simplifies analysis and reporting
Data Security for Critical Applications
The Kaye Validator is specifically designed to enable compliance with FDA 21 CFR Part 11. All recorded data, including calibration offsets, set-up parameters, and administrative tasks are saved in secure, encrypted, tamper-proof electronic records in a format accessible only through the system software.
- Designed specifically to conform with 21 CFR Part 11, and meets the EN285 and EN554 international norms for validation of pharmaceutical, biotechnology, and medical device manufacturing plants.
- IDs and passwords are required to start and stop a process, check configuration settings, and calibrate sensors
- Any action affecting study data is permanently captured in a comprehensive audit trail, which can be automatically stored in a network location
- Internal memory protects in-progress test results in case of storage or printer failure
Masy can calibrate every part of your validation system
- validator console, sensor input modules, RH sensors, CO2
sensors, and pressure sensors. Our NVLAP-accredited metrology laboratory is equipped with a fully-staffed calibration team that is dedicated to providing the most accurate and reliable validator calibration services for your company.
Rent or Purchase a Kaye Validator 2000 Package from Masy BioServices
Masy BioServices Rents Kaye Validators
For organizations that need Kaye Validators for periodic projects, the purchase and maintenance of these systems can be costly and time-intensive. If you have a fixed-scope project that doesn’t require the full investment of purchasing your own Validator 2000, or temporarily need additional systems for increased productivity, Masy BioServices can rent a Kaye validation system to you for as long as you need. Your Kaye Validator and related instruments will arrive calibrated from our NVLAP-accredited metrology laboratory, so you can be confident in the accuracy of your mapping results.
Used Kaye Validator Systems for Purchase
If you have ongoing mapping needs that an in-house function routinely manages, it may be more cost-effective to acquire a Kaye Validator system configured for your specific needs. Masy BioServices can put together the right combination of calibrated, pre-owned validation system components for you, empowering you to manage your ongoing chamber mapping projects with confidence at a fraction of the cost of new equipment.
Complementary Peripherals Support Your Validation Needs
We can also supply you with thermocouples, reference standards, IRTDs, baths, and other system components to help make your validation project successful. Masy BioServices has developed relative humidity, CO2, and pressure transducers that connect to a standard Kaye SIM.
Project Deadlines Looming? Let Masy Validation Services Help!
Masy BioServices performs precise IQ/OQ/PQ qualification and validation services, including environmental chamber mapping for temperature, humidity, pressure, and carbon dioxide. Our turn-key solution includes writing validation protocols, executing validation protocols, and a thorough quality review of the final documentation. Our team of trained, experienced engineers can augment your in-house validation staff for time-sensitive projects.
Masy BioServices is an experienced validation company and has been serving the pharmaceutical, medical device, and other biotechnology industries for over 30 years. As a NVLAP-accredited metrology laboratory, Masy BioServices can provide NIST-tracable calibration certificates for all the instrumentation we use in validating your biopharma processing equipment.