清洁在线
THE PHARMACEUTICAL AND HEALTHCARE SCIENCES SOCIETY
BEST PRACTICE FOR
PARTICLE MONITORING
IN
PHARMACEUTICAL
FACILITIES
Technical Monograph No. 16
CONTENTS PAGE目录
1 Foreword 1、前言
2 Acknowledgments 6 2、确认
3 Introduction 73、介绍
4 Air particle monitoring to EU GMP Annex 1:2008 84、欧盟GMP中关于空气粒子监测的附件 5 System design 145、系统设计
6 Operations 256、操作
7 Maintenance and Cleaning 307、保养和清洁
8 Disaster Recovery and Data Back-up 328、容灾恢复和数据备份
9 Training 339、培训
10 Appendix A - Worked example of monitoring system layout . . . 3410、附件A：监控系统布局的成功案例
11 Appendix B - Manifold and remote particle monitoring
systems 3611、附件B：集成和远程粒子监控系统的案例
12 Appendix C - Examples of particle loss in transport tubing 3912、附件C：管道输送中粒子损失的案例
13 Appendix D - Isokinetic probes 4213、附件D：等动力采样头
14 Appendix E - Validation and risk assessment standards and guidelines 4314、附件E：验证和风险评估的标准与指导方针
1FOREWORD
前言
The Pharmaceutical and Healthcare Sciences Society (PHSS) exists as a science based forum for individuals active in the fields of Pharmaceutical and Healthcare Sciences. The society evolved from the former Parenteral Society, which was primarily focused on sterile injectable and implantable drugs and devices, to meet the needs of a wider community and broaden its horizons and membership, with the change of name effective from 1 March 2006.
制药科学和保健学会（PHSS）是研究制药和保健学科，由活跃在制药和保健行业的专家组成的以科学为依据的社会团体。学会前身为注射剂协会，关注无菌注射剂和植入式药品和器械。为适应更多团体的需求，拓展会员并拓宽研究范围，学会从2006年3月1日起改名为制药科学和保健学会（PHSS） The PHSS objectives are:
PHSS的宗旨和目标是：
1.To foster and advance, in the interest of public health, pharmaceutical and healthcare science and practice.
促进和提高制药科学和保健领域的发展；
2.To provide and disseminate to its members information concerning all aspects of pharmaceutical technology
and administration of medicines.
3.To identify specific areas where there is a need for new information or the collecting together of existing
information and to satisfy this need by organising meetings or by publishing monographs or articles in the European Journal of Parenteral and Pharmaceutical Sciences.
通过组织研讨会或在欧洲注射剂和制药协会杂志发表专题论文或文章，识别行业内有需要技术突破的专项领域 4.To foster and encourage a spirit of friendly co-operation among the members of the society and to promote
favourable relations between its members and the medical, pharmaceutical, hospital and related health professions.
促进会员间的的友好合作，促进行业内会员间不同领域之间的友好互助，包括如制药，医院，医疗等健康相关领域。 5.To cultivate and maintain co-operative relations with governmental departments and agencies, medical,
pharmaceutical and related health organisations, the academic community and compendial bodies and other branches of the pharmaceutical and other life science industries; and to originate and participate in co-operative enterprises and undertakings with them.
培养和维持政府部门，政府各级代理机构，医疗组织团体，制药以及健康相关组织，学术组织，一些制药行业的分支机构和其他生命科学的企业的合作关系，并创造和参与以及协助相关合作事宜。
6.To encourage the education and training of personnel in the fields of pharmaceutical technology and
administration of medicines.
鼓励药事管理和给药技术的培训和教育
7.To promote high standards in the production, quality assurance and administration of pharmaceutical and
other life science products.
促进生产，质量保证和制药以及相关生命科学产品标准的发展。
The PHSS actively encourages it's members to form and contribute to Special Interest Groups (SIG) with the aims of:
PHSS鼓励它的成员积极投身于SIG(特别兴趣小组)中，目的在于：
●exchanging dialogue between suppliers and users
推动供应商和客户之间信息的交换
●discussing and shaping how and where the industry is moving
讨论企业的未来之路
●discussing practical issues and guidance
讨论标准规范
●networking and discussions
互相交流和讨论
●producing technical monographs on specialist and relevants subjects
针对某一专题创作技术专论
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