Planning a Successful

Warehouse Mapping Study

asy
SM

Author: Alex Debreceni

BioServices
 The Importance of
Thermal Mapping
Pharmaceutical, biological and medical device products require controlled environmental storage conditions.
Degradation can occur when the storage environment of the product exceeds the range of safe conditions
of the product. For example, some pharmaceutical materials need to be stored at ambient temperature to
preserve the potency of the product. If the temperature of the storage environment goes outside that range,
damage to the pharmaceutical material may occur. Thermal mapping of all storage areas is required to assess
the environmental conditions stored pharmaceutical materials will be exposed to. This is especially true of
warehouse storage due to large seasonal variations of environmental conditions.

Create a Plan
A critical step when temperature mapping
warehouses is to determine the scope of the
project. A number of factors must be considered
when determining the scope; the number of
mapping studies, study length, the temperature
range acceptable for operation, quantity of sensors,
sensor locations, storage envelope parameters,
and any other information deemed important by
the end user, all are critical pieces of information
to ensure a successful mapping study whereas
the storage envelope refers to a specific section
of the warehouse designated for product storage. the winter months. This is due to the greater
Parameters relevant to the storage envelope include temperature difference between the outside and
storage rack numbers, storage rack dimensions, inside conditions of the warehouse. Warehouses
storage rack and product spacing, and thermal mass located in colder environments will most likely
distribution. require more HVAC power in the colder months for
the same reason. This will be true for most ambient
Information about the geographic location of storage areas, as they are temperature controlled
the warehouse or storage area is necessary for by facility HVAC systems. Airflow in storage areas
planning a mapping study. For example, warehouses is extremely important for temperature regulation.
located in a tropical environment will require more If air is not properly circulated throughout the
HVAC power to maintain ambient temperature storage area, a stratification effect can occur.
and humidity during the summer months than This means there will be a distinct temperature

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gradient, with temperatures increasing from the
floor of the area to the roof. Warm air will become
stagnant on the upper levels of the storage space
during the summer months. Thermal conduction or previously qualified where the ”As-Is” loaded
through the walls of the warehouse will transfer condition is identified and documented with
heat to any product stored up against it. The walls respect to current load.
will also allow for the transfer of heat through
convection and conduction throughout the Temperature mapping studies need to capture
warehouse. normal operation of the storage area as well
as low foot traffic days to get the full range of
Seasonal temperature swings will greatly affect the temperature variations. Temperature excursions
operation of the HVAC systems in place to regulate can occur during normal operation events such
the temperature of the storage environment. It as opening a door, excessive foot traffic, product
is required by the United States Pharmacopeia, movement, and daily HVAC operation. For these
Article 36, Chapter 1079, to perform two mapping reasons, warehouse mapping studies are run for
studies; one in the winter, and one in the summer a minimum of 7 consecutive days to demonstrate
to capture warehouse environmental data for the area uniformity during both weekdays and
most extreme outdoor low and high temperatures. weekends.
Studies are usually performed under “As-Is”
conditions for warehouses already in operation

Fig. 1: This graph

represents a Summer
profile, 7 day thermal
mapping study shown in
Fahrenheit. Sensor 36
was located outside of the
warehouse where it was
exposed to the extreme
seasonal temperatures.

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 Executing the Plan
Temperature ranges in the warehouse are
defined with respect to the product in storage
and the ability of the environmental control
system to maintain the proper conditions.
From this information, acceptance criteria for
a passing mapping study can be determined.
Mapping studies can also be performed to
determine that the area mapped is suitable
for a specific pharmaceutical material that
requires a certain temperature and humidity
range. For ambient temperature storage, a
range of 15°C to 30°C is acceptable with
brief excursions due to outside environmental
variation.

Sensor locations and quantity will depend

greatly on the size and shape of the storage
area. Three sensors should be placed on
all corners of the storage area, one at the
top of the storage space, one in the middle
of the storage space, one at the bottom Sensors should be labeled with unique
of the storage space. Three sensors should identifiers to mark their location. A map
also be placed in the center of the area with sensor locations allows anyone to easily
and individual sensors should be placed determine locations of hot and cold areas
next to all monitoring probes, thermostats, in the warehouse. Well-documented sensor
entrances, or any other sources that influence placement allows for consistency in each of
temperature. It may also be beneficial to the seasonal mapping studies. Dataloggers
place sensors in storage rack areas to capture used for data acquisition must be calibrated
temperature conditions next to product. An and traceable to NIST or equivalent followed
additional sensor should be placed in an area by a calibration-verification after the
representative of outside temperature and qualification. This ensures the dataloggers
humidity for reference purposes only. This remained accurate within the application
is done to capture the outdoor temperature temperature range throughout the data
and humidity conditions the warehouse will collection process. Sensors should be secured
experience throughout the mapping study. to their locations for the entirety of the study.

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Analyzing the Results
After the mapping has ended, the data is
analyzed. Results from the mapping study
should be compared to the acceptance
criteria defined by the end user. In order
for the warehouse to pass the qualification,
the minimum and maximum temperatures
during the study must be within the specified
operating range. The humidity readings are
typically recorded and utilized as a reference
only. Because all of the sensors and locations
are labeled, the minimum and maximum
temperatures recorded will identify the coldest
and the warmest locations in the warehouse
as well as any non-conforming areas that fall
outside of the specified operating range. With
that information the end user can make key
decisions with regards to product storage. The Mean Kinetic Temperature
One way to eliminate non-conforming areas is defined as:
is to demarcate those as outside the range, if
any are identified. Monitoring sensors can be TK is the mean kinetic temperature in kelvin;
placed in locations that challenge the limits ΔH is the activation energy in kJ, R is the
universal gas constant, n is the number of
of the operating ranges so those areas are
sample events, when the samples are taken
constantly monitored and can be addressed
after the same time period, and Tn is the
if an excursion occurs. The maximum and
temperature taken at a sample point n in
minimum temperature locations may vary
kelvin. This equation weighs each data point
depending on season, so monitoring systems
against all of the other data points taken in
sensor placement should account for seasonal
a study, so small excursions from the normal
extremes. operation of the storage area, such as product
loading or movement, and door openings, will
Another key tool used to analyze data for not have a great effect on the calculation of
warehouse mapping is the Mean Kinetic the mean temperature of a specific location
Temperature (MKT). The MKT can be used to of the storage space.
evaluate readings from a single datalogger if
the temperature profile fluctuates in a distinct
pattern, such as a sinusoidal wave with
repeating temperature peaks and dips. The MKT
will give an accurate mean temperature for a
datalogger that experiences short excursions.

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 Conclusion
Pharmaceutical materials require controlled
environmental storage conditions to preserve
and protect the efficacy of the product.
Thermal mapping of warehouse storage areas
is essential to assess the environmental
conditions the products will experience.
Certain considerations need to be made prior
to the mapping study. Mapping studies should Citations
be planned to capture seasonal temperature
extremes and daily operations the storage area USP-NF. Good Storage and Distribution for Drug
can experience. Sensors should be placed in Products. USP 36 General Information / Good Storage and
Shipping Practices. Retrieved September 14, 2018
locations to identify at risk temperature areas
during mapping. Data collected through the
study should be analyzed and compared to the
acceptance criteria. Warehouse storage is a key
step in many pharmaceutical product life cycles.
Understanding all stages of the process is
essential in successful pharmaceutical storage.

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