Kaye Validator: Sensing & Inspection Technologies
Kaye Validator: Sensing & Inspection Technologies
Kaye Validator
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The Kaye Validator is a stand-alone thermal validation
system that simplifies the entire validation process by
reducing set-up time, minimizing sensor handling, and
presenting critical study data in easily customized report
formats. The Validator software now incorporates the
latest technology for faster data collection, improved data
management and more flexible reporting and analysis to
save you significant time.
Kaye Validator
Benchmark thermal validation system
Connects to your PC
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Regulatory Compliance Electronic Records, Secure Audit Trail,
and Electronic Signature
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.
Login Window
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A secure path for wiring sensors is provided for strain relief
Real-Time Process Monitoring and organization of your probes. The wired SIM shows 10
thermocouples and one pressure sensor (a shunt resistor is
Monitor and Control Qualification Studies with used by the Kaye Validator for converting current to
the Instrument or the PC voltage). You can order SIMs pre-wired with thermocouple
The Kaye Validator can show you the entire qualification probes, labeled numerically.
process in real timewhether you run a study using only
the Validator or in conjunction with a PC.
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Test Set-Up
Study Set-Up is Intuitive and Versatile
The Kaye Validator was designed to help you get the
data you want from a validation study quickly and easily.
It starts with the Validator software that allows you to
set up and customize sensor calibration, qualification, and
report generation.
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Clicking on Statistical Calculations Set up or modify lethality calculations Within each group, the Kaye Validator
allows you to select only those you by defining base temperature, Z, and can report intervals for each sensor
want to view during the study. Add D values. Select conditions when you and the group. You establish the
more calculations when youre ready want to calculate lethality. conditions upon which the group
to generate the final report. intervals start and end.
Humidity
Humidity
Inctmp 01
Inctmp 02
Inctmp 03
Inctmp 04
Inctmp 05
Inctmp 06
Inctmp 07
Inctmp 08
Inctmp 09
Inctmp 10
Inctmp 11
Inctmp 12
Inctmp 13
Inctmp 14
Inctmp 15
SIM 2
own labels and detailed descriptions, or applying an group max group max group max
group min group min group min
individual sensor definition to a range of sensors. interval max interval max interval max
interval min interval min interval min
humidity humidity humidity
Featuring interval calculations and monitored events, the
Kaye Validator provides more information about your
REPORT REPORT REPORT
study. You can calculate maximum, minimum and average FOR INCUBATOR 1 FOR INCUBATOR 2 FOR INCUBATOR 3
Reports
The Kaye reporting Software includes an intuitive, yet
powerful reporting utility for generating Set-Up, Calibration,
Qualification and Calibration Verification reports to
document validation study results. Reports are generated
from secure data files that can only be read by the system Cycle Headers
software. Upon study completion, process cycles to be
analyzed are defined using the intuitive system graphic The user can generate regulatory-accepted reports
feature. including detailed and summary reports by group and cycle
(interval data). Graph reports have been improved, allowing
Features: more inputs and better access to graph properties such as
colors and data limit lines.
Load set-ups, store study data and upgrade firmware via
USB or Floppy
Report templates are automatically created, allowing the
Common reporting software for Validator, ValProbe
user to reprint an exact copy of the report at a later date,
and RF ValProbe gives added flexibility and convenience
or save to a template for use in subsequent validation
in merging data files from multible Kaye devices.
studiesa significant time savings for system operators.
Powerful graphing tool during reporting with report
wizard shows all sensors and samples through a
complete study.
Report wizard allows to selsct lethality calculation also
during reporting. Lethality parameters can be changed.
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Merged Reporting
Users have the ability to combine or merge reports from
several Validators or ValProbes, providing the validations
were run concurrently. A typical example would be during a
freeze dryer validation where two Validators are needed, or
if a ValProbe pressure logger is used alongside Validator
temperatures.
Temperature Data(C)
Logger S/N Heating Up Exposure Cooling Down Totals
Cycle Cycle Cycle Total
Min Max Avg ALeth Min Max Avg ALeth Min Max Avg ALeth ALeth
101A-T01 (C) 51,13 119,95 91,66 0,03 120,11 123,44 122,91 8,91 68,27 120,83 96,92 0,06 9,00
102A-T02 (C) 51,06 120,03 91,78 0,05 120,18 123,41 122,89 8,86 67,79 120,75 96,56 0,06 8,97
103A-T03 (C) 51,70 120,35 92,43 0,11 120,50 123,47 122,97 9,00 66,85 120,38 95,70 0,03 9,14
104A-T04 (C) 51,28 120,01 91,91 0,05 120,16 123,29 122,78 8,63 67,60 120,49 96,27 0,03 8,71
105A-T05 (C) 50,95 119,99 91,54 0,03 120,15 123,50 122,98 9,04 68,52 120,98 97,13 0,09 9,16
106A-T06 (C) 51,46 120,40 92,40 0,11 120,55 123,53 123,03 9,14 66,97 120,51 95,78 0,03 9,28
107A-T07 (C) 51,26 120,10 91,94 0,05 120,25 123,42 122,91 8,90 67,72 120,63 96,41 0,06 9,01
108A-T08 (C) 51,71 120,55 92,64 0,14 120,63 123,58 123,08 9,25 66,77 120,34 95,52 0,02 9,41
109A-T09 (C) 51,10 120,09 91,76 0,05 120,25 123,52 123,00 9,10 68,15 120,87 96,82 0,08 9,23
110A-T10 (C) 51,76 120,53 92,63 0,14 120,65 123,58 123,08 9,23 66,65 120,35 95,51 0,03 9,40
111A-T11 (C) 51,66 120,37 92,35 0,11 120,51 123,49 122,98 9,03 67,25 120,33 95,88 0,03 9,17
112A-T12 (C) 52,04 120,70 92,96 0,17 120,26 123,54 123,03 9,11 66,06 119,95 94,85 0,00 9,28
201A-T13 (C) 51,18 119,95 91,72 0,03 120,10 123,31 122,80 8,67 67,99 120,55 96,53 0,03 8,73
202A-T14 (C) 51,87 120,62 93,05 0,17 120,46 123,48 122,97 9,00 65,60 120,15 94,72 0,00 9,17
203A-T15 (C) 51,94 120,41 92,71 0,11 120,32 123,38 122,88 8,83 66,34 120,01 95,09 0,00 8,94
204A-T16 (C) 51,33 120,13 92,09 0,05 120,28 123,34 122,84 8,75 67,29 120,49 96,03 0,03 8,83
Summary report
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Graphing
A powerful graphing utility within the system software
greatly simplifies process analysis and reporting. Sliding
vertical axes enable the operator to flag and define
process transition points, eliminating unnecessary
reporting and streamlining the review process. The graph
utility features increased flexibility for graph customization,
including specifying X and Y axis ranges, background
colors, line styles and labeled limit lines.
Sensor Calibration The PC shows the entire calibration process on one screen.
Data fields change color to show the progress of stability and
You save time and eliminate manual methods, of sensor deviation for each sensor. A status screen (above, right) lists
calibration, which results in better accuracy. By automating each step and indicates where the system is in the process.
sensor calibration, the system reduces training require-
ments for your department, and makes the operation
available to the non-metrologist.
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Fully Automated Sensor Calibration
Sensor calibration is one of the most difficult and time
consuming tasks associated with validation. The SOPs
in most companies require sensor calibration before the
validation study and a check afterwards to ensure the
integrity and accuracy of collected data.
Checkpoint Calibration
Verifying sensor calibration, typically at the point of use,
ensures all temperature measurements are within the
deviation criteria.
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High Accuracy Referencing Fast/Accurate References
One temperature reference covers the temperature range
for the high and low calibration point used for a typical
GEs temperature calibration equipment is designed validation study. Choose the model that best fits your need
specifically to maximize overall system accuracy. from the chart below.
Calibration equipment includes temperature references Temperature dry wells employ unique inserts that
with superior uniformity for sensors, traceable intelligent minimize cooling of the thermocouple tips due to stem
RTD standards, and validation software to communicate conduction. Without proper inserts, transfer uncertainty in
with the hardware. excess of 0.5C can occur with 22 gage, type T
thermocouples. GE units provide an uncertainty of 0.1C.
Intelligent RTD Standard
The IRTD Temperature Standard (IRTD-400) is a Calibrating over a more limited range will also increase
NIST-traceable instrument that is calibrated over the range accuracy. Since regulations require calibration for the
of -195 to 420C. It is accurate to 0.025C over the entire temperature range of a process, an autoclave, for example,
operating range. can be calibrated from 90 to 125C. This method reduces
the error from thermocouple characteristics to less than
The IRTD-400 is a completely self-contained measurement 0.05Ca two-fold improvement over a calibration at 0C
system, containing the electronics for calibration and and 125C.
temperature conversion.
The temperature bath, CTR-80, provides very fast
Communicating directly with the Validator software, the response (90 minutes from ambient to -80C) and quiet
IRTD-400 eliminates the potential for human error, assuring operation. Rugged casters allow this unit to be moved with
accurate and traceable measurements. little effort. A specially designed cover supports two IRTD
standards and all thermocouples from the Kaye Validator.
Calibration Wells,
9 mm (0.354 in)
without inserts
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Kaye Validator
Pressure Transducer
In order to meet the stringent requirements of EN554 and
ISO-17665, it is a requirement that saturated conditions
are also validated along with temperature.
Features
Designed for the harsh environment applications such as
steam sterilizers and SIP systems
High performance pressure transducer, specified at full
temperature range of autoclave
Can be directly connected to 1.5 in triclover flange
Full ISO-17025 traceable calibration over pressure and
temperature range
East of Use wires directly to Kaye Validator with no
additional wiring or power supplies required.
Specifications
Type
Absolute Pressure Transducer
Range
0 bar to 4 bar (59 psia) Absolute
Sensitivity
1V to 5V
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System Documentation The IQ/OQ Protocol includes the following:
Installation Qualification document
Quality Control Documents Operational Qualification document
GEs quality policy, the ISO 9001 implementation and Standard Operating Procedures document
certificate, and document control standard operating Set-up programs
procedures (SOPs)
Validation Reference
Development Procedures The Kaye Validator system is supported with
Design control and project management SOPs, and documentation that verifies a fully validated system,
functional specifications including software, hardware and firmware. The Validation
Reference Binder provides a comprehensive overview of
Quality Assurance Procedures the GE Quality Policy, description of ISO 9001
Test plan and test case procedures implementation and support procedures, and standards for
the development, testing, and maintenance of hardware
Release Documents and software. Quality Control documents, Development
Quality assurance certification and product release notices procedures, Quality Assurance procedures, Release
documents, and Quality Assurance test documentation are
Quality Assurance Test Documentation all included.
Quality assurance test plan and test cases The Validation Reference is a serialized document,
ensuring that registered users automatically receive
IQ/OQ Protocol notification and updates to keep documentation current.
The Installation Qualification/Operational Qualification The result is a summary of information you would obtain
Protocol defines a set of procedures to ensure that the by conducting an audit at GEs facilitycomplete, well
Kaye Validator system is properly installed and operated organized, neatly packaged, and immediately accessible.
according to GE recommendations, and is adequately
documented and controlled according to cGMP
requirements. The documents are provided in hard copy
and on CD, allowing users to modify the documentation to
suit specific organizational requirements.
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System Specifications Voltage Input Accuracy 30 days: (0.003% of reading + 2 counts + 4
microvolts)
1 year: (0.006% of reading + 2 counts + 4
Total System Specifications microvolts)
When you use specifications to compare equipment, be Sensitivity 0.5 microvolts/count on most sensitive range
sure to establish an error budget that accounts for all Voltage Temp. Coef. (0.1 microvolts + 0.001% reading)/C
possible measurement uncertainty. Sensor calibration is an
Compensator Temp. Coef. 0.01C per C
integral part of validation, and total system accuracy
Input Terminal Temperature 0.1C
should include potential error from the recorder, as well as
Non-uniformity
the temperature reference and traceable standard.
Input Ranges -6 to 30mV, -60 to 300mV, -2 to 10V
Since all component errors are additive to the total system, Environmental Temperature: 0 to 50C (32 to 122F)
every potential error is significant. A summary of the error Relative humidity: 95% non-condensing
budget for a GE validation system after sensor calibration Power 90 to 250 VAC, 50/60 Hz
with type T thermocouples, used at steam and dry heat, is Fuse Rating 2A Slo Blo
listed below. These specifications are guaranteed under
Size 191 H x 343 W x 343 mm D (404 mm with SIM)
worst case conditions. Under typical operating conditions, 7.5 in H x 13.5 in W x 13.5 in D (15.9 in with SIM)
you can expect significantly better accuracy.
Weight 9 kg (20 lbs)
Resolution 0.001C
Sensor Element 100 platinum sensor
Sheath Material Inconel 600
Immersion Depth 102 mm (4 in)
Calibration2 Traceable to NIST; recommended calibration period
is one year.
Power to Probe Unregulated DC, 10 to 25V; first probe: 850 mW at
15V; each additional probe: 550 mW
Power Supply3 Adapter: 110 VAC US-style, or 220 VAC
VDE-approved
Measurement Rate 30 readings per second
Software IRTDWin software for offline use to compare IRTD
probes
Environmental Ambient temperature range: 0 to 60C (32 to 140F);
humidity 0 to 95% non-condensing
Kaye Validator Specifications
Dimensions Overall length: 603 mm (23.75 in); grip: 89 mm x 32 mm
Analog Input Up to 36
(3.5 in x 1.25 in) sensor sheath: 457 mm x 6.35 mm
Thermocouples Type T, J, K: 0.1C or F resolution; T limited (18 in x 0.25 in)
range 0.01C resolution
Scanning Speed 8 or 12 inputs/sec at 50/60 Hz Notes: 1. Accurate for one year, from 0 to 60C ambient. Includes calibration
certificate with traceability to NIST.
Internal Memory 2 Mb for data collection
2. GE provides a recertification service for calibrating the Temperature
Internal Battery NiCad; 30 minutes of battery backup Standard.
Input Impedance 10K. Source greater than 10K produces 3. Power supply is not required for use with the Kaye Validator
system.
open circuit indication
Common Mode 160 db (8 inputs/sec) @ line frequency
Rejection 145 db (12 inputs/sec) @ line frequency
140 db @ DC
Max. Common 100V pk ch-to-ch
Mode Voltage 350V pk ch-to ch to frame ground
Normal Mode 82 db @ 60 Hz (8 inputs/sec)
Rejection 69 db @ 60 Hz (12 inputs/sec)
Voltage Input 0 to 10 VDC
Resolution 1:72,000
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Cryo Temperature Bath Specifications
CTR -40 CTR -80
Temperature Range -40 to 150C Temperature Range -80 to 100C
Temperature Stability 0.005C to -40C (ethanol) Temperature Stability 0.03C
0.005C to 25C (eau) Temperature Uniformity 0.03C
0.007C to 150C (huile 5012)
Bath Volume 1 US gallon ethanol or Halocarbon 0.8 oil
Temperature Uniformity 0.01C (-90 to 70C) (order ethanol locally,
Bath Volume 9 liters order oil from GE)
Immersion Depth 234 mm (9.25 in) Immersion Depth 203 mm (8 in) max.
Access Area 94 mm x 172 mm (3.7 in x 6.8 in) Access Area 108 mm2 (18 sq in), cover removed
Depth 234 mm (9.25 in) Depth 457 mm (18 in)
Heater Power 700 watts Heater Power 500 watts
Cooling Rate 25 to -40C 110 minutes, typical with ethanol Cooling Rate 25 to -80C 90 minutes, typical with ethanol
Resolution 0.01C Resolution 0.01C
Setting Repeatability 0.01C Setting Repeatability 0.01C
Temperature Controller 24-bit digital Temperature Controller 24-bit digital
Display LED w/0.01 (C or F) display resolution Display LED w/0.01 (C or F) display resolution
Communications RS-232 Ramp Rate Control 0.1C per minute to capacity of bath
Safety Over temperature limits, user settable; Communications RS-232 (for use with thermal validation)
low voltage cutout; automatic Safety Over temperature limits, user settable;
refrigeration turn-off at 55C low voltage cutout; automatic
Refrigeration R-507 single stage refrigeration turn-off at 30C
Drain Yes Refrigeration Cascade using two-1/4 HP compressors;
refrigerant first stage: R507;
Controls Power switch; setpoint and function buttons
second stage: R508B
Power 115VAC 60Hz, 16A or 230VAC 50Hz,
Drain Yes
8A 1700 watts
Controls Power switch; setpoint and function buttons
Dimensions Off Cart: 584 mm H x 305 mm W x 622 mm D
(23 in x 12 in x 24.5 in) Power 115 VAC 60Hz, 16 A; or 230 VAC 50Hz, 8 A
On Cart: 819 mm H x 305 mm W x 622 mm D Dimensions 762 mm H x 305 mm W x 610 mm D
(32.25 in x 12 in x 24.5 in) (30 in x 12 in x 24 in)
Weight 32 kg (78 lbs) Weight 57 kg (125 lbs) on casters
Certificate Conformance certificate provided with unit. Certificate Conformance certificate provided with unit
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HTR 400 LTR 25/140 LTR 40/140
Temperature Range 25C above ambient to 400C 25C to 140C 40C to 140C
Ambient Operating Range 5C to 50C 5C to 50C 5C to 50C
Set-Point Accuracy 0.2C to 300C 0.2C 0.2C
0.3C to 400C
Temperature Stability 0.02C to 300C 0.02C 0.02C
0.05C to 400C
Transfer Calibration Accuracy* 50C to 150C: 0.1C 25C to 80C: 0.1C 40C to 25C: 0.15C
IRTD Standard to Thermocouples 50C to 250C: 0.2C 80C to 130C: 0.15C 25C to 80C: 0.1C
250C to 350C: 0.3C 130C to 140C: 0.18C 80C to 130C: 0.15C
350C to 400C: 0.4C 130C to 140C: 0.18C
Typical Heat-Up Time Ambient to 90C: 5 minutes Ambient to 80C: 6 minutes Ambient to 80C: 6 minutes
90C to 125C: 3 minutes Ambient to 140C: 14 minutes Ambient to 140C: 14 minutes
350C: 25 minutes
Well Configuration Reference wells (2): 6.7 mm diameter x Reference wells (2): 6.7 mm diameter x Reference wells (2): 6.7 mm diameter x
x 127 mm deep 155 mm deep 155 mm deep
Calibration wells (8): 9 mm diameter x Calibration wells (6): 9 mm diameter x Calibration wells (6): 9 mm diameter x
155 mm) deep 155 mm) deep 155 mm) deep
Display LED w/0.01C resolution LED w/0.01C resolution LED w/0.01C resolution
Computer Interface RS232 RS232 RS232
Dimensions 343 mm x 198 mmx 317.5 mm 343 mm x 198 mmx 317.5 mm 343 mm x 198 mmx 317.5 mm
Weight 8.2 kg 13.6 kg 13.6 kg
Power 115 VAC 60 Hz, 6 A or 230 VAC 115 VAC 60 Hz, 3 A or 230 VAC 115 VAC 60 Hz, 3 Aor 230 VAC
50 Hz, 3 A 700 watts 50 Hz, 1.5 A 350 watts 50 Hz, 1.5 A 350 watts
Fault Protection Sensor burnout protection, over Sensor burnout protection, over Sensor burnout protection, over
temperature thermal cutout, temperature thermal cutout temperature thermal cutout
electrical fuse electrical fuse electrical fuse
* Transfer calibration accuracy is the difference between the thermocouple tip and the sensor of the IRTD temperature standard. This accuracy includes well to well
uniformity.
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