If you manufacture, process, transport, distribute, or deliver vaccines that require storage at ultra-low temperatures, there is no room for error. Improper handling of these vaccines can significantly reduce the potency of the product. Ultra-low temperature storage can be challenging to maintain, which is why ultra-low temperature monitoring becomes extremely important in these instances. There must be a data log demonstrating that the vaccine was stored properly throughout the cold chain from processing to usage.
The Centers for Disease Control and Prevention (CDC) has specific guidelines that should be followed throughout the cold chain to ensure consistency and that a vaccine retains maximum potency for the end user. Transportation of these vaccines is perhaps the most challenging part of this whole process, as it is more likely that unwanted temperature fluctuations may occur on the road or other form of transportation.
Most ultra-low temperature (ULT) freezers store their contents between −40°F and −123°F. The most common temperature standard with these types of units is −80°F, but exact recommendations vary depending on what vaccine or other product you are storing. Vaccines need to be stored upright in tray storage and generally need to be protected from light. The expiration date should be clearly labelled on the trays, though the use-by date may change if the type of storage changes.
Ultra-low temperature monitoring is critical to this process. The CDC recommends using a digital data logger (DDL) that has a detachable probe. This probe will best reflect an accurate temperature of the vaccine vials. Ideally, you will have a sensor or monitoring system that records the minimum and maximum temperature of each 24-hour period. This minimum and maximum will be checked daily and recorded, and all ultra-low temperature monitoring records should be kept for 3 years.