The cold chain and the pharmaceutical industry
The pharmaceutical industry supply chain requires a cold chain in the transportation of time and temperature-sensitive cargo globally. Aside from that, the cargo being transported is crucial in saving the lives of millions of people.
In the past, the pharmaceutical industry did not use the cold chain to transport its products. Many of the drugs before did not require a temperature-controlled environment. There has been an increase in the need for cold chain logistics in the industry. Because of the emergence of biologics and their effectiveness in combatting diseases. The latest trends in modern medicine also require sufficient temperature and time control. There is also an increased need for drugs that combat chronic diseases. Demand for over-the-counter medicines also increased. Most of these require cold chain transport. Fortunately, the pharmaceutical industry is keeping up with this demand.
Transporting the products through the cold chain ensures the maintenance of the quality of the products. It is crucial to maintain the cold chain throughout the process to guarantee potency,
The problem with the increasing complexity of the healthcare system
The production, transportation, storage, and deployment of biologics are expensive. Dysfunction in a single link in the process might render a batch of biologics ineffective. This could lead to product wastage and huge financial loss for the stakeholders. Wasted products could also lead to the loss of valuable data during clinical trials. Not only that, but its ineffectiveness also denies the public of a vaccine that could protect them from diseases. Poor logistics can be detrimental to an organization due to the possible emergence of lawsuits caused by poor treatment. Investigating takes up to 40 hours in labor and costs hundreds of thousands of dollars.
Pharmaceutical products are sensitive compared to other industries. It is important to take keen precautions during its transport. These life-saving products take time to develop, store, and transportation to ensure that no fatal side effects occur upon medicine consumption.
Determining the exact number of damaged pharmaceutical goods is hard to tell. Suppose the product administered to the patient is less effective. Estimating of degraded vaccines during the cold chain is around 20 percent.
There are a variety of factors that lead to product damage, such as:
– Improper package handling during packing, shipping, and receiving.
– Temperature excursions outside the allowable range.
– Light exposure
– Improper humidity settings
– Vibrations and shocks that occur during transportation
Pharmaceutical companies and manufacturers transport their cargo either frozen or chilled. To maintain the potency of their products. In 2015 through the cold chain, an estimated 31% of pharmaceuticals were shipped as chilled while around 17% were shipped as frozen.
A chilled cargo environment falls in the +2°C to +8°C (35.6°F to 46.4°F) range. It is imperative for products transported through a chilled atmosphere to avoid being frozen or being too warm. Otherwise, their potency will be reduced. Some vaccines need to within -15°C (59°F) during transport and storage. It is difficult to determine via eye test if the product was thawed and re-frozen, so these products need to undergo laboratory assessment before they are used. Some examples of cargo that need to be shipped as frozen are organs and tissues.
Globally transported pharmaceutical products
Various products are transported through the pharmaceutical cold chain worldwide.
This product includes:
- Biologics, prescribed drugs
- Over-the-Counter medicines
- Raw material
- Bulk pharmaceuticals.
These pharmaceuticals products come in three forms liquid, solids, and jellies. These products need to be appropriately labeled and packaged. Pharmaceuticals are damaged due to a variety of external factors. It is important for biological products to be handled properly.
Long-distance transport of pharmaceuticals
If pharmaceuticals are transported via air freight. But most pharmaceuticals that need to be transported to a further distance are done through ocean freight.
The International Air Transport Organization (IATA) says that pharma transport through air cargo has declined from 17% in 2000 to 11% in 2013. Meanwhile, 0.5 million tons of pharmaceutical goods were flown in 2018, while 3.5 million were shipped via ocean transport.
The reason for the decline is because air transport is often more expensive than ocean transport. Transportation via air freight experiencing more temperature excursions. This is opposed to road or ocean freight. During this, cargo is often most vulnerable and susceptible to a temperature excursion. Especially while on the airport tarmac before loading or during unloading.
The cold chain and the pharmaceutical industry
Implementation of cold chain logistics guarantees the temperature monitoring and management systems are in place—throughout every step of the process. Temperature excursions is a critical issue for pharmaceutical companies. Their products are dependent on proper temperature regulation. During distribution, monitoring maintains the efficacy of their products.
Due to the advanced therapies that are derived from human cells. The demand for temperature-sensitive products increased. Thus, increasing the need for cold chain logistics.
The cold chain industry makes significant advancements and develops equipment through innovative temperature sensors and data loggers—this integrated track and trace and real-time remote temperature monitoring systems. The emergence of these innovations is beneficial for the delivery of sensitive products.
Pharmaceutics also adopt cold chain logistics for quality assurance. Good Distribution Practices (GDPs) are a rule by many regulating bodies across the world. And they are strict on temperature regulation to preserve the quality of pharmaceuticals. To reduce incurred wastes and improved assurance, pharmaceuticals employ cold chain logistics.
There are different aspects that need to be considered by those involved in the cold chain process. Ensuring the appropriate usage of equipment such as storage units and thermometers. Employing the applicable storage and handling methods for frozen and refrigerated vaccines. Strategies and standard operating procedures should be in place to ensure the maintenance of the cold chain. There should be proper inventory management and emergency protocols to protect the vaccines
The World Health Organization and the EU Commission have strict requirements to ensure that the pharma goods being delivered are effective and, most of all, safe to use. Any pharmacy can be in trouble if they do not monitor their shipment.
Cold chains that use temperature monitoring equipment and data logging are better managed. Therefore, maintaining the products’ integrity, reducing product loss, conserving money, and improving health and safety.
The integration to cold chain systems allows monitoring of existing conditions of the pharmaceuticals. Data, whether appropriate conditions are met or not, are recorded through the data logs. This avoids a similar incident from occurring in the future and ensure improved shipping conditions. Monitoring different measuring points also increases the accuracy of determining the unusable shipments. The more evidence of a product is usable, the lesser it will be lost due to mishandling.
Data loggers work through the installation of one or two sensors. Each sensor records environmental phenomena. The sensor device, or data logger, has a microprocessor and memory. This is used for data storage that can be transferred to a computer or cloud software. This information will be available for monitoring and can be utilized right away. Supply chain managers analyze the collected data to formulate effective supply chain strategies. It also takes into account each sensitivity.
Proper data logging is crucial in the pharmaceutical cold chain. Since it can guarantee product safety, which is the foundation of the pharma and health care system. Initial costs of installing data loggers may be high. But to determine which products can be used or not improve operations and increase the general public’s trust.