1. Introduction

As globalization advances, the cross-border transportation of pharmaceuticals has become more common, underscoring the imperative to ensure the efficacy and safety of drugs throughout the transit process. Temperature-controlled logistics has been developed specifically to meet the needs of temperature- and pressure-sensitive medications, which aims to maintain a stable temperature throughout the transportation chain [1]. It has been demonstrated that even minor fluctuations in temperature can result in alterations to the chemical composition of pharmaceuticals, which may subsequently impact their efficacy. In the event that a pharmaceutical product has exceeded its shelf life and no longer meets the requisite regulatory standards, the manufacturer may be compelled to issue a recall, which could result in substantial financial losses and reputational risk. However, the supply chain for temperature-controlled drug transportation currently faces several challenges. The accuracy of temperature monitoring is critical for ensuring the quality of medicines, as maintaining stable temperatures during transportation is crucial to avoid economic losses and maintain supply chain efficiency, while companies must also ensure compliance with regulations. Despite numerous studies on advanced technologies in temperature-controlled logistics, gaps persist regarding their specific applications in regulatory frameworks. This paper aims to examine the issue of temperature control in the transport of pharmaceuticals and to assist pharmaceutical companies and logistics providers in developing a deeper understanding of the challenges involved and in formulating more effective responses.

2. Temperature Monitoring Systems in Pharmaceutical Logistics

2.1. Importance of Temperature Monitoring in Pharmaceutical Transport

Temperature monitoring is an indispensable core link in the pharmaceutical industry supply chain. In the context of rapid globalization, drugs are usually distributed across borders through various modes of transportation, such as road, sea and air, involving multiple links, including loading and unloading and final distribution. During this process, even short-term temperature fluctuations may significantly affect the efficacy of drugs, or even cause drug deterioration, thereby producing harmful byproducts to the human body. The World Health Organization has set strict requirements for temperature-controlled transportation, stipulating that all temperature-controlled vehicles must be equipped with temperature monitoring equipment with an accuracy of no more than 0.5°C and must be calibrated annually. These devices should not only be able to adapt to storage conditions, but also have real-time positioning capabilities and be able to record at least six temperature data points per hour to ensure the safety and effectiveness of drugs during transportation [2].

2.2. Advanced Temperature Monitoring Technologies and Their Applications

To address the temperature control challenges faced during drug transportation, pharmaceutical companies often choose temperature-controlled shipping boxes, which are equipped with insulation and electronic equipment to effectively monitor and maintain the temperature inside the box. In such transport boxes, logistics contractors usually use advanced temperature monitoring systems (TMS), which can track, control and adjust the temperature of the environment in which the drugs are placed in real time to ensure the quality and safety of the drugs. TMS provides automatic high and low temperature alarm functions to prevent extreme situations such as fire or temperature out of control. In addition, the system can track temperature in real time and send out alerts when the temperature changes. Even small temperature fluctuations will be fed back to the company in a timely manner, helping pharmaceutical companies and logistics teams make quick adjustments. At the same time, the system also allows the setting of maximum and minimum thresholds to ensure that temperature changes remain within an acceptable range [3].

In temperature monitoring, commonly used sensors include thermocouples, RTD sensors, and thermistors. Although thermocouples are low-cost, their monitoring accuracy is insufficient and they are not suitable for drug transportation. RTD sensors provide higher accuracy and are suitable for specific temperature ranges, but the monitoring range is relatively narrow. The nonlinear characteristics of thermistors require them to be used in conjunction with monitoring systems that support nonlinear curves. Also, thermal buffers can be connected to sensors to reduce response time and increase the speed of capturing subtle temperature changes [3]. The monitoring system features a temperature control unit that processes sensor data, records temperature information, manages data storage, sends alarm notification, and supports wireless transmission. For example, Pfizer uses a high-precision temperature monitoring system to ensure that drugs are kept within the specified temperature range during transportation. These devices are installed in each shipping box, allowing Pfizer’s logistics team to obtain monitoring data in real time and take the necessary temperature adjustments accordingly. This can effectively reduce the damage caused by temperature fluctuations to medicines [4].

3. Temperature-Controlled Logistics Technologies and Their Applications

3.1. Importance and Challenges of Temperature-Controlled Logistics

In the pharmaceutical supply chain, stable temperature-controlled logistics is an important link in ensuring the quality of drugs. The supply chain usually involves a combination of multiple modes of transportation, including refrigerated trucks, temperature-controlled containers, sea transport, air transport, and passive containers. Therefore, the temperature of the goods during transportation is easily affected by the external environment. At any link in the supply chain, the loss of temperature control of drugs may lead to deterioration and failure to meet regulatory requirements. Given the stringent temperature requirements for drugs, suppliers typically opt for temperature-controlled transportation instead of traditional cold chain logistics. The normal temperature storage range is 20 \( ℃ \) to 25 \( ℃ \) , the refrigerated storage range is 2 \( ℃ \) to 8 \( ℃ \) , and the low-temperature storage range is between 0 \( ℃ \) and -150 \( ℃ \) . Among the temperature-sensitive drugs transported, 51% need to be transported at room temperature, 31% need to be refrigerated, 17% need to be transported under low temperature conditions, and 32% cannot be transported under cold chain conditions [5].

3.2. Advanced Technologies in Temperature-Controlled Transportation

Pharmaceutical companies are actively implementing new technologies to enhance the stability of temperature-controlled transportation within their supply chains. These innovations encompass wireless sensor networks (WSNs), the Internet of Things (IoT), cloud computing platforms, and RFID systems. Through the synergy of these technologies, drugs can maintain a stable temperature environment during transportation, improve the visibility and controllability of the supply chain process, and thus help companies implement effective quality management [6]. As shown in Table 1, these technologies ensure the integrity and traceability of pharmaceutical products throughout the entire transportation process [7].

Table 1: Tracking of Goods at Every Step in IoT Applications

First, pharmaceutical companies collect the required data through WSNs, RFID technology, and the aforementioned temperature monitoring system. Table 2 details the specific methodologies and their advantages for maintaining and monitoring temperature conditions during pharmaceutical transportation [7]. WSN technology is usd in refrigerated trucks, temperature-controlled containers, and climate-controlled warehouses. Each drug package is fitted with an RFID tag that accurately tracks its temperature, location, and status. This data is transmitted between various sensors via WSN, ensuring comprehensive wireless network coverage [8]. Once collected, data is transmitted in real-time via WSN, IoT, and cloud computing platforms. Sensors monitoring drug temperature send data to the cloud, while IoT technology integrates sensors and RFID tags from various locations into a single platform for centralized management by pharmaceutical companies [8]. After successful upload, the cloud computing platform analyzes a large amount of real-time data to identify special situations such as extreme weather, emergencies, and abnormal temperatures. The platform can immediately trigger the automation control system through IoT devices and display real-time information in the IoT system, helping enterprises to respond quickly to logistics processes. For common abnormal situations, the cloud computing platform and IoT system can automatically adjust the ambient temperature of the medicine to ensure the accuracy and timeliness of temperature control while reducing manual operations. When serious abnormal situations occur, such as extreme weather, the cloud computing platform can provide enterprises with alternative transportation routes to reduce the risks faced by goods in logistics transportation [8]. Finally, RFID technology and temperature monitoring systems ensure that the entire transportation process is monitored by the enterprise to ensure that the temperature and transportation path of the medicine meet the requirements of the enterprise and national regulations. Thus, pharmaceutical and logistics companies can utilize WSN, RFID tags, IoT, and cloud computing platforms to enhance the stability of temperature-controlled logistics. These technologies enable monitoring of the logistics process, data transmission, and alert issuance. For example, IoT technology is essential for rapid responses to emergencies, improving supply chain transparency, and reducing the risk of drug damage from temperature fluctuations [7].

Table 2: Maintaining and Monitoring Temperature Conditions in IoT-Enabled Pharmaceutical Supply Chain.

4. Temperature Control Management in Pharmaceutical Warehousing

4.1. Importance of Temperature Control Management

After the logistics company safely delivers the drugs to the destination, it will store them in the warehouse for storage and distribution, so temperature control management is particularly important. Compared with the supply chain process, temperature control management in the warehouse can significantly reduce risks, but in emergencies, it may still cause significant economic losses. Not only may a batch of drugs be unacceptable, but the quality of temperature-sensitive drugs may also be affected. Warehousing is an important link in ensuring the continuous and rapid supply of drugs. Most pharmaceutical companies have warehouses in their operating areas. Because the storage environment required for drugs is different from that of general goods, many companies choose to manage warehouses internally. Studies have shown that warehousing costs account for 95% of the cost of pharmaceutical logistics, which is an expensive investment. However, if pharmaceutical companies cannot track the status of products in the warehouse in real time, they will face huge risks of losses.

4.2. Temperature Control Management Technologies and Implementation

During warehouse management, wireless sensor networks, RFID technology and wireless video surveillance systems are widely used to improve the effectiveness and accuracy of processes. RFID technology can achieve precise control of product entry and exit. Some companies even combine it with automatic guided vehicles (AGVs) to reduce labor costs and improve operational efficiency [7]. For pharmaceutical warehouses, temperature and environmental control are particularly important. With the advancement of technology, pharmaceutical warehouse management has become more reliable and efficient. The temperature monitoring system in pharmaceutical warehouses commonly utilizes technologies such as IoT, automatic alarms, integrated temperature control systems, and RFID. The IoT enables real-time monitoring of temperature, humidity, as well as environmental conditions, ensuring compliance with optimal storage requirements for the products. The automatic alarm system notifies management personnel in a timely manner through SMS, email and applications for quick response. The temperature control system is combined with the WMS to automatically adjust the warehouse temperature in real time, and RFID can accurately monitor the status of each drug and improve the accuracy of data [9]. For example, Alloga is a company that has performed well in the field of pharmaceutical warehousing, providing a variety of storage conditions, such as room temperature 15-25 \( ℃ \) , refrigeration 2-8 \( ℃ \) , freezing -24 \( ℃ \) and low temperature -170 \( ℃ \) [10]. They use the Internet of Things and automatic alarm systems to monitor warehouse temperature in real time and issue reminders in a timely manner. In addition, Alloga uses an integrated warehouse management system and temperature control system to ensure that drugs are always stored at the optimal temperature. For general temperature fluctuations, the system can quickly adjust to maintain a constant temperature. Finally, RFID tags are used to monitor each batch of goods, so that information such as drug batch, expiration date, status, quantity, temperature and environment can be viewed in real time on the cloud management portal, which is one of the important reasons why the company is a leader in the field of drug warehousing [11].

4.3. Regulatory Requirements and Quality Standards in the Pharmaceutical Supply Chain

In the pharmaceutical industry supply chain, the temperature control process is strictly regulated by a number of national laws and company standards. Ensuring that the quality of drugs meets these regulatory requirements and maintains high standards has become an important challenge for pharmaceutical companies. According to the EU’s Good Distribution Practice (GDP) guidelines, detailed requirements are formulated for temperature control, transportation conditions and warehouse management of drugs in logistics and transportation, highlighting the criticality of temperature monitoring equipment. The regulations clearly stipulate that drugs must maintain appropriate storage conditions at all times, including transportation, and inventory management must follow the First Expired, First Out (FEFO) principle, and clearly define the standards for drug returns and destruction of expired products [12]. The U.S. Food and Drug Administration (FDA) also has corresponding regulatory requirements, emphasizing that all prescription drugs must be transported and stored under appropriate temperature conditions, and that temperature monitoring systems are crucial in ensuring drug quality [13]. Besides, the international conference guidelines issued by the FDA pestablish global standards for drug quality management systems, encompassing all aspects of the drug supply chain, including temperature control measures during storage and transportation [14].

5. Conclusion

This paper delves into the critical importance of temperature control within pharmaceutical logistics, highlighting the necessity of precise monitoring and adherence to regulatory standards. One of the main findings is that effective temperature management can significantly reduce the risk of drug loss during transportation, ensuring that products remain safe and effective throughout their journey. However, the study has its limitations, as it primarily focuses on specific technologies and may not capture the full spectrum of innovations available. Looking forward, future research could explore the integration of advanced technologies, such as artificial intelligence and machine learning, to refine temperature management systems. These technologies could facilitate predictive analytics, allowing for proactive adjustments in response to environmental changes. Moreover, investigating the long-term impacts of regulatory compliance on overall supply chain performance would offer deeper insights into how adherence to quality standards influences operational efficiency and product integrity. Such studies could provide invaluable guidance for industry stakeholders seeking to enhance their logistics practices in a rapidly evolving regulatory landscape.