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杭州吉沃科技有限公司Hangzhou Geevo Technology Co., Ltd.
地址: Add: 浙江省杭州市余杭经济技术开发区五洲路18号No.18 Wuzhou Road, Yuhang Economic & Technical Development Area, Yuhang District, Hangzhou, Zhejiang, China
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无菌检查隔离器技术 The technology for Sterility Test Isolator
发布时间:2021-04-14     文章浏览:491
Release time:2021-04-14     Times of browsing:491

无菌检查隔离器

目前,隔离技术在制药行业领域的应用上已经非常普遍,并且无菌检查隔离器的数量继续以相当快的速度持续增长。该技术被认为是对传统洁净室的重大改进。在QC实验室中使用隔离器的主要好处之一是避免假阳性和由此产生的产品浪费。假阳性的减少增加了工作人员的信心,也降低了操作成本,特别是对于那些涉及昂贵无菌灌装产品的制药生产的人员。该技术在微生物无菌保持方面显然优于传统的洁净室。实现隔离操作的设备主要有RTP,传递舱及分体式蝶阀。

无菌检查隔离器是什么样的呢?
考虑到维护及使用寿命,一般客户会选择由不锈钢及钢化玻璃组成的硬墙式结构的无菌检查隔离器。内部环境为动态A级,单向气流。使用手套进行内部操作。它们是相对封闭的系统,出入空气通过HEPA过滤、正压和采用能达到6-log芽孢杀灭水平的过氧化氢灭菌方式来达到内部的无菌环境。西门子PLC系统进行全自动化监控压力、送风量,密封压力等参数,集成显示过氧化氢浓度监测功能,并带有失压报警功能。
随着新版药典的实施和新版GMP要求的不断发展完善,无菌隔离器技术将日趋规范。在2015年版《中国药典》增加了《9206 无菌检查用隔离系统验证指导原则》,

隔离器在药品无菌检查中的应用已经成为趋势。

附上传统无菌室和吉沃无菌检查隔离器的对比表



法规和指南:
1. USP <1208>  Sterility testing - Validation of isolator systems 
2. European Pharmacopoeia 2.6.1. Sterility
3. 中国药典2005版 “无菌检查法”无菌检查应在环境洁净度10000极下的局部,洁净度100级的单向流空气区域内或隔离系统中进行。
4. PDA TR 34《卫生保健产品制造和测试用隔离系统的设计和验证》

5. UK  Isolators for the aseptic preparation of Pharmaceuticals适用于无菌制剂医药品的隔离器

Sterility test Isolator

At present, Isolation technology has become very common in the pharmaceutical industry, and the numbers of the sterility test isolator and production isolator continues to grow at a fairly rapid rate. The technology is considered a major improvement over traditional clean rooms. 

One of the main benefits derived from using Isolator in the QC laboratory is the avoidance of if false positive and the resultant product waste. The reduction of false positives has increased staff confidence and has also decreased operational cost, especially for those involved with pharmaceutical manufacturing of costly aseptically filling products.   Achieve isolation of the operation mainly adapts RTP, transfer chamber and split butterfly valve.  


What are Laboratory Sterility test Isolator like?      

Considering the maintenance and service life, people will choose Isolator composed of stainless steel and toughened glass which is a hard wall structure. The internal environment is dynamic class A and unidirectional airflow. Use gloves for operation. They are relatively closed systems in which the incoming and exhaust air is filtered by HEPA, positively pressurized, and adapts hydrogen peroxide sterilization which it is up to a 6-log spore killing level to reach a sterile internal environment. Siemens PLC system for full automatic monitor of pressure, air speed, sealing pressure and other parameters, integrated display of hydrogen peroxide concentration, and with a loss of pressure alarm function.  

Here attached the contrast list between traditional sterile room and Geevo sterility test Isolator.


Regulations and Guidelines
1. USP <1208> Sterility testing - Validation of isolator systems 
2. European Pharmacopoeia 2.6.1. Sterility
3. 2015 Chp  9206Validation guidelines for isolation systems for sterility tests
4. PDA TR 34 on  Design and Validation of Isolator Systems for the manufacturing and testing of Health care Products 
5. UK Isolators for the aseptic preparation of Pharmaceuticals