Isolation Technology
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Isolation Technology: A Practical Guide

Isolation Technology: A Practical Guide


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About the Book

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.

Table of Contents:
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


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Product Details
  • ISBN-13: 9781574910599
  • Publisher: Taylor & Francis Ltd
  • Publisher Imprint: Interpharm Press Inc
  • Height: 235 mm
  • No of Pages: 336
  • Returnable: N
  • Weight: 644 gr
  • ISBN-10: 1574910590
  • Publisher Date: 31 Dec 1997
  • Binding: Hardback
  • Language: English
  • No of Pages: 336
  • Sub Title: A Practical Guide
  • Width: 156 mm


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