摘要：
CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions. While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product. Vials of biologicalproducts in contact with flood waters should be discarded given the possibility of contamination and the likelihood of significant exposure to temperatures outside of those recommended for cold chain storage.
Most biological products require specific storage conditions, as indicated in the product labeling, to maintain their safety, purity, and potency. These products include bacterial and viral vaccines, allergenic extracts, plasma derivatives, and other products requiring refrigeration or frozen storage, as well as products that can be stored at controlled room temperature (i.e., not exceptionally cold or hot). When there is an electrical power failure, whether due to accident, equipment failure, or disruption in the electrical power grid, the temperature control systems for product storage may not function. For example, on August 14, 2003, the northeast region of the country experienced a power outage lasting from one to several days, and some health professionals were uncertain what to do with products that they had in storage. Power failures are not only a concern regarding storage in a facility, as failure of the refrigeration or freezer unit on a carrier (e.g., truck) while the products are in transit may also occur. The information below may assist interested persons in determining what to do with their biological products in the event of a power failure.
Supporting:
http://www.fda.gov. Information from US FDA——Impact of Severe Weather Conditions on Biological Products[J]. 中国药学(英文版).
http://www.fda.gov. Information from US FDA——Impact of Severe Weather Conditions on Biological Products[J]. Journal of Chinese Pharmaceutical Sciences.
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