A study of the global pharmaceutical supply chain, which includes the delivery of vaccines, estimates that well over 30 percent of deliveries are damaged or spoiled by the time they reach their destination. The World Health Organization (WHO) says more than half of vaccines shipped globally are likely to go to waste due to inadequate temperature controls and other cold chain logistical issues.
Delivering vaccines around the world is tricky. Vaccine logistics issues such as wastage and spoilage aren’t new to the pharmaceutical sector. But, as many countries worldwide continue to vaccinate their populace against Covid-19, vaccine wastage has become an increasing concern for the pharmaceutical industry.
Having a robust temperature monitoring system in place is an obligatory part of a fail-proof vaccine logistics strategy. Its presence can mean the difference between getting a safe, effective vaccine to the right people on time and a disastrous vaccination roll-out. At the organizational level, monitoring critical temperature data along the vaccine supply chain, from research & development to administration, can protect the patient’s safety as well as a company’s reputation and bottom line.
To help you get started, we’ve put together four best practices for creating and implementing an effective vaccine temperature monitoring system.
1- Get to know your organizational needs
For superior management of your vaccine logistics, you must set well-defined goals and have clear-cuts plans for implementing your temperature monitoring system. It would be best to bring together all the stakeholders to discuss the broad aspects of the vaccine temperature monitoring strategy.
First, determine your temperature monitoring needs. In other words, how many data loggers do you need? How often should temperature data be measured? Where should sensors be installed? For example, if you’re dealing with the Covid-19 vaccines, it makes sense to place temperature data loggers inside each batch or cold box.
Do you need extra sensors? In most cases, vaccine temperature isn’t the only environmental parameter that needs to be monitored. Vaccines are sensitive to myriad environmental factors, so you may also need to keep an eye on ambient light, humidity, location, vibrations/shocks, and even tilt of the shipment to ensure complete protection of the vaccines along the cold chain.
Right from the start think about setting up extra sensors to record and monitor all parameters that may have an impact on vaccine safety and efficacy. Equipment diagnostics is another area that you may want to consider to make sure cold boxes, freezers, and other pieces of hardware are always in good operating order.
You must also conduct a risk assessment to identify areas of concern for consumer and vaccine safety. The FDA recommends a risk-driven approach to implementing a vaccine temperature monitoring system. At this early point you should craft an actionable incident response plan, making sure there is a dedicated team with a clear strategy for handling each potential risk, be it equipment breakdown, temperature excursions, power loss, or anything in between.
If the worst-case scenario does happen, a robust temperature monitoring strategy can ensure that quick and effective corrective action is taken by the right personnel. This helps prevent or at least mitigate the costs and damage resulting from any condition deviations or equipment failure. Planning for greater visibility and temperature monitoring of all points in the cold chain right from the beginning is paramount.
Last but not least, your company must also consider how your vaccine temperature monitoring needs will evolve, grow, and perhaps become more complex in the future. What happens if there is a sudden need for vaccines across the world? Do you have a contingency plan to put into motion?
2- Establish ongoing personnel training and education
Vaccine cold chain best practices, regulations, and guidelines are constantly evolving, and they vary from one vaccine to the next. For this reason, you must provide personnel who are involved in the vaccine cold chain with ongoing education and training.
Each person that handles the vaccines must be furnished with the latest procedures, techniques, policies, and any other information that they should know. Continuing education for personnel should be a constant priority to help staff keep up with all changes and ensure that the temperature monitoring system does its job.
This isn’t a good-to-have strategy; it is a must-have. As per the FDA’s 21 CFR Part 600, anyone involved in handling the vaccine must thoroughly understand all of their job functions. Here are a few key pointers to include in your vaccine temperature monitoring staff training:
- The fundamentals of each data logger, including essential maintenance, troubleshooting, and how to figure out if it is performing correctly
- A basic view of the temperature monitoring strategy, including its purpose and how it is associated with consumer and vaccine safety
- How to interact with software and ensure it is in proper working order
- How to react appropriately to common errors and alerts
- How responsible staff can access and analyze data, generate reports, and use them to check for trends
3- Create and implement a well-defined installation plan
The last thing you want is to incur hefty costs of remediation due to incorrect installation. Having a well-planned and executed strategy for the installation of your vaccine temperature monitoring system will go a very long way to prevent these costly problems in the first place.
According to Dickson guidelines, make sure to cover the following major areas in your installation plan:
- Data logger/sensor placement and data collection frequency – Start with a temperature mapping study and risk assessment. This way, you’ll know exactly how many sensors you need and where to place them for optimal asset protection vaccine safety.
- Operating procedures – Your team should write Standard Operating Procedures (SOPs) to cover every aspect of the vaccine monitoring system.
- Sensor calibration – Federal agencies such as the CDC recommend using NIST-traceable standards to calibrate sensors to ensure accuracy stays within ± 0.5 °C. Be sure to draw up a well thought out calibration/re-calibration plan.
- IQ (installation qualification) – This typically involves deep checks to make sure monitoring software and hardware are correctly configured (i.e., according to manufacturer’s instructions)
4- Create a strategy for testing, tracking, and reviewing your monitoring system
Your temperature monitoring system must be routinely tested, tracked, and reevaluated as part of quality control and management. That means examining temperature and performance data across the entire system to identify trends and plan how to fine-tune it for optimal performance.
