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Understanding the Operation and
Validation of Autoclaves - a
Practical Approach aims to give all those involved in the operation of
autoclaves, from hospital sterile supply to medicinal product and medical device
manufacture, whether responsible for specifying, validating, maintenance or day
to day operation, a better knowledge and understanding to assist them in their
everyday work. The book aims to present technical detail and
data in a simple, logical and palatable manner with particular emphasis being placed
upon the importance of complying with current and future Quality Assurance and
Good Manufacturing Practice standards when operating autoclaves.
Table of Contents
Introduction to Sterilization
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Sporing Organisms, Lethality, Bioburden, Moist Heat Sterilization, Inactivation
of Micro-Organisms
Steam for Sterilization
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Saturated Steam, Sensible Heat, Latent Heat, Superheat, Dalton's Law
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Clean Steam Systems, Steam and Condensate Quality, Steam Distribution, Steam
Traps, Pressure Reduction and Control
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Non-Condensate Gas, Dryness Value and Superheat Tests
Types of Autoclaves
Sterilizing Unwrapped Utensils and Instruments
Sterilizing Porous Loads
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Chamber /
Jacket, Door Seal, Air Leakage Test, Air Removal Systems, Cycle Operation,
Engineering Pipework Arrangement, Vacuum Pump
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Porous Load Cycles, Air Detector Systems
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Single Pack, Air Removal Efficiency, Air Detector Performance, Air Detector
Function, Steam Penetration Tests
Sterilizing Fluids in Sealed Containers
Multi-Cycle Autoclaves
Quality Assurance and Validation of Autoclaves
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Documentation, Qualified Personnel, Validation, Design Qualification
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Autoclave Control Systems, Process Data Retrieval, Validation Protocols,
Autoclave Procurement
Factory Acceptance Tests (FAT)
On Site Commissioning and Installation
Autoclave Qualification
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Installation Qualification, Operational Qualification, Performance Qualification
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Biological Testing, Production Operation, Change Control
Routine Maintenance, Testing and Auditing
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Maintenance Tasks and Schedule,
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Routine Monitoring and Testing Schedule for Unwrapped Utensil and Instrument,
Porous Load and Fluids Autoclaves
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Auditing and Self-Inspection Systems
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Parametric Release
Equipment Malfunction
Conclusion
Glossary of Terms
References
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