|
|||||
|
|
| 原料药无菌工艺模拟验证国际认证要求 | |
| 引用本文： | 高海燕,陈军丽,丁恩峰. 原料药无菌工艺模拟验证国际认证要求[J]. 医药工程设计, 2011, 32(2): 24-31 |
| 作者姓名： | 高海燕 陈军丽 丁恩峰 |
| 作者单位： | 1. 石药集团恩必普药业有限公司,石家庄,050031 2. 石家庄市第三医院制剂科,石家庄,050031 3. 英国施达化学集团公司中国代表处,石家庄,050031 |
| 摘 要： | 在欧美药政法规体系里面,如果无菌制剂采用无菌原料药（API）来制备,那么,无菌原料药的无菌性质对于制剂来说是至关重要的。无菌原料药一般采用两种方法来制造：灭菌工艺和无菌工艺。当原料药采用无菌工艺制造时,因为这种工艺无菌保证水平（SAL）较低,因此,需要采用模拟验证来评估无菌工艺的保证能力。在目前制药行业,通常采用无菌工艺模拟验证（也称为培养基灌装）方式评估工艺无菌保证能力。 |
| 关 键 词： | API 无菌工艺 模拟验证 培养基灌装 国际认证 美国注射剂协会 无菌保证水平 微生物数据偏差 |
International Certification Requirements for Simulating Validation of Asepsis Process for Raw Material Drugs |
|
| Gao Haiyan,Chen Junli,Ding Enfeng. International Certification Requirements for Simulating Validation of Asepsis Process for Raw Material Drugs[J]. Pharmaceutical Engineering Design, 2011, 32(2): 24-31 | |
| Authors: | Gao Haiyan Chen Junli Ding Enfeng |
| Affiliation: | Gao Haiyan,Chen Junli,Ding Enfeng(1.Shijiazhuang Pharma Group EBP Pharmaceutical Co.,Ltd Shijiazhuang,050031,2.Shiajiazhuang No.Hospital Shijiazhuang,3.China Representative Office,Great Briton Shida Chemical Group Co.Shijiazhuang,050031) |
| Abstract: | In European and American pharmaceutical system,the asepsis level of asepsis raw material drugs is greatly important if asepsis agent is prepared with asepsis raw material drugs.Generally,asepsis raw material drugs are produced with two processes -sterilization process or asepsis process.If raw material drugs are produced with asepsis process,the simulation validation is needed because sterile assurance level in asepsis process is comparatively low.This is the reason that currently simulation validation is o... |
| Keywords: | API |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |