|
|||||
|
|
| 浅析USP对生物指示剂的技术要求 | |
| 引用本文： | 高海燕,陈军丽,丁恩峰,郭娅楠.浅析USP对生物指示剂的技术要求[J].医药工程设计,2010,31(3):20-23. |
| 作者姓名： | 高海燕 陈军丽 丁恩峰 郭娅楠 |
| 作者单位： | 1. 石药集团恩必普药业有限公司,河北石家庄,050031 2. 石家庄市第三医院制剂科,河北石家庄,050031 3. 英国施达化学集团公司中国代表处,河北石家庄,050031 4. 北京赛铭医药科技有限公司,北京,100054 |
| 摘 要： | 灭菌技术是无菌药品制造中的关键制药技术;无论是使用无菌工艺制造无菌药品,还是使用灭菌工艺制造无菌药品,灭菌技术都发挥着不可替代的重要作用。对于灭菌设备和灭菌技术的研究与法规监管,也一直是无菌制药领域的热点和难点话题。生物挑战性试验对于灭菌技术的研发和验证具有重要意义,而其中生物指示剂的制备、采购、储存、使用和管理都对灭菌技术评估发挥着重要影响。USP32版〈55〉《BIOLOGICAL INDICATORS-RESISTANCE PERFORMANCE TESTS》和〈1035〉《BIOLOGICAL INDICATORS FOR STERILIZATION》详细介绍了生物指示剂的定义、种类、应用范围、采购、储存、使用和管理等细节要求。 |
| 关 键 词： | 灭菌 蒸汽状态过氧化氢 生物指示剂 验证 USP D值 Z值 孢子 |
Brief Analysis of Technical Requirements of Biological Indicator from USP |
|
| Institution: | Gao Haiyan Chen Junli Ding Enfeng (1. CSPC-NBP Pharmaceutical Co., Ltd Shijiazhuang, 050031; 2. Shijiazhuang No. 3 Hospital Shijiazhuang, 050031; 3. China Representative Office, Great Briton Shida Chemical Group Co. Shijiazhuang, 050031; 4. Beijing Spring Pharma Tech Inc. Beijing, 100054) |
| Abstract: | Sterilization technique is the key in sterile medicine production. Whatever sterile process is used or sterilization process is used in the production of sterile medicine, sterilization technique plays the irreplaceable and important role. The research of sterilization equipment and technique and the supervision under the support of the codes are always concerned in pharmaceutical industry. Trial biological test has the important meaning in the development and validation of sterilization techniques. While, to prepare, purchase, store, apply and manage biological indicator importantly influence the assessment of sterilization technique. In USP 32 Edition 55 ＂Biological Indicators – Resistance Performance Test＂ and 1035 ＂Biological Indicators for Sterilization＂, the definition, kinds, applicable scope, procurement, storage, application and management of indicators are introduced in detail. |
| Keywords: | USP |
| 本文献已被 维普 万方数据 等数据库收录！ | |