Logistics & Supply Chain
Temperature Mapping of Vehicles Used for the
Transportation of Pharmaceutical Products
In this article, Andy Hughes and Kane
Edgeworth talk about the recent history
of temperature mapping expectations,
the approach of mapping temperature-
controlled vehicles, the use of risk when
deciding to map or not, a recent mapping
study undertaken, and what to do with
the data gathered.
Why Map?
“When Pharmafreight brought its first
thermo vehicle into service back in the
middle of the last decade, temperature
mapping wasn’t the first thing on our –
or our clients’ – minds,” explains Andy
Hughes. “The most important thing
was that the vehicle held temperature,
it was well maintained, and the drivers
knew what they were doing.” Things
have certainly changed now, and more
specific demands from customers and
regulators on what was required from
a vehicle used to transport medicines
have radically changed. “As things have
developed, it soon became apparent that
good mapping procedures were essential
in order to guarantee client confidence
and maintain an increase in our customer
base, as well as comply with the GDP
Quality System we were operating to,”
says Andy.
From a regulatory perspective,
temperature mapping studies have been
a requirement for some time now within
GDP- and GMP-licensed environments.
John Taylor’s original article
‘Recommendations on the control and
monitoring of storage and transportation
temperatures of medicinal products’ back
in 2001 was a major catalyst, generating
a lot of discussion. More recently, the
release of the EU GDP Guidelines in
November 2013 and the revised 2014
Orange Guide both led to an increased
focus in this specific area (guidelines
from the HPRA, WHO, ECA/PQG and
the USP are also useful resources for
vehicle temperature mapping).
“However despite the new revised
GDP guidelines, you shouldn’t
necessarily assume that everyone else is
undertaking the mapping requirements
to that standard,” comments Andy. “We
have seen vastly different standards of
84 INTERNATIONAL PHARMACEUTICAL INDUSTRY
mapping reports from other transport
providers, and you also get the feeling
mapping is still looked upon as a nice to
have, rather than a specific requirement
that you must adhere to, if in fact the term
mapping is understood at all, especially
when we look to an international level.”
There is also talk of ATP certification
for thermo trailers – and how that is
sometimes used as a way of circumventing
the mapping process – however, although
useful it is not generally accepted by the
quality departments of pharmaceutical
companies.
On the back of John Taylor’s 2001
article – which is still quoted in the 2014
Orange Guide – mapping projects were
carried out to varying levels of quality,
but as the regulation and requirements
mature, the levels of expectation in
quality and traceability have increased
significantly. Many early projects
consisted of a few logger files with basic
graphs and diagrams – insufficient
for today’s requirements. Depending
on the regulatory environment, the
documentation approach can be different.
For example, the typical qualification
approach of IQ/OQ/PQ seems to be
mostly adopted in GMP-driven areas.
However, a standard but detailed type
of protocol leading to a comprehensive
final report is often sufficient within GDP
areas, and is recommended in the 2014
Orange Guide.
Do You Have to Map?
“From our side as a mapping provider,
vehicles used for the transportation of
pharmaceutical products have been our
largest growth category in temperature
mapping over the last couple of years,
partly perhaps due to the increased
focus on transportation by the regulator,”
says Kane Edgeworth. “It is true this has
been an area where there has been
less commitment compared to the more
traditional areas such as warehouses,
fridges and freezers over the last few
years, however things are changing.
Vehicle mapping can also be a difficult
subject to approach, especially with
larger vehicle fleets, knowing how
to achieve a balance in what can be
realistically achieved against both
cost and risk,” continues Kane. “For
example, if a fleet consists of more than
one hundred vehicles it is probably not
realistic to map every single one; instead
adopting a risk-based approach on the
fleet can be a good starting point.”
A mapping risk assessment should be
step one and will help you document all
of the different types of vehicles so that
you can build categories of the same or
similar types. The information gathered
for this exercise might include:
• Trailer/vehicle type (e.g. curtain-
sided, solid-sided, rigid vehicle, van,
etc.)
• Temperature controlled/or not
• Single or dual compartment/Single
or dual temperature
• Partition type, and dimensions for
each compartment
• Year of construction
• Insulation material used for the
panels.
• Overall size of the trailer/vehicle
• Air-conditioning unit – age,
manufacturer, model
• Maintenance history
• Temperature monitoring devices and
their locations
• Air-conditioning controls, e.g.
always on when engine running,
ability to run with external power,
etc.
Once the categories have been built,
decisions can then be made in regard
to which vehicles will be mapped. One
approach is to take a ‘master’ vehicle
from each category which will be subject
to a full schedule of tests. Then, based
upon performance, a percentage of the
remaining vehicles in the same category
can be tested to an abbreviated protocol.
Documentation can follow the typical
qualification approach of IQ/OQ/
PQ; the OQ may be an empty test to
determine correct air temperatures and
uniformity across the vehicles’ storage
space. The PQ may then extend to load
challenges and impact tests such as door
open and power down events – typically
this would be with a stationary vehicle
but also as a live shipment with dummy
loads.
Winter 2014 Volume 6 Issue 4

An Example Study
Pharmafreight purchased a
number of dual temperature
vehicles in early 2014 as part
of its ongoing fleet expansion.
The vehicles were Mercedes
3.5T box vans, with movable
bulk heads and dual-
temperature capabilities. This
type of vehicle is becoming
more popular as it provides
a lot more flexibility for
load sizes and temperature
requirements. However, dual-
temperature vehicles present
greater complexity in mapping
studies due to the number of
usable configurations, e.g.
+5.0°C front & +20.0°C rear,
+20.0°C front & + 5.0°C rear,
+5.0°C only, +20.0°C only.
This obviously increases the
project scope over a standard
single-chamber vehicle.
Project Overview
A documented mapping
risk assessment was carried
out and a test summary
was produced. All possible
configurations would be
mapped and the vehicles
would be subject to FULL
and EMPTY load challenges
as well as impact tests, most
notable a power failure test to
simulate an issue with power
supply during ferry crossings.
The test would be carried out
www.ipimedia.com
PAGO Stand-No. 130
during the full-load phase and
the time noted from the power
being switched off, to when
the first out-of-specification
reading was recorded within
the vehicle. The mapping
term would run over 48 hrs
and the vehicle would be
stationary during the tests and
the exercises would be carried
out in both summer and winter
to capture the performance
during seasonal extremes.
Pharma-compliant
The next step is to design
the mapping protocol and labelling solutions
recording location layout
(vehicle plan). This will All from one source
determine the works to be
carried out and should Pago is your competent specialist for pharma-compliant
be approved by both the product information with GMP certified self-adhesive labels:
document author and the user. • Multi-layer labels for comprehensive patient information
The protocol will dictate the • Booklets for clinical trials
final report content and can • New: Self-adhesive hanger device (SAHD) for infusion bottles and
include the following: injection vials, according to ISO 15137
• Security labels e.g. tamper-evident, anti-counterfeit, braille labels
• Unique project code • Pharma-compliant labelling technology and much more
• Mapping duration Pago labels and labelling technology satisfy all requirements
• Logger positions (loggers of the pharmaceutical industry.
are placed at top, middle Please contact us, we will be happy to advise you.
and bottom positions
Pago AG · CH-9472 Grabs
Pago Etikettiersysteme GmbH
DE-72631 Aichtal
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throughout the usable
load space. Loggers are
also placed in order to
record the air outlet and
return air temperatures)
• Temperature ranges
• Load state
• Season
INTERNATIONAL PHARMACEUTICAL INDUSTRY 85
 Logistics & Supply Chain
• Impact test/s
• Vehicle description
• Monitor type
• Mapping type (temperature/
humidity)
• Data logger specification important to implement ‘load limit’ lines
• Data logger configuration to avoid the vehicle being overloaded,
• Data logger calibration (3pt
traceable to national or international
standards)
• Mapping report content
overview more and more mapping is taking
• Deliverables place throughout the transport industry.
• Floor plans/diagram
Reviewing the Data
Once the mapping exercises have been
completed and the reports issued with
their findings and any recommendations,
the next critical step is to review the data
with your quality team. The data actually
helps to give you a better understanding
of how your vehicles perform in certain
conditions and situations, allowing you
to make good decisions based on actual
data gathered during these tests. As
mentioned in the vehicle test summary
here, one of the key parts in a good
mapping exercise is to conduct an
impact test. The data illustrates how long
the cargo compartment(s) being used
will hold the correct temperature range
required. Then put that data into a real-
life situation, whether that is a vehicle
breakdown, or there are no open-deck
positions available on a cross-Channel
ferry, so leaving the engine running on the
vehicle is not an option. The impact test
data gives you specific information about
what will happen to the temperatures
on the vehicle, allowing the transport
operator – along with its client – to make
informed decisions about what action to
take.
Recommendations
The data will also highlight any unusual
hot or cold spots within a vehicle, giving
you the appropriate information to be
able to make decisions about where not
to load product in a vehicle, or to make
some changes to a vehicle’s configuration
or layout. Any structural changes to a
86 INTERNATIONAL PHARMACEUTICAL INDUSTRY
vehicle will of course result in another Guide to Good Distribution Practice of Medicinal
mapping test being undertaken, but Products for Human Use
https://www.hpra.ie/docs/default-source/
better a new test than have temperature publications-forms/guidance-documents/
issues when shipments of actual product ia-g0046-guide-to-good-distribution-practice-
are loaded inside the vehicle. It’s also of-medicinal-products-for-human-use-v2.
pdf?Status=Master&sfvrsn=6
which can result in poor airflow and out-
of-specification readings in some areas.
Ultimately things are changing, and
It is in everyone’s interest to hope that
this upward trend continues, ensuring
regulatory compliance and that vehicles
are suitable for use, but ultimately Andy Hughes started his
ensuring we are doing our part in getting logistics career in 1992,
drugs to the patient in the best possible with a multi-national
condition. freight forwarder. He
moved on to work for the
References
UK’s freight association,
European Commission
Guidelines of 5 November 2013 on Good BIFA, as its head of
Distribution Practice of Medicinal Products for communications,
Human Use lobbying Government
http://eur-lex.europa.eu/LexUriServ/LexUriServ. on transport issues. In 2003 he helped
do?uri=OJ:C:2013:343:0001:0014:EN:PDF establish Pharmafreight, a freight
company handling only pharmaceuticals
The ECA (European Compliance Academy) & the
PQG (Pharmaceutical Quality Group) and related products, under good
Draft Chapters on GDP Interpretation of the EU distribution practice (GDP). Andy travels
GDP Guidelines – Section 9 Transportation extensively, setting up GDP operations at
http://www.pqg.org/shop/guidelines/43-eca- partners around the world, and offers
pqg-gdp-guideline-chapter-9-good-distribution-
advice to key industry organisations.
practice.html
http://www.good-distribution-practice-group. Email: andy.hughes@pharmafreight.com
org/gdp_news_3973_7940,S-GDP.html
h t t p : / / w w w. g m p - c o m p l i a n c e . o r g /
enews_03973_.html
Kane Edgeworth,
WHO (World Health Organization) Managing Director,
Annex 9 - Model guidance for the storage and Biomap Ltd. Kane has
transport of time and temperature sensitive worked in cold chain
pharmaceutical products
compliance since 1999
Section 6.6 Qualification of temperature-
controlled road vehicles and launched Biomap
http://apps.who.int/prequal/info_general/ Ltd in 2008, specialising
documents/TRS961/TRS961_Annex9.pdf in temperature
qualification services. Kane works across
MHRA 2014 Orange Guide
the pharmaceutical industry with clients
Rules and Guidance for Pharmaceutical
Manufacturers and Distributors 2014 – the throughout the UK and the Middle East,
‘Orange Guide’ regularly presents at GDP workshops
h t t p : / / w w w. m h r a . g o v. u k / P u b l i c a t i o n s / and is also a member of the GDP working
Regulatoryguidance/Medicines/ group driven by the ECA and PQG for
Othermedicinesregulatoryguidance/ interpretation of the 2013 EU GDP
CON2030291
guidelines.
HPRA (Health Products Regulatory Authority) Email: kane.edgeworth@biomap.co.uk
Winter 2014 Volume 6 Issue 4