Sterilization of drugs and devices: technologies for the 2000s
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Buffalo Groves, Ill.
Interpharm Press
1998
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XXI, 554 S. Ill., graph. Darst. |
| ISBN: | 1574910604 |
Staff View
MARC
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| 245 | 1 | 0 | |a Sterilization of drugs and devices |b technologies for the 2000s |c ed. by Fred M. Nordhauser ... |
| 264 | 1 | |a Buffalo Groves, Ill. |b Interpharm Press |c 1998 | |
| 300 | |a XXI, 554 S. |b Ill., graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 650 | 4 | |a Drug Contamination |x prevention & control | |
| 650 | 4 | |a Drugs |x Sterilization | |
| 650 | 4 | |a Equipment Contamination |x prevention & control | |
| 650 | 4 | |a Equipment and Supplies | |
| 650 | 4 | |a Medical instruments and apparatus |x Sterilization | |
| 650 | 4 | |a Sterilization |x methods | |
| 650 | 4 | |a Technology |x trends | |
| 700 | 1 | |a Nordhauser, Fred M. |e Sonstige |4 oth | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009589271&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-009589271 | ||
Record in the Search Index
| _version_ | 1804128862733336576 |
|---|---|
| adam_text | Contents
Preface xv
Acknowledgment xvi
Foreword xix
Kenneth Muhvich
1. Introduction 1
Fred M. Nordhauser
Historical Developments 2
Current Developments 3
References 4
iii
j
iv Sterilization of Drugs and Devices
2. The Sterilization of Pharmaceutical j
Solutions, with Emphasis on the Kinetics
of the Bacterial Death Process 5
M.J. Groves
Some Reminders: The Structure and Functions ;
of Microorganisms 5
The Behavior of Bacterial Populations 12
The Formation of Endospores 15
The Death Process 16
Killing Agents 17
Sites ofInactivation 18
External Cell Wall 19
Inner or Cytoplasmic Membrane and Membrane
Enzymes 19
Cytoplasmic Contents 20
The Effect of Heat 21
The Effect of Radiation on Bacterial Cells and Spores 23
Pulsed Light Sterilization 24
Sterility Testing 25
Filtration Sterilization 27
Kinetic Considerations in the Death Process 29
Concepts Versus Reality, and Some Speculation 35
Coda: Some Thoughts on Gilbert and Allison (1996) 42
References 43
3. SIP of Microbes in Deadlegs 45
Jack H. Young
Steam Sterilization Principles 49
Time 49
Temperature 52
Moisture 55
i
t
Contents v
Factors Affecting Steam SIP 57
Deadleg Orientation 59
Deadleg Diameter and Length 64
Flow Patterns Within Deadlegs 65
SIP Guidelines 69
Summary 71
References 72
4. Heat Processing for the
Pharmaceutical Industry 75
Vance Caudill, Mark Kaufmann, Michael Jordan
Background 76
History of Heat Processing 76
Fluid Flow Characteristics 77
Heat Transfer 81
Engineering Data 83
Process Drawings 83
General Arrangements 85
Detail Schematics 85
Equipment Selection 87
Controls 93
Plant Documents 94
Discussion 97
Sterilization Methods 97
HTST 97
UHT 99
Processing Data 102
Conclusion 104
References 105
vi Sterilization of Drugs and Devices
5. In Line Sterilization of Liquids, from
the Viewpoint of Food Processing 107
V. Robert Carlson
Pasteurization and Sterilization 107
Pasteurization of Milk (and Similar Dairy Products) 107
Pasteurization/Sterilization of Foods Other Than Dairy
Products 109
Thermal Process Determination 115
Time Temperature to Select 116
Calculation of D Values 117
Hold Time 117
System Design—Concepts with Pharmaceutical
Grade Water and Water for Injection 118
Indicator Tests or Procedures to Verify the Process 119
Suggested Procedures for Pharmaceutical Products 122
Electronic Controls and the Use of PLCs 124
Sanitary Design 125
Pumping and Timing 126
Holding 129
Flow in Conventional Holding Tubes 129
Proper Hold Tube Design 130
Heating 131
Plates 131
Tubes 132
HydroCoil® 133
Tube in Tube Heat Exchangers 135
VRC® MultiCoil Heat Exchangers 136
Continuous Sterilization of Liquids—
System(s) Design 138
Regenerative Sterilizing System 139
Nonregenerative Sterilizing System 141
Modified Simplified System 142
Aseptic Tanks 142
I
Contents vii
Cleaning of the System 143
Clean in Place (CIP) 144
CIP Solutions 145
Aseptic Barrier Seals and Valves 146
Barrier Seals 146
Aseptic VaJves 147
Controls 150
Summary 153
References 154
6. Sterilization of Medical Products
Using Gas Plasma Technology 157
Phillip A. Martens, Victoria Galliani, Gary Graham,
Ross A. Caputo
Plasma 158
Plasma Formation 159
Other Important Plasma Reactions 163
Plasma Reactors 166
Vacuum System 167
Power Sources 168
Gas Sources 170
The Development of Plasma Sterilization 170
Removing Aggressive Plasma Components 177
Combining Antimicrobial Agents with Plasma 182
Modern Plasma Sterilizers 185
The AbTox Plazlyte® Sterilizer 186
The ASP Sterrad® Sterilizer WO
Applications of Plazlyte® Sterilization 193
Acknowledgment 194
References 194
viii Sterilization of Drugs and Devices
7. Sterilizing Filtrations: Process 197
Wayne P. Olson
Utility of Sterilizing Filtration in Process 197
History and Theory of Sterilizing Filtrations 198
Adsorptive Mechanisms 198
Sieving Mechanisms 199
Adsorption by Membrane Filters 200
Comparison of Adsorption and Sieving 205
The Special Case of Filtering Air and Gases 205
Filtration as a Statistically Driven Event 206
Practice 208
Where to Filter in Process 208
Constant Pressure or Constant Rate 211
Issues 219
Nondestructive Tests 221
Membrane Structure 226
Issues of Filtration In Line with Filling 227
Validation of Filters and Tests 228
Sterilization of the Filters 228
Bacterial Removal by the Filter 229
Conclusion 232
Note 232
References 232
8. Am and Surface Sterilization
with Chemicals 235
Wayne P. Olson
The Requirement for Sterile Air and Surfaces 235
Definitions 236
Evaluation of a Sterilizing Gas 237
Hydrogen Peroxide 241
Peracetic Acid 245
Chlorine Dioxide 246 j
i
Contents ix
Ethylene Oxide 248
Formaldehyde 253
Isopropyl Alcohol with 3 Percent Propylene Oxide 255
Systems for the Delivery of Chemical Sterilants 256
Validation and the Choice of Biological Indicators 256
When Things Go Wrong in the Gas Chamber 258
Interpretations of the Data 259
Acknowledgment 261
References 261
9. Integrated Systems for the Aseptic
Filling of Sterile Product 267
Hans L. Melgaard Paul J. Haas
Hardware Requirements for an Integrated Aseptic
Filling Barrier Enclosure and Access to Equipment 269
Commodity Process Equipment 277
Glass Vial Transfer 277
Blow/Fill/Seal 281
Stopper Transfer 281
Air Processing and Pressure Balance Equipment 283
Isolator Internal Condition Control and Monitoring 285
Filling Equipment 288
SIP and CIP Equipment 292
CIP/SIP of Isolators 292
Materials Selection and Compatibility 299
Integrated System Physical Requirements
and Operational Rationale 300
Physical Configuration Alternatives 300
Facility Requirements 304
Operational Cycle 305
Validation Approaches 306
The Use of Physical Data for Validation 307
Duration of Sterility Maintenance 308
x Sterilization of Drugs and Devices
Summary 308
References 308
10. Gamma Radiation Sterilization of
Pharmaceuticals 311
Brian D. Reid Barry P. Fairand
History of Gamma Radiation Processing 314
Why Use Gamma Radiation? 315
Terminal Sterilization 315
Reliable, Reproducible Viral Inactivation 315
Complete Product Penetration 316
Ease of Validation 316
No Posttreatment Quarantine 316
Novel Product Design Potential 316
Reduction in Endotoxin Level 317
Environmentally Friendly 317
Cost Effectiveness 317
General Aspects of Gamma Radiation Processing 318
Physical Characteristics of Ionizing Radiation 318
Gamma Radiation—Definition and Sources 319
Production of Cobalt 60 319
A Typical Gamma Radiation Facility 322
Dosimeters and Dosimetry 329
The Science Behind Gamma Radiation Processing 333
Interaction of Gamma Radiation with Matter 333
Practical Consequences 336
The Effects of Ionizing Radiation on Bacteria,
Fungi and Viruses 337
Validation of Gamma Radiation Processing 354
The Validation Program 354
Validation Approaches 354
Product Qualification 357
Equipment Qualification 362
Process Qualification 364
Contents xi
Effects of Ionizing Radiation on Pharmaceutical
Products 369
Radiolysis of Water 370
Color Centers 371
Proteins 371
Carbohydrates 373
Excipients 374
Colors 375
Preservatives 375
Specific Drugs 375
Effects of Ionizing Radiation on Pharmaceutical
Packaging 379
Regulatory Considerations 382
Product Related 382
Personnel Related 385
Environment Related 385
Conclusion 385
Acknowledgments 386
References 386
11. PureBright® Pulsed Light Sterilization 393
Joseph Dunn
PureBrighi® Pulsed Light 394
A Simple Demonstration 395
Application of Pulsed Light 398
Pulsed Light Terminal Sterilization of Filled
Blow/Fill/Seal Containers 399
Automated Treatment of Blow/Fill/Seal Containers 401
PureBright® Inactivation Kinetics 405
Pulsed Light for High Quality Water—
Crytosporidium Disinfection 409
Oocyst Preparation and Treatment 413
In Vivo Infectivity Assays 413
Results and Discussion 414
xii Sterilization of Drugs and Devices
Summary 416
A Pulsed Light Point of Entry Water Treatment System 416
Some Comments on Microbial Inactivation
Mechanisms 418
The Peak Power and Broad Spectrum of
Pulsed Light Are Unique 418
PureBright® Ultraviolet Effects 418
Molecular Interactions of Ultraviolet Light 419
Kinder, Gentler Chemistry—No Measurable Oxidative
Cascade 421
PureBright® Peak Power Effects: Fluence Per Flash Is
Important 423
Ozone Production Is Minimal and Plays No Role in Kill 428
PureBrighi® Economics 428
Summary 429
References 430
12. Virus Inactivation and Removal 433
Wayne P. Olson
Viruses of Concern in Nature and in Cell Culture 434
Materials Requiring Viral Inactivation and
Elimination 437
Where Viruses Aren t 437
Methods for Viral Inactivation and Elimination 438
Decontamination of Materials Not Intended for
Injections 439
Decontamination of Materials Intended for Injections 446
Applications of Viral Inactivation and Elimination 461
A Viral Reference for Inactivation or Elimination 462
Prions 462
Acknowledgment 465
References 465
Contents xiii
13. Sterility Testing, Microbial
Monitoring, and Injured Organisms 471
Wayne P. Olson
Definitions 472
State of the Art in Sterility Testing 473
The MFST (Old Style) 473
The MFST—Canister + Isolator System 474
Recent Developments in the MFST 475
Recovery and Enumeration of Organisms
Upstream of Filling 475
Justification 475
Planktonic Organisms and Biofilms 476
Standard Plate Counts 476
Rapid Quantitation of Uninjured and Injured Microbes 477
A Note on Monitoring Aerosolized Microbes 481
Identification of Organisms 482
Economic Justification for Microbial
Analytical Methods Development 482
A Note on Medical Applications of
Analytical Methods Development 483
Acknowledgments 483
References 484
14. Parametric Release 487
James Wilson
Advantages of Parametric Release 488
Disadvantages of Parametric Release 489
Factors Influencing Sterilization Methods 489
General Expectations of the FDA 489
Regulatory Scope 491
xiv Sterilization of Drugs and Devices
PDA Response to FDA Compliance Guideline
on Parametric Release 493
Calibration and Maintenance 495
Operational Requirements for Parametric Release 496
Steam Sterilization Process 496
Ethylene Oxide Processing 500
Irradiation Processing 508
Dosimetry Systems and Dose Measurement 511
Data Management 515
References 516
Index 517
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| spelling | Sterilization of drugs and devices technologies for the 2000s ed. by Fred M. Nordhauser ... Buffalo Groves, Ill. Interpharm Press 1998 XXI, 554 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drug Contamination prevention & control Drugs Sterilization Equipment Contamination prevention & control Equipment and Supplies Medical instruments and apparatus Sterilization Sterilization methods Technology trends Nordhauser, Fred M. Sonstige oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009589271&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Sterilization of drugs and devices technologies for the 2000s Drug Contamination prevention & control Drugs Sterilization Equipment Contamination prevention & control Equipment and Supplies Medical instruments and apparatus Sterilization Sterilization methods Technology trends |
| title | Sterilization of drugs and devices technologies for the 2000s |
| title_auth | Sterilization of drugs and devices technologies for the 2000s |
| title_exact_search | Sterilization of drugs and devices technologies for the 2000s |
| title_full | Sterilization of drugs and devices technologies for the 2000s ed. by Fred M. Nordhauser ... |
| title_fullStr | Sterilization of drugs and devices technologies for the 2000s ed. by Fred M. Nordhauser ... |
| title_full_unstemmed | Sterilization of drugs and devices technologies for the 2000s ed. by Fred M. Nordhauser ... |
| title_short | Sterilization of drugs and devices |
| title_sort | sterilization of drugs and devices technologies for the 2000s |
| title_sub | technologies for the 2000s |
| topic | Drug Contamination prevention & control Drugs Sterilization Equipment Contamination prevention & control Equipment and Supplies Medical instruments and apparatus Sterilization Sterilization methods Technology trends |
| topic_facet | Drug Contamination prevention & control Drugs Sterilization Equipment Contamination prevention & control Equipment and Supplies Medical instruments and apparatus Sterilization Sterilization methods Technology trends |
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