usp30-1116(1-14页翻译)

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1、1116MICROBIOLOGICALEVALUATIONOFCLEANROOMSANDOTHERCONTROLLEDENVIRONMENTS洁净室微生物评价与其它控制环境Thepurposeofthisinformationalchapteristoreviewthevariousissuesthatrelatetoasepticprocessingofbulkdrugsubstances,dosageforms,andincertaincases,medicaldevices;andtotheestablishment,maintenance,andcontrolof

2、themicrobiologicalqualityofcontrolledenvironments.此章节报告的目的是综述了涉及到大量药剂的物料、剂型的无菌处理的各种问题，以及在某些情况下的医疗器械；和微生物的质量控制的环境建立、维护和控制。Thischapterincludesdiscussionson(1)theclassificationofacleanroombasedonparticulatecountlimits;(2)microbiologicalevaluationprogramsforcontrolledenvironments;(3)trainingo

3、fpersonnel;(4)criticalfactorsindesignandimplementationofamicrobiologicalevaluationprogram;(5)developmentofasamplingplan;(6)establishmentofmicrobiologicalAlertandActionlevels;(7)methodologiesandinstrumentationusedformicrobiologicalsampling;(8)mediaanddiluentsused;(9)identificationofmicrobi

4、alisolates;(10)operationalevaluationviamediafills;and(11)aglossaryofterms.Excludedfromthischapterisadiscussionofcontrolledenvironmentsforusebylicensedpharmaciesinthepreparationofsterileproductsforhomeuse,whichiscoveredunderPharmaceuticalCompounding—SterilePreparations797Therearealternativ

5、emethodstoassessandcontrolthemicrobiologicalstatusofcontrolledenvironmentsforasepticprocessing.Numericalvaluesincludedinthischapterarenotintendedtorepresentabsolutevaluesorspecifications,butareinformational.Giventhevarietyofmicrobiologicalsamplingequipmentandmethods,onecannotreasonablysug

6、gestthattheattainmentofthesevaluesguaranteestheneededlevelofmicrobialcontrolorthatexcursionsbeyondvaluesinthischapterindicatealossofcontrol.Theimproperapplicationofmicrobiologicalsamplingandanalysismaycausesignificantvariabilityandthepotentialforinadvertentcontamination.Samplingmediaandde

7、vices,andmethodsindicatedinthischapter,arenotspecificationsbutonlyinformational.此章节内讨论的内容包括有：（1）基于微粒子数界限的洁净室级别；（2）受环境控制的微生物评价程序；（3）人员培训；（4）设定的临界因素和执行的微生物评价程序；（5）抽样检验方法的开展；（6）微生物警报和动态级别的建立；（7）用于微生物样品的方法和检测装备；（8）培养基和稀释液的使用；（9）微生物的分离鉴定；（10）使用的培养基的可用性评价；（11）名词解释。尽管一些已获许