Hermanský M, Graichman T
Sb Ved Pr Lek Fak Karlovy Univerzity Hradci Kralove. 1990;33(2):83-8.
Among freeze-dried drugs there are many which may imperil manufacturing personnel, e.g. cytostatic drugs possessing carcinogenic effects. Production zones must be specially adapted for handling such drugs. There are many risks endangering a freeze-drying operation--power or water supply failure, but also improperly established freeze-drying cycle. A production batch of a rare, expensive and sensitive product represents a big value; modern equipment therefore features sophisticated automation, overriding possible human error. Problem of particulate contamination is less severe with vials stoppered inside the vacuum chamber, but rubber closures still may become a source of haze. Back-migration of oil from vacuum pumps may be another source. Economy of industrial freeze-drying may be much improved if freezing sequence, drying rate, adjustment of vacuum by "bleeding" nitrogen are tailored specially for each particular product.
在冻干药品中，有许多可能会危及生产人员，例如具有致癌作用的细胞毒性药物。生产区域必须经过特殊改造以处理此类药物。冻干操作存在许多风险——电力或供水故障，还有冻干周期设定不当。一批珍稀、昂贵且敏感产品的生产批次价值巨大；因此，现代设备具有先进的自动化功能，可避免可能出现的人为错误。对于在真空室内加塞的小瓶而言，微粒污染问题没那么严重，但橡胶密封盖仍可能成为产生雾状物的源头。真空泵的油回流可能是另一个源头。如果针对每种特定产品专门调整冷冻顺序、干燥速率以及通过“排放”氮气来调节真空度，工业冻干的经济性可能会有很大提高。
