Since the DSCSA (Drug Supply Chain Security Act) was introduced and approved by Congress and the Senate there has been a real concerted effort to reach total compliance aided by the International Standards champion GS1 who has worked to insure US and Global compliance.
COVID-19 vaccines, like all vaccines, are extremely sensitive to temperature variations, and require that specific temperature parameters are maintained. To help vaccine providers adhere to the temperature requirements, public health departments strongly recommend the utilization of continuous monitoring digital data loggers. Some public health departments are also recommending real-time vaccine monitoring.
These days, we’re all familiar with the importance of vaccines. You can read about the success rates of different vaccines and get a certain peace-of-mind. However, as the vaccines move down the supply chain from the production or primary storage facility, the vaccines can lose some of their potency—largely due to temperature abuses the vaccines experience. The World Health Organization (WHO) has released a “Temperature monitoring study: a fully documented process to detect weaknesses in the supply chain” showing why effective temperature monitoring is critical.
Because of the COVID-19 pandemic, vaccine shipping at extremely low temperatures has been in the news lately. But, such cold temperature shipping is really not new. Shipping and storing with dry ice and liquid nitrogen are the norm for some industries and products.
Which COVID vaccine will you get? The big debate taking place these days, around every watercooler and kitchen table, is whether or not to obtain the COVID vaccine. The other point of discussion, of course, is which vaccine individuals will receive.
Monitoring vaccine temperature can be complicated, but it doesn’t have to be. Separating the task into different components and answering two key questions makes it much easier. First, which vaccine do you need to monitor—Pfizer, Moderna or Johnson & Johnson? Second, are you looking for a temperature monitoring product to use during the vaccine transport or during storage? Of the three COVID-19 vaccines: Pfizer, Moderna, and Johnson & Johnson (Janssen), the Pfizer vaccine requires the most extreme temperature conditions.
In the world of monitoring coronavirus vaccines during storage and handling, there are three general temperature profiles. These profiles include refrigerated 2°C to 8°C (36°F to 46°F), frozen -25°C to -15°C (-13°F to 5°F), and ultra-low temperature -80°C to -60°C (-112°F to -76°F). A data logger is used to provide complete monitoring and a record of temperatures of which vaccines have been exposed. The logger enables you to ensure that your vaccines’ potency is preserved and that they have not experienced any temperature excursions.
When people think of the Pfizer COVID-19 vaccine, one of the first thoughts or questions usually concerns the extremely low temperature requirements to maintain the vaccine’s potency. But, how can you really know if you’re doing a good job in preserving the vaccines’ potency? Per the CDC temperature requirements, Pfizer vaccines will be shipped and arrive at a storage facility between -80°C and -60°C (-112°F to -76°F) in a thermal shipping container with dry ice.
On January 21, 2021, President Biden issued an “Executive Order on Protecting Worker Health and Safety.” In response to this executive order, on January 29th, the Occupational Safety and Health Administration (OSHA) issued a guidance “Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace.” While this guidance has not yet become a requirement, OSHA is investigating an emergency standard that correlates with this new guidance.
Temperature requirements for COVID-19 vaccines have been one of the most popular news topics over the last couple of months. But, how can you really know if you’re doing a good job in preserving the vaccines’ potency. Per the CDC temperature requirements, Moderna vaccines should be shipped and arrive at a storage facility between -25°C and -15°C (-13°F to 5°F) in a thermal shipping container.
Given what the world is experiencing as a result of the COVID-19 pandemic, I suppose one could say there are benefits to growing up in a country which was always at war. I was a soldier as a volatile South Africa transitioned to democracy. Because of my experiences, I am called upon when change is about to happen in an industry, the future is uncertain, and energy and heavy lifting are in high demand. I know how to deliver in situations where there is chaos and no clear answers.
Every year, vaccines prevent between 2 million and 3 million deaths. According to the World Health Organization, as a result of vaccinations administered between 2000 and 2016, there was an 84% worldwide reduction in the number of measles-related deaths. Over the last 10 years, more than a billion children have been vaccinated. Proper handling and storage is necessary to retain vaccine effectiveness.
In today’s world, there are few items more treasured than effective vaccines. But, understanding the vaccine’s value and actually doing something to protect it are two different things. It is absolutely critical to follow proper cold chain practices when handling and transferring vaccines through the supply chain from the manufacturer to the patient. In order to better monitor vaccine temperatures, DeltaTrak has developed the FlashLink 40527 Certified Vaccine Logger.
The coronavirus has dramatically changed the way we live. At least for now, many businesses and schools have turned to online meetings and instruction. Sporting and music events have been cancelled altogether. Yet, inevitably, sometimes people will have to meet face-to-face or “mask-to-mask.” What can you do to ensure that you minimize risk and keep the virus from spreading? The Centers for Disease Control and Prevention (CDC) is recommending that businesses consider daily screening of employees—
Proper cold chain practices are essential in minimizing risk when handling and transferring vaccines through the supply chain from the manufacturer to the patient. In order to lessen the risk and better monitor vaccine temperatures, DeltaTrak has developed the FlashLink 40527 Certified Vaccine Logger. This product conforms to all CDC guidelines and is prequalified by the World Health Organization (WHO) as a temperature monitoring device.
DeltaTrak will be exhibiting at the BIO International Convention in Philadelphia, June 4-6. Come by and visit us in Hall E, Booth 3415 and demo some of the latest products. For proper vaccine temperature monitoring, the FlashLink 40527 Certified Vaccine Logger offers the gold standard. This product conforms to all CDC guidelines and is prequalified by the World Health Organization (WHO) as a temperature monitoring device.
Refrigerator monitoring for cold chain drugs is one of the main essentials for insuring efficacy and safety of the drugs stored within these units, and a compliance requirement from the FDA, CDC, WHO, etc.