金币
UID185833
帖子
主题
积分664
注册时间2014-11-27
最后登录1970-1-1
听众
性别保密
|
欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
本帖最后由 1949stone 于 2015-10-6 23:17 编辑
Sterility, sterilisation and sterility assurance for pharmaceuticals
The technology involved in the manufacture of sterile pharmaceuticals,
in relation to medical devices, in all aspects of healthcare, and in the
production of medical devices, has expanded and developed considerably
in the twenty-first century. Such advances include new and innovative
methods of sterilisation, through the development and advancement of
barrier systems designed to support cleanroom operations. Each of these
is focused on eliminating or controlling microbiological contamination.
This book, Sterility, sterilisation and sterility assurance for
pharmaceuticals, has been written to fi ll a gap in the current literature.
The aim was to produce a book that is applicable to major pharmaceutical
production, as well as to small biotechnological operations; and to
provide relevant information about medical devices and healthcare. The
book balances academic concepts with practical advice, and each chapter
includes a mixture of scientifi c concepts, regulatory expectations and
operational advice. The target audience includes microbiologists,
engineers, production personnel, R&D scientists, quality assurance
staff, and students of pharmaceutical science and pharmaceutical
microbiology.
The focus of this book is to examine different means of rendering a
product sterile. This is by providing an overview of sterilisation methods
including heat, radiation and fi ltration. Sterilisation technology and the
biopharmaceutical manufacturing process are discussed, including
aseptic fi lling, as well as the design of containers and packaging, and
addresses the cleanroom environments in which products are prepared.
In doing so, the book comprehensively covers sterility, sterilisation and
microorganisms, pyrogenicity and bacterial endotoxins, regulatory
requirements and good manufacturing practices, and gamma radiation.
Other chapters discuss e- beam, dry heat sterilisation, steam sterilisation,
sterilisation by gas, vapour sterilisation, and sterile fi ltration, before the
final chapters analyse depyrogenation, cleanrooms, aseptic processing,
media simulation, biological indicators, sterility testing, auditing and
new sterilisation techniques.
I hope that this book will provide practical assistance and promote an
understanding of sterility and sterilisation processes, and that the
concepts and thoughts expressed will provide insights to facilitate and
stimulate further advances in the fi eld.
Tim Sandle, St Albans, UK
March 2013
|
|
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2015-10-6 23:06:24
置顶卡
变色卡
楼主
