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Sterile Filtration : A Practical Approach - Maik W. Jornitz

Sterile Filtration

A Practical Approach

Hardcover

Published: 18th December 2000
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This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals.
Addresses the complexities of globalizing redundancy in filtration
Enabling educated developmental, procedural, and regulatory judgments to be made in the manufacturing of sterile health care products, Sterile Filtration
considers how many filters should be in the process stream
examines the existence of nanobacteria and viable but nonculturable organisms
covers pore size designations, distributions, architecture, and numbers
discusses the latest findings in bubble point and diffuse flow measurements
describes pre- and postfiltration, up- and downstream testing, and after-stream sterilizations
details wetting liquid, polymer, temperature, and water purity effects
explains sieve retention, size exclusion, adsorptive sequestrations, charge-related phenomena, gravitational settling, and interference factors in liquids and gases
outlines filter validation, requirements, and operational specifics
and more
Advocating separation in addition to physical destruction of microorganisms, Sterile Filtration is a reference essential for pharmaceutical scientists; biotechnologists; microbiologists; virologists; process and chemical engineers; plant, production, validation, and quality control managers in the pharmaceutical and biotechnology industries; and upper-level undergraduate and graduate school students in these disciplines.

"From the foreword the authors of these chapters bring an abundance of technical knowledge and experience to this endeavor. Filters are all around us in sterile product manufacturing, and their selection, use, validation, and testing represent an essential fundamental discipline. This book will provide an analytical mind with basic scientific insight into this essential, dynamic, and still somewhat controversial area of contamination prevention. "-James E. Akers Akers, Kennedy & Associates Kansas City, Missour "well referenced and supported by appropriate tables and figures. a very worthwhile book.contains information useful to both experienced practitioners and students alikewill be a very worthwhile contribution to a reference section. "-Indian Journal of Toxicology

Forewordp. v
Prefacep. vii
Acknowledgmentsp. ix
Filter Porosity: Its Genesis and Characterp. 1
Introductionp. 1
Genesis of Porosityp. 2
Microporous Membranesp. 9
Comparison of Depth and Membrane Filtersp. 17
Numerical Pore Dimensionsp. 19
Sterilizing Filtersp. 30
Pore Distribution Analysisp. 46
Implications of Breadth of Pore Size Distributionp. 48
The Number of Poresp. 54
Pore Lengths and Tortuosityp. 58
Pore Shapesp. 60
Porosity Changes by Particle Accretionp. 66
The Polymeric Matrix and Its Influencep. 72
Introductionp. 72
Polymeric Compositionsp. 73
Mechanical Propertiesp. 74
Extractablesp. 84
Particle Shedding by Filtersp. 89
Particulate Matter in Pharmaceuticalsp. 94
Hydrophobic Vent Filtersp. 96
Subtle Incompatibilitiesp. 96
Adsorptionp. 108
Blocking Effectp. 122
Blockage by Surfactantp. 123
Membrane Fouling, Cleaning, and Sanitationp. 125
Membrane Foulingp. 125
Microporous Membranesp. 126
Biofoulingof RO Membranesp. 140
Sanitizationp. 142
Steamp. 156
Steam Sterilization of Filtersp. 160
Sanitization Summaryp. 163
Flow and Pressure, Flow Decay, and Filter Sizingp. 167
Introductionp. 167
Flowp. 168
Differential Pressurep. 168
Parallel Arrangementsp. 170
Pressure Arrangementsp. 172
Prefilter Actionp. 175
Selection of Applied Differential Pressure Levelp. 177
Consumption of Filter Capacityp. 181
Filter Sizing by Flow Decayp. 185
System Overdesignp. 200
Flow Rate Considerationsp. 203
Prefilter and Final Filter Combinationp. 205
Sizing Compressed Gas Systemsp. 210
Sizing Tank Ventsp. 215
Summaryp. 225
Mechanisms of Particle Removal from Liquids
Particle Trapping Mechanismsp. 227
Nature of Adsorptionp. 231
Colloidal Agglomerationp. 237
Hydrophobic Adsorptionp. 244
Particle Removal from Gas Streamsp. 252
Positively Charged Filtersp. 252
Desorptionp. 256
Finite Number of Adsorption Sitesp. 256
Competition and Selectivity in Adsorptionp. 257
Influence of Polymer Matrix on Organism Adsorptionp. 258
Influence of Suspending Medium on Organism Adsorptionp. 260
Influences on Organism Sizep. 265
Two-Phase Separationsp. 273
Tangential Flow Filtrationp. 275
Minimum Water/Product Bubble Pointp. 276
Absolute Filters and Filter Reliabilityp. 278
Surface Filtersp. 279
Organisms Smaller than B. diminutap. 280
Maximum Bioburdenp. 291
Filter Retention Additivitiesp. 292
Smaller Organism Retentionp. 293
Retention of Latex Spheresp. 295
Log Reduction Valuep. 301
Mechanisms of Particle Removal from Air and Other Gases
Depth-Type HEPA Filterp. 302
Historical Developmentp. 303
Separation Mechanismsp. 304
Van der Waals Forces (Restated)p. 314
Induced Chargesp. 314
Superiority of Filter Efficiency in Gasesp. 315
Most Penetrating Particle Sizep. 321
Membrane Filter Compositionsp. 324
Double Membrane Constructionsp. 332
Contaminantsp. 332
Prefiltrationp. 334
Sterilizing Grade Filter Qualitiesp. 337
Applicationsp. 342
Vent Filtersp. 345
Integrity Testingp. 346
Validation of Air Filtersp. 352
Filter Integrity Testing
Governing Regulationsp. 361
Sterilizing Membrane Ratingp. 365
Bubble Point Measurementp. 365
Diffusive Airflowp. 400
Multipoint Diffusion Testingp. 417
Pressure Hold Testp. 426
Water Intrusion Integrity Testp. 434
Integrity Test Considerationsp. 440
Automated Filter Integrity Testingp. 445
Troubleshootingp. 466
Cartridges, Cartridge Holders, and Their Carep. 471
General Filter Holder or Housing Designp. 471
Cartridge Housingsp. 479
Insertion and Removal of Filters from Sealed Housingsp. 497
Cartridge Constructionp. 501
Disposable Filter Devicesp. 513
Installation of Cartridgesp. 516
Filter Handlingp. 518
Contamination Guidep. 525
Troubleshootingp. 529
Validation of Filtrative Sterilizationp. 538
Introductionp. 538
The Sterilizing Grade Filterp. 539
Current Approachesp. 547
Pore Size Considerationsp. 549
Pore Size Designationsp. 549
Pore Numbers and Distributionsp. 550
Organism Sizingp. 552
Product-Specific Attributesp. 557
Filtration Conditionsp. 561
Recovery Methodp. 565
Sterility Testingp. 566
Direct Transfer Methodp. 567
Microbial Assaysp. 567
Further Validation Aspectsp. 568
Appendixp. 577
Referencesp. 581
Indexp. 609
Table of Contents provided by Syndetics. All Rights Reserved.

ISBN: 9780824702823
ISBN-10: 0824702824
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 640
Published: 18th December 2000
Publisher: Taylor & Francis Inc
Country of Publication: US
Dimensions (cm): 22.86 x 15.24  x 2.54
Weight (kg): 0.95
Edition Number: 1