Paper-heavy chart recorders are so 1999 in the world of vaccine production and distribution. Enter data loggers, paperless electronic chart recorders kitted out with sensors, microprocessors, and digital storage capability to help monitor, collect, and document environmental data.
Today, data loggers play a mainstay role in healthcare, especially when it comes to vaccines. This is especially true given that regulatory agencies like the FDA have put in place stringent regulations to make sure that vaccines are not only effective but also safe for patients.
The environment to which vaccines are exposed must be monitored, recorded, and documented in perpetuity down the entire supply chain, from the vaccine maker to where vaccination occurs. This is crucial for the validation process and regulatory compliance, as well as to guarantee optimal patient outcomes.
Environmental Monitoring for the Vaccine Supply Chain
Vaccines are exposed to an array of environments during the process of production, packaging, shipping, administration, and storage within healthcare facilities. It’s paramount that all the stages in the supply chain are constantly monitored to prevent contamination and vaccine spoilage.
That is where environmental monitoring proves invaluable. It refers to the process in which the vaccine’s environmental data is continually observed and collected, typically to satisfy regulatory requirements and ensure consistency in the prevalent conditions.
Typically, this means using data loggers to monitor, verify, and “log” temperature readings to which vaccines are exposed. Of course, other fundamental parameters such as relative humidity and pressure are also watched.
Depending on the type of vaccine, manufacturers and other vaccine handlers must also monitor and log container vibration, liquid levels, blend uniformity, and pH levels.
In a vaccine cold chain storage, data loggers and other monitoring systems can serve as alarms as well, alerting healthcare providers, regulators, and vaccine handlers when conditions like temperature go beyond the desired limits. This way, corrective actions to poor conditions can be arranged promptly, before potency is lost.
But that doesn’t tell the whole story of data loggers and vaccines. Let’s take a closer look at the points in the vaccine supply chain where data loggers — or environmental monitoring, to be more precise — are essential.
Vaccine Research and Development
Versatile R&D strategy allows researchers and scientists to develop vaccines that will help prevent and eradicate novel diseases like SARS, Coronavirus, etc. However, there are plenty of steps that have to be taken before a new vaccine can be approved for use on humans— and delivering consistent results is top on that list.
In a vaccine lab, results must be replicated or repeatable. More importantly, the researchers must be able to identify the precise conditions that resulted in a successful outcome. This is where data loggers and other environmental monitoring solutions can be indispensable.
Having the right data logger can mean the difference between going back to square zero and striking the next Nobel-worthy vaccine.
Vaccines are manufactured in clean rooms, which are enclosed facilities in which environmental conditions are required to be kept within a strict range, and pollutants, contaminants, and other airborne particulates must not affect the manufacturing process.
To ensure vaccines are safe and efficient, the conditions in the manufacturing facility must be continuously monitored and documented. Needless to say, this can only be accomplished with a top-notch environmental monitoring system complete with state-of-the-art data loggers. This is particularly important when it comes to the cold storage units at the manufacturing plant.
Keeping up with constantly changing regulations is another huge point for vaccine manufacturers. Staying in compliance is crucial but can be overwhelming in any facility. One of the biggest steps a manufacturer can take is to use proper environmental monitoring tools to continuously document all conditions to which the vaccines are exposed.
The bottom line is that data loggers can be extremely helpful for vaccine manufacturers, as they can be used to monitor conditions during the process of production, packaging, and on-site cold storage. They are a great tool to ensure that vaccines leave the facility uncontaminated and at full potency.
Vaccines are at the highest risk of losing potency during transportation. That’s because the potency of the vaccine is diminished every time it is handled improperly or exposed to inappropriate conditions at any point during shipping. This can happen due to overexposure to light, cold, heat, pressure, and other undesirable conditions in transit.
Unfortunately, the potency of a vaccine can’t be restored once lost. That’s why keeping an eye on the vaccine transport conditions is of paramount importance.
To enable temperature monitoring throughout shipment, for example, a data logger is packaged in with the vaccine. This end-to-end environmental monitoring technique provides clear historical temperature readings of the vaccine shipment.
Proper storage of vaccines is critical across the entire supply chain, from the time they are produced until when they are administered. If the vaccines are not stored appropriately, the active ingredient may lose potency and reduce the efficacy of the vaccination, which may expose patients to dangerous diseases and devastating side effects.
Exposing vaccines to freezing temperatures even once is enough to destroy some of their potency. It’s even worse if they are suspended in a liquid adjuvant, in which case the potency will be lost for good, and the vaccine must be discarded.
Because the appearance of the vaccine isn’t an indicator of improper exposure, data loggers must be used so they can alert the right people to any undesirable deviations in temperature and other conditions. Modern data loggers, especially those from Dickson, allow for checking of real-time data from anywhere, at any time, and can use any internet-connected PC, Mac or mobile device.
If you are participating in the Vaccines for Children (VFC) Program, for instance, you must adhere to the regulations set forth by the CDC:
● Check and document cold-room storage temperature at least twice a day. With data loggers, you can make temperature monitoring easy, methodic, and hassle-free.
● Examine your cold storage procedures to ensure vaccine storage and handling requirements are met.
● Make sure to fully inspect and record vaccine conditions and status upon delivery.
● Report all vaccine storage mishaps to respective public health authorities.
The safe and successful production, distribution, and storage of vaccines call for continuous environmental monitoring to ensure optimal safety, potency, and patient outcomes. It’s also critical when it comes to meeting strict regulations put in place by the Food and Drug Administration. Having the right tools, including advanced data loggers, in place will make monitoring easy, well-organized, and reliable.