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Isolation Technology: A Practical Guide, Second Edition 2nd edition [Kõva köide]

(University of Exeter, UK)
  • Formaat: Hardback, 236 pages, kõrgus x laius: 234x156 mm, kaal: 600 g
  • Ilmumisaeg: 27-May-2004
  • Kirjastus: CRC Press Inc
  • ISBN-10: 0849319447
  • ISBN-13: 9780849319440
Teised raamatud teemal:
  • Formaat: Hardback, 236 pages, kõrgus x laius: 234x156 mm, kaal: 600 g
  • Ilmumisaeg: 27-May-2004
  • Kirjastus: CRC Press Inc
  • ISBN-10: 0849319447
  • ISBN-13: 9780849319440
Teised raamatud teemal:
UK-based Coles has been active in the field of pharmaceutical isolation technology for 20 years. Suitable for both experienced and beginning professionals, the second edition of Coles' text reflects significant changes in the acceptance and the understanding of isolation technology in the five years since publication of the first edition. Revised and updated throughout, the text provides descriptions of and comments on new guidelines and standards, and describes technological advances, such as the new breed of sanitizing gas generators. Illustrated with b&w photographs, diagrams, and charts. Annotation ©2004 Book News, Inc., Portland, OR (booknews.com)

The second edition of this invaluable text is an updated source of information for both experienced and beginning 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 discusses setting up clean rooms and techniques for maintaining sterility and includes case studies, resource listings, and numerous photographs. Topics include technology, transfer methods, design specifications and control systems, project proposals, operation methods, and regulatory affairs.
Chapter one Introduction 1(20)
The background to isolation technology
1(1)
Isolation technology - a definition
2(2)
Isolation technology versus barrier technology
4(1)
The aim of isolation technology
5(5)
Improvement in product quality
6(1)
Reduction in costs
7(2)
Improvements in safety
9(1)
Flexibility
9(1)
Special conditions
9(1)
Qualification
10(1)
Aesthetics
10(1)
Some typical applications of isolation technology
10(10)
Sterility testing
10(1)
Aseptic filling
11(2)
Toxic containment
13(1)
Hospital pharmacy work
14(2)
Biomedical isolation
16(2)
Surgical and other miscellaneous uses of isolation technology
18(2)
What isolation technology is not: a panacea
20(1)
Chapter two An introduction to the technology 21(32)
The materials
21(5)
Flexible film plastic
21(2)
Rigid plastics
23(1)
PVC
24(1)
Acrylic
24(1)
Polypropylene
24(1)
Polycarbonate
24(1)
Stainless steel
24(2)
Mild steel
26(1)
Air handling in isolators
26(19)
Filtration
27(8)
Pressure regimes
35(2)
Flow regimes
37(4)
Turbulent flow
37(1)
Unidirectional flow
38(2)
Semiunidirectional flow
40(1)
Air conditioning
41(2)
Calculations for isolator air handling systems
43(2)
Handling the work in isolators
45(8)
Gloves
45(4)
Half-suits
49(1)
Full suits
50(1)
Robotics and automation
50(3)
Chapter three A review of transfer methods 53(34)
Simple doors
54(1)
Lockchambers
54(4)
Product passout ports
58(2)
Waste ports
60(3)
Rapid transfer ports
63(4)
Mode of operation
64(3)
Operational considerations
67(15)
Occluded surfaces
67(1)
"Ring of concern"
67(1)
Interlocking
67(1)
Engineering
68(1)
RTP containers
68(4)
Simple
69(1)
Gassable
69(1)
Autoclavable
69(1)
Partially disposable
69(2)
Totally disposable
71(1)
Isolator
72(1)
Powder transfer
72(1)
How good is the RTP?
72(3)
A further type of RTP: the split butterfly port
75(1)
Direct interface
75(3)
Dynamic mousehole
78(2)
Pipe and hose connection
80(2)
Services
82(5)
Chapter four Further design considerations 87(8)
Isolator control systems
87(3)
Simple, turbulent flow isolators
87(1)
Double-fan turbulent flow isolators
88(2)
Simple, unidirectional flow isolators
90(1)
Recirculating unidirectional isolators
90(1)
Temperature and relative humidity
90(1)
Isolator instrumentation
91(1)
Pressure
91(1)
Flow
92(1)
HEPA filter pressure drop
92(1)
Temperature and relative humidity
93(1)
Particle counting
93(1)
Air sampling
94(1)
Building interface
94(1)
Chapter five How to draw up a design specification 95(18)
User requirement specification (URS)
95(2)
Design qualification
97(1)
Standards and guidelines
97(3)
Workspace ergonomics and handling
100(1)
Rate of work
101(1)
Major equipment interface
102(1)
Positive pressure or negative pressure: the cytotoxic dilemma
103(2)
Turbulent airflow or unidirectional downflow
105(1)
Transfer
106(1)
The isolator room environment for sterile operations
107(2)
Control and instrumentation
109(1)
Sterilisation and decontamination
110(1)
Standard versus special isolator design
110(3)
Chapter six Seeing the project through 113(24)
Liaison with your designer and supplier
114(1)
Further project development
115(4)
The project plan
115(1)
DQ, IQ, OQ, and PQ
115(3)
DQ - design qualification
115(1)
IQ - installation qualification
115(1)
OQ - operational qualification
116(2)
PQ - performance qualification
118(1)
Some further points about qualification protocols
118(1)
Proposals and quotations
119(1)
Preengineering studies, models, and mockups
120(1)
Terms, payment structures, and guarantees
121(1)
The OQ in more detail
121(3)
HEPA/ULPA filter test
122(1)
Leak testing
123(1)
Leak detection methods
124(5)
Soap test
124(1)
Gas leak detection tests
124(1)
DOP smoke tests
125(1)
Pressure tests
126(3)
Pressure hold
128(1)
Parjo
128(1)
The oxygen test
129(1)
Expression of pressure decay test results
129(1)
Hourly leak rate
129(1)
Percentage volume loss per hour
129(1)
Volume loss per second (or per hour)
130(1)
Single-hole equivalent
130(1)
Classification by leak rate
130(1)
Further discussion of leak testing: the distributed leak test
130(1)
Testing gloves and sleeves
131(1)
Further leakage considerations
132(1)
When should leak testing be carried out?
132(1)
Instrument calibration
132(1)
Airflow patterns
133(1)
Miscellaneous checks
134(2)
Particle counting
134(1)
CIP drainage and drying
135(1)
Alarms
135(1)
Breach velocity
135(1)
Interlocks
135(1)
Any other relevant parameters
135(1)
Manuals
136(1)
Chapter seven Cleaning up: sterilisation and decontamination 137(26)
Sterilisation - manual wet processes
138(1)
Fogging processes
139(1)
Formaldehyde
139(1)
PAA and other agents
139(1)
Gassing systems
140(18)
Recent developments in gas-phase sterilisation
140(2)
La Calhene SA Sterivap®
142(2)
Astec Microflow Citomat
144(6)
Steris VHP 1000TM
150(1)
BioQuell ClarusTM
151(5)
HPV as a sterilising agent
156(1)
Other gas-phase sterilising agents
157(4)
Ozone
158(1)
Ultraviolet light
158(1)
Validating the sterilisation process
158(1)
CIP in isolators
159(2)
Decontamination in toxic and pathogenic applications
161(2)
Chemical decontamination: cytotoxics
161(1)
Chemical decontamination: unknown hazards
161(1)
Biological decontamination: pathogens and recombinant DNA
161(2)
Chapter eight Running the operation 163(10)
Operator training
164(1)
Physical validation
165(2)
Ergonomics and safety
165(1)
CIP functional test
165(1)
Particle counting during media filling trials
166(1)
Stability of the isolator parameters during production
166(1)
Alarm function
166(1)
Mechanical and electronic reliability (GAMP)
166(1)
Microbiological validation
167(3)
The cleaning process
167(1)
The sterilisation process
167(1)
Toxic decontamination
167(1)
Media fill trials
168(1)
Viable particle counting during production
168(2)
Miscellaneous checks
170(1)
Standard operating procedures
170(1)
Planned maintenance and servicing
171(1)
Documentation
171(1)
Conclusion
172(1)
Chapter nine Regulatory affairs 173(10)
The MHRA (formerly the MCA)
173(3)
The practical considerations
174(2)
The U.S. FDA view
176(3)
Further regulatory comment
179(4)
Standards and guidelines for isolators
179(4)
Chapter ten Case studies 183(22)
Aventis (previously Rhone-Poulenc Rorer), Holmes Chapel, Cheshire, UK
183(3)
Background
183(1)
Design and engineering
184(1)
Validation
185(1)
Conclusions
185(1)
Dabur Oncology, Bordon, Hampshire, UK
186(19)
Introduction
186(4)
Positive- or negative-pressure isolators?
190(1)
General layout and cleanrooms
190(2)
Filling line design
192(1)
General isolator design
192(1)
Specific isolator designs detail
193(2)
Formulation isolator
193(1)
Depyrogenation isolator
194(1)
Mobile isolators
194(1)
Filling isolator
194(1)
Freeze-dryer isolator
195(1)
Gas generators
195(1)
Sterility testing
195(1)
Validation
196(1)
Review in the light of experience
196(9)
References 205(4)
Glossary 209(4)
Index 213