Did you know about a third of the cold chain pharmaceuticals are in danger to erratic temperature ranges? Be it accidental or deliberate, it can mean thousands, if not millions, of dollars’ worth of medicines, are being wasted. Not to mention, that these medicines go to waste that could save someone’s life.

Better regulations and guidelines on the handling of these pharmaceutical products are now being implemented but the difference in the country’s laws makes it difficult to track the temperature settings of the cold chain.

For both the safety of the patients and business interests, monitoring these temperature excursions would be the first step. This should be equipped in the logistics operation and provide real-time data to optimize the delivery system.

Before the technology boom, warehouse managers manually collected information from temperature gauges or by inspecting the product. Cold chain monitoring with sensor-based technology can allow the managers to send that data for analysis instead of fixing the problems.

Investing in a cold chain monitoring system

The Invesment in a cold chain monitoring facility can be significant. You must balance between the loss of the products due to temperature fluctuations and the amount in acquiring this technology. If the costs justify the preservation of the products, then it is a good investment.

Now you have decided to acquire the temperature monitoring system. It’s time to choose which system is suited to your storage facilities. The problem here there is no one-size-fits-all option for cold chain monitoring. Locations and product specifications vary for the cold chain delivery system. Another is the place where the products are shipped. Countries have their own regulations as to what can be allowed inside their territory.

The monitoring system can go out of the confines of the warehouse to get a bird’s eye view of the supply chain’s climate. Then, companies would decide if they want real-time data or simply want to look at data when products arrive at a port or another location.

So what is a cold chain?

Cold Chain

It is referred to as the temperature cold chain, the immunization vaccine cold supply chain, and other names. It’s the transiting of the medical products or vaccines from the manufacturing warehouse to the delivery destination – i.e. from a pharmaceutical company to hospitals or health center. Every step of the cold chain must be tracked for temperature, from manufacturing to storage to shipping — all the way to the customer — to ensure product quality and safety.

It only takes a missed alert or power outage to lose an entire medical shipment. Preventing this mishap is first and foremost for every pharmaceutical company must risk undertaking.

vaccine supply chain
The route of vaccines, ensuring temperature compliance at each stage is a challenge

The major risks in cold chain supply are refrigerator or freezer malfunction, power outages, flooding, alert during off-hours, and human errors.

To protect the full potency of the vaccines, careful attention is practised at all levels of the cold chain. These include storage and transport of vaccines from the manufacturer through the primary vaccine store down to the end-user at the health facility and further down at the outreach sites.

A cold chain is the amalgamate system of equipment (for example; cold rooms, shipping containers, refrigerators, vehicles), procedures, records, and actions that handle, store, transport, distribute and monitor temperature-sensitive products. Like a physical chain, a cold chain is only as strong as its weakest link.

There is a general assumption that the cold chain complications occurred only in the developing countries when in fact it happens to every country where temperature monitoring has been observed. The Effective Vaccine Management initiative launched by W.H.O noticed also a non-acquiescence with temperature monitoring requirements in all levels of the vaccine cold chain to about 45 countries.

These temperature discrepancies reports come from the US Department of Health and Human Services, Office of Inspector General. In about 45 selected contractors, vaccines stored by 76% of them were exposed to sub-standard temperatures for at least five cumulative hours during the 2-week period. None of them followed the vaccine management requirements as established in the Vaccines for Children Program Operation Guide.

To address this problem, the United States Pharmacopeia, Health Canada, and the European Union introduced new guidelines to the pharmaceutical cold chain management. This is to regulate the storage and distribution of temperature-sensitive drugs.

Consider if the regulations were not in place, which would mean billions of dollars of worth of pharmaceutical products would be lost. That means the medicines intended for the patients are not reaching them.

As more and more of the highly valuable and temperature-susceptible biopharmaceuticals are entering the market, the importance of temperature monitoring and its maintenance will continue to increase.

In addition, these products can mean life or death to someone. Therefore, any mishap will ultimately create delays, damage costs, and even possible suffering for the patient who should be receiving that medicine.

To ensure that the patient gets the medicines he needs in pristine condition, the regulations advise the pharmaceutical company should adopt the best practices to guarantee everything is done right that the risk to the patient is completely eliminated.

This includes but is not limited to: finding the processes that are fit for the purpose; orientating personnel closely associated with the pharmaceuticals so that they know their responsibilities and know to exercise due diligence in their work, and building an exceptional management system to track the processes and that people are working up to par.

pharma cold chain monitoring
source: https://sensire.com

While in most cases it is difficult to ascertain how well a temperature monitoring technology would work for your process and improve your performance, these are the seven criteria you should follow:

1. Assess your current operations

It can be a challenge to find the problem until the system breaks down then try to fix it. Let’s start with the data where losses are occurring.

If an area in your warehouse is repeatedly damaging to the goods or the shipments are put in the wrong places and gets spoiled, then you have a blind spot in the cold chain and need to remedy it.

If you are handling other pharmaceutical companies’ goods, ask them about the conditions required for the warehouse to store their goods and what is expected from you. Future transactions will flow more easily and can add more valuable service that distinguishes you from the competition.

2. What goals do you want to accomplish?

Now that the operations of the warehouse are in full swing. It is operating up to standard? Is the monitoring system working perfectly? Are you looking for ways to increase revenue income and overtake the competition?

It could be enhancing the monitoring system, cutting costs, or getting more accessible data. Whatever the issues, you should know what you are looking for and take action to improve your cold chain.

3.  Have a meeting with the staff

Once you find the trouble spots, it’s best to talk to the people who have first-hand knowledge of the problems namely the staff working on the cold chain monitoring system. They are the experts who work on it every day. They will tell you what needs to be done and how to solve it. By doing this you can save yourself a lot of pain.  

Sometimes it just needs a little adjustment. But in case you need to replace the whole system, it’s best that you involve the staff from the very beginning. After all, they are the ones who are handling the system.

pharmaceuticals and temperature

4.  Looking for the right supplier

Now you are in the market for a new temperature monitoring system, you need a checklist on the options you are looking for in the monitoring system. Factors like a level of service, price, and knowledge of the field, references, and warranty options.

And more importantly, if they can deliver within the timeframe you set. Another getting suggestions from your staff since they know a number of suppliers and their offerings

Ultimately, reduce the list to two or three suppliers. Study their offerings and choose which best fit for you. But don’t discard the rest, if the first deal falls through, you may want to go over the list again.

5. Establishing some key performance indicators

Now you have chosen the suppliers, it time to do a test run which system works best for your cold chain. To do that you need to set up some key performance indicators (KPIs) like diminishing temperature range to a certain level or running capacity of the storage system.

Once the KPIs perform to your satisfaction, you can proceed to the next step on how well the KPIs can be complete by your set of potential systems.

6. Do a performance run on the monitoring system

Now you’ve chosen a few vendors to test run their systems and evaluating them based on your KPI’s. It’s time to see if these systems perform well in your actual pharma cold chain.

One thing to consider in the pilot stage is that the performance should follow the guidelines you set as strictly as possible, from setup to evaluation. This enables you to predict what performance to expect if you were to choose one and start refining it up.

After the tests are done, you can take some time to compare the results of the systems against each other. What is the best system to use, what system performed most efficiently, what was the one that gave out the most accurate data? Once you do the evaluation to your KPIs, you will get which of the options has worked best for you.

7.  Scale-up if successful

Scale-up shouldn’t be a problem once you have set the goals we discussed above. Knowing what you’re doing this for, you have even tested that the system according to your expectations and the set-up processes are already known to you.

If you have tested all the settings of the system during the pilot run, you should have a good grasp of what kind of data you’re receiving and from where.

And by being able to focus on the obstacles you won’t have to worry that something will slip through the cracks by and cause trouble further down the line.

Now you have acquired the right temperature monitoring system for your operation, you should now be able to start removing previously existing obstacles and improve those parts of your pharma cold chain that were doing merely fine before.

3 Common Types of Temperature Monitoring Systems:

  1.  Standalone data logger that operates separately from a PC. these are handheld models that use USB for data retrieval or rely on WiFi to transmit data. For outfield work, these models have battery storage that can last for a year or more.
  1. Networked LAN/WiFi measurement device. These can transmit data over to facility’s network of PCs. They can be wired or wireless. A common networked system has remote sensors to collect data locally and transmit it to a central station, which sends alarms and data via e-mail, or by FTP to a server.
  1.  Wireless measurement devices and wireless base station or gateway which can send alarms immediately to save time in rescuing the pharmaceutical goods. They connected directly to the internet. 

The various monitoring technologies are now available for monitoring temperature control system:

  • RFID and wireless sensor networks (WSN):

These are the leaders in the area for cold chain monitoring. RFID sensors are able to record the location and temperature and sent this information back to a database with more accuracy which calculates parameters like an estimated remaining shelf life. WSN devices have more sensors than RFID, but are also more expensive. RFID and WSN devices are usually limited to one per pallet, but the data collection involved can be relatively substantial.

Thermal imaging could be used to minimize the number of actual sensors (RFID or WSN) used within a storage setting. But this technology is not that reliable because of the type of packaging or surface it is trying to measure.

  • Computational Fluid Dynamics (CFD) is a system for analyzing the airflow during the cooling process and can determine the best ventilation for crates, pallet distribution and other variables within cold storage.

Now that you know what procedures in getting the right monitoring system, you might get anxious if you have done it right. Try getting outside help. There are lots of experts specializing in the pharma cold chains who can recommend the best system for your storage facilities.

Another is the free consultation offered by the suppliers. But there is the risk of being strong-armed into buying their system. But if you already have the mindset of looking for the monitoring system, that won’t be a problem.


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