Obtaining the Best Practices in Cold Chain Management

Published by Ariel Arcebido on

vaccine cold chain

Over the past years, cold chain logistics have been increasingly complex and complicated, thanks to strict government regulations and ever-changing demand in the pharmaceutical sectors.

There is a shift towards a structurally complex, biotechnology and specialty formulas, as well as complex clinical trials that have raised the stakes exponentially for cold chain logistics.

biotechnology

The reason behind these changes is that cold chain logistics failure is the primary element in drug spoilage. If there is the slightest change in temperature, it can endanger a shipment’s integrity.

A cold chain must have continuous refrigeration all through the storage and distribution to safeguard the medical product’s quality. But the problem here is that cold chain logistics are very complex, and it’s difficult to track the proper cooling process from the loading dock to the final destination. And using any obsolete cold chain management solution that does not have the ability to monitor perishable assets in real-time is a disaster waiting to happen.

Source: https://miro.medium.com

Nowadays 95% of warehouse management is not taking advantage of the benefits of digital supply chain technologies. But some are making the transition to implement technologies like IoT, data analytics, Blockchain, and machine learning to further enhance their operations.

Some of the benefits of digital cold chain logistics technologies have leverage digital technology, which can expect increased speed to market, higher revenues, and reduced costs. Thus, adding big value for businesses.

So how can a logistics supplier meet these challenges? Let us examine some of the practices across the supply chain:

  1. Shipment Preparation

To understand the cold chain logistic, the chemical/biological elements of the product must be studied, the ideal temperature range, and packaging requirements.

Cold chain equipment maintains the temperature at a prescribed level, not to bring up the temperature of the shipment. Thus, cooling systems are utilized to keep it at a constant level.

The temperature monitoring is very delicate work- a single mishap could affect the potency of the drug. Apart from temperature, humidity and hygiene checks are also critical.

Mobile equipment such as reefers needs to be pre-cooled and cleaned by steam before transporting to avoid the occurrence of spoilage or contamination.

  1. Emphasizing the ‘Cool’ in the Cold Chain

Cold chain technology today can cater to a wide variety of products to pre-set temperature levels – from cryogenic (-135°C / -211°F)) to deep-frozen, frozen, chilled, and different controlled room temperatures (CRTs). But keeping it at the required range at each link of the cold chain is daunting.

The surrounding temperature during the journey and at the destination, as well as weather patterns, need to be included in the equation. A reefer, with an independent power source, can hurdle those challenges. It also has to be versatile enough to carry at least 20-25 tons of temperature-sensitive medical products. Thus, it can be used for the intermodal transportation system for international markets.

To control the temperature of the vaccines in-transit, cold packaging is imperative. This can be achieved by wrapping the shipments in ice pack bags, which will prevent heat from entering the medicines.

RCW 27 vaccine cooler
vaccine cooler packed for transport

Less handling as well as unloading time is also important to maintaining the integrity of the shipment.

  1. Options of Packaging

Packaging depends on the active or passive in its approach and efficacy. Active packaging involves an active mechanism to keep the temperature constant, plus monitoring devices such as GPS and telematics.

Passive packaging is water/ ice/ dry ice containers to preserve the medical product at the required temperature. But these shipments have a time limit to reach their destination and can be vulnerable to outside temperature changes.

Choosing between the two methods should how much the cold chain logistics is willing to take. What are the pros and cons of adapting one method from the other?

Another risk is the regulatory compliance requirements of the various government agencies involved. Plus the possible loss of market share or brand value, should the product becomes spoiled.

  1. Specialized Cold Chain Networks

When it comes to temperature-sensitive pharmaceutical products, the logistics contractor’s equipment and facilities must be highly adapted to handle these products, and serve as an extended hand of the manufacturer.

An example of which is DHL that has a Life Sciences and Healthcare division, which maintains certified stations near major airports, that operate on global GDP (Good Distribution Practices) standards. This guarantees that shipments are held, handled and forwarded under controlled conditions.

Warehouses storing these shipments for an extended period should be GDP certified, and provide other services such as repacking, country-specific labeling, end-to-end tracking, and compliance documentation.

  1. Maintaining Standard Operating Procedures Internationally

Medical high-value goods traveling globally through the cold chain needs careful planning and step-by-step procedures in case there is a problem in transit. To formulate an action plan for the cold chain, an examination of the provider’s in-transit / storage requirements and risk factors in the supply chain.

This includes scenarios on what to do if there is a delay in flight or if a container was compromised and starts to leak etc. The SOP’s should be the same across markets, and the logistics provider needs to work together with the client on these SOP’s. The bigger the risks, the working together needs to be closer.

  1. Intelligent Cost Management

In transporting pharmaceuticals, rather than looking at the costs on a purchase price basis, it is better to focus on TCO (Total Cost of Ownership).

This includes direct as well as indirect costs like the risk of penalties, patient safety, loss of business/ market share/ brand value, investor concerns, etc. The hidden costs are the real risk factor in pursuing the business, should the cold chain fall through.

Hence, 3PLs should know that when they cut corners on one link of the cold chain without considering TCO, they put their client’s business in jeopardy.

  1. Getting the Latest Monitoring Technology

In the US, nearly a third of all medical products are wasted. Out of this, about 12% occurs during the distribution process. To avoid spoilage, it is absolutely essential to make sure that the cold chain temperature is working at an optimum level at a specified range while in transit.

The only way to monitor the temperature using state of the art technology for real-time tracking. Fleet management system can take advantage of the power of GPS and telematics to monitor all the temperature, humidity, and store settings of the cold chain supply.

It can send out alert signals in real-time so that corrective actions can be taken before it becomes worse.

  1. Creating Qualified Teams

Although technology and logistics are the foundation of the cold chain, it is the people with the knowledge that actually keep it operational. Pharmaceutical logistics providers need to create teams that have the skills and experience in the different cold chain stages like product needs, handling of shipments, and maintaining SOP’s.

Thus, it is imperative to train teams to work on cold chain logistics before delivering medical products to other countries. A good example is DHL Life Sciences and Healthcare employees got trained in GDP.

  1. Constant Compliance

With the different government regulations in various countries in the world, it’s a challenge to comply with all these procedures. 3PL’s are also required to be proficient in compliance rules. Fortunately, the WHO Performance Quality Safety (PQS) guidelines are accepted by all countries for the cold chain delivery compliance.

Not only do they monitor and log temperature and humidity for every shipment when it is in transit in the cold chain supply line, but they also have to provide the documentation as well.

This also means the logistics providers can present proof of product integrity to regulatory authorities. It also gives the pharmaceutical companies a peace of mind and can trust the providers

Last and not least, in case something goes wrong, these logs can be examined to find the source of the problem.

  1. The Advantage of Artificial Intelligence

The computing capabilities of Big Data can be a boom for the cold chain. By integrating AI in the cold chain logistics, it can analyze terabytes of data generated across thousands of shipments, find the risk trends and provide the methods of alleviating these risks.

Another advantage is by analyzing the procedures in packaging products, markets, temperature ranges, routes, transport modes, etc. it could give recommendations to improve the efficiency of the systems to shorten the qualification process for packaging

To ensure the cold chain delivery providers will perform what is expected of them. Here are some recommendations:

  1. Preventing waste with alert signals in real-time

Cold chain logistics usually collects data during transit. However, the information can only be examined after the arrival of the products to their destination. Today, IoT are used to check on the cold chains in real-time and send alerts immediately if something goes wrong.

For instance, companies use wireless temperature sensors for uninterrupted temperature monitoring and real-time alerts. If a drug shipment inside a reefer goes beyond its temperature range, the sensors will transmit an alert to the parties concerned. The system manager will send out a technician to transfer the shipment to another container or troubleshoot the problem. This approach gives the providers enough time to respond quickly to any situation.

2. Shifting to digital cold chain monitoring to comply with regulations

Pharmaceutical companies need to always comply with safety and quality standards set by the authoritative regulatory bodies throughout cold chain logistics. But the old cold chain logistic solutions cannot provide real-time data on the shipment and don’t always have an accurate data compilation.

Therefore shifting to digital cold chain logistic solutions can let companies record in real-time and previous temperatures in the cloud. Thus, meeting compliance standards the companies are required to provide. The data on the temperature of vaccines or medicine is then available when needed.

When finding a cold chain monitoring system, the best advice is to invest in a digital cold chain management technology solution that can document temperature changes in real-time. IoT sensors offer that solution to establish transparency in a cold chain. A compliance manager can will the track temperature and recommend actions before a problem occurs.

3. Optimize driver competence and safety to ensure safe delivery

The use of smart, connected sensors with IoT technology is the key to improving driver safety and delivery. The GPS equipped IoT devices to let the companies find shorter routes and keep in constant contact with drivers.

Driving data from the onboard diagnostics can also reward good behaviors that help drivers adopt safe driving habits. Telematics show how often a driver speeds, if he/she is going over the speed limit, taking corners too sharply, or how often they’re using their seatbelts. By analyzing this data, a company can evaluate their driver’s performance.

4. Find a system that has an all-in-one cold chain technology deployment

When looking for digital cold chain technology solutions, look for one that has everything you need to monitor and track your shipments:

Reliable connectivity — choose a platform that can offer wireless connectivity options so you can monitor your assets no matter where.

Real-time GPS tracking — find a system that already comes embedded with tracking features such as GPS and geolocation mapping services.

Real-time temperature monitoring and alarms — get a monitoring solution that already has temperature sensors built and pre-set to your company’s standards.

Dashboard analytics — used in monitoring and analyzing important asset parameters.

With the digital cold chain monitoring solutions, all scenarios are planned out as cargo is surveilled from the journey’s start through delivery. All areas of the supply chain are improved with IoT cold chain-management.

Conclusion

As technology is changing faster than anyone can predict. The global markets on pharmaceutical products, distribution processes, and regulatory requirements will get more and more complicated and complex.

A smart fleet management software can aid logistics providers the means to make sure and give confidence that products are not only stored at the prescribed temperature but also kept within an approved level in every link in the supply chain.

After all, when it comes to multi-million dollars’ worth of medicines, can you afford to have any weak monitoring system to safeguard the shipment?


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