Transportation of Covid Vaccines in India with Temperature Control

A project report by

Omkar Domale

Under the guidance of

Professor Mansi kapoor

Final year MBA-IB Student

Dr. Vishwanath Karad MITWPU, School of Management (PG)

S. No 124, Paud Road, Kothrud, Maharashtra- 411038

Roll No - 20MBAIB039

PRN-1062200227

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 ABSTRACT

The project is about how the covid 19 vaccines are transported from the manufacturing unit to
the end consumer maintaining the low temperature required for its storage. Packaging and labelling
play a very crucial role in the handling of the vaccines.

Packaging and labelling both are done in three stages – primary, secondary and tertiary. This
includes the glass vials, cushioning material, VPPAG, packaging inserts, barcode and vaccine vial
monitors. It also has a list of guidelines for the problems faced with solution how to handle the supply
chain for the vaccines maintain the temperature in minus degree Celsius.

INTRODUCTION

COVID 19:

The COVID-19 virus is a new virus linked to the same family of viruses Severe Acute
Respiratory Syndrome (SARS) and some types of common cold. Most people with the virus have
mild to moderate respiratory illnesses and recover without special treatment. Coronaviruses are a
group of related RNA viruses that cause disease in birds and mammals. In birds and humans they
cause respiratory tract infections that can range from mild to lethal. Its most common symptoms are
fever, dry cough, tiredness and serious symptoms are difficulty breathing or shortness of breath, chest
pain or pressure and loss of speech or movement.

TYPES OF COVID 19 VACCINES AVAILABLE IN INDIA:

1) Covishield
2) Covaxin

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 TRANSPORTING COVID-19 VACCINEWS

The vaccine storage, maintenance, preparation, and administration instructions vary for
each COVID-19 vaccine product. Both Covishield and Covaxin should be stored and transported at
temperatures between 2 and 8 ° C. Cold chain maintenance for both vaccines is carried out through
active and passive cold chain equipment available at nearly 29,000 cold chain points across India.
Health professionals using the COVID-19 vaccine should be well aware of the requirements and best
practices. It is important that healthcare professionals and other workers are aware of the COVID-19
vaccine product in their inventory. Non-clinical staff receiving the vaccine and those working on the
vaccine should also receive training in vaccine storage, handling requirements, and best practices.

PACKAGING and LABELLING OF COVID-19 VACCINES:

Packaging:

"Without the right packaging, there will be no COVID-19 vaccine," says a previous study. Vaccines
can be made, but without proper packaging and storage throughout the supply chain, vaccination will
not be effective. When vaccine production began, there was uncertainty about storage, substance and
portable temperature. The advent of advanced technology and facilities in India and around the world
has made vaccine manufacturing easier. There are currently around 200 vaccine candidates in
development, some of which require ultra-low temperature (ULT) and temperature controlled chains,
while others require a standard cold supply chain.

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Primary Packaging

 Glass vials

Borosilicate glass vials are the most common packaging material for vaccines
because of their immobility. More than 50 billion glass vials are produced and sold in various
locations around the world. Glass vials are commonly used in a variety of vaccines and treatments.
SCHOTT is a global conglomerate, one of the largest manufacturers of pharmaceutical filling systems
with 20 well-known glass factories and processors worldwide. Three of the four clinically proven
vaccine projects have used SCHOTT vials in their vaccination campaigns. In total, around 11 billion
glass vials are produced annually, and the COVID-19 vaccine campaign target is estimated to be
around 2 billion doses by the end of 2021. The global community of pharmaceutical glass
manufacturers includes large market players such as SCHOTT, Corning, Stevanto Group and
Gerresheimer, as well as DWK Life Sciences, which has increased its capabilities and quality due to
continued demand. Despite the need to improve the packaging of clear glass vials due to the different
storage conditions for COVID-19 vaccines and the ongoing pandemic, some vaccine manufacturers
are likely to use closed forms.

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 Any vaccine filter that uses a vial relies on stoppers and seals. Stoppers protect
it against environmental influences, while seals are essential for drug protection, the integrity and
safety of container closures. A protective fluoropolymer protective layer is applied to the elastomer,
which acts as a barrier against the transfer of elastomer components to the drug. The stoppers, which
are part of the closure system, can be sterilized before shipping, supplied as a sterile piece with a vial
or sterilized on the filling lines.

 Packaging System for Vaccines Distribution

The packaging system for distribution plays a predominant role in delivering the
vaccines to the ultimate consumers in suitable condition and at right time. A typical packaging system
for distribution includes secondary and tertiary packaging, and cushioning materials to protect the
glass vials the primary package from breaks and cracks during transport and storage. A cold chain is
required for some vaccine candidates to safeguard the vaccine until it reaches the injection point.

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Secondary Packaging

Once the vaccines are produced at the manufacturer’s facility, they need to be shipped
to multiple locations. Vials/ampoules/leaflets are packed in secondary cartons to optimize their
volume and weight for transport and storage. The number of primary packaging units per secondary
carton can be determined based on the domestic and international supply. Secondary packaging can
be influential in terms of reducing volume, cost-saving, minimizing logistical burden, and ultimately
reducing the carbon footprint.

VPPAG (VPPAG) is recommended to provide vaccine production companies in

formats that can reduce the number of steps and can remove errors when installing and managing.
VPPAG recommendations are:

 Rectangular arrays with internal dividers are encouraged for secondary packaging of vials
 A standard format of 100 vials in an array of 10 × 10 or 10 vials in a 5 × 2 array is being
followed  The dimensions should accommodate vials and dividers

For secondary packaging units, vials packed in rectangular arrays with 5 or 10 vial
units along with standardized diameter and height could provide better dimensional harmonization.
The secondary carton size should be optimally decided to accommodate vials, packaging inserts, and
internal dividers.

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Tertiary packaging

Tertiary packaging is the most prevalent packaging for the shipping and
transportation of vaccines. They have numerous advantages over other forms of packaging materials.
For shipments, outerinsulated boxes are used as shipping units, either alone or as pallet shippers. They
are characterized by physical integrity, can retain their properties, and can withstand mechanical
manipulation, repeated manual handling, and various climatic conditions. According to WHO
recommendations, insulated boxes should weigh less than 50 kg, as they can be handled manually at
airports and other distribution centres. These boxes are not seen by consumers as retailers remove
them before they reach the point of end use. Generally, cardboards, plane boxes, and shrink wraps are
used in tertiary packaging.

The recommendations made by the VPPAG are as follows:

1. It should be tested and qualified to withstand anticipated loads, shocks, and vibrations during
transportation and distribution.

2. Dimensional harmony is vital for stock management, and tertiary cartons can be helpful.

3. It should be a more convenient and robust stock-keeping unit than the secondary packaging
unit.

4. The width of the tertiary cartons must be in accordance with the available shelf width of cold
rooms and freezer rooms, i.e., 45–60 cm.

5. To take into account the stock, contents inside the tertiary packaging must be arranged in
multiples of 50 or 100 units.

6. The European Economic Community (EEC) Council Directive 90/269/EEC states that the
maximum weight of a tertiary carton should be in such a way that a person can lift it safely.

7. The tertiary carton dimensions are selected as per ISO standardized pallets with dimensions
1.2 m × 0.8 m or 1.0 m × 1.2 m so that these can be efficiently stacked without overlapping
individual pallet’s footprint.

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Labelling:

Labelling makes the invisible visible, but an improper label can put the patient’s life in jeopardy. An
unambiguous label is indispensable rather than consequential for a successful immunization program.
The labelling system contains primary container labels, secondary carton and tertiary container labels,
leaflets, packaging inserts, bar codes, quick response codes and vaccine vial monitors (VVMs).

Primary container label

A primary container label is vital in identifying the right drug, its mode of injection, and the
minimum quantity required per dose. The clearer the label, the more error-free is the vaccination
program. According to a previous survey, approximately 94% of healthcare providers agreed that
vaccine package labels are crucial for their work. The vaccine presentation and packaging advisory
group (VPPAG) had come across two genuine labelling issues:

 minimum font size for legibility

 expiry date format

As text legibility is directly related to the quantity of text, the advisory group has
recommended standardizing and minimizing information on primary packaging labels. The use of
multiple languages further decreases the label's space and forces manufacturers to use the minimum
font size. There should be one standardizing an all-numeric format for the expiry date, MM-YYYY.
Vaccine labels should not limit the ability of healthcare providers to see through the contents of the
vials. To avoid this, manufacturers are requested to provide a minimum viewing area for the contents
in the vials

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Secondary and tertiary packaging labels

Secondary and tertiary carton labels ease the process of identification and distinguish similar
types of vaccines during storage and distribution, thus minimizing the errors in selecting a product
and can help in accurate stock counting and management. To achieve the abovementioned targets,
secondary and tertiary cartons must be labelled at least on two opposite faces, as per the guidelines for
labelling of vaccines, proposed amendments to the Technical Report Series (TRS) 822, and
requirement for prequalified products. The printed content must contain both static and dynamic
information, such as bar codes and quick response codes that can be printed on one face only. To
unify the labelling system for the immunization program, the WHO has recommended the
manufacturers to follow model carton labelling.

 Package inserts

The package insert is a part of the labelling system, as complete information about the
product and its use cannot be specified on the primary package. Therefore, vaccine manufacturers
must provide mandatory information such as product information, prescribing information, and drug
hazards. The package insert contains advanced technical language product information that can be
confusing for healthcare providers and patients.

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 To avoid this ambiguity, the manufacturer can also provide a simplified fact sheet called the
patient information leaflet (PIL) The PIL contains basic information on prescribing and management
practices, which has been translated into the regional language depending on the issuing country to
reduce the risk of administrative errors. Regulatory requirements are essential to monitor the location
and content of package inserts. Often, the use of package inserts makes secondary cartons bulky and
increases the availabe volume.

 Bar Codes

Barcodes and quick response codes come under the category of data carriers, which are one
way readable in an electronic version. When read with the help of scanners, the data are analysed
digitally and reproduced to the consumer. In the case of vaccines, this technology is being used as a
supplement for printed information about the product. Barcodes are linear in nature and simply store
information about the vaccine expiration date and lot number. The components of a linear barcode
include a 12-digit serial number called the global trading identification number and a series of bars
and spaces. The GTIN has a deciphered meaning: the first two digits give the country code, and the
following digits provide details about the manufacturer, product, and batch.

It’s a quick response codes are 2D barcodes that are designed as a square modulus arranged
within a perimeter. They store every piece of information printed on primary packaging and
packaging inserts, including the route of administration, date of manufacture/expiration, batch
number, doses per vial, dosage, temperature requirements, and sometimes information about the
manufacturer for traceability purposes. It is highly suggested that they can be added to secondary
packaging as well. Recently, the Centres for Disease Control and Prevention has been encouraging 2D
barcodes to be added to the vaccine information statement for the COVID-19 vaccine to help both
patients and practitioners.

 Vaccine vial monitors

The inclusion of vaccine vial monitors in the primary packaging is a preferred feature of the
primary packaging. It's a type of sensor that helps determine if the vaccine is exposed to heat that has
built up over time. It's made of heat-sensitive material, wrapped in a small circle with a square, and
printed on the label or sleeve of the vaccine. With a darker inner square than the outer circle, the

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vaccine vial labels indicate that the vial has been exposed to a critical temperature and should no
longer be used. This visual cue successfully reduces the risk of under inoculation. The colour change
is an ongoing and irreversible process that makes it safer. The World Health Organization and
UNICEF strongly recommend vaccine vial considering the temperature sensitive nature of the
COVID-19 vaccine.

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 PROBLEM STATEMENT

1) How are the vaccines getting shipped from manufacturing facilities?

Serum Institute of India and Bharat Biotech sends its vaccines from its Pune facility and Bharat
Biotech from its Hyderabad to the city airport in special trucks. They send it to all major cities in the
country by an airplane.

2) What happens when they arrived in different cities?

Once vaccines leave the manufacturing facilities, Centre and state governments coordinate monitoring
of their transfer to the storage facilities. According to the Union Health Ministry, the vaccines will
initially be delivered to warehouses of the Government Medical Store Depots (GMSD) in Karnal,
Mumbai, Chennai and Kolkata.

The vaccines are then transported from these four nodal sites in refrigerated or insulated trucks to the
state vaccine stores. There are 37 state vaccination bulk storage stores.

3) Where are the vaccines shipped to after they arrive in state stores?

When a shipment of vaccines arrives at the state vaccination warehouse, it is the responsibility of
governments to ensure that the vaccine vial arrives at the final vaccination centre safely with minimal
or no waste.

Like state vaccine stores, local stores have temperature controls. Information is fed into the digital
platform and mobile application Co-WIN (Covid-19 Vaccine Information Network) throughout the
vaccine movement.

Co-WIN is an eVIN (Electronic Vaccine Information Network) program format used for the Global
Immunization Program in India for Children and Pregnant Women. During transport, real-time
information on vaccine concentrations and storage temperatures is entered into the digital platform.
This helps program managers determine the appropriate authorities when the temperature is below the
temperature of a particular storage point.

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 4) What is the capacity of cold chain equipment in the country?

All states have at least one regional vaccine store in the state. According to the Ministry of Health,
Uttar Pradesh has nine, Madhya Pradesh and Gujarat have four, Kerala has three, and Jammu and
Kashmir, Karnataka and Rajasthan have two each.

As on December 6 2020, there were 28,932 cold chain points, 240 walk-in coolers, 70 walk-in
freezers,
44,226 ice lined refrigerators, 40,792 deep freezers and 294 solar units, according to the National
Cold Chain Management Information System (NCCMIS).

5) How are vaccines delivered to the vaccination sites?

Vaccines are delivered on the last kilometres with "passive" devices such as cool boxes and non-
electrically operated vaccine carriers. Other previous storage locations use electricity or solar. It is
also necessary to monitor the temperature of ice cube trays and conveyor be

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 LITERATURE REVIEW

1) Multimodal Transport and Decision-Making:

There are various definitions of intermodal, multimodal, combined and through
transport related to the use of more than one mode in freight transportation. They are
sometimes used interchangeably and also in different contexts. Multimodal transport is also
called as ‘intermodal transport’ because both refer to the transport of goods through several
modes of transport from origin to the end. Multimodal transport involves the transport of
goods from the sender to the recipient using two or more different shipping methods for a
single price, through invoice and liability.. Gray and Kim argued that since developing
countries are unable to provide the full transport and communications infrastructure necessary
for a successful intermodal system, a multimodal or intermodal system, which can be seen as
an interim stage on the way to full intermodals, is a more real target.

An Analysis of Freight Forwarder - DENİZCİLİK FAKÜLTESİ

DATA COLLECTION METHOD

The data of this research has been collected through personal interaction with
employees of the company. Real life cases and scenarios of the company were discussed and
carefully analysed and interpreted. Data has also been collected through secondary sources like
internet, news articles and websites.

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 FINDINGS

• Transport vaccine using a portable vaccine refrigerator or qualified pack out.

• Eligible packaging includes containers and consumables specifically designed for use in
vaccine packaging for transportation. Laboratory qualified packaging is "qualified" under
controlled conditions to ensure that it reaches and maintains the desired temperature for a
specified period of time.

• Disposable containers for the vaccine are acceptable. Soft food coolers on the market are not
acceptable as most of them do not have good insulation and can be affected by room
temperature or the outside.

• Record the minimum / maximum air temperature in the temperature log each time the
container is opened and each time you return to the facility.

• Service providers must report all temperature fluctuations in good time.

• If the cold chain is properly followed, the perforated vial can be moved from one location to
another by the same healthcare professional. However, partially used vials cannot be
transferred from one provider to another or via government lines.

• If vaccines are exposed to temperatures outside of acceptable ranges, take immediate action.
Put a
“do not use” label on the vaccine until it is found useful. If the vaccine is thawed, do not
refreeze it. 

• The vaccine should be stored at a temperature between 2 ° (min) to 8 ° (maximum) ° C or 36 °

(min) to 46 ° (maximum) Fahrenheit. Aim for 5 degrees Celsius (40° Fahrenheit) or 36° (min)
to 46° (max) Fahrenheit.

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 CONCLUSION

The purpose of this perspective was to highlight the overall process of packaging and
labelling, handling and storage & transportation method implemented in India during an epidemic.
This report can be an essential document in preparing for the future epidemic and in adjusting and
refining strategies that will serve the general population.

India is well positioned worldwide to produce affordable medical, surgical, and

general medicine. India is also the largest manufacturer and distributor of vaccines in the world. The
current COVID-19 epidemic has resulted in rapid development, licensing for emergency use, and
unprecedented collaborative efforts by various stakeholders.

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 BIBLOGRAPHY

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8173863/

https://www.news18.com/news/india/covid-19-coronavirus-vaccine-site-transport-cold-chain-
explainedindia-3288296.html
https://www.health.state.mn.us/diseases/coronavirus/vaccine/transport.pdf

https://www.ibef.org/industry/biotechnology-
india/showcase/bharatbiotech#:~:text=Bharat%20Biotech%20is%20an%20Indian,%2C%20headquarte
red%20in%20Hyderabad% 2C%20India.

https://www.seruminstitute.com/

https://www.bharatbiotech.com/

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