Vaccine Transport Guidelines for Maximum Efficacy and Safety

May 22, 2023

Pharmaceutical Transport

Over the last few years, the world has become aware of the importance of vaccines as we fought to keep COVID-19 at bay. The reality is that there are a host of diseases that are treated with vaccines (Cholera, Dengue, Influenza, and many more) and they all need to be transported at the correct temperature to be effective.

Vaccines have an important role to play in keeping the world population safe and healthy, but vaccines also need to be made available by transporting them from the lab to the consumer. Given the importance of vaccines, transportation needs to be well-considered and conducted according to safety guidelines. To maximize effectiveness, transporters need to follow vaccine transport guidelines and track temperature data across their cold chain.

Vaccines are temperature sensitive products

Vaccines need to be kept at certain temperatures to retain their effectiveness. Some vaccines are sensitive to heat, some to freezing temperatures, and others to light. When vaccines are exposed to these adverse factors, they can become less effective or even unusable.

More specifically, all vaccines should be kept between 35°F and 46°F (2°C and 8°C) while in storage or transit. This range is also true for any accompanying diluents, though diluents should never be frozen. In some cases, where vaccines can be freeze-dried and kept frozen, vaccines can be kept frozen between 5°F and -13°F (-15°C and -25°C).

Vaccines that are sensitive to heat can be further broken down according to how sensitive they are. For example, the influenza vaccine is a lot more sensitive than the rabies vaccine. It is important to familiarize yourself with the specific temperature requirements of the vaccines you are transporting.

Vaccine temperature monitoring systems

The World Health Organization has created useful vaccine transport guidelines for monitoring vaccines across the cold chain. The guideline refers to a number of temperature monitoring methods that you should apply to your operations.

Vaccine vial monitors (VVMs)

VVMs form part of the vaccine's vial labeling. The VMM has chemicals that change the color of the label cumulatively as the vaccine is exposed to heat. The gradual change of color tells you how much heat exposure has occurred and whether the vaccine can still be considered viable. The VVM shows two squares, an outer and an inner square. If the color of the inner square changes to be the same or darker than the color of the outer square, the vaccine can no longer be considered viable and should be discarded.

Electronic shipping indicators

Electronic shipping indicators include a digital display and a colored card. The indicator records the temperature of the vaccines at specific time intervals (e.g. 10 minutes) for up to 20 days. These devices are useful for tracking the temperature of vaccines as they travel along the cold chain, especially during international travel. The data collected by electronic shipping indicators can be downloaded onto a computer for further analysis.

Smart temperature devices

Temperature monitoring devices are constantly being improved upon, making them more affordable, easier to use, and better at providing vital temperature information. Varcode has a suite of smart solutions that give you all the data you need to make important decisions about your vaccines. Varcode’s Smart Tag and Scanning Suite solutions tell you in real-time when temperature sensitive products go out of their safe range. You can also use the Varcode Management Suite to see your temperature monitoring data in one place.

Pharmaceutical warehousing guidelines

Facilities must put SOPs (Standard operating procedures) in place for the storage of vaccines. These SOPs should include information about how inventory should be managed, including ordering, receiving, packing, and monitoring storage conditions. The SOPs should also extend to what must be done in emergencies where sudden demand causes standard procedures to be insufficient.

Vaccines should be stored in purpose-built refrigerators and freezers. While household-grade refrigerators can be suitable in some instances, the fact that they often provide fluctuating temperatures is a risk to the vaccines.

Here are a few storage best practices to follow:

Avoid placing or storing any items other than vaccines, diluents, and water bottles inside storage units.
Place vaccines and diluents in rows and allow space between them to promote air circulation.
Whenever possible, store the diluent with the corresponding refrigerated vaccine. Never store diluent in a freezer.
Place vaccines and diluents with the earliest expiration dates in front of those with later expiration dates.
Store vaccines in their original packaging with lids closed in separate containers until ready for administration. This will protect them from light and provide additional thermal stability/protection.

Packaging and labeling guidelines

Vaccine transport guidelines stipulate that Vaccines be packed in three layers of packaging:

Primary

The vaccine vial or ampoule itself constitutes the initial level of container for the vaccine. The primary packaging includes a vaccine label which, in many cases, is specifically designed for cold and freezing temperature storage. The primary packaging label must adhere to dry, damp, and wet surfaces.

Secondary

Secondary packaging: consists of the intermediate packaging that houses the primary containers. It must be clearly labeled for the receiver and provide information about the contents. The outside of insulated packaging should be white or the natural color of a corrugated box. Avoid using dark colors. All tertiary packaging labels must be affixed on all four sides. The secondary label should indicate the contents of the package and whether it can be frozen or not.

Tertiary

Tertiary packaging is the third level of packaging. This outer box carries the secondary products. For international transport, it must be carefully labeled with the end user’s address, the priority of the package (in the case of a vaccine rush), a ‘do not freeze’ label, and a contents label. Each package should be numbered sequentially. Shipping paperwork should be placed in the box and should clearly state that the packaging contains vaccine shipping documents.

Smart cold chain management for vaccines

Start tracking and monitoring the temperature of your cold vaccine products the smart way with Varcode. Varcode’s Smart Data Solution gives you dynamic temperature updates when you need them, housed within an easy-to-use management dashboard. Varcode gives you access to smarts tags, scanning, and data reporting within one, dynamic solution.

With Varcode’s solutions at your fingertips, and these vaccine transport guidelines in mind, you are better equipped to transport vaccines safely and effectively.