下载后可任意编辑冻干机箱体极限真空升高原因分析冻干机箱体极限真空升高原因分析 王艳艳张渺 摘要:在制药生产过程中,真空冷冻干燥机是一种常用设备,真空度是冷冻干燥生产的关键因素之一,冻干机的密封性及真空性能与产品质量密切相关。车间生产用冻干机极限真空升高,会导致产品质量安全存在隐患。为找出导致该现象的原因,结合相关资料,我们进行了一些推测及验证,将冻干机极限真空升高的原因进行了一系列分析。 Abstract: In the pharmaceutical production process , the vacuum freeze dryer is a commonly used equipment. The vacuum degree is one of the key factors in freeze drying production. The tightness and vacuum performance of the freeze dryer are closely related to the product quality. Increasing the ultimate vacuum of freeze dryers used in workshop production will lead to hidden dangers in product quality and safety. In order to find out the cause of this phenomenon , combined with relevant data , we conducted some speculations and verifications, and conducted a series of analysis on the causes of the increase of the ultimate vacuum of the freeze dryer. 关键词:冻干机;真空度;制药生产;原因分析 Key words: freeze dryer;vacuum degree;pharmaceutical production;cause analysis 中 图 分 类 号 : TQ460.5 文 献 标 识 码 : A 文章编号:1006-4311(20XX)14-0203-02 0 引言 冷冻干燥,全称为真空冷冻干燥,简称冻干(FD),又称升華干燥、冻结1下载后可任意编辑干燥。冷冻干燥是指将被干燥物料低温冻结成固体,然后在低温减压条件下利用水的升华,使物料低温脱水而达到干燥目的的一种干燥方法。冷冻干燥得到的产物称为冻干物,冷冻干燥的过程称为冻干。在制药领域,冷冻干燥就是将药液预先降温冻结成固体,然后在真空的状态下,使水分从固体直接升华成水蒸汽而获得干燥的一种方法。在低温冻干过程中微生物和酶的作用几乎不进行,可较好保持被冻干药物的性状,冻干的药物大多疏松多孔,脱水彻底,药物可以进行长时间的贮存,而且容易重新吸收水分和恢复活性[1]。而冻干机就是完成这一过程的一种设备,冻干机一般由前箱...