FDA releases guidance on the safe treatment of biologic devices in adverse weather

CBER, the centre within the FDA that regulates biological products for use under federal law, has created guidelines relating to the handling of products in poor weather conditions. The guidelines cover all adverse weather situations and their knock on effects, and ensure that the conditions in which a product is stored does not pose a risk, should it be used at a later date.


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Most biological products require specific storage conditions, their temperatures need to be controlled and they should not come into contact with any other substances. Cross contamination can be an issue, as can ingredients going ’off’ or losing their efficacy.

The FDA has released the following guidelines, detailing the steps that may be taken when a power failure compromises biological products.


At a time of flood or other natural disaster, the need for vaccines may elevate, so it is essential that they are stored correctly. Generally, vaccines are not overly temperature sensitive, but those that are may need to be discarded and replaced, if temperatures exceed the recommended limits, and the integrity of the vaccines becomes compromised. If power has gone out, it is recommended that refrigerator doors are kept closed as much as possible to keep vaccines cool.

When power has been restored, vaccines must be checked to ensure that they are still within the temperature range that’s safe.

Blood plasma

Blood plasma and plasma derivatives are in huge demand in the medical field, and several new innovations are being worked on in this regard. Enlisting companies to help with FDA 510k fast tracking such as has helped many blood and plasma related products reach the market, but correct storage of these is essential.

Facilities that store this type of biological product generally have a backup plan and contingency procedures they can put into place in the event of an emergency. For home storage or physician offices, however, set guidelines apply.

Certain lyophilized coagulation products may be stored at room temperature without loss of factor, and as long as the room does not become too warm, they retain their integrity. Immune globulin products can also be stored at room temperature, but must be used before their expiry date.

In all cases products that require freezing must be discarded if they are unfrozen and not used straight away.

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