Design and Development of Cold Chain Monitoring System

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Design and Development of Cold Chain Monitoring System
Han-Jung Chen
Department of Industrial Engineering and Management
National Taipei University of Technology
Taipei, Taiwan
Fortunate0810@gami.com
Kai-Ying Chen
Taipei, Taiwan
Kychen@ntut.edu.tw
Lih-Guong Jang
Service Systems Technology Center
Industrial Technology Research Institute
Hsinchu, Taiwan
Lihguong@itri.org.tw
Teh-Chang Wu
Service Systems Technology Center
Industrial Technology Research Institute
Hsinchu, Taiwan
Tehchangwu@itri.org.tw
Zhi-Ping Lin
Taipei, Taiwan
Cplin@ntut.edu.tw
Abstract—Vaccines must be included into the cold chain
management in order to ensure the safety and maintenance of
a constant low temperature from the origin to the final usage.
Under technological advancements, the safety of vaccines has
been greatly improved during the enhanced manufacturing
process. However, it has been frequently reported in the news
that vaccines, which are intended to save lives, harm the
public’s health due to negligence in management. Mild
negligence may lead to the experience of discomfort, as well as
ineffective vaccines, while severe negligence may lead to a loss
of life. Therefore, it is necessary to strictly manage the
transport, storage, and use of vaccines. This study intends to
design a vaccine cold chain monitoring system (CCMS),
specifically for the two keys in the cold chain, namely
monitoring and temperature, in order to ensure that the
management chain is perfectly connected through information
conveyance and sharing among various roles. Moreover, the
system aims to prevent “unnoticed vaccine failure” through
constant temperature recording. The overall vaccine cold chain
system should be able to ensure the safety of vaccines through
monitoring, tracking, and timely reporting of vaccine safety
under various variables caused by natural disasters and
epidemics.
Keywords-cold chain; vaccine; temperature monitoring
I. INTRODUCTION
Globalization leads to frequent cross-boundary
exchanges, which leads to more frequent transmission and
spread of epidemic diseases. To prevent this situation, the
government in Taiwan has engaged in various disease
prevention programs. The crisis of rapidly spread diseases is
unforgettable for the Taiwanese. The outbreak of SARS
(Severe Acute Respiratory Syndrome (SARS) in 2002 and
the outbreak of Influenza A virus subtype H1N1 (H1N1) in
2009 both endangered the lives of the Taiwanese. The
competent health authorities also started to engage in the
R&D of vaccines and relevant disease prevention
engineering. However, the implementation of vaccination by
health authorities accidentally led to the death of several
people, and the public started to question the safety of
vaccines. Negligence of temperature control during the
transport process can lead to ineffective vaccines; therefore,
low temperature control of vaccines becomes an issue of
great importance for competent health authorities. Clearly
explain the nature of the problem, previous work, purpose,
and contribution of the paper.
Vaccines are not general commodities, but are medical
products affecting the health and safety of the public.
Consequently, it is necessary to strictly monitor the overall
transport, storage, and injection processes of vaccines. The
ineffectiveness of vaccines is usually caused by negligent
maintenance of low temperature control during the transport
process. The injection of ineffective vaccines will do harm to
the patients. A mild effect is discomfort and ineffectiveness,
while a severe effect is the loss of life. Therefore, the World
Health Organization (WHO) announced the “Guidelines on
the International Packaging and Shipping of Vaccines” in
2005, which stipulates the temperature range and effective
period of vaccines during shipping. SOPs and operating
regulations for transport, storage, and injection of vaccines

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were also established. The “Guidelines on the International
Packaging and Shipping of Vaccines ” also classified
vaccines according to their properties, types, and in vivo
characteristics. The regulations regarding the transport and
storage of vaccines varies with differences in classification
[1].
By reviewing related reports, as well as laws and
regulations of different countries, this study found that the
issue of the cold chain has begun to attract attention both
domestically and overseas. The “chain” actions have been
initiated from refrigeration of food to professional medical
refrigeration [2][3]. For example, the government of the
Netherlands established laws to restrict temperatures for
shipping medicines. GlaxoSmithKline (GSK) developed
complete regulations for their internal cold chain in
accordance with the laws of the government, and further
became a model of the European pharmaceutical cold chain.
Although applicable laws and regulations, or relevant
organizations, have not been established in Taiwan, the ITRI
(Industrial Technology Research Institute) has cooperated
with China to establish the Cross-strait Cold Chain Logistics
Technology and Services Alliance. The government in
Taiwan has initiated the development of a cold chain, and
with experts and various pioneering technologies in Taiwan,
it is believed that the development of the cold chain will
achieve great results and make breakthroughs.
This study intends to establish the traceability of vaccines.
Besides the regular vaccination periods, the use of vaccines
reaches the peak in times of natural disasters and epidemic
outbreaks. Chaotic management and control, as well as a
lack of resources, are challenges to the traceability of
vaccines. Compared with agricultural products, which have
stable traceability, the difficulty and urgency of vaccine
traceability are issues to be addressed [4][5].
II. ARCHITECTURE AND FUNCTIONS
The objective of a vaccine cold chain monitoring system
is to ensure the safety of vaccines through constant low
temperature monitoring and control. The members involved
in the vaccine cold chain can be divided into supplier,
manufacturer, logistics provider, and medical units. However,
at present, enterprises can only request the integration of
internal information systems, and it is impossible for them to
cooperate with all members involved to complete the
integration or elevate the information level to the same level.
This study designed a system that allows the members of the
cold chain to directly upload the information of vaccine cold
chain procedures to a webpage and input the data into the
system; thus, all members could assess the system if they can
access the Internet, regardless of their information capacity
and resources. The data input into the system are the basic
information of products, relevant requirements and planning,
and essential control data. Moreover, the system has to avoid
excessive information integration, which may reduce
enterprises’ willingness or lead to information errors. This
monitoring system can better manage and control the vaccine
cold chain, and is expected to contribute to the future
synergistic integration of cold chain-related industries.
The system structure of this study classifies the authority
limits of various roles, and strictly abides by the regulatory
restrictions of various communications protocols. Regarding
follow-up and reporting functions, they are established
according to similar hazard handling operating formats in
Taiwan. Regarding inspection and assessment functions,
they are established based on the imitation of the review of
CCQI (Cold Chain Quality Indicator). After reviewing the
above operating formats, experts confirmed that there is no
violation of rules or inadequacy. The system structure is as
shown in Fig. 1.
The experimental structure is divided into two parts to
provide explanations. Part 1 is to construct a system platform.
ASP.NET 4.0 and C# language are used to design the
vaccine cold chain monitoring system, which allows the
input of all parameters in the process into the vaccine cold
chain monitoring system through communications
technology, thus, facilitating information exchange and
sharing among various roles in the vaccine supply chain, as
well as the query operation of the system. Regarding Part 2,
in a vaccine cold chain monitoring system, the limits of
authority and relationships of various roles must be strictly
defined in order to meet the regulations for the protection of
safety, privacy, and users’ limits of authority in the
information system. In addition, the data collected from
various roles in this system must be properly archived as
reference for future follow-up, inspection, and review. This
study used Microsoft SQL Server 2005 and Microsoft Office
Access 2007 database to handle members’ limits of authority
and archive various data in the system.
Figure 1. System structure of CCMS
The member database recorded the account number and
password of members and set up their identity, such as
supplier, manufacture, etc. The limits of authority vary with
the differences in roles. In this system, many webpages are
only accessible to specific users. For example, the operating
data and requirement data input by the manufacturer are not
accessible for non-data owners to read, copy, or edit.
Therefore, corresponding regulations on archiving have to be

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established for the system. This study established rules of
archiving for each interface of the member database, with
limits of authority and corresponding “Access Not Allowed”
to prevent users from accessing interfaces that are beyond
their roles and limits of authority, which could lead to
information disasters of disclosure of information and
privacy.
This vaccine cold chain monitoring system includes
seven major functions: supplier, manufacturer, logistics
provider, medical unit, follow-up & query, hazard &
emergency handling, and inspection & assessment. Access
control prior to entering into the system could determine
relevant information accessible to users in order to control
limits of authority and avoid unauthorized access. The
supplier module enables suppliers to input the data of raw
materials, including name, source, import date, and serial
numbers of raw materials and relevant raw material
examination documents. The manufacture module enables
the manufacturer to input the data concerning the stock and
product, which includes the serial number of the product and
manufacture quality-related examination documents. The
logistics provider module enables the logistics provider to
input the data of the shipped product and its distribution data.
The logistics provider and the manufacturer could share
information concerning transport planning through the
connection between the chains of requirement data. The
medical unit module enables the medical unit to input the
data of the stock and vaccine. The establishment of medical
unit’s requirement data enables the Center for Disease
Control to distribute vaccines after understanding the
quantity of vaccine required by various medical institutions
and propose their requests to the manufacturer. The follow-
up & query module facilitates follow-up on the location
profile and temperature monitoring data through cold chain
number–based information query. The hazard & emergency
handling module facilitates relevant reporting and
emergency handling in case of any emergency. The system
function is as shown in Fig.2 [3].
III. CCMS DESIGN AND IMPLEMENTAION
Users could log into an interface conforming to their
identities after assignment of their roles according to their
identities. This system could strictly monitor members’
limits of authority according to the role-based entry and
verification. If members choose the wrong identities or
accessed the interfaces that are inaccessible to them, the
warning window of “Access Not Allowed” would show up
to notify them of the violation and request them to proceed to
the appropriate screen. Moreover, regarding violations, such
as the intention to “replicate a specific webpage, copy the
content of a website, or amend the webpage” and direct
linkage to an unverified screen, the system would direct the
user to the warning window to prevent non-specific users
from amending or viewing member data, thus, protecting the
privacy of the system, as shown in Fig. 3. Upon verification
of membership, users could access specific user screens,
where their account number would be displayed in a specific
area. Moreover, users could check their account number for
confirmation or choose to log out from this interface. The
interface included four working contents: establishment of
basic information of members, establishment of relevant data,
query of requirement data, and establishment of requirement
data.
Figure 2. Functions of CCMS
Follow-up & query is one of the important functions of
this system. The establishment of various data of members
through the cold chain enables follow-up and query. On the
webpage of follow-up & query, the first vaccine temperature,
as recorded by various members, is displayed. For the
detailed record form, users can click the “Detailed
temperature record form” on the rightmost column, where all
temperature records of a vaccine, from a certain unit, as well
as the location record, are available. The follow-up and
query function enables users to understand the units
responsible for the various processes of the vaccine, as
shown in Fig. 4.
The hazard and emergency handling module is
established in order to avoid a lack of reporting and
subsequent handling in cases of chain breakages owing to a
specific cause. Therefore, this system requests all members
of the cold chain to record the handling of relevant hazards
and temperatures, even when their operation is affected by
other factors, in order to provide accurate operating
information as reference for future inspection.

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Figure 3. CCMS main page
IV. SCENARIO
A. Scenario A
Vaccine-related events are frequently reported, such as a
vaccine management disorder in China in June 2005 leading
to public fatalities. The cause of the event was poor
management. Various roles involved the manufacture and
shipping processes of vaccines failed to maintain a low
temperature of raw materials and products in order to gain
huge profits. The vaccine history was not recorded, the
temperature record was not maintained,, and a similar review
of cold chain performance was not conducted. The scenario
hypothesized that the code chain number was “CCL020” –
marketing of a vaccine without systemic review. In this
situation, various roles would receive “false vaccines”,
which data were not input into the system. They could not
convey relevant information, thus, the vaccine cold chain
system underwent the examination of the national vaccine-
related authority, where the submission of test reports was
required. Therefore, the unapproved vaccines were
intercepted and tested by disease control authority and the
Bureau of Food and Drug Analysis. If any deficiency had
been found in a vaccine through cold chain monitoring, the
history of vaccine could be followed-up through a review of
the data input into the system by various members during
their operations. The vaccine could then have been recalled
and the cause for the deficiency could be rapidly determined,
as shown in Fig. 5.
Figure 4. CCMS temperature monitoring page
B. Scenario B
This scenario hypothesized hazard handling required by a
changing temperature in this cold chain and the follow-up of
the temperature history of a denatured vaccine. When an
error of a changing temperature occurs, it is necessary to
determine the difference between the time when the error is
found and the time it is reported, according to scientific
measurement. It is also necessary to record the hazard
according to the facts and submit the complete data of
temperature measurement as reference for subsequent hazard
inspection of the vaccine. Moreover, a crisis should be
concurrently managed, such as information conveyance to
the next unit, reporting to a higher-level unit, and notification
of relevant contact persons. If an ineffective vaccine is found,
the history of vaccine temperature can be rapidly followed-
up in order to determine the cause for loss of control over
temperature.

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Figure 5. CCMS temperature monitoring page
Based on the simulation experiments of scenarios A and
B, the system established for vaccine safety in this study can
ensure the safety of the vaccine. In addition, it can improve
the handling of a crisis, and involved members will no longer
expect their orders. In brief, this system can control the
members of a supply chain and establish a connection
between them. Members can share information with one
another and convey information to implement a follow-up on
a vaccine. In the case of hazard, the cause can be rapidly
determined. As all members of a cold chain have passed
review and inspection, they can better trust one another and
undertake fewer risks. The monitoring of temperature,
management of process records, and the strict management
and review for members all render this study beneficial to
relevant future studies and the improvement of safety and
quality of vaccine for people in Taiwan, where a cold chain
monitoring system will be fully implemented.
V. CONCLUDING REMARKS
Because vaccine-related safety events are constantly
reported, various countries and Taiwan have attached
importance to the issue of vaccine safety. Therefore, this
study developed a vaccine cold chain monitoring system for
follow-up of the cause and temperature records of
ineffective vaccines and the legal control of vaccines. This
study also established an emergency reporting system to
avoid failures of software/hardware, as well as to prevent
information stagnation from endangering vaccine safety.
Moreover, the establishment of a cold chain also enables
mutual information conveyance and sharing among
members, which significantly improves the overall
competitiveness and efficiency of organization. A cold
chain monitoring system has not been fully implemented in
Taiwan, and there are few studies and relevant operating
data regarding cold chains. The establishment of a cold
chain for products sensitive to temperature can ensure the
safety and operating efficiency of products. This study
established a vaccine cold monitoring system for Taiwan,
according to regulatory literature and information of cold
chains from advanced countries in Europe and North
America. The purpose of this study was to collect and
summarize the data provided by various roles/members,
present them on a system platform, and provide complete
vaccine history information to the government, cooperative
members, and medical units.
In summary, the contributions of this study are as
follows:
1. Members of the cold chain can immediately engage
in their operations through mutual information
connections. Vaccine information becomes transparent
through information conveyance, which enables
concerned users of vaccine-related processes to conduct
a thorough inspection through the system.
2. If the vaccine becomes ineffective or if there is any
error made, relevant units can effectively and rapidly
determine the cause through the follow-up & query
function. This function ensures the efficiency of the
subsequent handling of the product, as well as a recall,
should it be necessary.
3. The hazard & emergency reporting function
facilitates effective recording, hazard handling, and
reporting to higher-level units in the case of any
software/hardware malfunction within the cold chain,
thus, hazard situations become transparent and avoid
harm to humans caused by the injection of an ineffective
vaccine.
4. The strict restrictions on limits of authority of
members increase cold chain members’ confidence in
the system’s protection of privacy.
5. The detailed recording of temperature improves
cold chain members’ temperature management and
increases confidence in the product.
REFERENCES
[1] World Health Organization, ”Guidelines on the international
packaging and shipping of vaccine, ” WHO/IVB/05.23,2005, pp. 1-40.
[2] International Quality & Productivity Center, ”Identifying and
Managing Risks along the Cool Chain, ” 4th International
Symposium on Cool Chain, 2011, pp. 29-31 , Berlin, Germany.
[3] M. Net, E. Trias, A. Navarro, A. Ruiz, P. Diaz, J. R. Fontenla, and M.
Manyalich, “Cold Chain Monitoring During Cold Transportation of
Human Corneas for Transplantation, “ Transplantation Proceedings,
Volume 35, Issue 5, 2003, pp. 2036-2038.
[4] M. P. M. Meuwissen, A. G. J. Velthuis, H. Hogeveen and R. B. M.
Huirn, ”Traceability and Certification in Meat Supply Chains,”
Journalof Agribussiness, Vol. 21, No. 2, 2003, pp. 167-181.
[5] J. Ratcliff and M. Boddington, "Practical Use Of It In Traceability In
Food Value Chains, " IFIP Advances in Information and
Communication Technology, Volume 295, 2009, pp. 2161-2175.

Design and Development of Cold Chain Monitoring System

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