PDA TR9_粒子测量系统_Particllate Measurement Systems_1988.pdf

h Review of Commercially Available Particulate Measurement Systems 现有商用粒子测量系统的回顾 Preface In 1986,the Parenteral Drug Association Research Committee solicited proposals for a grant concerning an engineering related analysis of existing liquid-borne particle measuring equipment. Mr. Julius Knapp (RD Engineering) and Dr. Patrick DeLuca (University of Kentucky)were co-recipients of the grant. 在1986年，注射用药协会研究委员会请求给予建议书，内容关于现有液体传播粒子测 量仪器的相关工程分析。Julius Knapp先生 （研发工程师）和PatrickDeluca博士 （肯 塔基大学）为给予请求的共同收件人。 The PDA has electedto publishthe completed report of Mr. Knappand Dr. DeLucato serve as a possible basis for further discussion among the parenteral technology industry, and to perhaps provide the Research Committee with future constructive research project ideas related to particulate technology. PDA选择发表Knapp先生和Deluca博士的报告，作为在注射剂工业技术中深入讨论的可 能基础，并且为研究委员会提供关于粒子技术的未来建设性研究报告意见。 The contents of Mr. Knapps and Dr. DeLucas report contains technical statements and conclusions attained by the authors independent of the PDA Association and are not intended to reflect technical positions or interests of the PDA Research Committee, Board of Directors,and/ortheAssociationat large. Knapp先生和Deluca博士的报告内容包括由非PDA协会的作者完成的技术陈述和结论， 此内容并非普遍反映了PDA研究委员会，董事会和协会的技术立场。 MichaelS. Korczynski, Ph.D.Chairman, PDA Research CommitteeAugust 1987 MichaelS. Korczynski, 博士主席, PDA 研究委员会 1987年8月 Contents 目录 Part I—Instrumentation 仪器 I. Introduction 简介S5 II. Common Factors 常用系数S5 III. Optical Systems 光学系统S7 A. Filmy Materials 薄膜材料S8 B. Refractive Index Effects 折射率影响SM C.Conclusions 结论,SS IV. Resistance Modulation Systems (Coulter,etc.) 阻抗调制系统 （库尔特， 等） S9 A.Shape Sensitivity 形状敏感性S9 B. Filmy and Porous Materials 薄膜和多孔材料S\Q C.Sample Handling 样品处理SI0 D.Conclusions 结论SI 1 V. Present Detection Systems 现有检测系统Si 1 A.Comparison 比较S!1 B.Conclusions 结论S12 VI. Recent FDA Test Results 近期FDA测试报告SI 2 VII. RecommendedActions 推荐做法S13 A.Stop Gap 停止间隙SI3 B. NearTerm 近期SI3 VIII.Lon