Validation of a Laboratory Incubator using both wireless and cabled dataloggers,

Pamela Hardt-English, PhF Specialists, Inc., May 22, 2001

The purpose of this work was to validate the incubator using a traditional cabled
datalogger, Ellab's E-Val system, and to simultaneously conduct the same tests
using a wireless system, Ellab's TrackSense system. In the second article, the
results of the Validation will be presented with discussion comparing the use of the
wireless and cabled datalogging systems for this validation.
Why test both systems? Validation engineers have a great deal to accomplish and need
to know if newer systems can be used to save them time without sacrificing accuracy
and reliability. A wireless system can be much more convenient and efficient because
there are no wires to locate in the incubator. Finding an appropriate hole into the
chamber and locating each thermocouple can be time consuming. With a wireless
system, the loggers are initialized to specify a start time and sample rate and then the
small units (25 mm diameter by 45 mm high) can be placed anywhere. On the other
hand data from a wireless system are not displayed in real time and are downloaded
after the testing is completed. The challenge with historical systems is to accurately
estimate when the system will be stable and the next test, e.g., twenty four hour stability
testing, begun. Since most investigators will conduct a series of preliminary tests to
better understand new systems and have historical information on systems set for
revalidations, this limitation should not be difficult to overcome. Finally, thermocouples
can be reliable or not so reliable, depending on their condition and how they have been
constructed. An unsealed thermocouple is susceptible to corrosion and must be
calibrated frequently. The TrackSense wireless system uses a Silicon chip for the
sensor, which is very stable and the manufacturer only requires annual recalibration.
The accuracy of both these data collection systems is +/-0.25C. The Ellab
thermocouples are Type T, copper-constantan, and are completely sealed in a stainless
steel sheath attached to a silicone cable. The TrackSense thermisters are made of
Silicon chips and the timing is maintained with a crystal. Each logger and sensor has a
separate ID number and is factory calibrated at five points in the range of -40 to 140oC.
The software of both systems is compliant with 21 CFR, part 11 regarding Electronic
Signature.
Can these data collection systems be used interchangeably? Below is a summary of
print outs of 10 hours of data printed hourly from the data files of both the empty
chamber 24 hour test and the fully loaded incubator test for both the wireless and
thermocouple studies. The thermocouple data were collected on a real time system,
EVAL, and the wireless data were collected using Ellab's TrackSense system.
Type of
Test

Data file
name/
system

Empty
Eval1.dt4/
Chamber E-Val

Time
interval
(10
hours)

Max.
Min. for
for all
all min.
max.
values
values

Average
of
minimum
values

Average
of
maximum
values

DeltaT
Average
(range
of all
from
values
average)

6:00:0036.3
16:00:00

37.4

36.5

37.1

0.3

36.8

Track1.dt4/ 6:00:0036.3
TrackSense 16:00:00

37.4

36.7

37.1

0.2

36.8

Loaded
Eval22.dt4
Chamber

12:00:0035.5
22:00:00

36.9

35.9

36.3

0.3

36.1

Track2.dt4/ 12:00:0035.4
TrackSense 22:00:00

36.8

35.9

36.3

0.5

36.2

Table 1: Data collection comparison between thermocouples and wireless dataloggers.

All values are in degrees Centigrade.
This summary demonstrates that both systems generated comparable results. The
differences in values are well within the accuracy of both the thermocouples and the
thermisters, which is +/-0.2oC.
When complementing thermocouples with wireless loggers or using wireless loggers in
place of thermocouples, the issue of real time vs. historical data collection must be
addressed. Thermocouples are connected to real time dataloggers, i.e., the data are
displayed as collected. The wireless system is historical, i.e., the data are downloaded
and displayed at the conclusion of the test. Since the data cannot be seen, preliminary
tests might need to be conducted to determine the start time on a test such as the 24 hour
fully loaded incubator, because the temperature of the incubator might drop during
loading.
With a wireless system there are no wires to get tangled, and set up can proceed quickly.
The Ellab wireless datalogers are more stable and sealed and need less frequent
calibration than thermocouples. Thermocouples are frequently not sealed and therefore
subject to corrosion and degradation which will affect the calibration. It must be also
kept in mind that not all thermocouples and wireless dataloggers are as accurate as the
sensors used in this study.
Monitoring Temperature During Heat Processing, Werner Jensen, Ellab A/S
With proper probe design and careful choice of materials, the influence of
temperature gradients upon measuring accuracy can be reduced.
When using temperature probes to measure the "cold spot" temperature during heat
processing of canned products, the general laws governed by fundamental physics
sometimes are ignored. As these rules are valid for any probe type and cannot be
overruled, understanding the mechanisms that may have an adverse effect upon
measuring accuracy is essential.
Temperature gradients larger than 100oC/cm are not uncommon in canned products
during the dynamic stages of food preservation processes. To exactly determine the
product's temperature within the gradient layers, a probe must be able to measure the
temperature within a single point at any given moment. As to be expected, such an ideal
probe exists only in theory. With proper probe design and choice of materials, the
influence of wide temperature gradients upon the measuring accuracy can be reduced -but never completely eliminated.
A probe always indicates the temperature of its sensing element. This may or may not
correspond with the actual -- or expected -- product temperature at the probe tip. For
resistance-type probes such as a 100 ohm platinum RTD, the temperature reading is the

average value for the area covered by the sensing element. When used in a static field,
the location of the measuring point generally is stated as the geometric center of the
element. But, if the probe is used within a gradient layer of fast-changing temperatures,
the actual position of the measuring point is hardly predictable.
For thermocouple- and thermistor-type probes, the measuring point often is considered
"point-shaped" and situated at the very tip of the probe. This assumption is not quite
accurate: The actual position is a few millimeters from the probe tip (figure 1). The
actual location is governed by the physical dimensions of the assembly, which provides
electrical insulation and mechanical protection for the sensing elements.

Figure 1. The actual measuring point of most thermocoupleand thermistor-type probes is located a few millimeters
from the probe tip.
Sensor Performance Varies
The behavior of some thermocouple configurations within an area of equidistant
isothermal lines is shown in figure 2. It can be seen that even under static conditions, the
indicated value at the readout is the temperature at a "virtual" measuring point, which
can be displaced from the position of the thermocouple junction. For example, two
thermocouples (labeled A and B) are shown in figure 2. The reversed positions of the
virtual measuring points for the identical thermocouples (A and B) are caused by the
different thermal properties of the probe materials. For an asymmetrical thermocouple
(labeled C), at the equivalent conditions, the virtual measuring point is most distant
from the thermocouple junction. For obvious reasons, this is the only practical
configuration. Only for the symmetrical thermocouple (D), having the junction placed
some distance from the end of the extended wires, the junction senses the temperature
value corresponding to its physical position. Unfortunately, this does only apply for the
probe when used in a static temperature field.

Figure 2. As the thermal properties of different probe

materials vary, the position of the virtual measuring
point of the thermocouple varies.
The displacement of the virtual measuring point is a function of the thermocouple wire's
dimensions. The thermocouple wire diameter can be reduced to a size where this
influence generally may be ignored, but the use of such probes is confined to the
laboratory environment, as it is a difficult and time-consuming process to install such
probes in a precise and stable position and, at the same time, provide a positive pressure
seal. For such laboratory use, fast-responding miniature probes produced from 0.12 to
0.15 mm dia. thermocouple wires readily are available.
For standard probes suitable for routine measurements, the virtual measuring point may
differ from the actual position of the sensing element, depending upon the existing
temperature gradients, the container dimensions and the product's thermal properties.
But, for cold spot measurements in products where heat transfer mainly is due to
convection, the effect is usually negligible. For products in which the heat transfer is
solely by conduction, the effect may be appreciable during any phase where large
temperature gradients are spanned by the probe.
Because the deviation is proportional to the temperature gradients existing within the
product, any deviation from the actual temperature at the measuring points is most
evident during the dynamic first and last stages of a process. By contrast, the deviation
approaches zero near to and during static holding phases.
By measuring a small batch of containers using a few probes inserted at different
depths, the proper location for any subsequent cold spot measurements may easily be
established. To obtain the position by calculation only is hardly possible, as the effects
of container geometry and filling grade, and the thermal properties of the product in
combination with the probe and pressure sealing gland, can only be approximated.
Minimize Gradient Effects
To ensure adequate temperature sensing accuracy, select a probe with the smallest
possible diameter consistent with practical use. Eventually, use a sharp-tipped naked
probe without an external steel tube in connection with a piercing-type pressure sealing
gland. Estimate the position of the virtual measuring point for the entire assembly with
respect to the actual thermocouple junction, which is placed approximately 3 mm from

the cylindrical edge of the naked probe tip. Use this distance for centering the probe at
the "cold spot" position. Select the type, material and positioning of the pressure-sealing
gland with respect to the product and container size. For very small containers,
thermoplastic seals are recommended. And, for measuring temperature within steep
temperature gradients, insert the probe in parallel to the expected isothermal lines within
the product if at all possible.