Estimates say that every year, in the world, 20% of the temperature-sensitive medicines produced are wasted due to problems in maintaining the cold chain. We are talking about a value equal to approximately 35 billion dollars: a waste that is perpetrated on multiple levels (raw materials, energy, reduction of access to care by patients) and which in times like the ones we live we can no longer afford.
To ensure compliance with regulations without worsening the environmental impact, indeed lightening it, logistics operators are investing significant sums in improving the efficiency of tools, devices and packaging and in the development of green solutions.
The most critical products are biotech
The issue is an age-old one: temperature stability throughout the entire supply chain has always represented the most critical aspect of the pharmaceutical supply chain.
The Circular of the Ministry of Health n.2 of 13 January 2000, recalling the Community Directive CPMP/QWP609/96, specifies the references to be included on the label with the indications of storage temperatures. The document also specifies thatthe medicine which does not contain indications on the label must be stored between -2°C and +40°C.
The vast majority of pharmaceutical products on the market today are stable in the temperature range between 2 and 8°C. This market segment is currently experiencing strong expansion, legitimized by huge investments in the development of biotech products, in particular gene therapy, for which end-to-end logistics and storage temperatures of -150° are required. C(in liquid nitrogen). The biotechnological drug is the one that most depends, in terms of stability, on the efficiency of the cold chain, in terms of constant real temperature and in range. Beyond advanced therapy products, the red biotech market is made up of a wide range of substances, including antidiabetics, antirheumatics, vaccines, antivirals and immunosuppressants.
The reference legislation
The transport of temperature-sensitive medicines is subject to the implementation and compliance with Good Distribution Practices (GDP), aimed at guaranteeing the quality, effectiveness and safety of medicines for the end user. The legislation requires that pharmaceutical products be transported in appropriate packaging systems in order to ensure their correct conservation and that distribution and delivery take place without alteration of their characteristics.
In this regard, the official Pharmacopoeia (FU) establishes that, during the shelf life period, the active ingredient must be maintained at 90% of its activity and in any case the general characteristics of the product must be guaranteed drug. The FU also expresses its opinion on the definition of stability by specifying that “a medicinal product is considered stable when, in a given period of time, its essential properties do not change or change within tolerable limits, if stored in a suitable container, in defined conditions of temperature, humidity and exposure to light”.
Gccmp (Good cold chain management practice)
Italian legislation is represented by the Decree of 6 July 1999 with which the Ministry of Health approved the guidelines regarding Gdp of medicinal products for human use and imposed on distributors the obligation to comply with these good practices.
In 2005, the Parenteral drug association published the technical report “Cold chain guidance for medicinal products: maintaining the quality of temperature-sensitive medicinal products through the transportation environment”. The document describes in detail the steps of the cold chain, the methods of transport of temperature-sensitive products, the materials intended for primary and secondary packaging and the principles of validation of transport methods.
Gccmp (Good cold chain management practice) require all operators who act in the transport and storage phases to verify the integrity and stability of the product, as well as its conservation at the indicated temperatures. Good practices recommend the systematic use of control systems in all cases where the environmental variables (light, temperature, humidity) are subject to unpredictable or extreme situations, even when the use of validated containers. This is because the procedures relating to transport are described as “qualifiable” (imagining acting in the “worst reference scenario”) and not “subject to validation”, since it is not possible to foresee all the possible situations that may arise during of the transfer.
The data in the center
The cold chain is maintained through the use of continuous refrigeration systems and appropriate logistics plans.Temperature-sensitive medicines require the use of protection systems, insulated insulating containers and refrigerants which must meet relevant requirements to the transport system used, the route (and duration of the journey) and the stability of the products themselves.
Given the expansion of the market in the direction of biotechnological products, logistics investments have flowed in recent years precisely in the direction of the implementation of solutions for controlled temperature transport. In particular, the improvement of the design and quality of packaging allows for increasingly efficient protection of the quality of medicines with reduced energy consumption.
Several start-ups, including those from the Italian academic scene, have developed eco-sustainable packaging solutions manufactured with innovative biodegradable materials characterized by high thermal insulation capacity. Irene dei Tos and Stefano Seccia, recently graduated from the materials science degree course at the University of Milan-Bicocca, have created Bioaerovax, an insulating and eco-sustainable packaging startup for pharmaceutical products based on the use of a bio-derived, light, biodegradable and heat-insulating airgel.
The importance of packaging technology affects both primary and secondary packaging, both active and passive. The use of reusable passive packaging equipped with smart devices which record all the data of interest (temperature, position, exposure to light, humidity, opening of the package), transmit them in real time on cloud servers that can be shared by multiple users and send default alert notifications in the event of anomalies.
Logistics giant UPS has set up the Cold Chain Packaging Center of Excellence, the first logistics center in the United States to offer customers reusable cold chain packaging options : an initiative that has drastically cut the volumes of single-use waste and enabled significant savings.
Digital innovation applied to healthcare refrigeration systems has led to the development of intelligent refrigerators. The IoT (Internet of things) technology on which the operation of these devices is based uses the internet for remote control of the temperature and all deviations that may occur from the set reference values (from electrical blackouts to incorrectly closed containers).
This allows you to keep the situation constantly under control through the use of a smartphone and to intervene if necessary at any time. The system is also designed to automatically archive all temperature data, saving hours of work for the workers. The installation of an electronic inverter compressor allows the work of the equipment to be modulated based on the load that needs to be refrigerated, leading to a significant reduction in energy consumption.