PDA
PROCESS SIMULATION TESTING FOR
ASEPTICALLY FILLED PRODUCTS
PDA无菌产品模拟灌装工艺试验
PDA
ASEPTIC PROCESSING MONOGRAPH REVISION TASK FORCE
PDA无菌工艺技术专论修订版专题组
September 1996
    1996年9月
James P. Agalloco. Agalloco＆Associates (Co-chair)
James E. Akers,Ph.D.,Akers Kennedy & Associates, Inc.
Doris L. Conrad,SmithKline Beecham(Co-choir) ＆Upjohn,Inc
William  R. Frieben,Ph.D.,Pharmacia
Edmund  M.Fry,PDA
Carol M.Lampe,Baxter Healthcare Corporation
Russell E.Madsen,PDA
William R.McCullers, Merck & Company,Inc.
Terry E.Munson,Kemper-Masterson,Inc.
Ronald F.Tetzlaff,Ph.D.,Kemper-Masterson,Inc.
James D. Wilson,Isomedix,Znc.
PREFACE
前言
This document replaces the previous PDA technical documents on the validation of aseptic processing: Technical Monograph No. 2, Validation of Aseptic Filling for Solution Drug Products, 1980; and Technical Report No. 6, Validation of Aseptic drug Powder Filling Processes, 1984. Our intent in this effort was to update these documents and expand the coverage to  other  dosage  forms,  as  well  as  embrace  the  changing  nature  of  aseptic  processing technology within the global industry. We have attempted to address the subject as fully as possible, recognizing the notable contributions by other organizations, regulators, compendia and individuals who have worked in this area.
editor evaluating revision这期文件取代了以前关于无菌工艺验证方面的PDA科技文件：1980年第2期科技专论-可溶物产品的无菌灌装验证；1984年第6期科技报告-无菌药物粉末分装工艺验证。我们所做这些努力的目的是为了更新这些文件并扩大覆盖面到其他剂型，涵盖在全球行业范围内无菌工艺技术的变化特点。借于从事于这个领域的其他组织，监管机构，档案摘要和个人的突出贡献，我们试图尽可能充分地解决这个问题。
This Technical Report was disseminated in draft for public review and comment prior to pub
lication. Many of the submitted comments have been included in the final document. We believe this approach accomplished the widest possible review of the document and ensures its suitability as a valuable guide to industry in the area of process simulation testing for aseptic processing operations. We have also drawn heavily upon the responses received from the 1992 PDA survey on aseptic processing. The task force believes the use of survey information provides the most accurate information on industry practice.
这些技术报告出版之前先以草案的形式传播供公众审阅和评论。大部分提交的评论都包含在最后的文件中。我们相信这种方法可以实现对这个文件最大范围的审查，并确保它可以在行业中作为一份有价值的指导文件，主要是在无菌工艺操作的模拟试验方面。我们的起草很大程度上基于1992年PDA对无菌工艺调查的反馈。负责小组确保调查提供的是工业实践中最准确的信息。
Despite the use of an "open process" and consideration of survey information, this document should be considered as a guide; it is not intended to establish any mandatory or implied standard. This is especially true in areas such as "blow-fill-seal" and "isolation" where the rate of technological progress has been extremely rapid.
尽管使用了“出版前公开”和调查信息参考的方法，这份文件也只应作为一个参考指导；它并不是企图建立任何强制性的或潜在的标准。由于科技的进步是非常地迅速，在如“吹瓶-灌装-封口”和“隔离技术"方面它是非常准确的。
James P. Agalloco
Doris L. Conrad
Co-chairs, Aseptic Processing Monograph Revision Task Force
联合主席，无菌工艺修订版专论课题组

TABLE OF CONTENTS
目录
1.    INTRODUCTION    1
1      介绍    1
1.1    Previous Monographs    1
1.1    以前的专论    1
1.2    Reason for Revision    1
1.2  修订原因    1
1.3    Scope    1
1.3  范围    1
1.4    Purpose    2
1.4  目的    2
1.5    Considerations    2
1.5  思考    2
2    PROCESS SIMULATION CONCEPTS AND PRINCIPLES    4
2        模拟工艺的概念和原理    4
2.1    Number and Frequency of Tests    4
2.1试验次数和频率    4
2.2    Worst Case    5
2.2  最差工况    5
3    PROCESS SIMULATION TEST METHODS    6
3      模拟工艺试验方法    6
3.1    Solutions    6
3.1  解决方法    6
3.2    Lyophilized Products    7
3.2    冻干产品    7
3.3    Suspensions    10
3.3    悬浮液    10
3.4    Ointments/Creams/Emulsions/Gels    11
3.4    软膏/乳膏/乳剂/凝胶    11
3.5    Powders    12
3.5  粉末    12
3.6    Other Dosage Forms    16
3.6    其他剂型    16
3.7    Advanced Aseptic Processing Technologies    16
3.7  先进的无菌工艺技术    16
4    DOCUMENTATION    18
4      文件说明    18
4.1    Process Definition    18
4.1  工艺确定    18
4.2    Protocol Preparation    18
4.2    方案起草    18
4.3    Protocol Execution    20
4.3    方案执行    20
5    MICROBIOLOGICAL ENVIRONMENTAL MONITORING    21