Biologics in Severe Weather & Power Outages
June 23rd, 2008 | by caprice |If you use biological products, which are temperature sensitve due to their protein content, you will be interested to know that the U.S. Food & Drug Administration (FDA) issued the following notice about storing biologics during severe weather conditions and power outages. (Excerpt from the FDA’s websute - dated 6/16/08; link below.)
For health clinics, physician offices or in-home users that may not have emergency back up power, the following may be helpful:
- There is some evidence that lyophilized coagulation products such as Factor VIII and Factor IX may be stored at room temperature for a fairly long period of time without loss of factor potency. If you are concerned about the exposure or efficacy of a particular product, please call the supplier or the manufacturers’ customer service department.
- Many immune globulin products are licensed for storage at 36 to 46 degrees Fahrenheit, and some products may be stored at room temperature for all or part of the time before expiration. Because storage temperatures and times are specific to each product, you should follow the package insert recommendations for Immune Globulin Intravenous (IGIV), intramuscular IG (IG), and subcutaneous IG (IGSC) products. Products requiring lower temperatures can be stored on wet ice. All of these products should not be frozen. If you have any questions about the storage of these products, you should consult the package inserts.
Read the full article at: http://www.fda.gov/cber/weatherimpact.htm