Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations
Tim Sandle
Failure to adequately control any microbial challenge by sterilization will result in a contaminated marketed product, with potential harm to the patient. Sterilization is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals.
The author, Tim Sandle, examines different means of rendering a product sterile by providing an overview of sterilization methods including heat, radiation and filtration. Throughout 18 chapters, he outlines and discusses sterilization technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging and addresses the cleanroom environments in which products are prepared.
The author, Tim Sandle, examines different means of rendering a product sterile by providing an overview of sterilization methods including heat, radiation and filtration. Throughout 18 chapters, he outlines and discusses sterilization technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging and addresses the cleanroom environments in which products are prepared.
Thể loại:
Năm:
2013
In lần thứ:
1
Nhà xuát bản:
Woodhead Publishing
Ngôn ngữ:
english
Trang:
370
ISBN 10:
1907568387
ISBN 13:
9781907568381
Loạt:
Woodhead Publishing Series in Biomedicine
File:
PDF, 6.86 MB
IPFS:
,
english, 2013
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