TrackSense Pro

The
ultimate
wireless
data logger
 T R A C K S E N S E ® P R O I PAGE 3

The Ultimate Wireless

Data Logger
Time Temperature Pressure Vacuum Relative Humidity Conductivity CO2 Sky

TSP Pro XL • • • • • • • •
TSP Pro X • • • • • • • •
TSP Pro • • • • • • • •
TSP Basic • • • • • • • •
TSP Compact • • •
TS Frigo • •
TS Lab • • • •
TSP Mini • •
TSP Micro • • •

TrackSense® Pro parameter overview

Ellab has incorporated the latest in electronic Performance Multi Reader Station Sky Module Sky Access Point
technology and innovation to deliver a wireless multi The TrackSense® Pro X loggers are designed to operate Starting up and reading loggers can The Sky module contains all the The Sky Access Point offers many
channel data logger that is unmatched in accuracy, under extreme conditions without ever losing now be performed within seconds. necessary components for wireless advantages over standard wireless
performance, and versatility. valuable data. They operate in temperatures from 16 loggers can be started or read online communication between the Access Points. The proprietary
-80 to +150 °C and can withstand pressure up to 10 Bar simultaneously, saving time, logger and the Sky Access Point. wireless protocol significantly
Accuracy fully immersed. When used with a thermal barrier, the especially when 160 data loggers The standard Sky module comes reduces battery consumption in
The incorporation of state of the art technology and measuring range is extended to -196 to +400°C. The have to be started for one study. with an internal antenna. Should the data logger. All other wireless
extensive testing has resulted in outstanding non-volatile memory stores up to 60,000 data points communication stop, data will be equipment is rejected by the Sky
performances*: and it is possible to have up to 160 data loggers in one Introducing RF Data Transmission stored in the logger for transmission Access Point, greatly improving
validation study. Enjoy all the benefits of having real once communication has been transmission success and security.
• Temperature: ±0.05 °C time process information available restored or the logger has been A channel test function is available
• Humidity: ±2% Versatility on your computer and a reduced returned to the reader station. No to eliminate data interference.
• Pressure: ±0.25% full scale With the unique feature of interchangeable sensors it is setup time with self-contained data will ever be lost or corrupted due The Sky Access Point comes with
• Time: ±5 sec. per 24 hours possible to configure the logger for any specific wireless data loggers. Once the to loss of wireless communication. a standard antenna, but optional
• Conductivity: ±1 μS/cm application by mounting different interchangeable logger including a Sky module has The sky module is ATEX certified for remote antennas are available for
• CO2: ±0.2% sensors and, if required, an RF module for online data been started in the reader station, it use in environments such as EtO more difficult transmission
• Vacuum: ± 15-20% of reading collection. This unique feature is highly beneficial when can be read and restarted remotely processes. environments. To cover larger areas
TrackSense® Pro is it comes to flexibility and lowered operation costs. by the Sky Access Point. At the end or longer distances, multiple Access
the most accurate * For individual product performance please see of a test cycle, the logger is placed Points can be operated
specifications on www.ellab.com in the reader station to go offline for simultaneously.
data logger safety and backup purposes and to
available on the save battery life by turning the Sky
module off.
market today

Enjoy all the

benefits of
having real
Sensor
time process
information
available on
The TrackSense® Pro Multi Reader Station can be combined with modules for Micro, Mini, Compact,
Frigo or Pro loggers, allowing start up of 16 loggers simultaneously Sky Module Access Point your computer
Logger
 T R A C K S E N S E ® P R O I PAGE 5

TrackSense® Pro
Internal Temperature Sensor Rigid Temperature Double Rigid Temperature Semi Flexible Sensor
With Pt1000 element Sensor ø 2 mm Sensors ø 2 mm ø 1.5 mm
positioned internally, this Single rigid stainless steel Double rigid stainless Single or double semi

Interchangeable Sensors sensor is ideal for

applications where
sensor with round,
conical or sharp tip.
steel sensor with round,
conical or sharp tip.
flexible stainless
steel sensors
space is limited and/or All temperature sensors Straight design with with small
maximum protection of are made with Pt1000 an optional 90° sensor
the sensor is required. elements. or 180° bend. diameter for
Ellab offers the largest range of different sensors with Extreme Temperature Sensors
-80 to +150 ºC -196* to +150 ºC -196* to +150 ºC increased flexibility
1, 2 or 4 channels. The sensors are interchangeable, The standard temperature range goes up to +150 °C,
and usage for very
enabling the user to choose sensors for different but it is possible to order sensors which can measure
narrow lumen.
applications. This reduces costs as one set of down to -196 °C or up to +400 °C. The logger has to
-196* to +150 ºC
TrackSense® Pro loggers can be used for temperature, be placed outside of the environment when measuring
CO2, humidity, pressure and conductivity studies. All at -80 °C to -196 °C. When measuring from +150 °C Multipoint Sensor Low Temperature Sensor
sensors (except quad sensors) are compatible with up to +400 °C, a thermal barrier is required to protect ø 2.5 mm Rugged ø 1.2 mm
a Sky option to provide live data. The temperature the battery. The principle is to insulate the logger for a The multipoint rigid stainless Sensor Single, double,
sensors can be delivered in rigid, semi flexible and specific amount of time keeping the battery temperature Semi steel sensor is used to ø 2.5 mm or quad
flexible material for ease of use. Rigid sensors are below +150 °C. Flexible Sensor determine temperature The flexible
available with or without LED that shows the status of ø 2 mm differences in containers rugged sensors
the logger. An active logger is identified by the light TrackSense® Pro Logger Single or double to locate the cold spot sensor is with small
flashing green. This feature makes it easier to start Each logger has multiple channels for recording data semi flexible with a total of four extremely robust, diameter. Ideal
larger groups of loggers and helps to avoid the use of with a memory capacity of up to 60,000 data points. stainless steel Pt1000 elements but still allows for low temperature
non programmed loggers. In the case of an LED sensor The state of the art technology allows for variable sensors with round, measuring access to hard to applications such
being used in combination with a Sky module, the LED sample rates. A logger can be programmed to auto conical or sharp tip. simultaneously. reach areas. as lyophilization.
will also confirm communication status. start or increase the sample rate at a specific time or -196* to +150 ºC -80 to +150 ºC -196* to 140 ºC -196* to +100 ºC
temperature. The logger is made of AISI 316L stainless
steel and the electronics are sealed in heat and SmartFlex Vacuum/Temperature
moisture resistant material. The Pro logger is designed ø 1.8 mm Sensor Pressure Sensor Pressure/Temperature
for adaptation of interchangeable sensors and all Single or The sensor is The sensor is Sensor
loggers have user replaceable batteries and are ATEX double fully configured to measure configured to The sensor is
certified. The ATEX temperature range for each logger flexible color Vacuum and is ideal for measure pressure. configured to
can be found on the certificate. coded sensors. lyophilization 10 mBar to 6 bar ABS measure pressure
Sensors are SmartFlex secures applications. together with
the intended position 0.0001 to temperature.
compatible with of the sensor. 1,000 mBar 10 mBar to 6 bar ABS
a Sky option to -196* to +140 ºC -80 to +140 ºC 0 to +150 ºC

provide live data.

Relative Humidity/Temperature AutoMarker Sensor Conductivity/
High Sensor for EtO The Sensor offers Temperature Sensor
Temperature The sensor is developed for EtO automatic setting The Conductivity sensor
Basic Logger Pro Logger Pro X Logger Pro X Long Logger Sensor processes. The sensor has a of time markers on-the-fly as with integrated
TrackSense® Pro Basic is TrackSense® Pro Logger is TrackSense® Pro X is the most TrackSense® Pro XL is an Single or double capacitance element process events occur. temperature sensor for
specially designed for the designed to be accurate and versatile logger in the range. It enlarged logger with an semi flexible sensors, and is optimized for a measurements apply-
many applications below 100 °C durable in the harshest is specially designed for low extended battery capacity. specifically designed for very humid and ing to the control of
such as pasteurization or EtO conditions. All components temperature applications such Due to the larger capacity, the high temperature aggressive process. industrial processes.
sterilization. have been selected and tested as lyophilization or ultra low battery stability is particularly applications. 0 to +90 ºC 0 to 200 μS/cm
to withstand the high temperatures temperature storage while also increased in applications 0 to +400 ºC 0 to 95% RH 200 to 2000 μS/cm
and pressures associated with being able to handle higher where temperatures
steam sterilization and other tempertures, including change from being Relative Humidity/Temperature CO2 Sensor
demanding processes. sterilization. very high to very Sensor for Stability The sensor provides wireless
low. The standard humidity sensor measurements of CO2
has a fast response to concentration used
-30 to +105 ºC -50 to +150 ºC -80 to +150 ºC -80 to +150 ºC determine humidity levels for the validation
60,000 Data Points 60,000 Data Points 60,000 Data Points 60,000 Data Points during the validation or monitoring of
of a warehouse or biological cell
Diameter: 25 mm Diameter: 25 mm Diameter: 25 mm Diameter: 25 mm
stability chambers. growth incubators. *The sensor can measure down
Height: 44 mm Height: 44 mm Height: 44 mm Height: 68.8 mm
0 to +90 ºC 0 to 50 ºC to -196 ºC when the logger is
0 to 100% RH 0 to 18% CO2 placed outside the process.
 T R A C K S E N S E ® P R O I PAGE 7

TrackSense® Pro Compact X ø 2 mm Compact ø 2 mm Compact SemiFlex

Length: 35, 50, 75, 100 mm
Integrated Sensors The Compact X logger is The Compact logger is
Length: 30, 50 cm

configured to measure configured to measure The material is

temperature with a rigid or temperature with a semi flexible
flexible sensor. rigid sensor. stainless steel
ø 1.5 mm.
-50 to +140 ºC -30 to +140 ºC
30,000 Data Points 30,000 Data Points -30 to +140 ºC
Diameter: 25 mm Diameter: 25 mm 30,000 Data Point
Height: 35 mm Height: 35 mm Diameter: 25 mm

Compact Pressure/Temperature
Compact The Compact logger is Compact Pressure
SmartFlex configured to measure The Compact logger is
Length: 30, 50 cm pressure combined configured to measure
with temperature. pressure.

A large range A range of loggers with integrated sensors are available Just like all other Ellab products, these loggers are The material is -30 to +140 ºC -30 to +140 ºC
in temperature, pressure and humidity versions for made of AISI 316L stainless steel. PTFE ø 1.8 mm. 0 to 6 bar 0 to 6 bar
of loggers with various applications. The decision on which model to
-30 to +140 ºC 10,000 Data Points 15,000 Data Points
integrated choose should be based on physical dimensions and
process parameters. 30,000 Data Points Diameter: 25 mm Diameter: 25 mm
sensors to fit
Diameter: 25 mm Height: 55 mm Height: 55 mm
specific needs
Lab Relative Humidity/
Lab ø 2 mm Temperature
Length: 0 and 35 mm Ideal for monitoring humidity Lab ø 1.8 mm
The Lab logger is designed and temperature in long term Length: 50 cm
for stability studies. Ideal for stability applications. Can be The Lab logger
monitoring temperature. Can fitted with a SKY module. is designed with
be fitted with a SKY module. four temperature
0 to +85 ºC channels. The cables
-30 to +100 ºC 0 to 100% RH have different colors
60,000 Data Points 30,000 Data Points for easy identification.
Sky optional Sky optional
Frigo ø 2 mm Frigo
LED LED Included -30 to +100 ºC
Length: 0 and 35 mm SemiFlex
15,000 Data Points
ø 1.5 mm Diameter: 25 mm Diameter: 25 mm
The Frigo logger is designed Length: 30 and 50 cm Height: 46 mm Diameter: 25 mm
Frigo Height: 44 mm
specifically for ultra cold
SmartFlex Due to the design, this
applications. Using a large
ø 1.8 mm logger is ideal for
battery in an extended Mini ø 2 mm
Length: monitoring freezing
housing, this logger Length: 0, 10, 25, 50, 75, 100 mm
30 and 50 cm processes over Micro ø 2 mm
will be able to Compact Ultra X The small volume displacement makes Micro Pressure/Temperature
extended time Length: 10 mm
operate at ultra low Due to the design, The Compact Ultra X this logger ideal for measuring inside The Micro logger is configured to
temperatures for this logger is ideal periods such as uses a larger battery packaging. Due to its temperature range The small diameter makes these measure temperature/pressure.
up to 12 months. for low temperature biological sample and can go down to the logger is ideal for loggers ideal for measuring inside
applications such as storage. -80 °C. sterilization applications. bottles during pasteurization cycles. -20 to +140 ºC
-90 to +85 ºC lyophilization. 0 to 6 bar
60,000 Data Points -90 to +85 ºC -80 to +140 ºC 0 to +140 ºC -20 to +140 ºC
-90 to +85 ºC 60,000 Data Points 60,000 Data Points 30,000 Data Points 14,500 Data Points 10,000 Data Points
Diameter: 25 mm
Height: 60 mm 60,000 Data Points Diameter: 25 mm Diameter: 25 mm Diameter: 20 mm Diameter: 15 mm Diameter: 15 mm
LED Included Diameter: 25 mm LED Included Height: 60 mm Height: 12 mm Height: 22 mm Height: 30 mm
 T R A C K S E N S E ® P R O I PAGE 9

Fittings & Accessories

Luer lock
GVK Positioned on the syringe with pressure sensor
On bottle necks use the GVK packing gland for mounted on logger for pressure measurement in
pasteurization applications. pharmaceutical processes.

Custom Fittings
Packing glands and other fittings are available for pressurized. It is very important that sensors are
placing loggers and inserting sensors into any variety placed correctly in the “cold/hot zone” to obtain true
of packaging material. The glands are threaded to lethality values. See examples of typical applications
accept sensors and will maintain the seal when and configurations below.
TDJ TIK
Logger mounted inside pouch for sterilization applications. Internal fixture for measuring inside IV-bags.
It is very important
that sensors are
placed
correctly in the
“cold/hot zone”

TSS/FixPro LYO SHUTTLE GNK

Sleeves for protection during movement and silicone Vial holder with contact puck and rubber stopper for Logger mounted on ampoules in moist heat sterilization GVJ
case holder for secure positioning. lyophilization applications. applications. Packing gland for measuring inside ampoules or vials.

TBJ/TSK/TSJ and GKJ PTFE Thermal barrier TTB Thermal Barrier

TBJ/TSJ Fitting for internal mounting and packing gland for Logger protected in special PTFE Thermal barrier for Logger with high temperature sensor mounted in TTB
Fitting for internal mounting inside bottles. external mounting. liquid boiling applications. Thermal Barrier for depyrogenation applications.
 T R A C K S E N S E ® P R O I P A G E 11

ValSuite™ Pro
Operator: Validation Manager Vessel: Autoclave
Process: Sterilization Product: Medicine
Session Start: 15-06-2017 08:50:00 Time Zone: UTC offset 02:00:00
Session Stop: 15-06-2017 10:33:35
Session Name: Sterilization @ 122 °C with vacuum pulses.d7x
Session Text: Sterilization @ 122 °C with vacuum pulses Validation Solutions

Sensor Adjustment Report

Operator: Validation Manager Vessel: Autoclave

Sensor Adjustment Report
Process: Sterilization Product: Medicine
ID Session Start:
Sensor Value 15-06-2017
Standard Value08:50:00 Deviation
Time Zone: UTCCalibration
offset 02:00:00
Timestamp
30173 N/A Session Stop: N/A15-06-2017 10:33:35 N/A N/A
Session Name:
30178 N/A N/ASterilization @ 122 °C with
N/A vacuum pulses.d7x N/A Validation Solutions
Session Text: Sterilization @ 122 °C with vacuum pulses
30175 N/A N/A N/A N/A

Sensor adjustment report

29811 N/A N/A N/A N/A
35894 N/A N/A N/A N/A
35895
35897
N/A
N/A
N/A
N/A
N/A
N/A
Limit Report
N/A
N/A
30875 N/A Name: N/A N/A Report 1 N/A
30170 N/A Description: N/A N/A N/A 1
Limit Report Number
Operator: Validation Manager Vessel: Autoclave
30172 N/A N/A N/A N/A
Process: Sterilization Product: Medicine
35898 N/A N/A N/A N/A
Session Start: 15-06-2017 08:50:00 Time Zone: UTC offset 02:00:00
35896 N/A N/A N/A N/A
35899 N/A
Input parameters
N/A
Session Stop:
N/A
15-06-2017 10:33:35
N/A
Session Name: Sterilization @ 122 °C with vacuum pulses.d7x
30174 N/A Criteria: N/A N/A
Session Text: Passed when @
Sterilization 121,00
N/A °C with
122 °C < Value < 124,00
vacuum °C
pulses Validation Solutions
30171 N/A Triggering : N/A N/A All, TemperatureN/A
Data Series: LC 1, LC 2, LC 3, LC 4, LC 5, LC 6, LC 7, LC 8, LC 9, LC 10, LC 11, LC 12,

ValSuite™ Pro Software

33365 N/A N/A N/A N/A

Limit report
LC 13, LC 14, LC 15
Statistics
Name: Statistics
Range

Intuitive and user friendly software ValSuite™ Pro is an intuitive validation software which
Description: Operator: Validation Manager Vessel: Tunnel01
Time: 15-06-2017 08:50:00 to 10:33:35
Process: Lyophilisation Product: Pharma
Session Start: 02-03-2017 10:07:02 AM Time Zone: UTC offset 02:00:00
Session Stop:
Input parameters 02-03-2017 2:49:01 PM

collects and presents validation data from all Ellab

Session Name: Lyophilisation
Triggering Interval Data Series Type: Temperature Validation Solutions
Session Text: Lyophilisation
from to series:
Data LC 4, LC 9, LC 15, LC 10, LC 1, LC 14, LC 3, LC 2, LC 8, LC 5, LC 6, LC 12,
15-06-2015 09:31:00 15-06-2017 10:01:40 LC 7, LC 11, LC 13
Start Time: 15-06-2017 09:31:54.226
Adv. Phase Statistics Report
measuring devices. The software package is designed for Statistics report
Stop Time: 15-06-2017 10:01:15.753
Summary Time: Output: 00:30:40 Graphic Representation, Data Series analysis, Global Data analysis

The easy way to put the ValSuite™ Pro software Functions: Name:
Description:
Min., Max., Average, Max. - Avg., Avg.
Operator:
Adv. -Phase
Min., Delta,
Adv.Validation
Standard
Statistics ReportDeviation
1
ManagerReport 1 Vessel:
Phase Statistics Autoclave

Windows 10, 64-Bit. The software is developed

Total Test Result: Process: Sterilization
Passed Product: Medicine
Session Start: 15-06-2017 08:50:00 Time Zone: UTC offset 02:00:00
Global Data analysis

to work:
Session Stop: 15-06-2017 10:33:35
Session15-06-2015
Name: Sterilization @ 122 °C with vacuum pulses.d7x
Min. Input parameters 122,76 °C
Session15-06-2015
Text:
09:45:00
Sterilization @ 122
LC 10
°C with vacuum pulses Validation Solutions
09:45:05 LC 10

according to GAMP principles. ValSuite™ is available in

Process Start: 15-06-2015 09:45:1012:17:06LC
02-03-2017 PM10
Process Stop: 15-06-2015 09:45:152:16:09 PM
02-03-2017 LC 10
Detection Mode: Autodetect
09:45:20phases LC 10
Sensor Type:
15-06-2015
15-06-2015SensorGroup
09:58:45 LC 10 Validation Report

four versions, ValSuite™, ValSuite™ Medical, ValSuite™ Adv. phase statistics report
Sensor Groups - DataSeries: tray 1 - Position 3, Position 4, Position 5
Name: 15-06-2015 09:58:50 LC 10 Validation Report
15-06-2015Tray 2 - Position 6, Position
09:58:55 LC 10 7, Position122,00
8
Description: °C
Max. ∆(Max. - Min.) < 123,32 °C 3 °C Operator: Validation Manager Vessel: Autoclave
Cycle: 15-06-2015 09:32:00 LC 11
Average Standard Deviation <123,05 °C 3 °C Process: Sterilization Product: Medicine
Total Test Result Passed
Global ∆(Max. - Min.)0,28
< °C 4 °C Session Start: 15-06-2017 08:50:00 Time Zone: UTC offset 02:00:00

Login, program and start the loggers using

Max. - Avg.

Plus and ValSuite™ Pro. The ValSuite™ Pro version has

Session Stop: 15-06-2017 10:33:35

1
Avg. - Min. Global Standard Deviation
0,28 °C< 3 °C
Phase Definition Phase Name Session Name:
Set point Set point @ 122 °C with vacuum pulses.d7x
Sterilization
Delta 0,56 °C Validation Solutions
Standard Deviation 0,08 °C Input parameters Session Text: Sterilization
band @ 122 °C with vacuum pulses
Phase 1 -40 °C 4 °C
Process Temperature : 122,00 °C

a Repeat function, which includes a unit all features and all reports all while being fully validated
Phase 2 -20 °C 4 °C
Process Temperature Band (K): 3,00
Phase 3
Max. Allowed Temperature Fluctuation Saturated
(K):
-1 °C Steam
1,00 Analysis
4 °C
Phase 4 22 °C 4 °C
Max. Allowed Difference Temperature (K): Deviation: 2,00
Pressure 0,0419 bar
- Generated by ValSuite Pro - Maximum Equilibration Time: 00:00:15
Max. Pressure Deviation: 0,1000 bar

configuration and a selection of reports.

Printed: 15-06-2017 15:22:20 Page 1 of 1

and compliant with 21 CFR, part 11.

Minimum Holding Time: Pressure Deviation00:15:00

EN17665 report
Phase Calculation Maximum Pressure Deviation:
Test Result: Operator:
0,1000 bar
Validation Manager
Passed Vessel: Autoclave
Process: Sterilization Product: Medicine
Phase Name Phase Start Phase End Phase Duration Test Result
Session Start: 15-06-2017 08:50:00 Time Zone: UTC offset 02:00:00
Phase 1 02-03-2015 12:17:06 PM 02-03-2017 12:32:08 PM 00:15:02 Passed
Session Stop: 15-06-2017 10:33:35
Summary Report

Place the loggers in the load or process

Session Name: Sterilization @ 122 °C with vacuum pulses.d7x
Phase 2 Equilibration Time
02-03-2015 12:51:44 PM 02-03-2017 1:03:00 PM 00:11:16 Passed

Full IQ/OQ documentation and validation services are

Session Text: Validation Solutions
Phase 3 02-03-2015 1:19:48 PM 02-03-2017 1:32:48 NamePM 00:13:00 FluctuationPassed
(°C) DeviationSterilization @ 122 °C with vacuum pulses
Phase 4 Equilibration
02-03-2015 Start 02-03-2017
1:52:24 PM Time: 2:16:09
LC PM
1 00:23:45 15-06-2017
1,82 09:31:05
Passed 0,0064 bar
Equilibration End Time: LC 2 15-06-2017
1,96 09:31:10 0,0419 bar
Equilibration Duration: 00:00:05
LC 3 1,80 0,0035 bar
Lethality Overview
and run the cycle. available from Ellab. The software is currently available
Phase Statistics Max. allowed Equilibration Duration:LC 4 00:00:15
1,81 0,0033 bar
Equilibration Test Result: LC 5 Passed
1,91 0,0168 bar
- Generated by ValSuite
PhasePro
1 -
Printed: 15-06-2017 14:59:23 Page 1 of 1 LC 6 1,85 0,0158 bar
Sensor Groups Min. Value Max. Value ∆(Max. - Average LCStandard
7 Global1,93
∆ Global Global
0,0386 bar Operator: Validation Manager Vessel: Autoclave
Min.) Deviation (Max. - Input parameter
Average Standard Process: Sterilization Product: Medicine
Process band
in the following languages: Chinese, Dutch, English,
LC 8 1,91 0,0326 bar

Saturated steam report

Min.) Start Date Deviation
:0,0114 bar Session Start: 15-06-2017 08:50:00
15-06-2017 Time Zone: UTC offset 02:00:00
LC 9 1,83
tray 1 -39.80 °C -36.54Holding
°C Start
2.44 Time:
°C -37.81 °C LC 0.73 15-06-2017 09:31:10 Session Stop: 15-06-2017 10:33:35
10 °C 3.38 °C
1,88 -38.32
Ref.°C 0.63
Temperature: °C bar
0,0143 121,11 °C
Test Result Holding End Time:
Passed Passed 15-06-2017 10:01:35
Passed Passed Session Name: Sterilization @ 122 °C with vacuum pulses.d7x
LC 11 1,83 Min. Temperature
0,0124 :bar 91,11 °C Validation Solutions
Tray 2 -39.92 °C -37.40Holding
°C Duration:
1.31 °C -38.32 °C LC 0.37 00:30:25 Session Text: Sterilization @ 122 °C with vacuum pulses
12 °C 3.38 °C
1,92 -38.32 °C
Z-Value: 0.63 °C bar
0,0331 10 °C

French, German, Italian, Japanese, Polish, Portuguese,

Test Result Min. allowed Holding Duration:
Passed 00:15:00
LC Passed
13 Passed1,81 D-Value: Passed
0,0064 bar
Holding Test Result: Passed
LC 14 1,87 0,0121 bar
Phase 2 LC 15 1,84 0,0147 bar TrackSense Logger Settings Report
Sensor Groups -Min. Value byMax. ValuePro -∆(Max. - Band Average Standard Global ∆ SensorGlobal
Global lethality overview
Difference
Russian, Spanish, Swedish and Turkish.
Generated ValSuite
Min.) Deviation (Max. - Average Standard
Printed: 15-06-2017 13:04:36 Name Description Start Time End Time Max. Value
Difference Temperature (K): LethalityPage 1 of 5
Calculation
Min.)
0,30 Deviation Operator: Validation Manager Vessel: Autoclave
tray 1 -19.25 °C -17.26Max.
°C Allowed
1.02 °C
Difference-18.40 °C
Temperature 0.46
(K): °C 3.96
2,00°C
LC 1 (F0) Lethality 1
-18.25 °C 0.64 °C TrackSense Logger Settings
L-Calculation
Process: LoggerSterilization
08:50:00 S/N: 10:28:20
Product: 31358
52,81
Medicine
Lethality - Max. Pressure Deviation: LC 2 (F0) Lethality 1
0,1000 barL-Calculation 08:50:00 10:28:20 50,94
Test Result Selected Passed
data series: Passed Passed
LC 1, LC 2, LC 3, LC
LC 4,
Passed
LC 5,
3 (F0) LC 6, LC
Lethality 1 7, LC 8,L-Calculation
LC 9, LC 10,ID:
Sensor LC 11, LC 12, 30173 Session Start: 15-06-2017
Factory
08:50:00 15-06-2017
08:50:00Date: Time Zone:
Calibration
10:28:20
UTC offset 02:00:00
18-03-2017
Lethality - Min. Saturated Steam Duration: 00:15:00 Session Stop: 10:33:35 51,79

Lethality report
Tray 2 -19.99 °C -16.03 °C 2.03 °C -18.25 °C 0.77 °C 3.96
LC °C -18.25
13, LC 14, °C 170.64 °C
LC 15,
Lethality - Min. Lethality value: LC LP
4 (F0) Lethality 1
0,00 Logger S/N:
L-Calculation 31358 Start/Stop
08:50:00 Sterilization
Session Name:
Trigger Source:
10:28:20 51,05
@ 122 °C with vacuum pulses.d7x
N/A
Test Result DifferencePassed
Temperature Test Result:Passed Passed
Passed Passed Adjust Start Time: Yes Start Process Value: N/A Validation Solutions
Lethality - Reference Temperature: LC 5 (F0) Lethality 1
121,11 °C L-Calculation 08:50:00 Sterilization
Session Text: 10:28:20 50,38
@ 122 °C with vacuum pulses
LC 6 (F0) Lethality
Min. Temperature for Lethality-Calculation: Start Time:
1 °C L-Calculation
91,11 15-06-2017 08:50:00
08:50:00 Stop Process
10:28:20Value: 51,18 N/A
Lethality - Z-Value: LC 7 (F0) Lethality
101°C Adjust Stop Time:
L-Calculation No 08:50:00 Stop Process
10:28:20Enable Value:
51,12 N/A

Detailed Control of Validation Studies

Fluctuation Band Lethality time: LC 8 (F0) Lethality 1
15-06-2015 Stop Time:
L-Calculation
09:31:00 - 15-06-2015 10:01:40 17-06-2017 02:30:00
08:50:00 Sampling Control
10:28:20 Trigger Source:
51,18 N/A

Temperature Fluctuation (K): 1,00

LC 9 (F0) Lethality 1 Sample Rate 1:
L-Calculation
Sample Rate 2:
00:00:05
N/A
08:50:00 Sampling Control Minimum
10:28:20 50,92Value: Graph
N/A
- Generated by Fluctuation
ValSuite Pro(K):
- LC 10 (F0) Lethality 1 L-Calculation 08:50:00 Sampling Control Maximum
10:28:20 48,37Value: N/A
Max. Allowed Temperature 1,00 Firmware Version: 4.8.0.0
LC 11 (F0) Lethality 1 L-Calculation 08:50:00 10:28:20 52,06
Temperature- Printed: 03-03-2017
Fluctuation Test 8:10:57
Result:AM - Passed
LC 12 (F0)Page 1 of 21
Lethality L-Calculation 08:50:00 10:28:20Operator:50,68

The ValSuite™ Pro software documents and guides you

Validation Manager Vessel: Autoclave
LC 13 (F0) Lethality 1 L-Calculation 08:50:00 10:28:20Process: 51,23 Sterilization Product: Medicine
LC 14 (F0) Lethality 1 TrackSense Logger Settings Logger
L-Calculation 08:50:00 S/N: 10:28:20Session Start:
50,65 31344 08:50:00
15-06-2017 Time Zone: UTC offset 02:00:00
LC 15 (F0) Lethality 1 L-Calculation 08:50:00 10:28:20Session Stop:
52,69 15-06-2017 10:33:35
Sensor ID: 30178 Factory Calibration Date:
Session Name: 18-03-2017
Sterilization @ 122 °C with vacuum pulses.d7x

through the complete thermal validation process. The Equipment used

Logger S/N: 31344 Start/Stop Trigger Source:
Session Text: N/A
Sterilization @ 122 °C with vacuum pulses Validation Solutions
Adjust Start Time: Yes Start Process Value: N/A
Start Time: 15-06-2017 08:50:00 Stop Process Value: N/A
Adjust Stop Time: No Stop Process Enable Value: N/A
Stop Time: 17-06-2017 02:30:00 Sampling Control Trigger Source: N/A Unit Configuration
database structure in the software enables complete
Sample Rate 1: 00:00:05 Sampling Control Minimum Value: N/A
- Generated by ValSuite Pro - Sample Rate 2: N/A Sampling Control Maximum Value: N/A
Printed: 15-06-2017 13:29:48 Page 1 of 3 5.8.0.0 Name: Chamber mapping
Firmware Version:
Description: Heat distribution study

Read the loggers. Data analysis and

Type: Sterilizer

2 documentation and procedural control for the operators. TrackSense Logger Settings Logger S/N:
Sensor ID: 30175 Sensor
Factory Calibration Date: Setup
31356
18-03-2017

reports are made automatically. Graph & Zoom

Logger S/N: 31356 Start/Stop Trigger Source: N/A
Position: Sensor S/N: Label: Position Name: Position Description: Sensor Alias: Sensor Sample
Adjust Start Time: Yes Start Process Value: N/A
group: Rate:
Start Time: 15-06-2017 08:50:00 Stop Process Value: N/A
1 None Upper Left Upper left Upper left 00:00:30
Adjust Stop Time: No Stop Process Enable Value: N/A
2 None Upper Right Upper right Upper right 00:00:30
Stop Time: 17-06-2017 02:30:00 Sampling Control Trigger Source: N/A
- Generated by ValSuite Pro -

Test Setup
3 None lower r Lower right Lower right 00:00:30
Sample Rate 1: Graph Zoom Sampling Control Minimum
00:00:05 Value: N/A
Printed: 15-06-2017 16:09:26 Page 2 of 3 4 None Center Center Center 00:00:30
Sample Rate 2: N/A Sampling Control Maximum Value: N/A
5 None lower l Lower left 00:00:30
Firmware Version: 20.7.0.0

Report function allows detailed test criteria to be TrackSense Logger Settings Logger S/N: Image Set 1 31375

Unit
Sensor ID: 29811 Factory Calibration Date: 18-03-2017
Logger S/N: 31375 Start/Stop Trigger Source: N/A

programmed in the software by the operator.

Adjust Start Time: Yes Start Process Value: N/A
Start Time: 15-06-2017 08:50:00 Stop Process Value: N/A
Adjust Stop Time:
- Generated byNoValSuite Pro - Stop Process Enable Value: N/A
Stop Time: 17-06-2017
Printed: 16-06-2017 02:30:00
16:04:23 Sampling Control Trigger Source:
Page 1 of 1 N/A

Information on sensor placement, operator, test, vessel,

Sample Rate 1: 00:00:05 Sampling Control Minimum Value: N/A
Sample Rate 2: N/A Sampling Control Maximum Value: N/A
Firmware Version: 22.6.0.0

required temperature limits, start and stop time,

monitoring interval and specific calculations can all be
Upper left
- Generated by ValSuite Pro -
Printed: 17-06-2017 16:18:33 Page 11 of 197
Upper right

repeated. This ensures accurate documentation and Center

correct implementation of required procedures for Lower left

- Generated by ValSuite Pro -

consistent repeatable tests. Monitoring Features Reporting

Printed: 16-06-2017 15:24:26
Lower right Page 1 of 1

ValSuite™ Pro software also offers several monitoring  Sample validation reports
3 Print the reports and logout.
Software Data Analysis Features type features such as on screen statistical calculations, Lethality report - Generated by ValSuite Pro -
Printed: 15-06-2017 15:27:10 Page 1 of 2

Data analysis tools greatly reduce the time needed to limit alarms, alarms over internet and notification via Limit report
find critical data. The ability to zoom graphically and e-mail services. Further to this, a “transport logger” Statistics Report Samples of typical validation reports
display multiple windows at once simplifies identifying function makes it possible to start and read the logger Adv. phase statistics report
important data. Multiple calculations such as min/max, from two different databases / PC’s thus allowing the Calibration report
standard deviation, average, deltaT and lethality can be logger to be used to monitor parameters during Autoclave validation
calculated using any block of data displayed, eliminating transportation over long distances. Washer disinfection validation
the need to export data thus improving data security. MKT report
ValSuite™ Pro Main Feature List Combined uncertainty report
ValSuite™ Pro collects and presents validation data  One software for both TrackSense® Pro loggers and Leak test report
from both E-Val Pro and TrackSense® Pro data logging E-Val Pro wired systems Advanced validation report Fully compliant
systems. The data from both systems can be presented  Can be run from a stand alone PC or a server/Citrix Dew Point Calcution
and analyzed in the same session. The system can solution. Network security can be applied.  Printed or PDF format
with 21 CFR,
run up to 160 channels which can be identified and  Full synchronization of all data meaning no  Comment field and Word document attachment Part 11
displayed in different groups such as penetration and “phantom” values in reports  Heat Factors/Ball Simulation
ValsuiteTM Pro Data Integrity is approved distribution. Any grouping or specific channels can be  Up to 160 channels in one session  3D Visualization
by Quality Compliance Partners Inc. displayed in a separate data block and analyzed.  Switch between multiple languages
It is also possible to merge individual sessions and run  Drivers for calibration equipment
analysis for comparison purposes.
 T R A C K S E N S E ® P R O I P A G E 13

Producing Reports Validation Report

Report header: 1 Process Start Time: 2 Process End Time: 3

Validation Report 10-05-2017 13 23 53 10-05-2017 15 01 56
Name: Preselected Timestamps Preselected Timestamps
Revalidation of autoclave in room 66 First possible start Last possible end

A complete set of reports can be produced with Pass/ or EN15883 for washer disinfectors and NFX 15-140 Description: (Use of preselected timestamps is optional)
Fail criteria, detail on mapping positions, operator and for stability chambers. The templates can be customized According to EN 17665

vessel ID, calibration offsets for sensors, real data and to organize the data and perform calculations to exact
statistical summaries on the data. criteria. Process Lethality Calculation

Current Sensors
Process Temperature: 4 134.00 ˚C
ValSuite™ Pro also maintains templates for reports This feature greatly reduces the time needed for the LC 01
Process Temperature Band: 3.00 K
designed to meet the specific requirements of tests data analysis process. Reports can be reviewed with the LA 02
Maximum Temperature Fluctuation: 1.00 K LC 03 6
such as EN17665 (EN554) for moist heat autoclaves print preview feature and saved in a PDF file format. LC 04
Maximum Temperature Difference First 60 Sec.: 5.00 K LC 05
Maximum Temperature Difference: 2.00 K LC 06
LC 07
Maximum Equilibration Time: 00 00 15 LC 08
LC 09
Use individual sensor for start equilibration time:
LC 10
LC 04 LC 11
LC 12
Holding Time : LC 13
Minimum Holding Time: 00 03 00
Select All Select None
Maximum Holding Time: 00 35 00
Use 24 hours as minimum holding time Select Core Select Ambient

Automatic by temperature
Manual by time markers

Max Pressure Deviation: 0.1000 bar

Cycle (optional):
5
Dynamic Pressure Test
Max 10 bar/min. Calculated in 3 sec. interval
Max 10 bar/min. Calculated in 2 sec. interval

Save template Load template 7 OK Cancel

Unit configuration with drag and drop Report Setup

Operator: Validation Manager Vessel: Autoclave

Process: Sterilization Product: Medicine
Session Start: 15-06-2017 08:50:00 Time Zone: UTC offset 02:00:00
Session Stop: 15-06-2017 10:33:35
Session Name: Sterilization @ 122 °C with vacuum pulses.d7x
Session Text: Sterilizarion @ 122 °C with vacuum pulses Validation Solutions
Operator: Validation Manager Vessel: Autoclave
Process: Sterilization Product: Medicine
Session Start: 15-06-2017 08:50:00 Time Zone: UTC offset 02:00:00

Name:
Validation Report
Validation Report
Session Stop:
Session Name:
Session Text:
15-06-2017 10:33:35
Sterilization @ 122 °C with vacuum pulses.d7x
Sterilization @ 122 °C with vacuum pulses Validation Solutions The example shows the layout of the Validation report. 6 Definition of which measuring points (sensors)
Description: 121,00 °C
Cycle:
Total Test Result Failed
Validation Report
All reports are designed with the concept in mind to should be included in the reporting.
provide maximum flexibility and easy input of data. This feature
Name: Validation Report
Input parameters Description: 122,00 °C
Process Temperature : 121,00 °C Cycle:
Process Temperature Band (K): 3,00 Total Test Result Passed
Max. Allowed Temperature Fluctuation (K): 1,00
7 Saving and uploading of preconfigured report
greatly
Max. Allowed Difference Temperature (K): 2,00
Maximum Equilibration Time: 00:00:15 Input parameters

Input for report header, name of report as well as templates.

Minimum Holding Time: 00:15:00

1
Maximum Pressure Deviation: 0,1000 bar Process Temperature : 122,00 °C
Process Temperature Band (K): 3,00
Max. Allowed Temperature Fluctuation (K): 1,00

a more detailed description. reduces the time

Max. Allowed Difference Temperature (K): 2,00
Equilibration Time Maximum Equilibration Time: 00:00:15
Equilibration Start Time: 15-06-2017 09:30:55 Minimum Holding Time: 00:15:00
Equilibration End Time: 15-06-2017 09:31:00 Maximum Pressure Deviation: 0,1000 bar
Equilibration Duration: 00:00:05
Max. allowed Equilibration Duration: 00:00:15
Equilibration Test Result: Passed Equilibration Time
Equilibration Start Time: 15-06-2017 09:31:05
Input for process start time and optional time The result of the analysis is presented in a clear format needed for the
Process band
Equilibration End Time:
Equilibration Duration:
15-06-2017 09:31:10
00:00:05 2
data analysis
Max. allowed Equilibration Duration: 00:00:15

marker setting. ready for printing, saving or distributing electronically.

Holding Start Time: 15-06-2017 09:31:00
Holding End Time: 15-06-2017 10:01:40 Equilibration Test Result: Passed
Holding Duration: 00:30:40
Min. allowed Holding Duration: 00:15:00
Holding Test Result: Passed Process band

process
Holding Start Time: 15-06-2017 09:31:10
Holding End Time: 15-06-2017 10:01:35
Difference Band
Input for process end time and optional time A non-successful validation process will not only show
Holding Duration: 00:30:25
Difference Temperature (K):
Max. Allowed Difference Temperature (K):
Selected data series:
0,63
2,00
Min. allowed Holding Duration:
Holding Test Result:
LC 1, LC 2, LC 3, LC 4, LC 5, LC 6, LC 7, LC 8, LC 9, LC 10, LC 11, LC 12,
00:15:00
Passed 3
Difference Temperature Test Result:
LC 13, LC 14, LC 15, LP 17
Passed Difference Band marker setting. Failed, but also indicate in which part of the process it
Difference Temperature (K): 0,30

Fluctuation Band
Temperature Fluctuation (K): 1,96
Max. Allowed Difference Temperature (K):
Selected data series:
2,00
LC 1, LC 2, LC 3, LC 4, LC 5, LC 6, LC 7, LC 8, LC 9, LC 10, LC 11, LC 12,
LC 13, LC 14, LC 15, LP 17
failed making it easier to diagnose and correct.
Difference Temperature Test Result: Passed

Input fields and selection of process parameters

Max. Allowed Temperature Fluctuation (K): 1,00

4
Temperature Fluctuation Test Result: Failed

Fluctuation Band
Temperature Fluctuation (K):
Max. Allowed Temperature Fluctuation (K):
Temperature Fluctuation Test Result:
1,00
1,00
Passed
according to appropriate standard.

- Generated by ValSuite Pro -

Printed: 15-06-2017 13:32:12 Page 1 of 3
5 Further input fields and selection of process
- Generated by ValSuite Pro -
parameters according to appropriate standard.
Validation reports Printed: 15-06-2017 13:29:48 Page 1 of 3
Use ValSuiteTM App to survey active
processes and validation reports
 T R A C K S E N S E ® P R O I P A G E 15

ValSuite™ Pro
Calibration Audit Trail

ID Text Category User Time stamp Import User

Ellab ValSuite™ Pro is not only a validation software A report is automatically generated that shows the 1307 Add user:Dennis Bishop Administration Master 2017-06-16 10:55:46 AM.48

but also a calibration software. This means that all overall calibration results. When using the Calibration (UTC+01:00)
Romance Summer Time
sensors can be user calibrated at defined intervals Setup, users can choose Manual, Semi-Automatic, or 1306 Add user:Jane Miles Administration Master 2017-06-16 10:55:09 AM.06
(UTC+01:00)
and store offset values. Full-Automatic Calibration. At the same, time vari- Romance Summer Time
ous templates can be stored and uploaded whenever 1305 Edit user:Michael Smith Administration Master 2017-06-16 10:54:21 AM.56
(UTC+01:00)
Using the ETS temperature standard and appropriate required. The found offset values are linked directly to Romance Summer Time

reference instruments connected to the PC, a fully the ID number of sensor and will be taken into account 1304 Add user:Michael Administration Master 2017-06-16 10:54:10 AM.70
(UTC+01:00)
automatic calibration can be executed without any inter- whenever the sensor is used in future measurements. Romance Summer Time
1303 A dd u ser :QA Ma na ger Administration Master 2017-06-16 10:51:33 AM.49
ference of operator – a very safe and time saving feature. (UTC+01:00)

Edit user:Michael Smith

Operator: Validation Manager Vessel: LiquiCal HM

Process: Calibration Product: Pharma View by Caregory: Text:
Session Start: 12-06-2017 12:53:24 Time Zone: UTC offset 01:00:00
Session Stop: 12-06-2017 16:14:06
Session Name: Post calibration of sensors.d7x
Session Text: Post calibration of sensors Validation Solutions
User: From: To: Print
Calibration Setup 2017-06-16 2017-06-16 Clear Search
Operation Type Device Type Calibration Type
Print Preview Close
Calibration Full-Automatic Calibration E-Val Pro Calibration
Verification

Name: Calibration Report Semi-Automatic Calibration

E-Val Flex Module
Temperature Standard Info
Audit Trail
TS Pro Logger
Description:
Serial Number
Total Calibration Result: Passed Manual Calibration ETI
110001

Temperature Standard
Stability Criteria Calibration Points

Add
Compliant to FDA Guidelines GAMP guidelines and ISO 9001:2008
Fluctuation Band : 0.200 °C °C 140.0
Manufacturer:
Fluctuation Time :
Temp Adj. Point Remove  SQL database where complete sessions or All documentation for development of ValSuite™
Model Number: ETS 110001 00 03 00
Serial Number: 110001
Holding Time : 00 03 00
0
60
Insert individual data cannot be deleted or manipulated Pro software is in accordance with the guidelines set
Certificate Number:
Calibration Date:
90
120
Clear

 Audit trail report out in GAMP. Software package includes appropriate

Calibration Expiry Date: Pass Criteria
140
documentation. Ellab quality system is compliant with
Temperature Standard Fluctuation Band: 0.100 °C
 Electronic signature
Stability Criteria
ISO 9001:2008
Fluctuation Band: 0,20°C
Channel Temperature Deviation Before
Adjustment (+/-):
0.30 °C
 Access manager with user ID and passwords
Fluctuation Time:
Holding Time:
00:03:00
00:03:00
Channel Temperature Deviation After
Adjustment (+/-):
0.30 °C  Sensor ID provides complete traceability
Pass Time : 00 01 00  Customized report generator eliminating export
Pass Criteria of data
Templates
Temperature Standard Fluctuation Band: 0,15°C Set Point Tolerance (+/-) 1.00 °C
Sensor Temperature Deviation +/-: 0,20°C
Load Save Endpoint 25.00 °C
Pass Time: 00:01:00
Status for Temperature Standard: 30,00°C Passed
37,00°C Passed
45,00°C Passed OK Cancel Access Manager
60,00°C Passed
Active users:
65,00°C Passed
75,00°C Passed Calibration Setup QA Manager
Michael Smith
Username: QA Manager
Administrator
90,00°C Passed John Johnson Select Security Mode
AD Admin Group
Jane Miles Fully qualified
100,00°C Passed domain name
Dennis Bishop Standard user
120,00°C Passed
130,00°C Passed Initials: AD Group Security Enabled
QA
140,00°C Passed
Change Password Security
First name: John
Profile ValSuite Security
Calibration Summary Before Adjustment Middle Name: Peter

Deviation: Difference between Temperature Standard and Sensor in calibration point (middle point of pass time) Windows Security
Last name: Schmidt
Max Deviation: Max difference between Temperature Standard and Sensor in pass time
Inactive users:
Sensor ID Set point Before Adjustment Deviation Max. Deviation
Department: QA
LC 01 16519 30,00°C Passed 0,02°C 0,04°C
Verification
LC 01
LC 01
16519
16519
37,00°C
45,00°C
Passed
Passed
0,02°C
0,00°C
0,03°C
0,02°C Phone: +001 14 14 48 56
ValSuite Start
Ellab ValSuite™
LC 01 16519 60,00°C Passed 0,00°C 0,01°C
LC 01
LC 01
16519
16519
65,00°C
75,00°C
Passed
Passed
0,00°C
-0,01°C
0,01°C
-0,01°C
Address: Denver
Access Points is not only a
LC 01 16519 90,00°C Passed -0,01°C -0,02°C AD GroupName:
LC 01
LC 01
16519
16519
100,00°C
120,00°C
Passed
Passed
0,00°C
0,02°C
-0,01°C
0,03°C Search for domains Modules validation
software but also
Search for AD groups
E-Val Pro
Calibration Equipment Change password on next login
- Generated by ValSuite Pro -
Printed: 15-06-2017 11:22:56 Page 1 of 17
E-Val Pro User OK Cancel a calibration
OK Cancel
software
Close

Calibration Report Access Manager Security Setup

 Ellab

Since the late 1940’s Ellab A/S has been a leading manufacturer of process validation
and monitoring systems used in the food, medical device and pharmaceutical
industries.

Calibration Certifications and Service

Ellab maintains a complete calibration facility for annual certifications and service.
Ellab A/S temperature, resistance, pressure and humidity calibration laboratory is
accredited according to ISO 17025 by DANAK under registration no. 520. Service and
maintenance contracts are available.

Rental & Demos

Demo systems are available for trial and rental. Please contact your local Ellab
representative for details.

Training
Ellab Academy offers regular training courses for end-users. On-site individual
training and equipment installations are also available through Ellab. Our Validation
Consultants are available to assist you with IQ, OQ, and PQ procedures.

Building Confidence
Industry leading 2 year warranty on loggers, non-flexible sensors, Sky components
and reader stations.

Publ. no. 3009_E /2017.12.21

Ellab A/S
Trollesmindeallé 25
DK-3400 Hilleroed
Denmark
P: +45 4452 0500
F: +45 4453 0505
[email protected]
www.ellab.com