PHARMACEUTICAL COLD CHAIN

PHARMACEUTICAL COLD CHAIN

Introduction
Medicinal products require controlled storage and transit conditions in order to ensure that their
quality is not compromised. This applies to low-risk products as well as high-risk products such
as vaccines, insulins and blood products (such as Factor VIII), which normally require storage
between 2°C and 8°C. These are high risk because they are at risk from freezing as well as elevated
temperatures.
All distributors of drug products are required to record storage and transportation temperatures, as
well as being licensed by the appropriate authorities. Temperature monitoring devices should be
used to demonstrate compliance with the records that are kept.
Protection against extreme and long ambient temperatures (i.e. extreme heat +63°C Kuwait or cold
-35°C Russia) should be considered.

The World Health Organization acknowledges that about 25% of vaccines are delivered to the
customer in damaged form due to failures of the temperature mode during storage and
transportation.
Cold chain
A cold chain is a temperature-controlled supply chain.

Vaccine cold chain

A cold chain is a temperature-controlled supply chain that includes all vaccine-related equipment and
procedures. The cold chain begins with the cold storage unit at the manufacturing plant, extends to the
transport and delivery of the vaccine and correct storage at the provider facility, and ends with
administration of the vaccine to the patient. An unbroken cold chain is an uninterrupted series of storage
and distribution activities which maintain a given temperature range. It is used to help extend and
ensure the shelf life of products.

“Cold chain" is the process of storing vaccines properly during delivery, handling, and storage in
refrigerators. If the temperature is not maintained between +2°C and +8°C, vaccine effectiveness
may be decreased.

The cold chain is the system of transporting and storing vaccines consumables within the safe
temperature range of 2oC to 8oC (For frozen vaccines the optimum temperature is -15°C or lower)from
the place of manufacture to the point of administration ensuring people receive an effective vaccine that
have retained their viability and have not had exposure to temperature excursions (i.e. hot and cold both).
 Regulatory aspect of pharma cold chain
The movement and storage of temperature sensitive products defines the supply chain as a cold chain, a
cool chain, or simply a temperature-controlled supply chain. With this definition comes the need for
temperature to be consistently maintained and that the cold chain not be broken to ensure product quality
is not compromised. This need for product quality, and the requirement for a dependable cold chain, can
be illustrated with the Food and Pharmaceutical sectors, where not only are companies concerned with
quality assurance, but also fall under the purview of federal regulatory and enforcement agencies to
ensure public confidence. In the US, the federal regulatory agency is the US Food and Drug
Administration (FDA), with other countries managing their own jurisdictions or share entities such as the
ICH (International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use)—with all agencies are mandated to ensure companies are compliant.
In the USA, the Food and Drug Administration (FDA) sets outs its standards for the manufacture, storage
and distribution of pharmaceutical and food products in the Current Good Manufacturing Practices
(CGMP). It covers all the steps in the supply chain, from transport operations, labelling and
packaging to personnel training and record-keeping. Likewise, the EU has published the Good
Distribution Practice of Medicinal Products for Human Use (GDP). The aim of compliance is to
maintain the quality and the integrity of medicinal products. Like its USA equivalent, it covers
aspects such as quality management systems, personnel, premises and equipment,
documentation, and qualification of suppliers and customers.
 Regulatory aspect of pharma cold chain(cont’d)
FDA regulations for cold chain
▪ 21 CFR 205.50 Minimum requirements for the ▪ 21 CFR Part 11 ELECTRONIC RECORDS,
storage and handling of prescription drugs and for ELECTRONIC SIGNITURES
the establishment and maintenance of Refers to the regulations and criteria in which the
prescription drug distribution records. agency considers electronic records and signatures
Refers to the minimum requirements for the storage trustworthy
and handling of drugs and specifically details the ▪ Food Safety Modernization Act (FSMA)
requirement for temperature recording and record Information on the Food Safety Modernization Act
keeping. from CFSAN
▪ 21CFR 203.32 Drug sample storage and handling ▪ Current Good Manufacturing Practices (CGMPs)
requirements. Updates to Current Good Manufacturing Practice,
Refers to the need to maintaining the drugs under Hazard Analysis, and Risk-Based Preventive
conditions to maintain stability, integrity and Controls for Human Food
effectiveness as per the manufacture’s ▪ Foreign Supplier Verification Programs (FSVP)
specifications The FDA FSMA final rule on Foreign Supplier
▪ 21 CFR 203.36 Fulfillment houses, shipping and Verification Programs (FSVP) for Importers of Food
mailing services, comarketing agreements, and third- for Humans and Animals
party recordkeeping. ▪ Food Safety Plan Builder
Refers to the responsibility for maintaining forms, ▪ HARPC
reports and records used to meet requirements ▪ HACCP
▪ 21 CFR 211.150 Distribution procedures.
Refers to procedure of how drugs are to be distributed
The basic elements of a pharmaceutical or biologic cold chain
 Cold chain management

Cold chain management or cold chain solution is a

strategic approach to maintain the quality of products in
transit under controlled temperature conditions. The
objective of the cold chain management is to establish
processes to maintain product quality and ensure
compliance with global regulations and industry standards
for the storage, handling and distribution of temperature-
sensitive products.

Cold Chain Diagram

Proper storage temperatures must be
maintained at every link in the chain.
 Cold Chain Application

▪ Fruits & vegetables

▪ Dairy
▪ Fish, meat & seafood
▪ Processed food
▪ Pharmaceuticals
 Cold chain products
There is an increasing number of medicinal products requiring controlled storage and transit conditions.
Among the cold-chain items are high-risk products such as
❑ vaccines,
❑ insulins,
❑ blood products (such as Factor VIII)
❑ immunoglobulin
❑ hormones
❑ drugs based on monoclonal antibodies and
❑ other proteinaceous materials,

which normally require storage between 2ºC and 8ºC. These products must be protected from freezing;
even a brief period at sub-zero temperatures may irreversibly denature the protein, leading to a loss of
efficacy. There are also products such as emulsion systems and solutions of sparingly soluble
components which may become physically unstable at sub-zero temperatures.
Before setting up a cold storage facility or transport system, or before taking on a new range of products,
it may be useful for distributors to carry out a risk analysis to establish a list of high, medium and low risk
products and to make appropriate arrangements for their handling.
 Importance of pharmaceutical cold chain

❑ Vaccine are sensitive biological substances ❑ Individuals who are immunized with exposed
that can lose their potency and effectiveness if vaccines often need to be recalled by their health
they are exposed to temperatures (heat and/or care provider and reimmunized to ensure that they
cold) outside the required temperature range of are protected against the specific vaccine
+2°C to +8°C or when exposed to light. preventable disease(s).
❑ Freezing refers to a situation where vaccines ❑ Vaccines may be wasted if they have been
experience temperatures at or below 0°C. exposed to temperatures below +2°C and/or above
Vaccines may not appear frozen but may have +8°C or if they are not used prior to the expiry date.
been damaged at these temperatures. Most ❑ Vaccine wastage results in increased costs(to
vaccines are considered to be damaged at replace the wasted vaccines, human services and
0°C. specialized transportation).
❑ Failure to adhere to cold chain requirements ❑ With the globalization of the vaccine manufacturing
may reduce vaccine potency, resulting in lack industry, and intermittent global vaccine shortages, it
of protection against vaccine preventable is not always possible to quickly obtain additional
diseases and/or increased local reactions after quantities of vaccines to replace vaccine
administration of vaccine. that is wasted.
❑ The loss of vaccine effectiveness due to
cold chain exposures to adverse conditions is
cumulative, permanent and irreversible.
Reasons of maintaining potency of vaccines
❑ There is a need to ensure that an effective product is being used. Vaccine failures caused by
administration of compromised vaccine may result in the re-emergence or occurrence of
vaccine preventable disease.
❑ Careful management of resources is important. Vaccines are expensive and can be in short
supply. Loss of vaccines may result in the cancellation of immunization clinics resulting in lost
opportunities to immunize.
❑ Revaccination of people who have received an ineffective vaccine is professionally
uncomfortable and may cause a loss of public confidence in vaccines and/or the health care
system.

❑ When a cold chain break is identified after a vaccine has been administered, local public
health office or immunization program* should be consulted for advice. The type of vaccine,
duration and temperature of the exposure will be taken into account when assessing the
situation. Serological testing or revaccination may be suggested.
 Storage Condition(Temperature)

▪ Ambient storage 15°C to 30°C

▪ Refrigerated storage 02°C to 08°C

▪ Frozen storage -15°C to -25°C

▪ Ultralow storage -70°C to -90°C

Strategies for an effective vaccine cold chain

An effective cold chain requires three key elements:

1. a well trained staff,
2. reliable storage and temperature monitoring equipment, and
3. accurate vaccine inventory management.

The Vaccine Storage and Handling Toolkit specifically advocates for:

▪ The use of pharmaceutical-grade units specifically designed to refrigerate and/or freeze
▪ Vaccine storage units with temperature monitoring device (preferably with digital data loggers)
▪ A range of temperature uncertainty not to exceed +/-0.5C (+/-1F)

Application of these best practices can potentially minimize the temperature excursions and
inappropriate storage conditions that can lead to devastating consequences for patients and
healthcare systems.
The Effective Cold Chain
Three main elements combine to ensure proper vaccine transport, storage, and
handling.
• Trained personnel
• Transport and storage equipment
• Efficient management procedures

People

Equipment
Procedures
Vaccines vulnerable to heat

OPV

Measles, MR, MMR

DPT, DPT+HepB, DPT+Hib,

DPT+HepB+Hib , Yellow fever V

BCG

DT, Hib

TT , Td, hep B, JE
Vaccines vulnerable to freezing

hep B

Hib liquid

DPT, DPT+HepB, DPT+Hib,

DPT+HepB+Hib

DT,

Td

TT
 Light sensitive vaccines
Sensitive to strong light, sunlight,
ultraviolet, fluorescents(neon).

❑ BCG
❑ Measles
❑ MR
Vaccines should be stored
❑ MMR in their original packaging
❑ Rubella until point of use to protect
❑ Varicella them from light
❑ Meningococcal c conjugate
❑ OPV
❑ Among all the vaccines, polio vaccine is most sensitive to the heat, requiring storage at minus
20oc.
❑ Freezer compartment: Polio & Measles (P & M)
❑ Cold compartment: “T” series (DPT, TT, DT), Hepatitis B, Hib vaccine, BCG and diluents.
❑ Vaccines must be protected from sunlight and prevented from contacts with the antiseptics.
❑ At the health centre , most vaccines (except polio) can be stored up to 5 weeks if the refrigerator
temperature is strictly kept at +2oc - +8oc .
❑ Reconstituted BCG vaccine and measles vaccine can be kept at +2oc - +8oc for maximum 4
hours and JE vaccine for 2 hours.
❑ To be on safe side, write the time of reconstitution on the label of these vaccine vials.
Distribution
Following dispatch from a manufacturing facility, the distribution chain for medicinal products can be
complex, potentially involving a number of storage locations, wholesalers and modes of transport,
before the delivery finally reaches the pharmacy.
The transportation arrangements from one location to another should be regarded as an extension
of the storage activities and distributors are expected to treat each journey as unique with the length
and complexity, as well as any seasonal variations, being considered when choosing the packing
method and mode of distribution.
Cold chain products should be packed in such a way as to ensure that the required temperatures
are maintained throughout the journey and the medicines are transported in accordance with their
labelling requirements to prevent jeopardizing their quality.
For small volumes of lower risk products, with short journey times of less than three hours,
insulated containers are generally used. For extended journeys gel or ice packs are added to the
packaging to maintain appropriate temperatures throughout. The positioning of these packs within
the consignment is extremely important: they must not be allowed into direct contact with the
products being shipped.
The challenge of transporting cold chain pharmaceuticals
The importance of keeping temperature-sensitive pharmaceuticals within their prescribed ranges
throughout their journey (including storage at their final destination) cannot be overstated.
Pharmaceutical manufacturers know this because it is their responsibility to account for a product’s
quality until its final use.
Pharmaceuticals sensitive to high temperatures can become less effective, and in some cases
even toxic, while those sensitive to low temperatures usually lose their therapeutic
properties if frozen. Either way, not transporting or storing pharmaceuticals within their prescribed
temperature range can have a serious effect on the health of individuals, in some cases it can even
be life-threatening.
To preserve the efficacy of their products, pharma manufacturers ship a significant proportion of
their cargo as either chilled or frozen. In 2015, around 31% of pharmaceuticals were transported as
chilled and around 17% of pharmaceuticals were transported as frozen.
Risk in Cold Chain

Managing the cold chain requires transporting the goods from the manufacturers to distributors and
retailers, provided the goods to remain within the optimum temperature and other special conditions
that are required. The problem arises when there is a wastage in the process mentioned above
such as loss due to mishandling and inefficient refrigerated supply chain, another major loss in
transportation time occurs due to the intervention of various external factors such as traffic, weather,
road conditions. etc. These are the main reasons that asks for the constant monitoring and
controlling of the cold chain.
Critical / Major good distribution practice deficiencies
in UK-2003/2004
Safeguarding the cold chain in pharmacies
▪ Avoid siting a refrigerator near a heat source and keep the surroundings clear (eg, paperwork, bags,
etc, should not be stored on top of the unit)
▪ Put a sign near the socket where the fridge is plugged in (and the circuit breaker box) saying that the
power should not be turned off
▪ Make sure that the refrigerator plug and cord is situated so that it is unlikely to be knocked out by
accident
▪ Put fridge lines in the refrigerator as soon as they are received
▪ Do not overstock the fridge — make sure there is space for air to circulate
▪ Only open the refrigerator door when necessary and keep it open for as short a time as possible
▪ Read and record the maximum and minimum temperatures daily
▪ Make sure dispensary staff know correct storage requirements (eg, ensuring the the fridge is not
crowded and products are not allowed to freeze)
▪ Designate responsibility of storing and handling fridge lines to at least two trained staff
▪ Keep procedures to follow in the event of fridge failure near the fridge
Handling cold chain breaches in pharmacies
1) Quarantine the products, label them “do not use” and communicate the incident to staff
2) Record the details of the adverse conditions, including the range of temperatures and
duration
3) Assess each product
4) Review all the information
5) Dispose of products that have been rendered unsafe (err on the side of caution to
safeguard patients)
6) Document your actions and monitor the outcome
 Storage Requirements for Covid-19 Vaccine Products

Sl. Manufacturer Vaccine Storage Storage Protection Remarks

Type Condition Temperature from Light

1. Moderna mRNA Frozen Frozen between Protect

USA Vials -25°C to - from light
15°C
2. Pfizer Bio-Ntech mRNA Frozen Frozen between Protect
USA/Germany Vials -80°C to - from light
60°C
3. Oxford- Adenovirus Solution 2°C to 8 °C Protect
AstraZeneca for Do not freeze from light
UK injection
4. Gamaleya National Adenovirus Lyophilized 2°C to 8 °C Sputnik V
Research Institute of (dry) form. in its
Epidemiology and lyophilized (dry)
Microbiology
form.
Russia
5. Jhonson and Adenovirus Solution 2°C to 8 °C
Jhonson for Do not freeze
Vaccine Where to store Acceptable Diluent storage Diluent temperature
temperature range ranges

All DTaP vaccines Refrigerator For those with Diluent, 2°C–8°C

(DTaP-Hep B-IPV – Pediarix, Do not freeze or 2°C–8°C Refrigerator
DTaP-IPV – KINRIX, DTaP-Hib- expose to freezing
IPV – Pentacel temperatures

Hib vaccines (PedvaxHIB and Refrigerator 2°C–8°C For those with Diluent, 2°C–8°C
Comvax, ActHIB, Hiberix) Do not freeze or Refrigerator
expose to freezing
temperatures

Hep A: Havrix, VAQTA Refrigerator 2°C–8°C No diluent

Hep B: Engerix-B, Do not freeze or
Recombivax HB HepA-Hep B: expose to freezing
Twinrix temperatures

HPV2: Cervarix HPV4: Refrigerator 2°C–8°C No diluent

Gardasil Do not freeze or
expose to freezing
temperatures
Vaccine Where to store Acceptable Diluent Storage Diluent temperature
temperature range ranges
VAR: Varivax Freezer Refrigerator or 2°C–8°C or 20°C–25°C
(chickenpox) Vaccine should be -50°C to -15°C room temperature Do not freeze diluent or
zoster/shingles) stored only in freezers Store separately expose to freezing
or refrigerator/freezer from vaccine. temperatures.
units with separate
compartments and
exterior doors
MMRV: ProQuad Freezer Refrigerator or room 2°C–8°C or 20°C–25°C
Vaccine should be -50°C to –15°C temperature Do not freeze diluent or
stored only in freezers Store separately expose to freezing
or refrigerator/freezer from vaccine. temperatures.
units with separate
compartments and
exterior doors
Zostavax (herpes Freezer -50° to -1​5°C Refrigerator or 2°C–8°C or 20°C–25°C
zoster/shingles) Vaccine should be room temperature Do not freeze diluent or
stored only in freezers Store separately expose to freezing
or refrigerator/freezer from vaccine. temperatures.​
units with separate
compartments and
exterior doors
Summary of vaccine vulnerability
 Handling temperature excursion in vaccine storage unit

Temperature excursion of vaccine

Any temperature reading outside ranges recommended in the manufacturers’ package

inserts is considered a temperature excursion. Temperature excursion should be quickly
identified and immediate action should be taken to correct them. This can prevent vaccine
waste and the potential need to revaccinate patients.
Handling temperature excursion in vaccine storage unit (cont’d)
 Expiration dates and beyond use dates (BUD)
Understanding Expiration Dates Some vaccines have a beyond use date (BUD), which is
Determining when a vaccine or diluent expires is calculated based on the date the vial is first entered and the
a critical step in maintaining proper storage and storage information in the package insert. If the vaccine has
no BUD, use the expiration date provided by the
handling. Understanding vaccine expiration dates
manufacturer.
can help save your practice time and money. The BUD replaces the manufacturer’s expiration date and
When the expiration date has only a month and should be noted on the label along with the initials of the
year, the product may be used up to and including person making the calculation. Examples of vaccines with
the last day of that month. If a day is included with BUDs include: Reconstituted vaccines have a limited
the month and year, the product may only be period for use once the vaccine is mixed with a diluent.
used through the end of that day. In some This period or BUD is listed in the package insert. Multidose
instances, such as the examples for beyond use vials might have a specified period for use once they have
been entered with a needle. For example, the package insert
date (BUD) below, vaccines must be used before
may state that the vaccine must be discarded 28 days after it
the expiration date on the label. is entered. If the vial is entered on 06/01/2019, the BUD is
Beyond Use Dates 06/29/2019. The vaccine should not be used after the BUD.
Beyond Use Date (BUD) is very different from Manufacturer-shortened expiration dates may apply when
expiration date. USP defines BUD as the date or vaccine is exposed to inappropriate storage conditions. The
time after which a compounded sterile preparation manufacturer might determine the vaccine can still be used,
(CSP) may not be stored or transported and is but will expire on an earlier date than the date on the label
calculated from the date or time of compounding.
Storage in the pharmacy
The code of ethics states that pharmacists should ensure
that “refrigerators used for pharmacy stock are capable
of storing products between 2 and 8°C. They must be
equipped with a maximum/minimum thermometer, or
other suitable alternative, which is checked on each day
the pharmacy is open and the maximum and minimum
temperatures recorded.”
 Monitoring vial exposure to heat

A vaccine vial monitor (VVM)

is a small sticker that adheres
to a vaccine vial and registers
the cumulative heat exposure
of the vial over time. The color
of the sticker shows health
workers when the vaccine has
hit its preset limit of heat
exposure, indicating the
vaccine should not be used.
 Monitoring vial exposure to freezing temperature

▪ Freeze Indicators consist of a small

vial or a specially designed ampoule
of highly sensitive liquid attached to
a white card and covered in plastic to
monitor exposure of temperature-
sensitive products to freezing
temperatures.
▪ The vial / ampoule breaks if the
temperature where the indicator is
located drops below 0°C for more than
one hour, and the vaccine must then
be destroyed. Before freezing After freezing

e.g. Diphtheria, pertussis, tetanus

vaccine and hepatitis B vaccines.
 Shake test
Shake the control and test sample
Shake test: Summary
 The stability tests of vaccines
The vaccine plays an increasingly important role in ▪ Accelerated stability test of vaccines
disease prevention. In recent years, the stability of the Accelerated stability study is the rate of change in physical,
vaccine has a big impact on the success of the global chemical and biological characteristics of a vaccine that is placed
immunization program. As part of the effort to ensure at sequence temperature including above the actual preservation
the quality of the vaccine, WHO acknowledges the temperature. The study provides supporting data on the shelf-life
importance of defining clearly defined characteristics or release criteria for vaccines.
of vaccine stability and emphasizes the role of national
regulatory authorities in the overall assessment of the ▪ Extreme conditions stability test of vaccines
vaccine. The purpose of checking vaccine stability The extreme conditions stability study, is to put the vaccine under
is to prove that vaccine products have acceptable extreme environment conditions, such as, light and extreme
quality, effectiveness and safety for a certain temperatures. The main purpose is to determine packaging,
period of time under certain preservation labeling requirements, shipping, preservation and use
conditions. considerations and measures to be taken once exposed to
extreme conditions.
The types of vaccine stability study ▪ Thermal stability test of vaccine
▪ Real-time stability test of vaccines Thermal stability test, it is to put vaccine in higher storage
It is to observe and study the physical, chemical, temperature after a certain period of time, to observe the main
biological characteristics and change of efficacy of the quality standards of compound situation and change ratio, is an
vaccine over a period of time under the expected important component of the vaccine to approve and release
conditions of use and preservation standard. The main purpose is to assess whether a batch of
vaccine stable enough and to determine whether a product batch
and batch quality uniform.
 Vaccine storage

At state level:

Refrigerator Walk-in Freezer Walk-in Cooler

Truck

At district level:

Deep Freezer (DF) 300 ltr

Ice-Lined Refrigerator(ILR) 300 ltr
Cold Box
At small unit level :

Deep Freezer (DF) 140 ltr

Vaccine Carriers
Cold Box

Ice-Lined Refrigerator(ILR) 140 ltr

 Temperature (thermal) mapping

Temperature Mapping (T-mapping) is the process of mapping the temperature

of controlled storage areas such as a pharmaceutical warehouses, fridges and
freezers .

A thermal study involves collection of temperature data around the length and breadth of a
cold room for couple of days and analyzing the data to check whether the temperature was
within the limits at all times
There is an increased emphasis on compliance by the regulators for areas where
products are stored.
In warehouses, fridges and freezers temperature variations can be expected near air
vents, doors, packing areas etc..

It is important to understand where these hot and cold spots are to monitor most
vulnerable areas, ensuring all the goods are stored at the correct temperature.
 Temperature (thermal) mapping(cont’d)

A temperature mapping exercise is expected to collect the following information:

❑ The impact of interventions (door openings / power failures, etc.)
❑ Identification of hot and cold spots
❑ Variation of temperature at a single point
❑ Temperature variation across the area
❑ Length of time of any temperature excursions
Temperature (thermal) mapping
 Temperature mapping sequences
Write
protocol

Place data
Temperature mapping is the process of mapping the logger
differences and changes in temperature that occur within
Carry out
a single temperature controlled system due to influences various
Collect data
like opening doors, proximity to cooling fans, personnel for 7-14 days
operational
procedure
movement, and the quantity of products being stored at
any given time
Analyze the
data

Rectify
deviations if
any

Mapping
study
completed
 Thermal mapping of a pharmaceutical warehouse

Thermal mapping of storage areas is

required to assess the environmental
conditions that stored pharmaceutical
Materials (API, excipients and reagents) will
be exposed to. This is especially true
of warehouse storage due to large seasonal
variations of environmental conditions.
 Cold chain packaging
There are two types of cold chain packaging systems: active and passive.

Active systems consist of cold chain transport containers featuring advanced electric or
battery-powered temperature controls. Active systems often have built-in cooling units or
rely on dry ice as a coolant. A system pushes cool air from the refrigeration system into the
main payload area. Active systems work better for larger shipments and offer greater security,
which minimizes the risk of theft. Active refrigeration systems, in addition, offer greater security
as they are not limited like dry ice systems to operation only for a certain amount of time until
the dry ice would all be consumed and need to be replaced.

Passive packaging systems typically include polyurethane or polystyrene insulation or

vacuum-insulated panels that can keep the product at a predetermined temperature for up to
96 hours or longer. Passive systems can maintain tighter temperatures than active systems and
are not susceptible to internal freezing. Disadvantages of passive systems include the need to
condition the refrigerant to specific requirements and more complex shipping configurations as
well as the primary constraint of time — passive systems will fail at a 100% rate to maintain
temperature if they do not arrive at the final destination within the required packaging
specification.
 Cold chain packaging
Refrigerant gel pack

Cryo-Gel™ / 0°C Gel Flexible Ice Flexible Ice

Packs Blanket™ / 0°C Ice Pouch™ / 0°C Ice
Blanket Pouch
 Cold chain packaging (cont’d)

Insulated pallet shippers

RePak™ 2-8°C Series

Refrigerated trucks are often
used to transport temperature-
sensitive items.
DATA LOGGERS

Data loggers are continuous monitoring and recording devices that provide
detailed information on all temperatures recorded at pre-set intervals. Data
loggers provide the most accurate storage unit temperature information,
including details on how long a unit has been operating outside the
recommended temperature range.
 Cold chain data logger

Cold Chain loggers record and monitor time and Three Simple Steps to compliance:
temperature for vaccines, pharmaceuticals, Place the data logger on your product or container
biologics, and other perishable products Press Start/Mark when it's time to ship/at each
during distribution and short-term stop
storage. The single-use loggers eliminate the Download the Logger via USB to automatically
need for readers and proprietary software and create a 21 CFR Part 11-compliant PDF report
are optimal in clinical trials, material transport, Pre-calibrated and pre-programmed for time and
sample shipping, and "last mile" distribution. temperature range
One-click export to CSV file
Direct USB to PDF document generation
Single-use loggers do not require recalibration,
battery replacement or servicing
How the cold chain temperature monitoring system works:

Before a vehicle leaves the distribution

centre a wireless transmitter is attached to
a pallet or lorry. Each transmitter will log
temperature data at 10-minute intervals for
up to 1 or 4 days (depending on
requirements). On arrival either back (at the
same distribution centre or a store
networked to the main cold chain
temperature monitoring system)
transmitters will immediately and
automatically download data without the
need for a manual interception.
 Closed loop data acquision schematic
The schematic below shows how the
transport system can even manage
multiple deliveries: