欧盟GMP关于无菌室要求

 
ANNEX 1
MANUFACTURE OF STERILE MEDICINAL PRODUCTS
附录01-无菌药品制造(2008版)
Principle原则
The manufacture of sterile products is subject to special requirements in order to minimize
risks of microbiological contamination, and of particulate and pyrogen contamination. Much
depends on the skill, training and attitudes of the personnel involved. Quality Assurance is
particularly important, and this type of manufacture must strictly follow carefully established
and validated methods of preparation and procedure. Sole reliance for sterility or other quality
aspects must not be placed on any terminal process or finished product test.
无菌药品制造要求特殊条件,以使得微生物,微粒和热源污染的风险最小。其
很大程度上要取决于所涉及到人员技术水平,培训与态度。质量保证特别重要,
这种生产必须严格遵守小心建立的并经过验证的生产方法和工作程序。不能单独依
靠无菌与其它质量方面测试来取代最终过程或成品测试。
Note:
This guidance does not lay down detailed methods for determining the microbiological and
particulate cleanliness of air, surfaces etc. Reference should be made to other documents such
as the EN/ISO Standards.
注:
本指南没有制订测定空气,表面等微生物与微粒洁净度的详细方法。请参阅例如
EN/ISO标准的其它文件。
General总则
1. The manufacture of sterile products should be carried out in clean areas entry to which
should be through airlocks for personnel and/or for equipment and materials. Clean areas
should be maintained to an appropriate cleanliness standard and supplied with air which has
passed through filters of an appropriate efficiency.
无菌产品制造应当在洁净区域内进行,进入这些区域内的人员和/或设备与物
料,应当通过气闸室。洁净区必须保持一定的洁净级别标准,空气必须通过适当
效率过滤器供给。
2. The various operations of component preparation, product preparation and filling should be
carried out in separate areas within the clean area. Manufacturing operations are divided into
two categories; firstly those where the product is terminally sterilised, and secondly those
which are conducted aseptically at some or all stages.
各种部件准备,产品准备与灌装,应当隔离的洁净区进行。制造操作分为两类,
第一类是产品最终灭菌型,第二类是部分过程或全过程的无菌操作型。
3. Clean areas for the manufacture of sterile products are classified according to the required
characteristics of the environment. Each manufacturing operation requires an appropriate
environmental cleanliness level in the operational state in order to minimise the risks of
particulate or microbial contamination of the product or materials being handled.  
无菌产品生产的洁净区应按照所需要的环境特性进行分级。每一步生产操作,对环境有相应的
洁净级别的要求,以使对所处理的物料或产品造成粉尘以及微生物
的污染最小。
In order to meet “in operation” conditions these areas should be designed to reach certain
specified air-cleanliness levels in the “at rest” occupancy state. The “at-rest” state is the
condition where the installation is installed and operating, complete with production
equipment but with no operating personnel present. The “in operation” state is the condition
where the installation is functioning in the defined operating mode with the specified number
of personnel working.  
为达到"动态"的条件,这些区域在设计上要达到"静态"安装状态的空气洁净
度。"静态"设备已经安装并运行中,生产设备就位但是没有操作人员在场。"动
态"是指在设备正常运转状态下和有规定的工作人员在场的情况下。
The “in operation” and “at rest” states should be defined for each clean room or suite of clean
rooms.
应当对每个清洁室或每套清洁室都分别确立"静态"和"动态"。
For the manufacture of sterile medicinal products 4 grades can be distinguished.
无菌产品制造有4个环境级别:
Grade A: The local zone for high risk operations, e.g. filling zone, stopper bowls, open
ampoules and vials, making aseptic connections. Normally such conditions are provided by a
laminar air flow work station. Laminar air flow systems should provide a homogeneous air
speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position in open clean
room applications. The maintenance of laminarity should be demonstrated and validated.
A级:高风险操作区,如,灌装区,加盖区,安瓿与瓶开口区,进行无菌连接。通常这
种条件用层流空气工作点来提供。在开放的洁净室的工作点上,层流系统
应该能提供风速为0.36-0.54m/s(指导值)的均匀气流。层流能力的保持需通过证实并以验证。
         A uni-directional air flow and lower velocities may be used in closed isolators and glove boxes.
         密封隔离器以及手套箱内可采用单向低速气流。
Grade B: For aseptic preparation and filling, this is the background environment for the grade
A zone. 对于无菌准备和灌装,B级区域是A级区域的背景环境。
 
Grade C and D: Clean areas for carrying out less critical stages in the manufacture of sterile

WWW.AN-TAI.NET Corporation of China 2010苏州安泰空气技术有限公司净化工作台生物安全柜洁净工作台 公司简介 联系我们

客服电话
  • 15157563004
  • 18767572630