E n g i n ee r i n g f o r N o n - E n g i n ee r s

Monitoring by
Data Logging

Brandon J. Patterson, Sr. Process Engineer, Kymanox

Justin Pawlik and Brandon J. Patterson

32 Journal of GXP Compliance

Engineering for Non-Engineers discusses science and engineering principles

associated with equipment, utilities, facilities, and associated GMP systems useful to practitioners in compliance and validation. We intend this column to be a
useful resource for daily work applications.
Reader comments, questions, and suggestions are needed to help us fulfill our
objective for this column. Suggestions for future discussion topics or questions
to be addressed are requested. Case studies illustrating engineering principles
submitted by readers are also most welcome. Please send your comments and
suggestions to column coordinator Stephen Perry at stephen.perry@kymanox.com
or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS DISCUSSED

The following key points are discussed in this article:
Data logging is the activity of collecting information from electronic
sensing instrumentation over specified time periods at predetermined
intervals
Data collected may include temperature, relative humidity, chemical
concentrations (i.e., % CO2), pressure, particle counters, electrical current, and many other forms of data
Applications include areas required to maintain a specific condition
such as warehouses, production rooms, refrigerators, freezers, and
sterilizers
Data loggers may be stand-alone or integrated with tethered computers
Temperature is typically recorded by thermocouples, thermistors, or
resistance temperature detectors (RTDs)
Data loggers may be configured including wiring, multiple channels,
or by self-contained instruments
Data loggers must be calibrated using an appropriate tolerance; the
calibration should be National Institute of Standards and Technology
(NIST) traceable and be documented in a manner consistent with good
documentation practices (GDPs)
Data loggers are used in validation to qualify environmental chambers,
steam sterilizers, warehouses, and other controlled environments
Probe placement is the most important aspect of data collection.

Justin Pawlik and Brandon J. Pat terson

Sampling interval and duration of sampling are

other important aspects of the test protocol.
Electronic data in data loggers is stored in secure
files that may be downloaded for data treatment.
Data loggers must comply with the critical aspects
of 21 CFR Part 11 including security access and
data integrity.
Quality and compliance personnel should focus
on critical performance aspects of data loggers
including calibration, probe placement, sampling
interval and test duration, and data analysis and
retrievability.
INTRODUCTIONWHAT IS DATA LOGGING?
Data logging is the process of collecting information
over a certain period of time at predetermined time intervals. The data is generally collected sequentially and
at rates faster than what is possible by human observation. Data logging instruments allow highly accurate
measurements to be obtained.
One of the most common types of data logging is
temperature data recording. This practice is common
in the pharmaceutical, biotech, and medical device industries and will, therefore, be the primary focus of this
article. However, with appropriate instruments, many
other forms of data can be collected. Examples include:
Relative humidity
Pressure
Electrical currents.
Many of the concepts discussed in this article can
also be applied to other forms of data logging.
Applications And Importance Of Data Logging
Data logging is used in engineering and validation
activities to gather sequential readings that can be analyzed to gain a greater understanding of a system. Systems that may utilize data logging can include any area
that has a requirement to maintain a given temperature
specification such as the following:
Warehouses
Production rooms
Refrigerators
Freezers
Sterilizers.

Data are usually collected simultaneously at multiple locations within the area being tested. Locations are carefully chosen so that the entire area is
mapped. The data are then analyzed to determine
the worst-case locations within the area or system
(i.e., the hottest or coldest locations). The data
are then used to perform additional calculations
including the following:
Minimums
Maximums
Averages
Standard deviations
Lethality of a sterilization cycle (F-sub-zero).
Because a complete data-logging event contains
hundreds to thousands of data points, these calculations make it possible to draw conclusions about the
system from the data collected.
Data logging is critical to obtaining an accurate
and detailed representation of how a system operates.
Some systems, such as a sterilizer, change temperature very fast. Others, such as a refrigerator, change
temperature slowly. These systems may also have
long cycle times that make it impractical for manual
data recording.
Data logging also enables a significant number of
measurements to be collected over short or long periods of time. The large number of measurements can
easily surpass the quantity of points required to be
statistically significant.
This discussion of data loggers will address the
following topics:
Types of data loggers, including stand-alone and
computer-based instruments
Temperature elements used in data loggers,
including thermocouples, thermistors, and resistance temperature detectors (RTDs)
The configuration of data loggers, including
wiring, multiple channels, and self-contained
instruments
Calibration of data loggers
Use of data loggers in validation (qualification),
including environmental chambers, steam sterilizers, warehouses, and production rooms
C
 ollecting data, including probe placement,
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sampling intervals, and the duration of monitoring protocols

Electronic data, including electronic files, printing
directly from software, exporting to Microsoft Excel, and key aspects of 21 CFR Part 11 compliance.

Figure 1:
Kaye Validator 2000.

(photograph by Justin Pawlik)

Specific issues of data loggers especially relevant to

quality and compliance are also discussed.
TYPES OF DATA LOGGING INSTRUMENTS
The following sections describe the available types of
data logging instruments.

Computer-Based Data Loggers

A Kaye Validator 2000 (1) is a data logging instrument that can be used as a stand-alone or computer
controlled data logger (i.e., tethered to a laptop computer). Up to three sensor input modules (SIMs) can
be utilized; each SIMs can be configured with up to
12 sensors. Multiple units can also be linked together
with an Ethernet cable. The Kaye Validator is 21CFR
Part 11 compliant, and includes passwords, audit
trails, and user levels. Data can be grouped to aid in
calculations and graphing of the data. Data can also
be exported to Excel for further analysis. See Figure
1 for a photo of a Kaye Validator 2000.
SmartReaders (2) are ACR Systems data loggers
(see Figure 2) that are available in many configurations. There are single-channel and multi-channel
34 Journal of GXP Compliance

Figure 2:
ACR Systems SmartReader.
(Reprinted with permission from ACR Systems)

Stand-Alone Data Loggers

A stand-alone instrument does not require a computer to operate and gather data. A chart recorder
is a common instrument included in this category.
It uses a circular piece of paper and different pens
to plot measurements. The chart turns at a precise
speed according to the programmed time period,
such as 24 hours or one week.
Strip chart recorders are similar to circular chart recorders, with the exception that they print from a paper roll. As a result, much longer time durations can
be charted before changing the paper. Chart and strip
recorders are limited in the number or data points that
can be recorded simultaneously. Typically there are
maximum four pens available to plot the data.

data loggers as well as 8-bit and 12-bit models. The

12-bit models have an optional larger storage capacity
and faster sampling rates of up to 25 points per second. Optional equipment is required to achieve this
sampling rate. All data loggers utilize ACR Systems
TrendReader software to configure the data loggers.
The software is used to setup the data logger, view
and graph the data, and export the data in various
formats (including .csv files for Excel).
TempTale (3) data loggers are available in single-use
and multi-use models. The data loggers are self contained with internal sensors, memory, battery, and
an LCD display. Storage capacity ranges from 1920
to 16,000 data points at sampling rates of 10 seconds to 2 hours. Data can be retrieved from the data
logger directly to PDF format, which allows for easy
access to the data from any computer. The TempTale

Justin Pawlik and Brandon J. Pat terson

TYPES OF TEMPERATURE ELEMENTS

The following sections describe the types of temperature elements involved in data logging.
Thermocouples
Thermocouples measure temperature by generating a small voltage signal that is proportional to the
temperature difference between the junctions of two
dissimilar metals. One junction (the hot junction)
is typically encased in a sensor probe at the point of
measurement. The other junction (the cold junction)
is connected to the measuring instrument.
Thermocouple temperature measurement is
based on reading the voltage signal and the cold
junction temperature. The information is then used
to compute the temperature with mathematical
equations that are applicable to the type of thermocouple used (5).
Thermocouples are grouped by types according to
the materials of construction and sensitivity. Thermocouple types include K, J, N, R, S, B, T, and E.
Type T is a widely used thermocouple type constructed of copper and constantan and has a temperature
range of approximately -185C to 300C.
Thermistors
A thermistor is a resistive device comprised of metal
oxides that are formed into a bead and encapsulated
in epoxy or glass. As temperature changes, so does
resistance, which in turn causes a large voltage drop.

Figure 3:

(Reprinted with permission from Sensitech)

TempTale data logger.

Figure 4:
Veriteq data logger.

(Reprinted with permission from Veriteq)

Manager Desktop software is also available and allows

the user to view, save, print, graph, or export the data
(see Figure 3).
Veriteq Data Loggers (4) (see Figure 4) are self
contained with internal sensors, memory, and
battery. Storage capacity is 35,100 samples and
sampling rates range from 10 seconds to once a day
with the VL 2000 series. Configuration of the data
logger is performed using the vLog software. The
software is also used to perform calculations and to
view, save, print, graph, compare, and export the
data. The vLog software also provides audit trails
and encrypted files that meet all the requirements of
21CFR Part 11 compliance.

Sensors are quite small and normally encased in a

protective shell, stainless probe, or wire coating (6).
Thermistors are thermally-sensitive resistors and
have, according to type, a negative (NTC), or positive (PTC) resistance/temperature coefficient. NTC
thermistors are temperature dependent semiconductor resistors. They have an operating range of -200C
to 1000C. They also offer mechanical, thermal, and
electrical stability with a high degree of sensitivity (7).
Resistance Temperature Detectors
Resistance temperature detectors (RTDs) are sensors used to measure temperature by correlating the
resistance of the RTD element with temperature.
Most RTD elements consist of a length of finely coiled
wire wrapped around a ceramic or glass core. The
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element is usually quite fragile, so it is often placed

inside a sheathed probe for protection. The RTD element is made from a pure material whose resistance
at various temperatures has been documented. The
material has a predictable change in resistance as the
temperature changes. It is this predictable change
that is used to determine temperature (8). The most
common material used for RTDs is platinum. This
type of RTD is often referred to as a Pt100 RTD for its
material and resistance of 100 Ohms at 0C.
INSTRUMENT CONFIGURATION
The following sections describe the requirements
involved in instrument configuration.
Wiring
Wiring is integral to the configuration of instruments that utilize external temperature elements.
Wiring is available in various qualities from standard to ultra-premium. The quality of the wire is
more important for highly accurate instruments and
calibrations or for long lengths of wire. Wire should
be kept to a reasonable length in order to avoid difficulty in handling. This also limits the possibility
of poor signal transmission.
However, more wire is almost always needed than
originally anticipated, so a general guideline is to
take your initial estimate and double it. If absolutely
necessary, instruments such as the Kaye Validator
can use wires up to 500 feet in length. There is no
defined limit for wire length. The user must calibrate the sensors with the entire length of wire to
determine if the sensors function acceptably with the
chosen wire length.
Multiple Channels
Some data logging instruments, such as the SmartReader Plus 8, are capable of recording multiple data
points simultaneously. This feature helps reduce the
total number of instruments required for a project.
However, it is still a requirement to have the same
number of thermocouples and data points.
In addition to the external channels for the thermocouples, data loggers often contain an internal
temperature element that is included in the total
36 Journal of GXP Compliance

number of available channels. This is a key point to

remember because it may not be possible or practical
to utilize the data logger itself as one of the recorded
data points. The Collecting Data section of this
article contains further discussion of this topic.
Self-Contained Instruments
Some models of the TempTale data loggers explained
in the Types Of Instruments section of this article
are examples of self-contained instruments. Self
contained simply means that there are no wires or
thermocouples attached to the instruments. The
instrument contains all of the sensing elements inside
its case. These instruments can simplify placement
of the data loggers when large areas, such as warehouses, are being monitored.
This approach has some disadvantages. There
needs to be one instrument for every data point,
which can be expensive. The collection of the data
onto a computer is also more time consuming because each data logger has to be connected, downloaded, and analyzed separately.
CALIBRATION
Calibration is a common topic in any pharmaceutical activity that involves instruments. Data logging
is no exception. When data are being collected for
use in production, validation, or quality records, the
instruments must be calibrated to the tolerance and
range of the measurements taken. They must also
be post-calibrated following the collection of all data
to ensure the instrument is still operating within its
original specifications.
Tolerance
The instruments must be calibrated to a more rigid
tolerance than is required by the acceptance criteria
of the quality document. A conservative rule-ofthumb used by many established pharmaceutical
companies is to calibrate to an accuracy ratio of 4:1.
For example, if the quality document specifies that
temperature meet the criteria of +/- 1C, then the
instrument should be calibrated to +/- 0.25C, which
is a 4:1 ratio. If a 4:1 ratio cannot be achieved, then
a justification is usually required. In the end, a risk

Justin Pawlik and Brandon J. Pat terson

assessment should be performed to determine the required calibration tolerance and accuracy; this assessment should be documented and include the downstream impact of an OOT or inaccurate measurement.
This risk assessment can refer to any critical process
parameter (CPP) justifications because similar information and logic is required. The calibration must
also be performed against a National Institute of
Standards and Technology (NIST) traceable standard
that has a tolerance less than or equal to the accuracy
needed for the instrument.
Range
Instruments cannot be assumed to provide accurate
readings over their full operating range. The calibration must be performed over the intended measuring range. If the measurements are expected to be
in the range of 20-40C, then the calibration at a
minimum should include this range. A wider range
could also be used, such as 10-50C. This allows for
temperature excursion that may not be anticipated.
This specific instrument should not be used for taking measurements in a freezer that has an operating
range of -40C to -20C.
Calibration Checks
Prior to starting a data logging study, the instrument
should be precalibrated with a full calibration. A full
calibration includes multiple data points that bracket
the range of measurements that will be collected. Following completion of the study, the instrument should
be post calibrated with either a full calibration or a
calibration check. A calibration check is a single-point
calibration that is usually performed at the setpoint,
or middle point, of the systems operating range. This
helps reduce the cost of calibration activities.
QUALIFICATIONS USING DATA LOGGERS
The following are several basic concepts common to
all qualifications that utilize data loggers:
Generating a temperature map of the equipment or room during production
Creating a temperature map by placing probes at
various locations throughout the space to identify
the hottest and coldest locations within the space

V
 erifying that the temperature cycles of the
equipment or room remain within the required
temperature ranges by analyzing the continuous
data measurements.
Environmental Chambers
Environmental chambers include any equipment
that is designed to maintain certain environmental
conditions, such as temperature, humidity, or CO2
level. Equipment in this category includes, but is not
limited to the following:
Refrigerators
Freezers
Ultra-freezers
Cryogenic tanks
Incubators.
Operational and/or performance qualification of
these chambers involves temperature mapping the
chamber in reasonable worst-case conditions. The
qualification is written to ensure that the entire volume
of the chamber is maintained within a specified operating temperature range for a given duration.
Steam Sterilizers
Steam sterilizers are used to keep items free of living microorganisms and bacterial endospheres prior to transfer
into a sterile production room or for products prior to
shipment. Steam sterilizers operate at temperatures of
at least 121.1C. Data logging is crucial to identifying
whether or not all locations in the chamber reach and
maintain 121.1C for the duration of the sterilization
cycle. This test is an operational qualification of the
sterilizer and is performed with an empty chamber.
Because the sterilizer monitors temperate at the
drain, which is the worst-case location, a thermocouple
should also be placed at this location. Failure at any
of the data points in the sterilizer could indicate a
mechanical problem with the sterilizer. There may be
a leak in the door seal, inadequate insulation, or insufficient steam supply.
Performance qualification of the sterilizer is executed with a worst-case load using actual items that
will be processed. Thermocouples are inserted into
the items in the sterilizer at the worst-case locations.
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This ensures that all surfaces, pockets, and crevices

of the items are properly sterilized. The primary
acceptance criterion is accumulated lethality (F0). Accumulated lethality uses temperature, time, and data
from biological indicators to calculate a theoretical
microbial reduction. The accumulated lethality can be
performed automatically by a Kaye Validator, which
greatly simplifies the task of analyzing the data.
Warehouses
Warehouses are qualified based on the United States
Pharmacopeia (USP) <1079> definition of controlled
room temperature of 20-25C (68-77F). Qualification
also requires the mean kinetic temperature (MKT) to
be calculated (9). According to the International Conference on Harmonization (ICH) stability testing guideline, MKT is defined as A single derived temperature
that, if maintained over a defined period of time,
affords the same thermal challenge to a drug substance
or drug product as would be experienced over a range
of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature
is higher than the arithmetic mean temperature and
takes into account the Arrhenius equation (10).
In addition to temperature, if any of the products or
materials stored in the warehouse require a specific humidity, then the applicable humidity range must also
be qualified. Like any other temperature mapping, the
worst-case locations must be identified prior to starting
the qualification. Justification must be provided for
each location. Locations could include the highest
product storage levels, areas around doors, next to
steam lines, or near air vents.
Production Rooms
Qualification of production rooms is also dependent
on the requirements of the products that are processed.
If the products must be maintained at a specific temperature or humidity, then the room must be qualified
to include those operating ranges. However, unlike
warehouses or environmental chambers, there may not
be a requirement to perform a complete temperature
mapping of the room. Data point locations may only
include three to six points across the working height of
the process. It is not likely that product will be stored
38 Journal of GXP Compliance

at a level near the ceiling or very close to the floor.

Evenly spaced locations around the room are sufficient
to capture the temperature variations caused by air
ducts and equipment configuration.
If there are no product specifications for temperature
or humidity, then the qualification of the room could
utilize the USP <1079> definition of controlled room
temperature of 20-25C (68-77F). However, this USP
chapter is specific to storage and shipping practices (5).
Although the room conditions do not directly impact
product quality, the qualification ensures operator
comfort and reliable, repeatable operation of the rooms
heating, ventilation, and air conditioning (HVAC)
system. The following are additional room conditions
specified in USP <1079>:
Cold storage of 2-8C (35-46F)
Cool 8-15C (46-59F) MKT
Controlled room temperature 20-25C (68-77F)
MKT.
COLLECTING DATA
Steps required in the collection of data are described in
the following sections.
Probe Placement
Placement of the probes is an important step in the design of a successful data logging activity. If the location
of the probes is not justified and representative of the
entire equipment or area, then the data collected will
not be robust enough to defend using locations other
than the points studied.
However, if locations are carefully chosen to represent the entire useful area of the equipment, then it
is easy to justify utilization of locations that were not
specifically tested. Locations can be divided into the
following groups:
Worst-case
Representative
Backups.
There are usually a limited number of probes available for a study. As a result, there must be a balance
between these groups. If there are not enough probes
to create a backup by doubling up data collection at
any of the locations, then the qualification document

Justin Pawlik and Brandon J. Pat terson

should include provisions that it is acceptable if one or

two probes malfunction or do not pass post calibration.
Choosing worst-case locations should be done first
and requires some basic knowledge about the operation of the system. The following are some general
guidelines for choosing worst-case locations:
Heat rises (most of the time). In larger areas,
such as rooms and warehouses, higher locations
are more likely to be warmer than lower locations.
However, in small chambers such as a freezer, the
temperature is more dependent on the location of
the cooling source. The coldest locations could be
at the top instead of the bottom.
Identify heating or cooling sources. This
includes air diffusers for an HVAC system, cooling coils in freezers, or steam ports in a steam
sterilizer.
Identify locations of heat transfer. This can
include doors, seals, inconsistent insulation, or
return air vents.
Representative locations are chosen second.
This is performed with the purpose of filling in
the space and to correlate readings with other
sensors.
Identify controlling sensors. There is always a
sensor used by the system to control temperature.
Identify monitoring sensors. Some facilities
use data historians that continuously collect data
from the equipment, such as a Rees Monitoring system or OSI-Pi. Chart recorders are often
used on environmental chambers as a redundant
monitoring system.
Identify product storage locations. Typically
probes can be placed on top, middle, and bottom
shelves. If additional probes are available, they
can be placed to the left and right sides of the
shelves.
Figure 5 represents an environmental chamber
that contains four levels where product can be stored.
Probes are placed at the four corners of the top and
bottom shelves of the chamber to represent worstcase locations. These locations are where temperature extremes can be expected due to the differences
in height and proximity to door seals. One probe is

placed next to the equipments temperature element

used to control the chamber temperature.
In situations that do not make it possible or
practical to utilize the data logger itself as one of the
interior chamber data points, it must be left outside of
the chamber. However, this satisfies another possible
probe location, the ambient room temperature. For
example, the manufacturer of the data logger may not
recommend placing the instrument directly into a
freezer operating at -30C. Therefore, the thermocouples are fed through an access port to the interior of
the chamber while the data logger is left outside the
freezer. This allows the data logger to be the ideal
probe to collect the ambient air temperature. This
data may be useful in determining whether or not the
temperature cycles of the freezer are impacted by the
temperature cycles of the room.
Sampling Interval
The sampling interval is the frequency at which data
is recorded. Choosing the appropriate sampling rate
is important to obtaining meaningful data. Data
points must be recorded at a small enough interval
to capture the changing conditions of the system.
Instruments generally allow the user to choose the
sampling interval, which may range from one second
to five days.
A basic understanding of the system is required
before choosing the sampling interval. For example,
a sterilizer has a relatively short cycle time. Its temperature changes rapidly as the chamber is heated. A
sterilization cycle that is 40 minutes in duration may
have an initial heating time of only several minutes.
Therefore, a sample rate of 2 minutes is not sufficient to
capture the true temperature curve of the sterilizer. It
would be impossible to identify the exact time at which
the sterilizer reached the target operating temperature.
In this situation, a sampling interval of 10-15 seconds is
recommended. A 10-second sample interval will result
in 240 data points per thermocouple.
Systems that have longer cycle times, such as a
freezer, may use longer sampling intervals. A full
cycle, from coldest to warmest back to the coldest
temperature, typically takes about one hour. A sufficient sampling interval is approximately five minutes.
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Figure 5:
Environmental chamber with four storage levels.

A shorter interval could provide more detail, but this

results in a very large number of samples. A longer
interval increases the possibility of missing data
points at the extremes of the cycles. Increasing the
sampling interval decreases the ability to capture sudden changes, or spikes, in temperature.
Duration Of Monitoring Studies
The duration of the study is also an important factor
in creating a meaningful set of data. The total duration of the study must capture enough of the systems
operation to justify consistent and repeatable opera40 Journal of GXP Compliance

tion. The study must also attempt to capture events

that could be considered worst-case conditions.
A study of a small room or environmental chamber may justify that 24 hours is a sufficient amount
of time to capture day and night operation of the
buildings HVAC system. Time duration of 24 hours
is also sufficient to capture the numerous temperature
cycles of the refrigerator. A large room or warehouse,
however, is impacted by the outside weather conditions. A warehouse study should be conducted
for several weeks or months during the summer
and winter. This is the only method to ensure that

Justin Pawlik and Brandon J. Pat terson

the HVAC systems are capable of maintaining the

required temperature specifications during both hot
and cold months.
ELECTRONIC DATA
The following sections discuss the elements of collecting and storing electronic data.
Electronic Files
Each of the data loggers examined in this article
protects the collected data by creating secure files that
cannot be altered. These original files usually require
the proprietary software to view the data. However,
the data can usually be printed to Adobe PDF files for
universal access and viewing. The original files and
any PDF files generated should be burned to a CD
and attached to the qualification document for retention. Note that although secure data files are created,

not all data loggers and software can be considered

21CFR Part 11 compliant.
Direct Printing From Software
Because the original files are not easily accessible,
it is generally required to print the files and attach
the printout to the qualification document. This
provides easy access to the data as is required during audits.
Exporting To Excel
Data can also be exported to Excel for additional
analysis. The data is exported from the data logger
software as a comma separated values (.csv) file.
Any number of activities can be performed in Excel
to format, perform calculations, and graph the data.
See Figure 6 for a graph of a 24-hour temperature
map of a freezer.

Figure 6:
Freezer 24-hour temperature map.

Freezer 24-hour Temperature Map

-22.0

Degrees celcius

-24.0

'2-01

-26.0

'2-02
'2-03
'2-04
'2-05

-28.0

'2-06
'2-07
'2-08
'2-09
'2-10

-30.0

'2-11
'2-12

-32.0

-34.0
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
:0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0
00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20
:
7 7 8 9 10 11 12 12 13 14 15 16 17 17 18 19 20 21 22 22 23 0 1 2 3 3 4 5 6

Time
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However, exporting the data to Excel does not

maintain the integrity of the data and is considered
transcription. For this reason, the original files must
also be maintained. To ensure that the data has not
been altered, a second person must verify all data
transcription and calculations performed in Excel.
21 CFR Part 11 Compliance
Whether or not Part 11 requirements are applicable
to the records created by the data loggers depends on
the unique situation of the user and how the instruments and data are handled. Part 11 compliance is a
very broad topic and cannot be explained in sufficient
detail in this article. The intent of this article is to
make the reader aware that Part 11 should be considered when using data loggers and electronic records
for the purposes of meeting current good manufacturing practice (CGMP) guidelines.
Make note that not all commercially available data
loggers are capable of being 21CFR Part 11 compliant.
Also, data loggers and software that claim to be Part
11 compliant still need to be used correctly to maintain the principles of Part 11. For example, improper
administrative procedures, such as creating a single
user name and password for all users, could result
in poor data integrity and do not satisfy the requirements of Part 11.
Part 11 requirements may be mitigated or
eliminated by proper documentation within the
qualification document. The need for electronic
signatures is eliminated if the qualification document contains all critical events, which include the
following:
Start and stop times
Probe locations
Corresponding probe IDs
Signatures and dates.
In addition, printing of the final secure data files
eliminates the electronic storage of the data. The
printed copy now serves as the lasting record of the
data. Lastly, any software deficiency related to Part
11 compliance should be mitigated with written
procedures (i.e., standard operating procedures) to
ensure data integrity issues do not become a problem
for the validation.
42 Journal of GXP Compliance

QUALITY CONCERNS
The wide use of data logging in the pharmaceutical industry makes it very likely that most people
will encounter this activity in some way or another
during their careers. Quality organizations may be
approached to review or approve these activities.
This helps to ensure that the tests are pre-approved
and executed in such a way that the data is valid and
meets CGMP requirements. This article is merely
an introduction to the concepts of data logging, and
should provide a basic understanding of what is involved and some of the important factors to consider.
When evaluating a test plan, the following items
could impact quality if not executed properly:
Data loggers are calibrated before and after
the qualifications. Calibrations bracket the
expected operating range of the equipment
or room. The calibrated tolerance of the data
loggers is tighter than the specifications for the
system being tested.
Probes are placed in worst-case locations with
supporting justification. The author of the test
plan should exhibit a general knowledge of the
system through the justifications provided in the
test plan.
Extra probes are available in case of a malfunction or calibration failure. If no additional
probes are included, the qualification should
allow for the exclusion of one or two data loggers in the event of a malfunction or calibration
failure.
S
 ampling interval and test duration are appropriate. The sampling interval should be relatively short for dynamic systems. The test duration
should capture several heating or cooling cycles.
P
 roper handling of the original, transcribed,
and printed data. Electronic files are saved to a
CD, original data is printed and verified, and any
transcriptions to Excel and subsequent calculations are verified by a second person.
CONCLUSIONS
This discussion of data logging has addressed several
general topics, including equipment, calibration,
configuration, probe placement, data handling, and

Justin Pawlik and Brandon J. Pat terson

data analysis. The equipment should be capable of

performing the required testing by utilizing appropriate sampling rates, memory, software analysis,
and security. The user must then configure the
equipment properly based on the system being qualified. Calibration, probe placement, sampling rate,
and test duration should also be taken into account.
This is the basis for generating a meaningful set of
data during qualification.
Following the collection of the data, the software
is used to download the data from the data loggers
and create a presentable analysis of the data, including tables, graphs, and calculations. Proper handling
of the data and second person verifications are
required to maintain the integrity of the data and to
meet CGMP requirements.
This article discusses the basics of data logging at
a high level and provides the reader with the fundamental knowledge that assists in the review and approval of qualification documents utilizing data loggers. This fundamental knowledge is not intended to
answer all questions, but to provide a starting point
to determine where additional information is required and to initiate more detailed discussions with
the technical experts conducting the qualifications.

8. Omega, What is a Resistance Temperature Detector (RTD)?

Omega.com http://www.omega.com/rtd.html, retrieved
March 3, 2009.
9. USP, USP<1079> for Good Storage and Shipping Practices.
10. International Conference on Harmonization (ICH), Q1A Stability Testing of New Drug Substances and Products, August 2001,
Revision 1.

ARTICLE ACRONYM LISTING

CFR
Code of Federal Regulations
CGMP
Current Good Manufacturing Practices
CPP
Critical Process Parameter
F0
Accumulated Lethality
GDPs
Good Documentation Practices
HVAC
Heating, Ventilation, and Air Conditioning
ICH
International Conference on Harmonisation
MKT
Mean Kinetic Temperature
NIST National Institute for Standards and
Technology
NTC Negative Resistance/Temperature
Coefficient
RTD
Resistance Temperature Detector
PTC Positive Resistance/Temperature
Coefficient
SIM
Sensor Input Module
USP
United States Pharmacopeia

REFERENCES
1. Information about the Kaye Validator 2000 can be obtained
online at http://www.gesensing.com and http://www.kayeinc.
com.
2. Information about ACR Systems SmartReaders can be obtained online at http://www.acrsystem.com.
3. Information about TempTale data loggers is available online at
http://www.sensitech.com.
4. Information about Veriteqs data logger can be found online at
http://www.veriteq.com.
5. Veriteq, Temperature Measurement: Thermocouples vs.
Thermistors, Veriteq.com, http://www.veriteq.com/validation/
thermocouples-vs-thermistors.htm, retrieved March 3, 2009.
6. Veriteq, Thermal Validation in the Pharmaceutical Industry:
An argument against the use of thermocouples, Veriteq.com,
http://www.veriteq.com/thermistor/, retrieved March 3, 2009.
7. Gesensing, Thermometrics Products, Gesensing.com,
http://www.gesensing.com/thermometricsproducts, retrieved
March 3, 2009.

ABOUT THE AUTHORS

Author: Justin Pawlik is vice-president of midwest operations at
Kymanox, Highland Park, IL. Justin has over a decade of manufacturing and quality experience in the pharmaceutical industry
as a quality manager, technical project manager, and operations
manager. He can be reached at justin.pawlik@kymanox.com
Research author: Brandon J. Patterson is a sr. process engineer
at Kymanox, Highland Park, IL. Brandon has over eight years of
CGMP manufacturing experience as a validation engineer, equipment/process engineer, and maintenance supervisor. Brandon
has participated in major equipment installations, product
launches, and a facility qualification. He can be reached at
brandon.patterson@kymanox.com.
Coordinator: Stephen M. Perry is coordinator of Engineering for
Non-Engineers and is the founder and president of Kymanox, a
company specializing in technical project management and related
services for the pharmaceutical, biotechnology, and medical device
industries. He can be reached at stephen.perry@kymanox.com.

Spring 2009 Volume 13 Number 2

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