Isolation Technology
A Practical Guide
1st Edition
Published on 31. December 1997
Book
Hardback
336 pages
978-1-57491-059-9 (ISBN)
Description
This text is an invaluable source of information for both experienced and beginner professionals worldwide. Drawing on his vast experience in this field, the author provides practical ways to improve product standards, increase operator productivity, efficiency, and safety, and cut costs. He covers the technology, transfer methods, design specifications and control systems, the project proposal, the operation, regulatory affairs, and more. He includes case studies and resource listings.
More details
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
College/higher education
Professional and scholarly
Microbiologists, analytical chemists, and medicinal chemists
Dimensions
Height: 235 mm
Width: 156 mm
Weight
644 gr
ISBN-13
978-1-57491-059-9 (9781574910599)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions
Book
05/2004
2nd Edition
CRC Press
€402.34
Shipment within 15-20 days
Person
Content
o Introduction: Background; Definition; Aim; Applications
o The Technology: Materials; Air Handling; Work in Isolators
o Transfer Methods: Door; Lockchambers; Passout Ports; Waste Ports; Transfer Ports; Direct Interface; Mousehole
o Design: Control Systems; Instrumentation; Interface
o Design Specification: DQ; Standards & Guidelines; Ergonomics & Handling; Work Rate; Equipment Interface; Positive or Negative Pressure; Turbulent Airflow or Unidirectional; Transfer; Isolator Room Environment; Control & Instrumentation; Sterilization & Decontamination
o The Project: Liaisons; Proposals & Quotations; Pre-engineering Studies; Terms, Payment Structures & Guarantees; OQ in Detail
o Cleaning Up: Manual Wet Processes; Fogging; Gassing; Validation; CIP; Decontamination Applications
o The Operation: Training; Physical Validation; Microbiological Validation; SOPs; Maintenance; Documentation
o Regulatory Affairs: MCA/FDA
o Case Studies
o Resource Listings
o The Technology: Materials; Air Handling; Work in Isolators
o Transfer Methods: Door; Lockchambers; Passout Ports; Waste Ports; Transfer Ports; Direct Interface; Mousehole
o Design: Control Systems; Instrumentation; Interface
o Design Specification: DQ; Standards & Guidelines; Ergonomics & Handling; Work Rate; Equipment Interface; Positive or Negative Pressure; Turbulent Airflow or Unidirectional; Transfer; Isolator Room Environment; Control & Instrumentation; Sterilization & Decontamination
o The Project: Liaisons; Proposals & Quotations; Pre-engineering Studies; Terms, Payment Structures & Guarantees; OQ in Detail
o Cleaning Up: Manual Wet Processes; Fogging; Gassing; Validation; CIP; Decontamination Applications
o The Operation: Training; Physical Validation; Microbiological Validation; SOPs; Maintenance; Documentation
o Regulatory Affairs: MCA/FDA
o Case Studies
o Resource Listings