Advice of manufacturers about effects of temperature on biologicals

Information was obtained from manufacturers on the stability of biologicals when exposed to higher-than-recommended temperatures, and procedures were developed for determining whether the quality of these products is compromised after such exposure. Questionnaires were sent to 24 manufacturers asking for product information regarding stability of frozen biologicals exposed to refrigeration or room temperature, stability of refrigerated biologicals exposed to room temperature, shelf life under optimal conditions, and recommended transport temperature. Information was provided by 20 of the manufacturers. Some manufacturers declined to make general recommendations; instead, they stated that the manufacturer should be contacted regarding the individual situation. The responses indicated that most products do not require freezing for storage and transport. Most must be stored refrigerated but can be transported at room temperature. Use of manufacturers' stability recommendations can help the pharmacist determine whether biologicals are of an acceptable quality for patient use.