The Six Key Features of a Pharma Cold

Chain Early Warning System

There is a lot of progress and advancement in technology that helped humans in different aspects,
especially science. In pharmaceuticals, the import and export of medicines evolved from manual data
logging to real-time logging using Bluetooth devices and wireless data connection. While these
advancements resolved some technological troubles, filling some gaps is still necessary. One of the
substantial gaps is having real-time and accurate data stipulation, also known as an early warning system.
The implementation of the early warning system comes with various factors, so it is noteworthy to take a
look at the six key features that make up an excellent pharma cold chain warning system.

Pharma Cold Chain

The cold chain is the most crucial of all types of logistics, especially when it comes to food perishables
and pharmaceutical products that make up the broadest part of the country’s supply chain. It involves
constant product refrigeration from the time of its production, transportation, handling, turn over, and
storage. Also, it requires a full understanding of the chemical and biologic processes linked to the
perishability of goods. The success of importation relies solely on the shipment and temperature control
by adapting to different circumstances. A slight change in temperature can damage a particular drug that
can cure or save a life. One way to prevent this is to find an innovative approach to mitigate the
occurring risks of product shipment that compensate for the price.
Manual data logging is quite outdated, so we need something more advanced to prevent the worse from
happening — a pharma cold chain early warning system. It will alert people and would make an
immediate action possible.

Early Warning System Vs. Manual Data Logging

The early warning system can provide you real-time, accurate, and visible data, while manual data
logging will just give you a glimpse regarding the condition or the temperature alone. The early warning
system is a combination of live data gathering that can result in a preemptive action and reduce the
assumed risks or losses from the damaged goods. It means there will be lesser risks, better performance,
market share, and brand image. When dealing with pharmaceutical products, investing in an early
warning system is crucial. An early decision making and contingency planning will prevent such
anomalies, so take necessary actions before the problem arises.
The Six Key Features of an Early Warning System
Since wireless monitoring provides you execution and connectivity, you can track the products’
temperature in real-time. This system can provide you information that you can utilize instead of
manually scanning through hardcopies or spreadsheets. You can retrieve these data automatically with the
help of an early warning system to contain further damage. Here are the six key features of a good
pharma cold chain early warning system.

1. Accuracy of Data

Location and condition, particularly temperature, vibration, tamper, and vibration, should be accurate.
The range of temperature depends on the type of goods. Hence, changes in the condition of the products
could make or break the quality. Accuracy of data will help you determine and monitor the shipping of
goods. Therefore, ensure that the sensors are NIST-certified.

2. Package-Level Sensing

Small packages in small pharma consignments are at high risk of a temperature excursion, and it is
noteworthy to keep track of the conditions of individual packages. Package-level sensing is essential
while transporting cargo into separate pieces by air. Hence, every package can be monitored during
reconsolidation. It requires the use of non-Lithium batteries to comply with airline regulations, which
restrict you to two sensors per airway bill if Lithium batteries are used.

3. Real-Time Data Update

A quick and better decision making can be achieved if the data gathered are in real-time. Dealing with
delicate pharmaceutical goods, such as vaccines and vials, is crucial. Hence, live data gathering should be
done to prevent damages. Data are now cloud-based, so make sure your device has strong connectivity
and large memory to store data. Receiving early warning means trouble. Therefore, you can prevent these
by having live data.

4. System of Analysis

The system needs predictive analysis and decisions based on evidence to elevate efficiency and reduce
possible risks. It should support real-time MKT (Mean Kinetic Temperature) for an easy determination of
damage concerning the condition of the package.

5. Receptiveness
The system should have a sense of receptiveness to respond to incidents as quickly as possible. If the
system is not responsive, you can’t guarantee that the person in charge will attend it on time. You can
achieve it with the help of a three-fold plan —IoT+AI+RPA. It is a combination of the Internet of Things
(IoT) that determines the delay or condition difference in time, Artificial Intelligence (AI) that helps one
to make a timely-decision based from the information gathered from human intervention, and the Robotic
Process Automation (RPA) for a prompt implementation of decisions.

6. Compliance

There are several regulations and sensor certifications for pharma products when it comes to shipment to
different locations. Ensure that the platform you are using is globally compliant and genuine. Having
NIST certification means that the system is tested for accurate temperature. The 21 CFR Part 11 of the
Food and Drug Association (FDA) requires the companies to have electronic documentation for data
security and authenticity.

Conclusion

Implementing this early warning system can benefit the company in the long run. Not only damages,
spillage, and delays in pharmaceutical goods can be prevented but also putting people’s lives into great
danger. Manual data logging is outdated, while an early warning system could be a lifesaver and help you
get the job done in no time.