BETTER

WAREHOUSE
MAPPING

Step by Step
 Table of
CONTENTS

Prerequisites 4

Preparing a warehouse mapping study 6

Evaluate the Warehouse Space 6

Determine Sensor Location 6

Reducing Sensor Density 8

Write Mapping Study Protocol 9

Warehouse Mapping Step-by-Step 10

High Density Monitoring 13

2
Step by Step
BETTER
WAREHOUSE MAPPING
Temperature mapping is vital for preserving GxP product
quality during manufacturing, storage, and distribution,
especially for frozen products. Warehouses pose unique
challenges for temperature mapping due to their size, study
duration, and seasonal variations. However, the principles
for temperature mapping remain consistent, whether for
warehouses, chambers, refrigerators, or freezers.

As concerns over GDP and the cold chain have grown,

more regulatory attention has been directed at mapping
activities. In this white paper, we provide essential
instructions to map warehouses of any size while adhering
to GxP regulations and best practices.

Vaisala Mapping/Validation service provides

comprehensive mapping and analysis of
environments with Vaisala’s mapping system.
Available in selected regions. Visit vaisala.com/en/
services/continuous-monitoring-system-services/
mapping-service for more info.

3
 Specifications, Mapping SOPs, Equipment
STARTING
WITH FOUR PREREQUISITES
ASSUMPTIONS
Prior to performing a mapping study, there are certain
prerequisites:
1. This white paper > Identify Specifications
is written with the > Read your Validation Mapping SOP
assumption that you > Select and Validate Mapping Equipment
have a validation
master plan that
includes warehouse PREREQUISITE 1: Identify Warehouse Specifications
mapping as a
validation activity. If Start by determining for the space. This will
not, you must update your warehouse storage include both the acceptable
your validation master specifications. This first step temperature range as well as
plan to incorporate helps set the acceptance any acceptable excursions.
warehouse validation. criteria for mapping, which is Typically, this will be
the primary focus of validation. presented as a range from
2. There is no pre-
Some mistakenly view 20°C to 25°C, or it may be
existing mapping
mapping studies as solely for as simple as Not More Than
equipment is available,
which means you environmental data collection. (NMT) 25°C. Usually, there
can choose mapping Instead, the goal of validation is an acceptable excursion
equipment and the is to gather and document limit. The excursion limit
mapping process can evidence that demonstrates ensures that every excursion
be adapted based on the fulfillment of acceptance does not require a deviation
equipment constraints. criteria for the area. report. Know the temperature
specification beforehand
3. The warehouse is To determine acceptance because it is the target for
new and has not been criteria, you need to know acceptance criteria.
previously mapped. the temperature specification
4. Temperature mapping
is part of the larger
IQOQ effort to validate TEMPERATURE
the entire warehouse, SPECIFICATIONS
including the HVAC ACCEPTANCE
system and control > Acceptable
CRITERIA
elements. This white temperature range
paper focuses solely
on mapping warehouse > Acceptable excursions
conditions, excluding
other IQ or OQ
activities like verifying
P&ID drawings for A NOTE ON EXCURSIONS:
HVAC control elements.
We assume that For most products, small, brief excursions have little
commissioning, SAT, effect on product quality, especially for bulk or packaged
and related validation products, which have some protection from temperature
tasks have been changes from thermal mass and packaging. The USP
successfully completed, definition of controlled room temperature typically
and the warehouse allows for unlimited excursions down to 15°C, and limited
functions correctly, excursions up to 30°C. It would not be unusual to
requiring temperature see 4-hour excursions allowed up to 30°C, and 1-hour
mapping only. excursions allowed to 40°C.

4
PREREQUISITE 2: Read the
Site Validation Mapping SOP
Ideally, the facility has an existing
SOP that outlines a method
for temperature mapping. The
Standard Operating Procedure
should contain:
1. Mapping equipment
2. Intervals between re-mapping
3. Study duration(s)
4. Data sampling frequencies
5. Sensor calibration intervals
If you do not have a Mapping
SOP, or would like to improve
the SOP in use at your facility,
this white paper contains tips
on how to create a mapping
SOP so that the decisions
you make while mapping
your warehouse are granted
posterity, allowing others
to learn from your mapping
experience.
PREREQUISITE 3: Select and
Validate Mapping Equipment
Using pre-existing mapping
equipment is not always ideal,
but often, it is the only option.
Mapping equipment limitations
will dictate how the mapping
process will be executed.
In GMP compliance validation
efforts, most resources
are allocated to mapping
equipment designed for use
under extreme conditions
(e.g., ovens, autoclaves,
sterilizers, and lyophilizers).
This is where consultants
profit most, companies save,
and equipment providers
concentrate their efforts.
These environments demand
frequent remapping and
multiple runs per recipe.
While it is possible to adapt
an autoclave data logger for
ambient warehouse mapping,
it is costly and suboptimal.
Ideally, you should use
tools specifically designed
for warehouse mapping or
monitoring, typically employing
data loggers tailored for large
spaces, free from extreme
pressure and temperature
protection requirements.
Data loggers designed for
warehouse mapping should have:
• Independent memory that
can hold 30 days’ worth of
1-minute samples.
• Battery power for at least
three months
• Sensor accuracy of ± 0.25°C
minimum
Software designed for
warehouse mapping should have:
• Reporting capabilities for
clear graphs, historical data,
and the necessary statistics.
(Detailed later in this paper)
• Intuitive, easy-to-read interface
• Simple data retrieval from
the data loggers
• Compatibility with
requirements for 21 CFR Part
11 and Annex 11
• A vendor-supplied validation
protocol

A NOTE ON SENSOR ACCURACY:

• For most warehouse mapping studies ±0.5°C is sufficient.

• However, because post-calibration will be performed at the end of the study, a sensor with
accuracy of ±0.25°C is more likely to meet a ±0.5°C acceptance limit on the post-calibration
because a physical post-study calibration typically doesn’t control uncertainty as well as
the factory or laboratory calibration, which is often used as evidence of pre-calibration.

Control calibration costs with a calibration care agreement. Learn more...

vaisala.com/en/services/calibration-and-repair-services/calibration-care-agreement

5
 PREPARING A WAREHOUSE MAPPING STUDY
EVALUATE THE WAREHOUSE SPACE
Analyzing the area to be mapped will help
determine sensor placement for the study.
You have the temperature specifications. The
sampling frequency will be between 1 minute
to 15-minute intervals, and the study duration
will be 7 to 14 days. Those important details
are usually provided by existing specifications
or a Mapping SOP at the facility. We analyze
the physical area in order to determine where
the mapping sensors will be placed.
6
DETERMINE SENSOR LOCATION
The objective is to fill the space with data
loggers placed at regular intervals and heights.
A common solution is to work in stacks
of three sensors, with the lowest sensor
approximately one meter from the floor,
the highest sensor at a height equal to two
meters above the highest storage rack, and
the middle sensor placed between the top
and bottom sensors. Use this three-sensor
stack to create a grid of sensors in three
planes in three dimensions.
In a warehouse where all the racks run parallel
across the space, you need to know where
the racks are located for pragmatic reasons.
First, the product only goes in the racks, so
you will map the areas where product will be
stored; mapping hallways and access areas
is not necessary. Second, we need a physical
structure to attach the data loggers; these
can be racks and columns that are usually
lined up with the racks.
Place a stack of three sensors in each corner
of the space. Then fill in the sides parallel
to the racks with stacks of three. Each stack
should be no more than twenty meters away
from the next stack of three sensors. Try to
have an odd number of stacks.
Next, fill the sides with the open ends of
the racks, again with no more than twenty
meters between sensors. Again, try for an
odd number of stacks. At this point you have
created a perimeter of stacks of three, with
odd numbers of stacks on each side. All
stacks should be co-located in the racking
or next to columns to ensure that we have
a positive mounting location for the data
logger. Finally, fill in the space in the middle
with stacks of three sensors aligned with the
perimeter stacks.
Having placed sensors in stacks of three to
provide a sensor distribution that will satisfy the
most risk averse institutions, we can ask if this
is too many sensors. If your sensors are reliable
and accurate, it’s feasible to use less sensors.
STACKS OF 3 VS.
STACKS OF 5
The World Health Organization
recommends stacks of five sensors.
This is a good number of sensors
if the data logger sensors are less
accurate or likely to fail.
This can also work if the warehouse will
not be under long-term GxP control.
The WHO recommendations are more
appropriate for temperature profiling
of smaller and uncontrolled spaces to
demonstrate storage conditions and
capability.
A temperature mapping in the context
of GxP validation should use accurate,
stable sensors.
In a controlled-temperature warehouse
that will be operated under GxP
controls after mapping, ISPE guidance
suggests that a stack of three sensors
is adequate.
See our webinar:
Mapping made
easy: where to
place sensors
and why vaisala.
com/en/events/
webinars/lp/
mapping-made-
easy-where-place-
sensors-why
7
 REDUCING SENSOR DENSITY

In the stacks that are in the corners, remove only the middle sensor, retaining both the top
and bottom sensors. Focus on the perimeter first; moving around the perimeter, in either
direction, the next stack will get the top and bottom sensor removed but keep the middle
sensor. Alternate removals in this manner around the entire perimeter. This only works when you
have an odd number of stacks of three. Once you have removed sensors from the perimeter,
you have an alternating array of sensors. Repeat the same activity for each row of three-sensor
stacks in the interior of the warehouse.

Video: More
Guidance on
mapping sensor
placement
vaisala.com/
en/blog/2020-
10/video-qa-
guidance-
warehouse-
mapping-sensor-
placement

When you have completed this removal of
alternating sensors, you will have removed
close to half of the sensor locations yet
maintained some important features:
1. There are sensors in all corners and the
center of the space.
2. There are sensors in 3-planes and in
3-dimensions.
3. There are sensors distributed throughout
the racks where product will be stored.
The sensors removed have created the bare
minimum of sensors to create a representative
mapping study. You can consider adding
sensors back to areas of interest, such as
doors or HVAC vents.
Although there is no guidance that states how
far apart sensors should be to ensure your
data are representative of the conditions,
sensors should never be more than twenty
meters apart. The smaller the distance
between sensors, the greater the level of
confidence that there are no unexpected
temperature fluctuations between the sensors.
Document sensor locations and attach to the
protocol. A drawing or schematic as a visual
guide is helpful.

8
Sensor location documents should uniquely
identify each sensor (by serial number or
other identifier) and the location of each
sensor (IE: SW corner of the warehouse, one
meter from each wall, and five meters above
the ground.)

WRITE MAPPING STUDY PROTOCOL

Before creating a protocol, talk to decision

makers about their expectations and
determine their level of risk tolerance. This
will help to define the adequate density of
sensors for the study. Many decision makers
are risk averse, preferring as many sensors
as possible. However, this decision has some
practical consequences in cost to execute.

9
 Warehouse Mapping
Step-by-Step
Action Key Considerations
Select • Ideally, if you have other areas (small chambers) to study, your warehouse mapping
Mapping system is flexible. This allows you to map shipping containers, refrigerators, freezers, etc.
Solution with the same system.
• It can simplify things if the mapping solution uses the same sensors as the monitoring system.

Validate
Mapping • You must qualify your mapping solution before performing any mapping activities with it.
Solution • A vendor-supplied validation documents and/or execution saves time.
Software

Write • Acceptance criteria is the key.

Protocol • Acceptance criteria often draws upon other sources that contain specifications.
• Be specific but build in some flexibility. Example: “Temperatures must be not more than
25°C and not less than 10°C. Excursions are permitted for up to two hours and not to
exceed 30°C and not below 5°C.

Schedule • Determine availability of the space to be studied.

the Study • If operations in the area will remain active, verify that activities will neither disrupt, nor
affect the study.
• Reserve the space.
• Recommend that the study duration be communicated to prohibit interruptions.

Pre- • Verify sensor accuracy prior to the study.

calibration • Instructions can be a standalone pre-calibration SOP or included in the protocol.
Verification
• Check calibration certificates of all sensors and record key data (I.E., calibration dates.)
• If the sensors are less stable, thermocouples for example, a full calibration procedure
is recommended, with sensors in a controlled temperature environment, such as a
temperature bath. Adjust the offsets to get the reading within acceptable accuracy levels.

Place • Create a consistent, grid or network of sensors throughout the warehouse space.
Sensors • Place sensors in stacks of three, (lower height, middle height, highest) creating three
planes in three dimensions.
• No more than 20m maximum between stacks.
• Document the location of each sensor using a unique identifier for both the sensor and
the location.
• Use safety equipment for high, hard-to-reach locations. This often requires a crew of at
least two people.
• Placing and retrieving sensors is labor intensive, especially with high locations. You will
save time if your mapping solution allows you to check progress during the study.

Set Study • An established GxP facility is likely to have a pre-set study duration as defined in existing SOPs.
Duration If not, select one.
• Seven days to two weeks are common durations, so long as you capture a full duty cycle.
• The longer the study, the higher the confidence in the data.
• The World Health Organization and International Society of Pharmaceutical Engineers
give some guidance:
• “Temperature mapping of storage areas” Technical supplement to WHO Technical
Report Series, No. 961
• “ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and
Qualification, Mapping and Monitoring” (Second Edition)

10
 Action Key Considerations
Determine • Typically, this rate is set between 5 and 15 minutes. Often, the rate is predicated by the equipment.
Data • Faster data collection (smaller sampling intervals) provides higher resolution data, which
Collection improves the ability to identify excursions and hot/cold spots.
Frequency
• Longer sample intervals reduces bulk data and mitigates the risk of exceeding the data
storage capacity capability of your mapping system.
• Most modern data loggers can store lots of data, supporting a shorter sample interval.
• However, if you must attach all raw data as printouts to the final report, faster sampling is
problematic because it generates more data.
• If your monitoring procedure states that you are only interested in excursions greater than
15 minutes in duration, then a 1-minute sampling interval may be too much.
• A 5-minute sample interval is a perfect match for a 15-minute allowable excursion (or a
10-minute allowable excursion as well) because four consecutive 5-minute measurements
are sufficient to identify an excursion that has exceeded 15 minutes.
• Select a sample interval that is a divisor of your allowable excursion limit.

Begin • It is a good practice to place signs on the warehouse doors and on the thermostat indicating
Study that a mapping study in process. Placing signage can be added as a step the protocol.
• Some data loggers will already be taking data as they are placed, others can bet set to
begin at a pre-set time, and some have a start button.
• Your protocol may require you to take independent readings during the study, typically at
locations near thermostats, control probes, or monitoring sensors.
• If readings are taken automatically, and safely stored by your monitoring system, you
should be able to access this at the end of the study and not actively collect it as you go.
• Independent readings serve to reconcile mapping data and the monitoring data.

Check • Ensure equipment is in place and functioning.

Mapping • Ideally you have a system that allows you to view live data.
Equipment
• Check live data at the beginning, middle, and end of the study.
• If the warehouse is operational – with personnel – mid-study checks of physical equipment
is a good idea to ensure sensors have not been disturbed, moved, or otherwise damaged.
• Further, when mapping an active warehouse, post new entry logs. Any time a door is
opened it can affect the mapping study. Post signs on the door, where employees can log
door openings.
• Replace these entry logs often to ensure this data can be recorded.

End study • Retrieve the data loggers and download the data.
• Some wireless data loggers download automatically when in proximity of a network access
point, others will need to be manually connected to a PC or mapping system to download.
• All data must go immediately into a validated and protected data storage system. The data in
this system should have an audit trail so the data cannot be edited or modified undetected.
• Verifying the system’s audit trail functionality would have been part of the validation of
your mapping solution.

Analyze • Data is contained in electronic records and placed into a protected database that either
the data does not allow any changes or has an audit trail to log any data changes.
• Use the mapping solution’s integrated reporting tool. Exporting data provides
opportunities for data manipulation that must be avoided.
• Mapping analyses contains basic information:
• Start time, End time.
• Minimum and maximum values and timestamps for each data logger.
• Average values for each data logger. (Note: Averages may not be useful because they do
not apply to acceptance criteria, but some firms employ them.)
• Identification of any excursions, including locations involved, duration, max/min value,
and timestamp of the max/min.
• If acceptance criteria were not met, now is the time to figure out what happened. Does
the setpoint of the warehouse need to be adjusted, or the control system tuned?
• If the study data shows that acceptance criteria were met, move to post-calibration.
11
 Action Key Considerations
Post- • Prove that the sensors are accurate at the end of our study, proving that the data
calibration collected is valid.
verification • Post-calibration acceptance criteria should not be tighter than pre-calibration criteria.
For example, with thermocouples, ±0.2C as pre-calibration accuracy criteria for
thermocouples and post-calibration criteria of ±0.4C would be appropriate because
thermocouples are known to drift with use over time, especially with the dynamic use that
comes with temperature mapping.
• With RTDs or thermistor-equipped data loggers, which are more stable, pre- and post-
calibration acceptance criteria might be the same, but post-calibration acceptance criteria
could still be a wider range.
• If you have a high level of confidence in the equipment, you could forgo the post-calibration,
but it’s not recommended and must be supported by a documented risk assessment.
• Post-calibration does not need to bracket the range of the acceptance criteria rather, it
can be at the use point.
• For example, a warehouse with a target temperature of 10°C to 25°C, and pre-calibration at
0°C and 40°C could have a post-calibration at any temperature between 15°C and 20°C.
• Data loggers need to be located close as possible to an accurate temperature reference, allowed
time to equilibrate, and in a controlled insulated area with no airflow to control uncertainty.
• If the sensors had a full pre-calibration in a lab, you have the facility to create the
necessary conditions and likely an SOP that has been evaluated by a metrologist to ensure
that uncertainty is controlled.
• If you only verified the calibration certificates as a pre-calibration, it is still possible to get
some confidence that your data loggers are accurate with a simple documented post-
calibration procedure. You may want to validate the post-calibration procedure with a
documented study where you run through the procedure three times, showing that your
procedure provides good results and correctly identifies known good loggers as good, and
known bad loggers as bad.
• The procedure can be simple; but must be documented; place all the data loggers and the
temperature reference in an insulated box or cooler. Place the sensing tip of the reference
as close as possible to the sensing tips of the data loggers. Place the box in a location
with a stable temperature and let it equilibrate. Compare ten consecutive readings from
the data loggers against ten consecutive readings from the temperature reference. If
all the readings are within ± 0.25°C (or ± 0.5°C) you know the data loggers passed pre-
calibration and can have confidence in the data gathered by the mapping study.
• With Vaisala data loggers with smart probes, you have an additional option for post
calibration. Remove the smart probe from the data logger and attach it to a handheld
measurement device with a built-in temperature reference. This can provide real-time
readings for the smart-probe and a temperature reference.
• Once post-calibration is complete and successful, you now know your mapping study data are
good. And since you have already analyzed the data, you know whether the warehouse has
passed or failed.

Create • If the study failed, the mapping report is an interim report that shows failed results and
Mapping details issues identified, corrective action, and intent to remap.
Study • If you passed, then the report will contain the results. Record all steps performed
Report compared to the protocol.
• Present the data and results compared to the acceptance criteria for each section.
Show that the mapping was performed according to the protocol and that the data you
collected met the acceptance criteria.

Optional: • Warehouses are often mapped in both the coldest and the hottest seasons. Some firms
Set remap warehouses every three years. If there are changes made to the warehouse HVAC
Interval for system or to how the warehouse is organized and operated, remapping is a good idea.
Remapping Changes to the warehouse layout often changes the air flow and temperature distribution.
• Even without major changes to the warehouse, expect to map the space about eight
times in 10 years. This involves two mappings to start, to capture seasonal effects in the
hottest and coldest seasons and repeat those two seasonal mappings every three years.

12
HIGH DENSITY MONITORING
In conclusion, warehouse mapping can be
labor-intensive and disruptive, especially in
tall warehouses and economies with high
labor costs. Maintaining a high density of
monitoring data loggers and leaving them
deployed can save time and resources when
performing mapping studies. A high density
of data loggers, also called continuous
mapping, is a robust solution that can reduce
the costs of mapping. There are some initial
drawbacks to this method. First, you will
have to install more data loggers to monitor.
Second, calibration costs are increased to
maintain the sensors.
However, the highest costs of warehouse
mapping come from the labor and downtime
involved. By reducing those costs, you can
save resources over the long term. Redundant
Learn more about Vaisala Mapping Solutions
vaisala.com/en/products/software/validation-mapping-system
sensors also improve monitoring coverage
and data. Other benefits include:
• Assurance that you can map during the
hottest and coldest seasons, whenever
those occur. You can also capture conditions
in unanticipated, harsh weather.
• Rather than performing pre- and post-
calibrations, you calibrate your sensors
annually, or on your normal calibration
schedule for monitoring sensors.
• You know if the mapping failed or passed as
it is happening so you can take immediate
corrective actions.
• The cost of failed mapping is reduced or
eliminated.
• The costs of changes to the HVAC system
or warehouse are greatly mitigated because
you can conduct a study quickly.
13
 Ref. B212768EN-A ©Vaisala 2023
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