This withnell sensors specialises in the temperature and humidity validation sector offering product solutions and service predominantly to the pharmaceutical and biotech industries. Kaye validator ukas calibration withnell sensors has recently expanded its scope of accreditation to include the kaye validator 2000 and kaye sims. They are made from ultrapremium select grade wire, which provides the highest purity and uniformity available in the industry. A sensor calibration can be performed by either kaye validator avs or kaye validator 2000 with any temperature source. All recorded data, including calibration offsets, setup parameters, and administrative tasks are saved in secure, encrypted, tamperproof electronic records in a format accessible only through the system software. Cleaning validation was completed, including manual cleaning, validated. Selectable input capacity 1 to 4 sims up to 48 total inputs. Featuring interval calculations and monitored events, the kaye validator provides more information about your study. We offer a full range of calibration services including the kaye validator, kaye irtd and kaye temperature baths. The kaye validator avs advanced validation system combines accurate sensor measurements with all gmp requirements for calibration and traceability to national standards, while generating compliant reports and managing the validated assets and validation equipment.
First and foremost is a change to the form factor, and the way validation technicians can use the system. We are able to calibrate this equipment onsite and offer a ukas accredited calibration at our lab in lancashire. Masy bioservices gmp storage, calibration, validation. Selfcontained thermal validation device with high accuracy sensor measurement hardware and secure data recording capability. The kaye validator simplifies the entire validation process by reducing setup time. For the kaye validation system kaye validator, valprobe, and rf. Customers with a validator 8 years or older, currently validator serial numbers beginning 99, 00,01,02,03,04 were recently informed that the manufacturer had identified electronic board components within the validator. The kaye validator is specifically designed to enable compliance with fda 21 cfr part 11. Each connection port is labeled with an icon representing its function. Masys ultrapremium select grade, type t thermocouples are optimally designed for validation and thermal mapping, from 200c to 300c. The kaye validator is a standalone thermal validation. Kaye digistrip 4 validator multichannel temperature recorder. Do not use the calibration interface box with the validator kl or the kaye validator. This section describes the kaye validator 2000 system and associated.
The console can be docked directly to the validator avs and is used as the operator interface to the validator avs. The first part of this manual provides an overview of the validator hardware, instructions. An easy to use, accurate and reliable pressure transducer is available for the kaye validator system. Kaye is committed to developing the best thermal validation systems available. The kaye validator software provides flexibility in other ways. Sims with t 12thermocouple sensor harnesses, user manuals and software cds. Free download ebooks backup20070127011706876 o18 protocol bwt0s 522f74e70d984a7a8d3650edf69f06e3 c program files logitech desktop messenger 8876480 program bwplugprotocol8876480. For nearly two decades the kaye validator 2000 has been the standard for wired validations systems in the pharma biotech industry. Our engineers have many years of experience offering kaye equipment calibration. Steaminplace validation sip controlled temperature units. Ge kaye validator 3 2000 full pn x2005 model with usb port. New advanced validation system from kaye kaye validator avs. Ultrapremium validation thermocouples masy bioservices. Avsx2015 advanced validation system user manual kaye.
Validator 2000 users guide, document m4350e, rev 3. Combining kaye s precision thermal measurement hardware and data. This unit will need recalibration, and possible adjustments. Ge kaye instruments validator x2000 w manual last cal. Used kaye validator avs for rent for sale by transcat, inc. Up to four kaye sensor input modules sims per validator each sim supplies up to 12 thermocouple sensors. Ge ge kaye instruments validator x2000 w manual new dallas chip oc39 this is a used piece of equipment, that is in functional condition. Traditional validators like the kaye validator 2000 and others were designed for semistationary use on a rolling cart or on a nearby bench or table. The kaye valprobe is a wireless process monitoring and validation system that collects temperature, humidity, and pressure data in environments that are hostile to traditional sensor wires or that are difficult to access. Mar 17, 2021 kaye valprobe rt realtime is a wirefree realtime process validation and monitoring system designed around the measurement and reporting requirements of the most intensely regulated industries. The downside is that the steps are more manual, the upside is that the acquisition price might be lower. Software interface for all existing kaye products irtd, validator 2000, validator avs, valprobe and rf valprobe software for automatic manual calibrations easy to use touch screen universal power supply 100 240 vac 50 60 hz addition inserts available for calibrating specialty or process probes.
They are a traditional tool used in the accurate validation of environmental chambers, freezers, autoclaves, and other analytical and processing equipment in the biopharma industries. The validator avs modernizes the kaye validator line in a number of ways. It is backward compatible to the existing validator 2000, valprobe and rf valprobe and therefore a logic and natural step in the 55 years of kaye product evolution. Kaye validator avs for sale buy kaye validator avs. The original thermal validation system of choice the validator 2000 is a standalone thermal validation solution specifically designed to conform with fda data protection guidelines 21 cfr part 11 and meet international and european cgmp requirements for inspection of pharmaceutical, biotechnology and medical device en285, en554 manufacturing. Thermal validation system for nearly two decades the kaye validator 2000 has been the standard for wired validations systems in the pharma biotech industry. A thermal validation solution for inspection of pharmaceutical, biotechnology and medical device manufacturing. Kaye equipment calibration kaye validator calibration. Kaye validator 2000 user manual downloadkaye validator 2000 user manual. Eliminating impurities from distilled water is a critical step in these applications. Withnell sensors continues to deliver cost effective services to kaye equipment users with the offering of the latest component swap out. Our type t thermocouples are specifically designed for validation and thermal mapping. Detailed info and photos for this can be found on our website at kayevalidator 3 2000 fullpnx2005modelwithusbportor call.
Thousands of users trust and rely on the accuracy, reliability and proven performance of the validator 2000. The validator is a standalone thermal validation system designed to meet new regulations worldwide for validation processes. This unit is onsite, is setup and we welcome for you to come inspect this unit. Otherwis e, the protection provided by the instrument may be impaired. In fact, the united states pharmacopeia usp standard for water purity testing mandates that all validation equipment must have a cell constant accuracy of 2% or better. Kaye validator 2000 kaye v2k rental withnell sensors limited. Ge kaye instruments validator x2000 w manual last cald 2015 ny61. The kl is run using any laptop with windows software.
Kaye validator pressure transducer in order to meet the stringent requirements of en554 and iso17665, it is a requirement that saturated conditions are also validated along with temperature. For the convenience of our customers, we permit the installation of kaye validation software on multiple workstations provided the computers are used within the same company. Standard operating procedure for the kaye validator 2000. Failure to meet these requirements can result in loss of product, retesting costs, or. Rent the kaye validator avs kaye validator avs rental. Insacal conductivity meter calibration equipment masy. Thermal validation system kaye validator 2000 the kaye validator simplifies the entire validation process by reducing setup time, minimizing sensor handling, automating sensor calibration, neatly organizing study data and generating regulatory required reports. The back of the validator has ports for electrical and communication connections. The kaye validator august 2009 about this manual this manual is intended to provide overview information on the valid ator, instructions on getting started with the software, and stepbystep instructions on using the validator in standalone mode.
Kaye validator 2000 user manual floppy disk verification. We use ge kaye validators model 2000 and wireless data logger temperature mapping systems capable of logging a detailed. The software allows the user to interface with the hardware to setup the system inputs, run parameters, calibration, and reports. You can define sensors individually creating your own labels and detailed descriptions, or applying an individual sensor definition to a range of sensors. Refer to the safety information in the warnings and cautions sections below. This is a used piece of equipment, that is in functional condition.
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