Temperature visibility and intervention  in the pharmaceutical supply chain: Ensuring integrity and safety

18 九月 2024

Sebastian Steinmueller Business Product Owner for Pharma Cold Chain Management

In the pharmaceutical supply chain, maintaining the appropriate conditions for temperature-sensitive products are paramount to ensuring their safety, efficacy, and quality. Ensuring temperature visibility and implementing intervention strategies are essential components of a robust supply chain management system that can mitigate risks and preserve the integrity of pharmaceutical products from manufacturing to patient delivery.

The critical role of temperature monitoring

Temperature visibility refers to the ability to continuously monitor and track the temperature conditions of pharmaceutical products throughout the supply chain. This visibility is crucial for several reasons:

Ensuring product integrity

Many pharmaceuticals, including vaccines, biologics, and certain medications, require stringent temperature controls to remain effective. Deviations from specified temperature ranges can degrade these products, rendering them ineffective or unsafe.

Compliance with regulations

Regulatory bodies such as the FDA, EMA, and WHO have established guidelines for temperature management. Compliance with these regulations is essential to avoid penalties and ensure the safe distribution of products.

Risk management

Temperature visibility allows for real-time monitoring and the early detection of potential issues. This capability enables stakeholders to take proactive measures to mitigate risks before they lead to product loss or safety concerns.

As part of our Maersk Pharma Cold Chain Management Solution (P-CCM), we provide visibility while goods travel in our refrigerated containers. This is possible through our Remote Container Management (RCM) system. The data obtained from RCM is also used for related actions such as power-off time management, operational excellence and vendor management that helps safeguard medicines and ensure patient safety. The full visibility provided also enables shippers to initiate their release processes while the cargo is still in transit. This leads to decreased time-to-market and better inventory management.

Technologies enhancing real-time temperature visibility

Advancements in technology have greatly improved the ability to monitor temperatures accurately and in real-time:

IoT sensors and data loggers:

These devices can be attached to shipments to provide continuous temperature data. Internet of Things (IoT) sensors transmit data in real-time, allowing for immediate alerts if temperatures fall outside acceptable ranges. Throughout the journey, data loggers record temperature data, which can be reviewed upon delivery to ensure compliance.

Blockchain technology:

Blockchain can be used to create an immutable and transparent record of temperature data throughout the supply chain. This technology enhances trust and accountability by providing a verifiable history of temperature conditions.

Cloud-based monitoring systems

These systems aggregate temperature data from various sensors and are a centralised platform for monitoring. They offer features such as real-time alerts, historical data analysis, and integration with other supply chain management tools.

At Maersk, we closely follow the developments in this space and work together with our supplier Maersk Container Industry to have the latest generation of technology applied to our reefer container fleet. In addition, with Captain Peter^TM, our digital visibility tool, we are able to integrate the data with the systems of our pharma customers. This enables true end-to-end visibility and reduces the number of systems customers must handle to check information. Captain Peter^TM is part of the customised solutions we offer under Pharma Cold Chain Management (P-CCM).

Intervention strategies for temperature deviations

Despite the best efforts to maintain temperature control, deviations can still occur. Effective intervention strategies are crucial to address issues promptly and minimise impact:

Real-time alerts and notifications

Immediate alerts sent to stakeholders when temperature deviations are detected allow for quick action. For example, logistics providers can be notified and through dedicated control-tower teams who have the necessary tools. They address issues such as equipment malfunctions or improper handling with the right parties in a timely manner.

Automated corrective action

Advanced systems can trigger automated responses to temperature deviations. These include adjusting refrigeration units, switching to backup power sources or rerouting shipments to maintain optimal conditions.

Contingency planning

Having predefined contingency plans in place ensures that all stakeholders know their roles and responsibilities in the event of a temperature excursion. These plans might include protocols for repackaging, re-icing or the transferring of products to alternative storage facilities.

Training in standard operating procedures (SOPs)

Regular training for all supply chain personnel on the importance of temperature control and the correct handling procedures can prevent many issues. SOPs should be updated regularly to reflect the latest best practices and technological advancements.

Intervention is an integral part and a key building block of Maersk Pharma Cold Chain Management Solution. Our integrator strategy, and full asset ownership across refrigerated containers and vessels, combined with the availability of temperature data enables our trained employees to quickly intervene in case of any deviations, ultimately safeguarding product integrity.

The impact of effective temperature visibility and intervention

Implementing robust temperature visibility and intervention strategies has several benefits:

Product safety and efficacy

Ensuring that pharmaceuticals are kept within their required temperature ranges maintains their effectiveness and safety for patients.

Regulatory compliance

Adherence to regulatory guidelines through effective temperature monitoring and intervention helps avoid legal issues and potential fines.

Cost savings

Preventing product loss due to reduced temperature deviations and the ability to intervene while the goods are in transit reduces financial losses and improves the overall efficiency of the supply chain.

Enhanced reputation

Companies that can consistently deliver high-quality and safe products build trust with healthcare providers and patients, enhancing their reputation in the market.

We are very pleased to see that our pharmaceutical customers truly value the benefits from partnering with Maersk when it comes to ensuring product integrity, regulatory compliance and saving costs. And it is encouraging to see that the visibility we provide enables customers to kick off product release processes earlier which reduces time-to-market and improves inventory management.

Gaetan Van Exem, Global Vertical Head, Pharma and Healthcare, A.P. Moller-Maersk

Temperature visibility and intervention are critical components of the pharmaceutical supply chain. By leveraging advanced technologies and implementing effective monitoring and intervention strategies and processes, stakeholders can ensure the integrity of temperature-sensitive products. This not only helps in maintaining compliance with regulatory standards but also plays a crucial role in safeguarding public health. As the pharmaceutical industry continues to evolve, the emphasis on temperature visibility and intervention will remain a key factor in delivering safe and effective medications to patients worldwide. At Maersk, we support our customers to achieve that every day with our passionate and experienced teams on sea, on land and in offices across geographies.

Read more about our Pharma Cold Chain Management Solution