金币
UID1294
帖子
主题
积分56733
注册时间2011-8-1
最后登录1970-1-1
听众
性别保密
|
发表于 2014-5-22 21:29:09
|
显示全部楼层
Archier.xu 发表于 2014-5-22 21:13 
原文：
Sterility assurance is best accomplished by a focus on human-borne contamination and the ...
FURTHER CONSIDERATIONS ABOUT DATA INTERPRETATION
In the high-quality environments required for aseptic processing, detection frequency typically is low. As can be seen from the rates recommended in Table 3, the majority of samples taken in an aseptic processing area will yield a recovery of zero contamination. In the most critical areas within an aseptic processing operation, it is expected that less than 1% of the samples will yield any recoverable contamination. In the most advanced of modern aseptic operations that use separative technologies such as isolators or closed RABS, the recovery rate will approach zero at all times.
The microbiologist responsible for environmental control or sterility assurance should not take this to mean that the environmental quality approaches sterility. The sensitivity of any microbial sampling system in absolute terms is not known. In environmental monitoring, a result of zero means only that the result is below the limit of detection of the analytical system. A false sense of security should not be derived from the infrequency of contamination recovery in aseptic processing.
Sterility assurance is best accomplished by a focus on human-borne contamination and the facility design features that best mitigate risk from this contamination. Greatest risk mitigation can be attained by reducing or eliminating human interventions through proper equipment design and by providing sufficient air exchanges per hour for the intended personnel population of the facility. Other risk mitigation factors include effective personnel and material movement and the proper control of temperature and humidity. Secondary factors for risk mitigation include cleaning and sanitization. Risk analysis models that analyze processes prospectively to reduce human-borne contamination risk by minimizing operator interventions are more powerful tools for sterility assurance than monitoring. Environmental monitoring cannot prove or disprove in absolute terms the sterility of a lot of product. Environmental monitoring can only assure those responsible for a process that a production system is in a consistent, validated state of control. Care should be taken to avoid drawing inappropriate conclusions from monitoring results. |
|
[复制链接]
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
