The COVID-19 vaccine rollout is in full-swing in the U.S. and around the world in 2021. Governments and private companies are working together to get the approved vaccines to as many people as possible in as short a time as possible in order to curb the spread and, hopefully, eventually eliminate COVID-19.
Each of the approved vaccines in the U.S. has very specific temperature requirements. These requirements are based on the type and the sensitivity of the biological material the vaccines contain. To maintain their effectiveness and safety, some vaccines have to be kept at normal refrigerated temperatures; others have to be kept frozen or even in a deep freeze.
To ensure these precise temperature standards are maintained throughout the distribution process, the people and institutions responsible for the rollout must engage in rigorous temperature monitoring. This process starts with the raw biological materials made to create the vaccine and continues all the way through to the time the dose is taken out to be administered to a patient. Here are five principles of sound vaccine temperature monitoring organizations must observe.
1. Understand the Vaccine
The first principle of sound vaccine monitoring is understanding how each of the vaccines works and what your organization’s role is in their handling. For pharmaceutical companies producing the vaccines, this is relatively easy because each company is only responsible for its own vaccine. For logistics companies, vaccine providers, and government entities, this may prove more difficult because they may be responsible for a growing number of vaccines.
Knowing as much as possible about the vaccines in your organization’s care is key to setting up a sound vaccine temperature monitoring plan. This will inform what environment you will have to maintain and the equipment you will have to use to create and monitor these temperatures. As this Dickson guide explains, this assessment is a critical first step in temperature monitoring.
2. Qualifying Data Loggers
Data loggers are the key piece of equipment needed for precise temperature monitoring. These sensors monitor the temperature (and any other necessary environmental conditions) of a controlled space. In regulated industries, like the pharmaceutical industry, quality control is incredibly important for storage units in which vaccines and other delicate substances are kept. To qualify data loggers and other parts of the temperature monitoring system, organizations must follow a quality assurance procedure known as IQ OP QP.
IQ OQ PQ is an acronym for installation qualification, operation qualification, and performance qualification. This process deals with taking the appropriate steps to make sure a piece of equipment or system is installed, operates, and performs under normal conditions and stress properly. Doing this right, especially when it comes to installing data loggers must be the focus of any vaccine temperature monitoring program.
3. Calibrate and Monitor
When the data loggers are properly qualified and installed, they need to be correctly calibrated . These devices will only provide precise temperature information if they are calibrated in a way that allows them to do so. When it comes to the vaccine, the U.S. Center for Disease Control and Prevention (CDC) sets the calibration requirements. The CDC recommends that data loggers be calibrated by an accredited lab to +/- 0.5 degrees Celsius.
After the data loggers are calibrated and ready, it is time to start monitoring. Today, many data loggers are internet-connected and part of the Internet of Things. This allows for cloud-based remote monitoring which makes the entire process much easier and more efficient. Instead of having an employee physically check the data loggers, all the information can be communicated to a central location monitored by a single person or small team. This saves money and time and allows for a rapid response to any issues that arise.
4. Train Employees
Sound vaccine temperature monitoring isn’t just a technological process. It’s a human one, too. Since humans will be involved in much of this activity, proper training is crucial. Hopefully, your organization is already engaged in a thorough onboarding training process. Whether you are or not, this type of continuous training is important to meet new challenges such as the current vaccine rollout. This specific training can not only be applied to this situation but it can also be added as a regular feature of your employee engagement programs.
Training for sound vaccine temperature monitoring means teaching employees about the vaccines themselves as well as the temperature monitoring procedures for which they will be responsible. Along with the initial education, continuous training is important. This means testing for comprehension and retention as the program goes on and updating policies and standard operating procedures (SOPs) as the situation dictates.
5. Constant Improvement
Just because your vaccine temperature monitoring program is up and running, doesn’t mean your organization’s job is done. The best temperature monitoring programs, whether related to the vaccine or not, are dedicated to a state of continuous improvement. Temperature monitoring produces tons of data. This data can be tracked, collected, analyzed, and ultimately used to make data-driven decisions.
The ability to easily track and analyze data is one of the key benefits that come from using IoT data loggers and a cloud-based remote monitoring system. When using this technology, all data is collected in one place and can easily be processed by data analytics algorithms to help stakeholders decide where things need improvement and what can be done to improve them.
The COVID-19 vaccine rollout is one of, if not the most important activity going on in the world right now. It is taking a wide-reaching, consolidated effort from all types of organizations to make this happen in 2021. Several factors will determine the success of this rollout and how fast it is accomplished. One of the biggest factors is sound vaccine temperature monitoring by all of the organizations involved.
To create the best temperature monitoring program for the vaccine (or any other type of sensitive product in the future), the five principles described above are vital. Organizations must always remember to work on understanding the vaccine, qualifying systems, calibrating and monitoring equipment, training employees, and constant review and improvement of the process.