Isolation Technology

A Practical Guide

Tim Coles (Autor)

Buch | Hardcover

336 Seiten

1997
Interpharm Press Inc (Verlag)
978-1-57491-059-9 (ISBN)

Infos

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.

Inhalt

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

Produkt-Details

• Erscheint lt. Verlag: 31.12.1997
• Verlagsort: London
• Sprache: englisch
• Maße: 156 x 235 mm
• Gewicht: 644 g
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• ISBN-10: 1-57491-059-0 / 1574910590
• ISBN-13: 978-1-57491-059-9 / 9781574910599
• Zustand: Neuware