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Research Inventy: International Journal of Engineering And Science
Vol.10, Issue 9 (September 2020), PP 37-41
Issn (e): 2278-4721, Issn (p):2319-6483, www.researchinventy.com
37
Temperature Management of Thermolabile Medicines: Transport
Device Development
1Bernardo Takeshi Ueda, 2Otto A. Froehlich de Jesus, 3Emílio Diniz,
4José de Souza
1, 2, 3 & 4Fundação Liberato - Diretoria de Pesquisa e Produção Industrial (DPPI) - Rua Inconfidentes, 395, Bairro
Primavera, Novo Hamburgo - RS - ZIP CODE 93340-140, Brazil
Corresponding Author: José de Souza
ABSTRACT: This paper presents a study on the development of a temperature-controlled thermal
refrigeration container to facilitate the transport of thermolabile drugs to remote places or places
without access to medicines. Because of this, the project has as its problem the manufacture of a
refrigerated thermos container with temperature control that can help the transportation of
thermolabile drugs. Consequently, its objectives are: to study the materials and tools to complete such
a task, as well as to design their operation through studies, and to utilize existing equipment from other
operations. The methodology was modified as a polyurethane cooler, where we added a device to cool
the container, a sensor for monitoring, and a power bank to power the refrigerators. The results
obtained in the studies are valid, and we believe the project is viable, but we will only have concrete
results after the prototype tests.
KEYWORDS: Thermolabile Medicines, Refrigeration, Temperature monitoring.
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Date of Submission: 15-09-2020 Date of Acceptance: 30-09-2020
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I. INTRODUCTION
The exposition of thermolabile drugs to adverse conditions recommended by the manufacturer may suffer
a decrease in their potency, a reduction in their shelf life, and changes in their toxicity [1]. Also, improper
packaging of thermolabile products can cause adverse effects in patients who use it [2]. The American
Pharmacopoeia's MEDMARX medication error notification system recorded almost 1000 notifications involving
errors associated with thermolabile drugs, most of the time due to incorrect transport, and therefore, the transport
of these drugs requires special attention [3].
The main factors in maintaining the quality of the drugs are the temperature during storage and transport
so that if not respected, they cause changes and the deterioration of the drugs [4].The transport of thermolabile
medicines is a significant step to reach the final consumer in the ideal condition of consumption, without changes
in their formulas and having the effectiveness proposed by the manufacturer [3]. Acceptable transport practices
are part of the quality assurance that attests that the transport process occurs within the appropriate quality
standards for developing all stages of the transport of medicines [5]. This guarantee in transport does not always
occur since the thermal packaging used for this function does not meet the conditions necessary to keep the
medicine preserved [6]. To carry out transporting medicines, thermal packages, or refrigerated vehicles must be
used, to guarantee the ideal conditions of transport [4].
The storage of drugs must be done in appropriate environments, according to the specific characteristics
and conditions of conservation [1] and must be done based on each drug's requirements according to its
manufacturers [3]. The storage of thermolabile medications requires a constant temperature of around 20 ° C with
± 2 ° C of variation, constant temperature measurements and records, and an alert system for possible defects in
refrigeration equipment [4].
The transport of thermolabile medicines in places of difficult access becomes complicated because one
of the factors that hinder locomotion is that the national roads are in critical condition, lacking adequate vehicles
and inadequate containers [7]. The transport of thermolabile medicines occurs with polystyrene boxes, the
medicine stored with ice, and the monitoring is done with laser thermometers or with an extension cable. It is an
inadequate form, and without guarantee, we are often unable to guarantee that the medicine temperature remained
in the range of 2 ºC to 8 ºC [8].
There is an apparent problem concerning the low conservation of thermolabile drugs and the difficulty
in transporting them. With that said, it is justified to develop a device that can transport the thermolabile medicines
Temperature Management of Thermolabile Medicines: Transport Device Development
38
while maintaining their temperature so that the medicine does not lose its properties and to facilitate transportation
in more remote places with difficult access to these medicines.
This paper is a study in which it contains the procedures for the theoretical realization of a cooling device
to transport thermolabile medicines with automatic temperature adjustment.
II. LITERATURE REVIEW
The storage of thermolabile medicines is temperature-sensitive products that must occur according to the
pharmaceutical industry's temperature range. Many of the thermolabile drugs indicated for treating chronic
diseases, such as diabetes, and cancers when a cold chain failure occurs, they may have their effectiveness
impaired [9]. Most thermolabile is in the range of 2 °C to 8 °C, and if they do not occur at this temperature during
transport or storage, they can have their cold chain destabilized, thus impairing its performance.
Thermolabile medications require a specific storage process, as they are sensitive to temperature action.
Thus, for the correct storage of medicines and thermolabile products to occur, they must be stored in refrigerated
equipment, with continuous temperature control, through maximum and minimum thermometers, adequately
calibrated and qualified [10].Storage of thermolabile medications requires a constant temperature in the range of
2 to 8 ° C with ± 2 ° C of variation, constant temperature measurements and records, and an alert system for
possible defects in refrigeration equipment [9]. Temperature records must be kept at least during the product's
validity period and available for possible evaluations [4].
The proper storage of thermolabile medicines maintains their integrity and efficiency during the entire
storage period in which these medicines pass so that the environments dedicated to this are clean, dry and are
adequate to the temperature standards and the medicines are distributed organized form and away from the floor,
facilitating its cleaning and inspection [4-10]. Temperature mapping should also be carried out in these
environments, in different seasons, to check the uniformity of temperature distribution in these locations and
adjust the thermometers [4-10].
To guarantee the best transportation of the thermolabile medicines is necessary to make sure that the
medicine transportation occurs in suitable thermal packages, and for that, the process of qualification and
validation of thermal packages is carried out [11].The qualification deals with a set of procedures to prove and
register that a passive isothermal system works appropriately to achieve the expected results [8]. This process
occurs in two stages, operational qualification, and performance qualification. Under extreme conditions, the
operational qualification determines that an experimental packaging acts as expected, within parameters such as
thermal mass, thermal box cubage, time, and temperature [4-8].
The performance qualification proves that thermal packaging designed according to acceptable transport
practices' criteria observes the essential requirements. It is characterized by the sending of thermolabile products,
through known routes, to determine if the packaging is being adequate and reproductive for the transportation of
these products. This type of test must be performed twice a year, in winter and summer, evaluating the temperature
records during the entire transport period [4]. Projects developed using 3D modeling software, simulation, and
computational support are suitable for Assistive Technology (AT) [12] or improvements in hospital devices and
devices to support people with disabilities [13-14].
III. MATERIALS AND METHODS
The projection of a thermal box according to the packaging model for the transport of thermolabile
medicines (Fig. 1) where the material of the box will be polyurethane, the thermal insulator will be the styrofoam
or thermal blanket. For the cooling system, we will adapt the model for the cold element, because instead, we will
use another cooling system where we will use the principle of the Peltier effect, using the Peltier tablets, therefore,
in the box, there is an opening to just couple the cooling system. Cooling, and an opening in the front to place the
thermometer display. The projected box has dimensions of 260 mm x 200 mm x 20 mm, which supports up to 5
L. However, the volume reduction with the cooling system will occupy a little of the box's internal space.
Temperature Management of Thermolabile Medicines: Transport Device Development
39
Figure 1. Image of the 3D projection.
In the cooling system's projection occurs the use of two Peltier, as we can point out that they are incredibly
light. Peltier has precise temperature control, is completely silent, there is no vibration, requires less physical
space than compression and absorption cycles, and require little maintenance, and to avoid overheating of the
insert plates, heat sinks and fans occurs on both sides of the inserts (Fig. 2). To increase its efficiency, we will use
thermal paste between the plates and the heatsinks to make the heat exchange easier. This system will be coupled
to the upper rear part of the container, so that an air cycle can be generated inside the container, because as the
cold air goes down, and the hot air goes up, they enter a cycle, thus improving the efficiency of the cooler.
Figure 2. Refrigeration system image made by the Inventor.
In the projections made in Inventor, the components and systems are not with the real dimensions since
the projection is just a demonstration and assumption of what the real prototype will be necessary. A 12 Volts
source will power the cooling system since this is the source recommended by the manufacturers, but we plan to
add a battery. The transportation of the container occurs without needing any source of energy.
To choose the thermoelectric pads, research on the most used in refrigerators and containers with a similar
purpose to ours occurs. They are sold in the market today, and the model Peltier Cell Tec1-12706 has dimensions
of 40 mm x 40 mm x 4 mm, its temperature range varies between -30 Cº to 70 Cº, its weight is 30 g and its power
consumption when in operation is 72 Watts.
For the choice of standard aluminum sinks, since our module has a consumption of approximately 70
Watts, and a fan for increasing heat dissipation. The chosen heatsinks were of the Heatsink model of the brand
3C Digital Electronic with 40 mm x 40 mm x 11 mm dimensions, where it will be glued together with the
thermoelectric chip with a thermal paste to facilitate the heat exchange. The fans will also be 40 mm to facilitate
fitting in the heatsinks.
Finally, we will add the monitoring system, which initially planned to install only a thermometer with an
external sensor and a display to check the temperature from the outside of the container. Future an intelligent
Temperature Management of Thermolabile Medicines: Transport Device Development
40
temperature sensor that will take temperature measurements and transmit data for those responsible for monitoring
the container for generating quality control reports on the conservation of thermolabile drugs, since this is a
requirement for carrying out the task of transporting such drugs (Fig. 3).
Figure 3. Final projection of the thermal box with cooling system.
IV. RESULTS
The material defined by the group for the future manufacture of the box is polyurethane recommended
for the manufacture of refrigeration coolers. It is a thermal insulator of excellent quality and follows the packaging
model for the transport of thermolabile medicines. Recommended using some thermal insulator inside the
packaging, which we define as Styrofoam or thermal blanket.
The cooling system of the thermal packaging defined was using the Peltier effect since there are many
cases where the transport of these thermolabile drugs using dry ice or other refrigeration methods that are not very
reliable. The tablet chosen by the group is of the model Peltier Cell Tec1-12706, which will also use heatsink of
the model Heatsink of the brand 3C Digital Electronic.
For the monitoring system, the use of a monitoring sensor provided by the company SensorWeb defined,
since this sensor emits temperature variation data to generate reports and thus be able to control and verify the
quality of the medication preservation, which must be issued by the least during the validity of the drug to be
stored.
V. CONCLUSION
After analyzing the results shows that it is still possible to proceed to realize the proposed product;
however, losses of efficiency of the cooling system not considered due to lousy sealing or problems during the
heat exchange, for example. As the tests start to occur, the results can become more realistic and valid. The
research has not yet been completed, so the authors have the prospects of making the prototype, made with
different types of thermal insulating materials, to improve it in the best possible way, as well as checking the
efficiency of the refrigeration system and trying to improve it by increasing its effectiveness.
ACKNOWLEDGEMENT
This study is part of projects of a group of researchers of Teachers and Mechanics Students of the
Fundação Escola Técnica Liberato Salzano Vieira da Cunha (http://www.liberato.com.br/) from Novo
Hamburgo, Brazil. The research group does not receive any funding to support it.
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41
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Bernardo Takeshi Ueda, et. al. " Temperature Management of Thermolabile Medicines: Transport
Device Development. Nigeria." International Journal of Engineering and Science, vol. 10, no. 09,
2020, pp. 37-41.
