Isolation technology a practical guide 2nd Edition by Tim P Coles ISBN 978-0849319440 0849319447
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Product details:
ISBN 10: 0849319447
ISBN 13: 978-0849319440
Author: Tim P Coles
Table of contents:
Chapter one Introduction
The background to isolation technology
Isolation technology – a definition
Isolation technology versus barrier technology
The aim of isolation technology
Improvement in product quality
Reduction in costs
Improvements in safety
Flexibility
Special conditions
Qualification
Aesthetics
Some typical applications of isolation technology
Sterility testing
Aseptic filling
Toxic containment
Hospital pharmacy work
Biomedical isolation
Surgical and other miscellaneous uses of isolation
technology
What isolation technology is not: a panacea
Chapter two An introduction to the technology
The materials
Flexible film plastic
Rigid plastics
PVC
Acrylic
Polypropylene
Polycarbonate
Stainless steel
Mild steel
Air handling in isolators
Filtration
Pressure regimes
Flow regimes
Turbulent flow
Unidirectional flow
Semiunidirectional flow
Air conditioning
Calculations for isolator air handling systems
Handling the work in isolators
Gloves
Half-suits
Full suits
Robotics and automation
Chapter three A review of transfer methods
Simple doors
Lockchambers
Product passout ports
Waste ports
Rapid transfer ports
Mode of operation
Operational considerations
Occluded surfaces
“Ring of concern”
Interlocking
Engineering
RTP containers
Simple
Gassable
Autoclavable
Partially disposable
Totally disposable
Isolator
Powder transfer
How good is the RTP?
A further type of RTP: the split butterfly port
Direct interface
Dynamic mousehole
Pipe and hose connection
Services
Chapter four Further design considerations
Isolator control systems
Simple, turbulent flow isolators
Double-fan turbulent flow isolators
Simple, unidirectional flow isolators
Recirculating unidirectional isolators
Temperature and relative humidity
Isolator instrumentation
Pressure
Flow
HEPA filter pressure drop
Temperature and relative humidity
Particle counting
Air sampling
Building interface
Chapter five How to draw up a design specification
User requirement specification (URS)
Design qualification
Standards and guidelines
Workspace ergonomics and handling
Rate of work
Major equipment interface
Positive pressure or negative pressure: the cytotoxic
dilemma
Turbulent airflow or unidirectional downflow
Transfer
The isolator room environment for sterile operations
Control and instrumentation
Sterilisation and decontamination
Standard versus special isolator design
Chapter six Seeing the project through
Liaison with your designer and supplier
Further project development
The project plan
DQ, IQ, OQ, and PQ
DQ- design qualification
IQ – installation qualification
OQ- operational qualification
PQ-performance qualification
Some further points about qualification protocols
Proposals and quotations
Preengineering studies, models, and mockups
Terms, payment structures, and guarantees
The OQ in more detail
HEPA/ULPA filter test
Leak testing
Leak detection methods
Soap test
Gas leak detection tests
DOP smoke tests
Pressure tests
Pressure hold
Parjo
The oxygen test
Expression of pressure decay test results
Hourly leak rate
Percentage volume loss per hour
Volume loss per second (or per hour)
Single-hole equivalent
Classification by leak rate
Further discussion of leak testing: the distributed leak test
Testing gloves and sleeves
Further leakage considerations
When should leak testing be carried out?
Instrument calibration
Airflow patterns
Miscellaneous checks
Particle counting
CIP drainage and drying
Alarms
Breach velocity
Interlocks
Any other relevant parameters
Manuals
Chapter seven Cleaning up: sterilisation and decontamination
Sterilisation – manual wet processes
Fogging processes
Formaldehyde
PAA and other agents
Gassing systems
Recent developments in gas-phase sterilisation
La Calhène SA Sterivap
Astec Microflow Citomat
Steris VHP 1000M
BioQuell Clarus™
HPV as a sterilising agent
Other gas-phase sterilising agents
Ozone
Ultraviolet light
Validating the sterilisation process
CIP in isolators
Decontamination in toxic and pathogenic applications
Chemical decontamination: cytotoxics
Chemical decontamination: unknown hazards
Biological decontamination: pathogens and recombinant DNA
Chapter eight Running the operation
Operator training
Physical validation
Ergonomics and safety
CIP functional test
Particle counting during media filling trials
Stability of the isolator parameters during production
Alarm function
Mechanical and electronic reliability (GAMP)
Microbiological validation
The cleaning process
The sterilisation process
Toxic decontamination
Media fill trials
Viable particle counting during production
Miscellaneous checks
Standard operating procedures
Planned maintenance and servicing
Documentation
Conclusion
Chapter nine Regulatory affairs
The MHRA (formerly the MCA)
The practical considerations
The U.S. FDA view
Further regulatory comment
Standards and guidelines for isolators
Chapter ten Case studies
Aventis (previously Rhone-Poulenc Rorer), Holmes Chapel,
Cheshire, UK
Background
Design and engineering
Validation
Conclusions
Dabur Oncology, Bordon, Hampshire, UK
Introduction
Positive- or negative-pressure isolators?
General layout and cleanrooms
Filling line design
General isolator design
Specific isolator designs detail
Formulation isolator
Depyrogenation isolator
Mobile isolators
Filling isolator
Freeze-dryer isolator
Gas generators
Sterility testing
Validation
Review in the light of experience
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