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FDA认证咨询/FDA无菌加工设施中操作的分隔或指定区域应当受到合理控制

来源:本站 作者:ADMIN 发布时间:2020-01-01

IV.  BUILDINGS AND FACILITIES

      厂房和建筑

21 CFR 211.42(b)states, in part, that “The flow of components, drug product containers,closures, labeling, in-process materials, and drug products through thebuilding or buildings shall be designed to prevent contamination.”

CFR211.42(b)规定,“药物成分、容器、密封、标签、中间材料和药品在厂房内或厂房间的运输应该能够防止污染。”

21 CFR 211.42(c) states,in part, that “Operations shall be performed within specifically definedareas of adequate size.  There shall beseparate or defined areas or such other control systems for the firm’soperations as are necessary to prevent contamination or mixups during thecourse of the following procedures: * * * (10) Aseptic processing, which includes as appropriate:  (i) Floors, walls, and ceilings of smooth, hard surfaces that are easilycleanable; (ii) Temperature and humidity controls;  (iii) An air supply filtered through high-efficiency particulate air filtersunder positive pressure, regardless of whether flow is laminar or nonlaminar;(iv) A system for monitoring environmental conditions;   (v) A system for cleaning and disinfectingthe room and equipment to produce aseptic conditions; (vi) A system formaintaining any equipment used to control the aseptic conditions.”

CFR211.42(c)规定,“操作应当在有充足空间的指定区域内进行。操作应该分隔或指定的区域,或者有其它控制系统,以便在下面过程中防止污染或混淆:10)无菌加工,措施包括以下:(i)地面、墙面和天花板的表面平滑、坚硬并且容易清洁;(ii)温度和湿度控制;(iii)供应通过HEPA滤器过滤的空气,并保持正压,不论气流是层流或非层流;(iv)检测环境质量的系统;(v)清洁及消毒房间和设备以产生无菌条件的系统;(vi) 维护用于控制无菌环境的任何设备的系统。”


21 CFR211.46(b) states that “Equipment for adequatecontrol over air pressure, micro-organisms, dust, humidity, and temperatureshall be provided when appropriate for the manufacture, processing, packing, orholding of a drug product.”  


CFR211.46(b)规定,“当对生产、制造、包装或储存药品有利时,应当提供能充分控制压差、微生物、尘埃粒子、湿度及温度的设备。”

21 CFR 211.46(c) states,in part, that “Air filtration systems, including prefilters andparticulate matter air filters, shall be used when appropriate on air suppliesto production areas * * *.”

CFR211.46(c)规定,“当对供应生产区域的空气有利时,应当提供空气过滤系统,包括初效过滤器及颗粒空气过滤器。”

21 CFR 211.63 statesthat “Equipmentused in the manufacture, processing, packing, or holding of a drug productshall be of appropriate design, adequate size, and suitably located tofacilitate operations for its intended use and for its cleaning andmaintenance.”  

CFR211.63规定,“用于生产、加工、包装及储存药品的设备应当设计合理,有足够空间并且被适当定位,以方便其既定用途的操作并且方便清洁和维护。”

21 CFR 211.65(a) statesthat “Equipmentshall be constructed so that surfaces that contact components, in-processmaterials, or drug products shall not be reactive, additive, or absorptive soas to alter the safety, identity, strength, quality, or purity of the drugproduct beyond the official or other established requirements.”

CFR211.65(a)规定,“设备接触药品成分、中间材料或药品的表面应该无反应、无添加并且无吸附,不会改变药品的安全性、成分、浓度、质量或纯度并使它们超出官方或已经建立的标准。”

21 CFR 211.67(a) statesthat “Equipmentand utensils shall be cleaned, maintained, and sanitized at appropriateintervals to prevent malfunctions or contamination that would alter the safety,identity, strength, quality, or purity of the drug product beyond the officialor other established requirements.”

CFR211.67(a)规定,“设备和器具应当以合适间隔清洁、维护和消毒,以预防故障或污染改变药品的安全性、成分、浓度、质量或纯度并使它们超出官方或已经建立的标准。”

21 CFR 211.113(b) statesthat “Appropriatewritten procedures, designed to prevent microbiological contamination of drugproducts purporting to be sterile, shall be established and followed.  Such procedures shall include validation ofany sterilization process.”

CFR211.63(b)规定,“应当建立及遵从预防无菌药品受到微生物感染的合适书面程序。这些程序应当包括任何灭菌工艺的验证。”

Asprovided for in the regulations, separate or defined areas of operation in anaseptic processing facility should be appropriately controlled to attaindifferent degrees of air quality depending on the nature of the operation.  Design of a given area involves satisfying microbiologicaland particle criteria as defined by the equipment, components, and productsexposed, as well as the operational activities conducted in the area.


如法规规定,无菌加工设施中操作的分隔或指定区域应当受到合理控制,以根据操作的性质而获得空气质量的不同水平。给定区域的设计应该满足微生物和尘埃粒子标准,所述标准根据设备、成分和暴露的产品以及在该区域内进行的操作而确定。


Cleanarea control parameters should be supported by microbiological and particledata obtained during qualification studies. Initial cleanroom qualification includes, in part, an assessment of airquality under as-built, static conditions. It is important for area qualification and classification to place mostemphasis on data generated under dynamic conditions (i.e., with personnelpresent, equipment in place, and operations ongoing).  An adequate aseptic processing facilitymonitoring program also will assess conformance with specified clean areaclassifications under dynamic conditions on a routine basis.


洁净区域控制参数应当得到验证期间获得的微生物和尘埃粒子数据支持。洁净室的首次验证其中包括对空态、静态条件下空气质量的评价。区域验证和分级中,重要的是将大部分重点放在动态条件(即设备到位、人员到岗并且进行操作)下产生的数据。充分的无菌加工设施监测程序也将评估在日常运作的动态条件下与特定洁净区域分级的符合性。

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