摘要
为了满足生物制品在分装过程中液体均匀性的要求,按照2010年版《药典》三部中生物制品分装和冻干规程的规定,以96-1型磁力搅拌器进行色水搅拌试验、氯化钠注射剂搅拌试验、明胶溶液搅拌试验,验证了96-1型磁力搅拌器液体搅拌效果满足分装过程中液体搅拌均匀性的要求,具有分装生产的适用性。验证结果确认了该方法能满足分装生产的需要,同时为对有均匀性要求的分装生产提供了一套新的验证方法。
To meet the filling uniformity requirements for liquid biological products, tests were made according to the Filling and Packaging Requirements for Biological Products of book Ⅲ, Chinese Pharmacopeia, 2010 edition. Coloring water stirring test, sodium chloride injection stirring test and gelatin solution stirring test were made by using magnetic stirrer type 96-1. The results showed that the liquid stirring effect of magnetic stirrer type 96-1could met the requirements of stirring uniformity in filling process. It is proved to be a satisfied method for products filling. Meanwhile, a new set of validation methods was provided for filling process which filling uniformity.
出处
《中国医学装备》
2011年第3期36-38,共3页
China Medical Equipment
关键词
磁力搅拌器
试验
均匀性
验证
Magnetic stirrer
Test
Uniformity
Validation
