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粉针注射剂生产设备的无菌处理技术研究

单松波

吉林医药学院学报Issue(4):257-259,3.
吉林医药学院学报Issue(4):257-259,3.

粉针注射剂生产设备的无菌处理技术研究

Study on aseptic processing technology of powder injection production e-quipment

单松波1

作者信息

  • 1. 漳州卫生职业学院,福建漳州 361021
  • 折叠

摘要

Abstract

Objective To formulate a set of practical and easy to operate aseptic processing technology of pharmaceu -tical production equipment to ensure powder injection productions meets quality requirements .Methods Each de-vice and each specific aspects of aseptic processing technology in powder injection production were studied under the guidance of new GMP standards combined with production management experiences .Results The aseptic processing technology of powder injection production equipments were standardized; standard operating procedure of key equip-ments such as the membrane filter ,the crystallization tank ,and operating standards grinder were established .Conclu-sion Practice has proved that powder injection product meet sterile quality requirements , because the product is made by this set of aseptic processing technology in the strict operating conditions .

关键词

粉针注射剂/新版GMP/制药生产设备/无菌处理技术

Key words

powder injection/new GMP standards/pharmaceutical production equipment/sterile processing technolo-gy

分类

化学化工

引用本文复制引用

单松波..粉针注射剂生产设备的无菌处理技术研究[J].吉林医药学院学报,2014,(4):257-259,3.

吉林医药学院学报

1673-2995

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