Temperature
Monitoring for
the Vaccine
SupplyChain
V1.0
21.Sept.2020
WHITE PAPER

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 2 / 13
Vaccines &temperature
Vaccines have transformed public health safety by eradicating, or significantly reducing,
certain infectious diseases. It was revolutionary to discover it was possible to use the disease
itself, to create antibodies and immunity in the human body. The current list of infectious
diseases that can be prevented by vaccines is below. (Status 2020):
Effect of temperature excursions on vaccines
Every vaccine is a carefully engineered product
containing the right vaccine potency, having the
ability to adequately protect the vaccinated patient.
Vaccine potency may be reduced when the
vaccine is exposed to inappropriate temperatures
outside the defined stability budget. These
temperature excursions can accumulate to regard
the product ineffective.
Sources: Vaccine-preventable infectious agents or diseases,
WHO
Whyarevaccinessensitivetotemperature?
Vaccines are engineered biological preparations
that help humans or pets to acquire immunity to
a specific infectious disease. Most vaccines
contain a killed or weakened part of the
disease-causing microorganism and train
the body to build immunity. Depending on
the construction of the vaccine, the
manufacturing method and the treatment
process, every vaccine has a specific
sensitivity to temperature. Most liquid
vaccines require refrigeration, are very
sensitive to heat, and freezing. Some
lyophilized (freeze-dried) vaccines can be
kept frozen and are only sensitive to heat.
A stability budget is set by the drug manufacturer
who has tested the stability and efficacy of a drug
product to certain temperature ranges over
periods of time. If stability or efficacy of the
product is lost, vaccine potency cannot be
regained and this is a significant threat to patient
safety:
 Patients who receive a vaccine with
insufficient potency may not obtain the
desired immunization and thus expose
themselves to unwanted risks.
 Freezing might cause crystallization, which
not only may cause loss of potency but also
in addition have other unwanted effects in
the patient’s body.
Temperature control along the entire vaccine
supply chain is vital to secure patient safety! Read
more here to learn more about how to set up a
stability budget.
Two vaccine supply chains
The history of vaccines goes far back to old
Chinese traditions of immunization and was
scientifically discovered in the late 18th century on
smallpox. In the 19th century, Louis Pasteur, the
microbiologist from Alsace, invented the basic
techniques for the industrial production of
vaccines. Since then, an

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 3 / 13
entire industry has grown, saved millions of lives
and was even able to extinct or at least limit
some of the most dangerous infectious
illnesses.
The“vaccinesupplychain”canbesplitinto
two types:
Vaccines for the modern world:
Based on recommendations from WHO (Wold
Health Organisation), the responsible national
government agency of each country is setting
guidelines and recommendations for vaccination
plans for children and risk groups (healthcare
workers, elderly, travellers) in their territory.
Although the national authorities coordinate
sourcing and distribution of some vaccines (e.g.
seasonal flu vaccine), the standard supply chain
of vaccines is not different from any other
pharmaceutical product: Hospitals/Clinics order
from wholesale. Wholesale normally purchase
and import directly from regional distribution
centres or the product owner.
Temperature monitoring lies in the responsibility
of each party in the supply chain (producer
importer
typically dominated by product owner’s chosen cold
chain monitoring solution.
Vaccines for developing countries:
Together with local authorities, UNICEF (United
Nations Children's Fund) and PAHO (Pan
American Health Organization) are setting-up
vaccinations programs for children and adults in
developing countries. Typically financed by
NGO’s (Non- Governmental Organisation), the
entire supply chain and the local distribution is
coordinated by UNICEF or PAHO – in war
regions often in cooperation with MSF (Doctors
Without Borders – Médecins sans frontières) or
ICRC (International Committee of the Red
Cross). The supply chain of vaccines in those
programs is often significantly different since
they are typically purchased ad-hoc and in large
batches. A large amount of is produced in India
and shipped to developing countries where they
are donated to national health systems or often
distributed by local NGO’s.Thesupplychainis
“ad-hoc”andtherefore the temperature
monitoring must be simple during shipment and
storage on-site. The system must be self-sustained, self-
explainable and at the same time reliably ensuring patient
safety.
Developing countries have the larger
need for vaccines in terms of volume,
and at the same time, it is the more
challenging supply chain.
Vaccines for developing countries
Vaccine logistics for developing countries –
who is in the lead?
When shipping vaccines to developing countries,
there are a number of organisations playing an
important role. Following a list of the most
important NGO’s and organisations:
WHO
The World Health Organization is a specialized
agency within the United Nations and is
responsible for international public health.
Headquartered in Geneva, it is setting important
standards for vaccine quality by performing
Prequalification of equipment and devices used
for maintaining quality and safety (PQS
Catalogue).
Role: Standards, Prequalification of methods
and devices
https://www.who.int/

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 4 / 13
UNICEF
The United Nations Children's Fund (UNICEF)
was founded by the United Nations (UN) after
world war
II. Headquartered in Copenhagen, UNICEF
often takes the lead in the vaccine supply
chain by sourcing and delivering lifesaving
supplies where they are most needed.
Role: Expertise, Sourcing, Logistics
https://www.unicef.org/
PAHO
The Pan American Health Organization (PAHO)
is a partner organisation of the WHO working to
improve health and living standards of the
people of the Americas. When it comes to
vaccine programs for the 3rd world, PAHO plays
a similar role to UNICEF – but with a focus to
middle and South Americas.
Role: Expertise, Sourcing, Logistics
https://www.paho.org/en
Bill & Melinda Gates Foundation
The Bill & Melinda Gates Foundation is collecting
large amounts of funds and is committed to
saving millions of lives each year by providing
support for global immunizations and vaccine
delivery. Role: Financing (Donator), Analysis,
Technical Support, Logistics Support
https://www.gatesfoundation.org/
Gavi
The Global Alliance for Vaccines and
Immunization (Gavi) is a global partnership of
government leaders, scientists, health experts
and philanthropic organizationswhose missionisto
savechildren’s lives through increased access to
immunization in the world’s poorest countries.
Role: Financing (Donator),
Expertise https://www.gavi.org/
GVAP
UNICEF has established a Global Vaccine
Action Plan (GVAP) signed by the 194 Member
States of the World Health Assembly. GVAP
ensures adequate resources, develops
healthcare systems, and works
with countries to train health workers needed
to reach remote and marginalized
populations Role: Coordination, Planning
https://www.who.int/immunization/global_vaccine_
action_plan/en/
IVAC
The International Vaccine Access Center
(IVAC) at the Johns Hopkins Bloomberg
School of Public Health (Baltimore, Maryland)
is another important player in proving
knowledge and expertise for international
vaccine programs in poor countries.
Role: Expertise
https://www.jhsph.edu/ivac/
MSF
Médecins Sans Frontières (MSF), also known as
“Doctors Without Borders”, is an international
humanitarian medical NGO supporting conflict
zones and countries affected by endemic
diseases.
Vaccination programs play an important role in
the work of MSF.
Role: Logistics
Support
https://www.msf.ch/
ICRC
The International Committee of the Red Cross
(ICRC) is ensuring humanitarian protection and
assistance for victims of war – such as providing
medical support and vaccines.
Role: Logistics
Support
https://www.icrc.org/
BARDA
The Biomedical Advanced Research and
Development Authority (BARDA) is a
department of the US government responsible
for procurement and development of
countermeasures principally against pandemics.
They are leading the search for a Covid- 19
vaccine.
Role: Research
https://www.phe.gov/about/BARDA/Pages/default.
a spx

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 5 / 13
Vaccine logistics – what are the specific
challenges?
Compared to other pharmaceutical
products, vaccines often have a different
supply chain and different needs when it
comes to temperature monitoring:
Temperature monitoring of vaccines
Monitoringtemperaturealongthesupply
chain –three approaches
Given the special logistics challenges, time and
temperature is of the essence when shipping
vaccines. During the past 30 years, vaccine
producers, FDA and WHO have been evaluating
and promoting different solutions:
 Chemical Indicator: A chemical time and
temperature indicator (TTI) is a small “item”
which is indicating (alarming) if time and
temperature limits are exceeded. Most
chemical indicators provide a smooth
progression of the indicated status from
“Good-to-use” to “Don’t use”.
 Electronic Indicator: An electronic (time
and temperature) indicator is an electronic
device which is measuring temperature,
knows allowed temperature limits and times
and indicates a clear digital result (OK =
product
canbeused,ALARM=don’tuseproduct).
 Data logger: An electronic data logger is a
device, which is measuring and storing
temperatures. Most devices have an internal
assessment (allowed temperature limits and
times) and indicate a clear digital result (OK
= product can be used, ALARM = don’t use
product). However some data loggers just
measure, store the measurement row and
provide them to a software solution
where they are assesse.
Seasonal vaccines, large occasional
and bulky shipments
Government tenders, cost pressure,
pick-up ex-works, buyer takes risk
NGO’s donating and delegating
distribution, delegation of control,
end-to-end temperature monitoring
required
Production in low cost countries (e.g.
India) shipped to poor countries,
difficult logistics, ad-hoc shipments
Recipient has no training and
infrastructure, need of simple
temperature monitoring solution (e.g.
temperature indicator)
No large pharma involved, no
defined cold chain database and
validated data loggers available
Pandemic situations, high public
interest/short notice, governments
power, military

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 6 / 13
Chemical indicators for vaccines
In the last few years of the last millennium,
UNICEF has begun to equip certain vaccine
vials with chemical indicators – known as
"Vaccine Vial Monitor" (VVM). This was
particularly useful for deliveries to very poor
countries and in areas that were previously not
accessible with a traditional cold chain. In the
following years, the VVM has become an
industry standard being widely applied to many
vaccines. WHO has defined four levels:
The VVM primarily serves, to warn health
workers when the cumulative heat exposure of a
vial of vaccine has exceeded a pre-set limit,
outside the stability budget of the specific
vaccines. But VVM’s (and any other chemical
indicator) have weaknesses:
 Lack of start: Chemical indicators
reacting on temperature right after
production. They don’t have a start
mechanism. To avoid false positive,
chemical indicators must always be
stored and transported at defined
storage conditions. It is nearly impossible
to find out the level of “use” (degradation)
before or during the application of the
indicator to the product.
 Lack of clarity: Chemical indicators (such
as the VVM) typically show a gradual
change: It is very difficult to take an
OK/ALARM decision looking at the visual
appearance (e.g. color change) of a
chemical indicator.
 Lack of limits and lifetime: Chemical
indicators have limited capabilities in terms
of number of thresholds (either upper or
lower limits) and in terms of number of
allowed excursion hours. While short and
simply structured permissible deviations
(e.g. 24 hours above 8 °C) are reasonably
reliable in a chemical indicator, long and
complex permissible deviations (e.g. 120
days above 8 °C, above 30 °C
immediate alarm) are impossible in a
chemical indicator. VVM's don't take
cold temperature and freezing into
consideration: even though the VVM
shows OK, the potency of the vaccine
might have been harmed by freezing.
 Lack of accuracy: Measurement accuracy
in terms of temperature and time is not the
strengths of chemical indicators. Various
factors such as time, mixture, purity of
materials or humidity can have a negative
influence on the accuracy during
production, storage and use. Those factors
are difficult to control during production and
maintain during storage and use. A
validation of a chemical indicator is very
difficult since every batch might show
different results.
 Lack of calibration: Calibrations are not
possible for chemical indicators for two
reasons. On the one hand, the necessary
accuracy is missing. On the other hand, the
chemical indicator would be consumed by a
test – and thus calibration per se becomes
impossible.
 Lack of documentation: Chemical
indicators don’t have a stop mechanism
andconstantly change their status with time
and temperature. Although you might try to
take a picture or photocopy, the status at a
given time cannot be documented in a
100% reliable and reproducible way.

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 7 / 13
 Lack of statistics: Chemical indictors do
not contain digital information, which
could be read-out and processed
electronically. In case of a deviation, there
is no opportunity to find out when the
excursion happened and how severe it
was.
 Lack of traceability: Most chemical
indicators do not have unique ID-
numbers. Therefore, traceability to each
single item is not possible.
To overcome some of those shortcomings, the
WHO issues training material, develops methods
and tutorial videos – e.g. the “Shake and Tell”
Test by WHO (vaccines changing their physical
appearance after heat exposure).
Source: WHO
Whydataloggersarenotidealforvaccines
either
Traditionally, when shipping vaccines there was
the choice of using a chemical indicator or a
traditional data logger. However, while chemical
indicators lack important functions and qualities,
the data logger also has important
disadvantages:
 Cost: Traditional data loggers are
simply too expensive for vaccines
shipments to developing countries. In
particular, since those shipments are
typically financed by NGO’swith tight
budgets
less than 5 USD per piece.
 Size: Data loggers are relatively large
and bulky. They often do not fit into a
vaccine box.
nic indicators are small,
thin (stamp-size), and can even go
into each vaccine box.
 Infrastructure & Training: In developing
countries and war regions where many vaccine
shipments are sent to, there is often no
infrastructure available (not even a PC with a
USB-interface).
“OK/ALARM” indication at all times and
without additional infrastructure,
internet- access or training.
 Lifetime: Traditional data loggers have a
battery life of one year and just need to
cover one shipment from A to B. With
vaccine shipments to developing
countries and war regions, the device
often follows the product into the
refrigerator to also monitor storage.
attached to the product directly and last
for the entire lifetime of a vaccine (up to 4
years).
Types of electronic time and temperature
indicators
The history of electronic temperature indicators
have started with very simple multi-level
indicators monitoring multiple times and
temperatures.
Coming from expensive single-use data loggers
(at the time >50 USD), the industry was looking
for something simpler just indicating “OK/ALARM”
at a lower price point. The concept thereby is to
develop a simple but energy saving and cost-
efficient, dedicated microchip capable of
measurement temperature, assessing a few
alarm limits and indicating its status. Compared
to traditional data loggers this means reduced
functionality in a smaller form factor while having
longer battery life.

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 8 / 13
Today there are a few manufacturers of
electronic indicators dedicated to the vaccine
industry. The devices offered can roughly be
divided into three different categories:
 A “No freeze indicator” is an electronic
indicator monitoring if a vaccine has ever be
frozen. There are various products on the
market with different settings (e.g. 60
minutes < -0.5 °C = ALARM). The problem of
“No-freezeindicators”isthattheyoftendon’t
offer a start functionality. Therefore, they
must be transported and stored at controlled
conditions even before being attached to the
vaccine. Also many vaccines are not only
sensitive to freezing but also to elevated
temperatures.
 Traditional multi-level indicators typically
have two or more temperature limits with
dedicated allowed excursion hours. They have
a large display indicating the over-all result
(OK/ALARM) but also provide additional
statistics functions keeping some important
time stamps. The need for documentation has
traditionally been solved with a photocopy of
the entire device including the display.
 Modern multi-level indicators with download
functionality also have the capability to monitor
several alarm limits and allowed excursion
hours. They indicate the status by a green/red
LED and instead of a display have the
capability to download the statistics and some
of the most important events (start date,
highest/lowest temperature, alarm date and
time) to a Smartphone or cloud database.
Solving the documentation challenge at
destination: Download statistics!
We have seen that electronic indicators are
perfectly suited for vaccine shipments. The
indicator is attached to the sales unit directly and
arrives at vaccination centre or practitioner where
the display or LED of the indicator provides a clear
Go/No-Go.
The indicator typically stays with the vaccine
during local distribution and storage in a
refrigerator waiting to be used. Each time a nurse
or doctor takes out a vial from the box, they check
the status of the electronic indicator: “Green = OK
to use” (or “Red = ALARM”). But what happens in
case of ALARM?
The main weakness is definitively the "deviation
handling and documentation process". So what
happens in case of an ALARM? Let's go through
the process of a traditional electronic indicator
at destination when an alarm was found:
1. After pressing a button, the device
indicates ALARM. In this case, you need
to Quarantine the product, file some
documentation and inform the product
owner or sender.
2. The normal process is usually to take a
photo copy of the device showing the
alarm status and also include the ID
number and the shipping documents.
After you would probably scan the
photocopy.
3. Then the person at the destination would
ideally search for the training
documentation provided some months
ago, to find out the right email address of
the quality responsible, attach the
document, send it and wait for instruction.
4. Finally, the scanned document must be
archived locally and/or centrally at the
product owner.
A modern multi-level electronic indicator
with download functionality can solve this
documentation challenge:
 By reading out the electronic indicator,
you can document the most important
parameters like time stamps, highest
temperature, time per temperature zone
very

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 9 / 13
easily. The data you download is safe and
cannot be manipulated (document compliance
is critical in the pharma industry).
 But equally important is the process of
escalation. The download software and
database in the background should have the
capability to notify the responsible quality
person automatically.
Table: Comparison of escalation processes in case of
ALARM
What is the WHO PQS catalogue
The WHO – in its function as leading
partner organisationofmanyNGO’sinthe
vaccineand healthcare segment – has
taken the leadership in setting standards
for cold chain equipment (CCE). The
program is called PQS (Performance,
Quality and Safety) and includes products
and devices typically used for the logstics
of immunization programs such as
refrigerators, trucks, cold rooms or
electronic temperature indicators.
PQS/E006 is the category for temperature
monitoring devices. In this category, there
are various sub-categories:
User programmable temperature loggers
WHO/PQS/E006/TR05.1
User programmable temperature loggers are
measuring and storing temperature for further
download and analysis on a PC or in a cloud
database. They are used for monitoring bulk
shipments to hubs or for mapping purposes
(transport route profiling or mapping of cold
rooms, refrigerators or refrigerated vehicles).
 Single-use PDF temperature data logger
used for bulk shipments
 Multi-use PDF temperature data logger
used for shipment and following the vaccine
into a refrigerator to monitor temperature
during one year
 Multi-use wireless temperature logger for
refrigerators
Electronic shipping indicators WHO/ PQS/
E006/ TR07.3
Electronic shipping indicators measure
temperature every minute and compare them with
a pre- programmed defined stability budget (alarm
limits and allowed excursion times) reflecting the
heat and/or freeze sensitivity of the vaccine being
shipped. Electronic shipping indicators have either
digital displays or LEDs showing a clear OK or
ALARM. Some devices are able to download the
temperature data to a Smartphone.
 WHO PQS Type 1 indicator for end-to-end-
monitoring (shipment and storage) of freeze
sensitive vaccines
 WHO PQS Type 2 indicator for end-to-end-
monitoring (shipment and storage) of heat
sensitive vaccines
Electronic freeze indicators WHO/ PQS/ E006/
IN07.1
These are small digital devices that are placed
with freeze-sensitive vaccines during transport or
storage. The devices have a visual indicator
(display or LED) that shows whether the vaccines
have been exposed to freezing temperatures.
 Cost efficient and small electronic multi-
level indicator programmed with just one
alarm limit
30- day electronic temperature recorders (30
DTRs) WHO/PQS/E006/TR06.3
These stand-alone devices are typically placed
with the vaccine load in a vaccine refrigerator.
They log the refrigerator temperature at a given
interval (e.g. every 10-minutes) for 30
consecutive days on a rolling basis. They also
record and display a 30-day history of any heat
and freeze alarm violations that have occurred.

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 10 / 13
 Multi-use wireless temperature logger for
refrigerators generating a min/max report of
the previous 30 days each time a report is
generated
Programmable remote temperature and
event monitoring systems
WHO/PQS/E006/TR03.2
Programmable remote temperature and event
monitoring systems are in the industry also
referred as Central Monitoring Systems or lately
as Cloud Monitoring Solutions. They are used to
monitor many refrigerators, cold rooms or
freezers in a combined system and consist of
hardware (sensors) and software collecting,
assessing and archiving the temperature data.
Central data storage in the Cloud (or on a
computer) allows temperature records to be
analysed electronically, generate events (e.g.
alarm emails or SMS) and the system can be
configured to produce periodic reports. This is
much more efficient than a manual review
process.
 Starter-Kit with Radio Bridge & Wireless
Temperature Sensors connecting to the
Cloud Monitoring Solution
 Mobile-IOT temperature sensors
connecting to the Cloud Monitoring
Solution
WHO types (stability budget profiles) for
international shipments
When it comes to temperature monitoring and
stability budget (acceptance criteria for shipment
and storage), WHO classifies vaccines into four
different types. The four types stand for different
sensitivities of the vaccines:
WHO PQS alarm setting Type 1*
:
 DTP, DT, TT, Td; DPT is the class of
combination vaccines against three infectious
diseases: diphtheria, pertussis (whooping
cough), and tetanus. DTaP and DT are given
to children less than seven years old, while
Tdap and Td are given to those seven years
old and older.
 HepB; Hepatitis B vaccine prevents hepatitis B.
 IPV; Polio vaccines are used to prevent
poliomyelitis. IPV (inactivated poliovirus
vaccine) is a liquid vaccine given by injection
produced from wild-type poliovirus strains that
have been inactivated with formalin. Children
usually get multiple IPV-vaccinations between 2
months and 4-6 years.
 liquid Hib and combination vaccines; Hib
conjugate vaccines are highly effective in
producing immunity to the Hib bacteria.
 MenAfriVac; is a vaccine developed mainly for
use in sub-Saharan Africa for children and
adults between 9 months and 29 years of age
against meningococcal bacterium Neisseria
meningitides.
 HPV; the vaccine helps protect against certain
types of Human papillomavirus that can lead to
cervical cancer or genital warts.
 Pneumo other than Prevenar; Pneumococcal
vaccines are vaccines against the bacterium
Streptococcus pneumonia.
WHO PQS alarm setting Type 2*
:
 BCG; Bacillus Calmette–Guérin (BCG) vaccine
is a vaccine mainly used against tuberculosis
(TB).
 lyophilized Hib; Hib conjugate vaccines are
highly effective in producing immunity to the Hib
bacteria. The lyophilized (freeze-dried) form is
less sensitive to cold temperatures.
 Measles, MR, MMR; Measles can be prevented
with the MMR vaccine protecting against three
diseases: measles, mumps, and rubella. MR
covers measles and rubella only (but not
mumps).
 meningitis (polysaccharide); The
Meningococcal polysaccharide vaccine is used
to prevent infections caused by the
meningococcal bacteria.
 OPV; Polio vaccines are used to prevent
poliomyelitis. The oral polio vaccine (OPV) is a
weakened poliovirus given by mouth.

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 11 / 13
 Rabies; Rabies vaccines are used to
prevent rabies. They can be used to
prevent rabies before and after exposure
to the virus such as by a bat or a dog bite.
 Rotavirus (other than rotateq); Rotavirus
vaccines are used to protect against the
rotavirus infection, which is the leading
cause of severe diarrhea of young
children.
 Yellow fever; vaccine protects against
yellow fever.
WHO PQS alarm setting Type Rotateq*
:
 Rotateq; is a branded vaccine
(merckvaccines). It is used to protect
against the rotavirus infection, which is the
leading cause of severe diarrhea of young
children. Other than generic rotavirus
vaccines it has specific stability data (more
sensitive to high temperatures compared
to Type 2).
WHO PQS alarm setting Type Prevenar*
:
 Prevenar 7 and 13 – valentconjugated
vaccine; Prevnar is a branded vaccine
(Wyeth/Pfizer). Prevnar 7 is a vaccine
used to prevent infections caused by 7 (of
total about 90) different types of
pneumococcal bacteria. Prevnar 13 is
covering 13 different types of
pneumococcal bacteria. It has specific
stability data (slightly more sensitive to
high temperature compared to Type 1).
WhatareyelloworblueWHOPQS
shipment indicator cards
Electronic temperature indicators are either
mounted directly on the product, or in the case
of WHO-driven vaccine shipments, also
mounted on a card representing one out of four
PQS-types defined. The cards have a data entry
section on one side, which the manufacturer fills
in at the point of dispatch, an instruction and
interpretation section on the reverse side for the
recipient. These cards are colored yellow or
blue.
Yellow cards are used for freeze-sensitive
vaccines (Type 1 and Prevenar) and blue cards
(Type 2 and Rotateq) are used for heat-sensitive
vaccines. When a shipment is received, the
current status is read from the electronic device
on the card. In case of alarm, the data may be
downloaded onto a Smartphone. The data will
provide a summary of the journey with time-
stamps, number of excursion hours from the pre-
set alarm limits and the highest/lowest
temperature measured during the entire journey.
This enables recipient countries to determine
whether shipments have been exposed to
excessively high or low temperatures; it also helps
the procurement agency to determine when,
where and to what extent the temperature limits
have been exceeded by a service provider in the
cold chain.
How to ship WHO PQS Type 1
WHO PQS Type 1 shipments are typically +2 to
+8 °C shipments (e.g. passive insulated box with
phase change materials or vacuum insulated
panels). The vaccines in Type 1 are very
sensitive to freezing and have a limited heat-
stability – otherwise they may lose potency and/or
crystalize. When stored, they are kept in a
refrigerator.
Electronic indicators configured with a WHO PQS
Type 1 profile are often used with a yellow card
on NGO shipments.

White Paper | Temperature Monitoring for the Vaccine Supply Chain Page 12 / 13
27°
17°C
8°C
2°C
-25°C
1mi
sing
WHO PQS
Type Rotateq
40°C
30°C
8°C
2°C
-0.5°C
WHO PQS
Type Prevenar
+8 °C conditions. When stored, they are kept in
a refrigerator. Electronic indicators configured
with a WHO PQS Type Rotateq profile are often
used with a blue card on NGO shipments
How to ship WHO PQS Type 2
WHO PQS Type 2 vaccines are sensitive to
heat and not at all sensitive to freezing. As a
shipment method, low cost ice packs can be
used in a simple insulated box. When stored
they are either kept in refrigerators or freezers.
Electronic indicators configured with a WHO
PQS Type 2 profile are often used with a
blue card on NGO shipments.
How to ship WHO PQS Type Rotateq
Rotateq is a vaccine manufactured by
MerckVaccines and has a very particular stability
budget. It is very sensitive to high temperatures
and should therefore be shipped with boxes and
containers protecting the vaccine from warm
temperatures. Ice packs could be an option, but
since the product is also sensitive to temperature
below -25 °C, it might make sense to choose a
packaging solution maintaining strict +2 to
How to ship WHO PQS Type Prevenar
Prevnar is a vaccine manufactured by
Pfizer/Wyeth. The profile is very similar to Type
1 but with one minor difference: The highest
limit is not 45 °C but only 40 °C. The ideal
transport and storage condition is +2 to +8 °C.
When stored, they are kept in a refrigerator.
1h
singl
e
10h cumlative exposure
Ideal transport and storage condition
1h
singl
e
Electronic indicators configured with a WHO
PQS Type Prevnar profile are often used
with a yellow card on NGO shipments.
Summary
Vaccines have revolutionized pharmaceuticals
over a century ago. Yet today they still pose
challenges to the pharmaceutical supply chain,
especially when shipping into developing
countries where resources are limited. Careful
planning and sufficient monitoring technology all
play an important role in supporting vaccinating
the world’s populations against a growing list of
infectious diseases.
1m
sing
C
in
le
2h cumlative exposure
Ideal transport and storage condition
n
le