Miller L G, Loomis J H
Am J Hosp Pharm. 1985 Apr;42(4):843-8.
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.
从制造商处获取了生物制品在高于推荐温度下暴露时的稳定性信息，并制定了程序以确定这些产品在这种暴露后质量是否受到影响。向24家制造商发送了调查问卷，询问有关冷冻生物制品暴露于冷藏或室温下的稳定性、冷藏生物制品暴露于室温下的稳定性、最佳条件下的保质期以及推荐运输温度的产品信息。20家制造商提供了信息。一些制造商拒绝给出一般性建议；相反，他们表示应就个别情况联系制造商。回复表明，大多数产品储存和运输时不需要冷冻。大多数必须冷藏储存，但可以在室温下运输。使用制造商的稳定性建议有助于药剂师确定生物制品对患者使用而言质量是否可接受。
