Cold Chain Vital for Pharmaceutical Industry Logistics
The therapies manufactured by the pharmaceutical industry require proper control and handling. This includes maintaining a specific temperature during their storage and distribution to preserve their properties. It is necessary to carry out a strict procedure from the moment it leaves the laboratory, is transported, stored, distributed, and delivered to its final destination.
Vaccines, as well as other high-specialty drugs are products that need to be at low temperatures continually. By sustaining the required temperature for each drug, the contents of its formula are preserved so that when it reaches the end user, the product maintains its quality, efficacy and safety. This proper handling of therapies generates confidence in the medical community.
To preserve their properties, a cold chain or cold network is available. This is considered essential for the logistics of medicines and vaccines as it keeps the required temperature ranges.
The Pan American Health Association (PAHO) defines a cold chain as a set of standards and procedures that ensure the correct storage and distribution of drugs and vaccines to health services from the national to the local level. This is intertwined with refrigeration equipment that enables keeping drugs at the appropriate temperatures to maintain their efficacy.
In this sense, the rigorousness of an appropriate control of the cold chain network is required. The application of cold is one of the oldest and most widespread methods of preservation since it acts as a total or partial inhibitor of processes that are able to alter the product.
The cold chain network in the pharmaceutical industry must have four main stages:
Temperature-controlled storage at the production center.
Transportation in vehicles equipped with refrigeration systems and temperature monitoring.
Temperature-controlled storage in the distribution center.
Specialized infrastructure for distribution in health centers.
Transportation is considered one of the most delicate stages of the cold chain in the pharmaceutical industry. It is of utmost importance to be clear that if the product fails to be at the right temperature, an issue known as “excursion,” even for a short time, it can cause the drug to lose its properties. That is why having transport equipped with refrigeration is essential for successful delivery. The cold chain ensures product conditions are kept within optimal ranges and maintain the desired states from start to finish.
This year, Maypo celebrates 30 years of providing logistics services to the pharmaceutical industry and the health sector in Mexico. Throughout these three decades, the company has developed and implemented its knowledge, experience and infrastructure to offer comprehensive solutions for the distribution, storage and dispensing of high-specialty and cold chain medicines.
One of Maypo’s greatest strengths is the storage and transportation of medicines in cold management, for which we have protocols and specialized transportation units to guarantee the temperature of the drug during the entire distribution process.
We also have four storages conditioned and certified for the handling of pharmaceutical products in dry (no less than 30°C), controlled (15 to 25°C), and cold (2–8°C) environments, where we have the capacity to store 15 million vials (bottles intended to contain injectable drugs) under the conditions required to preserve their quality, efficacy, and safety.
We have a certified freezer for the warehouse of frozen products from -15°C to -25°C and from -10°C to -20°C. There is also a freezer for the conditioning of frozen gels that are used to assemble the thermal containers used for distribution. We have two configurations for thermal containers and are about to include a new reusable configuration that reduces our carbon footprint and waste and lowers costs.
Our cold chain infrastructure is certified annually for its design, installation, operation, and performance. All our cold storages are monitored by a specialized system that guarantees temperature control at all times. Sensors are strategically placed, manually calibrated, and record temperature data every 15 minutes, generating thermal mapping reports. If there is an out-of-range number, the system alerts maintenance, operation, and quality areas to take action during a contingency.
The cold storages have their own temperature control system to ensure their performance and employ redundant systems for operation. In the event of a power failure, we have additional power generators and batteries with a duration of up to 48 hours.
For the transportation of drugs, we have a specialized cold management procedure that describes the correct handling of the medicine from reception to the delivery of the product. Depending on the quantity and according to the delivery point, it is sent in a thermal container and in a temperature-controlled or refrigerated vehicle.
A cold chain network, such as the one we have in Maypo, must have the following attributes to function optimally:
End-to-end traceability and visibility: in order to avoid breaks or waste. According to the World Health Organization (WHO), 25% of vaccines arrive at their destination in degraded conditions due to poor transportation.
Regulatory compliance: disruptions and the ability to adopt new technologies that help monitor and ensure regulatory compliance. Some technologies that help regulatory compliance are real-time sensors and reporting, machine learning, and blockchain, among others.
Management of storage, transportation, and inventory holding costs: a cold supply chain also requires adopting best practices, such as logistics studies, investing or renewing assets, and working capital management.
Training of operating personnel: in order for the other improvement tools to be successful, it is of utmost importance that the human component is trained; therefore, specialized teams capable of leading and managing any change must be prepared.
Cold chain operations have been key elements in expanding daily service delivery in pharmaceutical logistics, enabling therapies and biotech products to reach the end user with the right properties for their use.