Introduction
Revisiting the chronology of developments in the pharmaceutical industry reveals that logistics with cold chain storage were optional in the past. Most were non-temperature-dependent drugs such as pills (tablets and capsules), suspensions, and ointments, which needed no sophisticated facilities.
Compared to pharmaceuticals, cold chain logistics and cold storage systems were mainly used in the food processing industry. With the advent of new drug molecules with diverse origins (gene therapies, biologics, vaccines) in recent decades, the use and adaptation of cold storage and logistic chains have exponentially boomed with respect to the pharmaceutical industry. This article highlights the essentials of cold chain logistics and temperature-controlled storage and their increasing demand in pharmaceutical supply and transport chains.
Why Are Chain Logistics and Temperature-Controlled Storage Needed in Pharmaceuticals?
Storing certain pharmaceutical products and transporting them through cold-chain logistics is essential because these substances are primarily temperature sensitive and would undergo degradation at high temperatures or in improper storage procedures.
Some of the pharmaceutical products that need cold storage and logistics are as follows -
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Biologicals include vaccines, monoclonal antibodies, immunomodulating agents, growth factors, and plasma or blood-derived products.
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Cell therapy products like human embryonic cells, hematopoietic stem cells, and other stem cell types (neural, mesenchymal, and differentiated).
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Reagents that are needed for biomarker and genetic testing.
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Molecular diagnostic products such as primers, nucleotides, and polymerase enzymes.
The need for cold chain logistics and temperature-controlled storage has increased in pharmaceuticals because of the following reasons -
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High temperatures cause structural disintegration of sensitive pharmaceutical products, making them unconsumable and leading to harmful effects from using damaged medications.
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Cold storage and associated logistics ensure quality assurance and sustain the efficacy of the therapeutic products.
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Most biopharmaceutical products are temperature sensitive and require time-controlled delivery and distribution. They are fragile and should reach hospital or pharmacy settings within the stipulated duration for effective clinical outcomes.
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These are high-value shipments involving huge production costs. Damaged products incur heavy financial losses, affecting the whole healthcare system. Cold chain logistics and associated storage facilities greatly reduce such setbacks.
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Pharmaceutical companies require cold storage logistics to prevent the marketing of spoiled pharmaceutical products. This avoids unnecessary lawsuits, tarnishes public relations reputations, and saves companies from shareholder distrust.
What Does Cold Chain Logistics Mean?
Cold chain logistics widely refers to the supply chain of temperature-controlled products. It constantly requires persistent refrigeration systems for the products, starting from the initiation of their synthesis and production, followed by their transportation, safe handling, and storage, until the delivery time. This cold chain system preserves and maintains the efficacy and usability of pharmaceutical products and other substances like chemicals and food items.
Regulatory organizations like the FDA (the United States Food and Drug Administration) have introduced strict standard operating procedures (SOPs) for pharmaceutical products' ideal cold chain logistics. They ensure that good manufacturing practice (GMP) and good distribution practice (GDP) guidelines are followed by the drug distributors for the safety and viability of the products.
The key features of cold chain logistics are as follows -
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Temperature Management - Devices like temperature recording loggers are packed along with the desired shipment. This records the products’ temperature and other environmental parameters like humidity throughout the transport duration and is automatically uploaded to the temperature monitoring system.
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Informatics - GPS tracking facility enhances real-time surveillance, and the occurrence of any discrepancies is reported immediately to avoid negative impact. RFID (radio frequency identification) hardware systems are installed for efficient end-to-end monitoring and data generation.
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Packaged-Dependent Temperature Control - These systems maintain the optimal predetermined temperature conditions. Depending on the requirement, some devices are set to be passive or activated to alter the temperature.
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Digital Communication - Effective data collection and communication play a prime role in cold chain logistics. The whole chain of processes and supplies is executed with automated integration by linking the data support devices, regulatory protocols, and high-quality demands (zero marginal errors).
What Is Temperature-Controlled Storage?
The World Health Organization (WHO) defines a pharmaceutical product as any potential product for human use marketed with an optimal dosage form and subjected to pharmaceutical legislation involving exporting, importing, prescribing, or selling the product over-the-counter (OTC medications). Medical devices are not included in these criteria. Certain recently developed pharmaceutical products require a temperature-controlled environment for maximum drug stability. In a temperature-controlled environment, the temperature is either actively regulated or passively controlled at the prescribed level within standardized limits, showing large variations from the surrounding temperature.
What Are the Types of Pharmaceutical Temperature-Controlled Storage?
Special pharmaceutical compositions that are easily fragile about temperature or duration are time- and temperature-sensitive pharmaceutical products (TTSPPs). Following a predefined and well-controlled environment for storing and transporting TTSPPs is mandatory.
Various temperature ranges are used in temperature-controlled storage conditions, which are as follows -
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Controlled Room Temperature - Ambient temperatures ranging from 68 degrees Fahrenheit (20°C) to 77 degrees Fahrenheit (25°C) are used for non-temperature sensitive products and are stable at room temperature. Most drugs, vaccines, and medications are stored in a positive cold environment. It is also used in preparatory labs where reagents and products are kept to thaw after being removed from deep freezing.
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Refrigerator Temperature - A temperature range from 35.6 degrees Fahrenheit (2°C) to 46.4 degrees Fahrenheit (8°C) is required for products that need chilled surroundings but are not to be frozen. This is followed mainly by reconstituted medications prepared for intravenous (IV) infusions for transient storage.
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Cryogenic Temperature - Here, the temperature ranges from -112 degrees Fahrenheit (-80°C) and extends even below very low or ultra-low temperatures (lower than -238 degrees Fahrenheit or -150 degrees Celsius). Cryogenic refrigerators are used for achieving such extreme sub-zero temperatures (negative cold environment). These storage facilities need competent cooling solutions for cryogenic freezing processes.
Monoclonal antibodies, gene therapies, and mRNA require -112 degrees Fahrenheit (-80°C) storage systems.
Biopharmaceutical products for cell therapy are stored at or below -202 degrees Fahrenheit (-130°C).
Cryogenic temperatures below -238 degrees Fahrenheit (-150°C) are required for gene-modulating cell therapy products.
Conclusion
The pharmaceutical industry maintains high quality and standards in manufacturing healthcare products and medications for the general public. New research and clinical studies have led to the development of diverse therapeutic agents that are sensitive and fragile to fluctuations in temperature and handling (transport).
Cold chain logistics and temperature-controlled storage facilities provide safe handling and transportation, assuring drug stability and efficacy. Globally, pharmaceutical temperature-controlled storage and cold chain logistics are steadily rising, especially post-COVID pandemic, due to the increased demand for vaccines and biological therapeutic products. Further groundbreaking drug discoveries and life-saving therapeutics would open new perspectives in managing pharmaceutical temperature-controlled storage and cold chain logistics.
