Isolation Technology
Interpharm Press Inc (Verlag)
978-1-57491-059-9 (ISBN)
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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
| 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 |
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