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 addressing the complexities of globalizing redundancy in filtration. Chapters cover: filter porosity; the polymeric matrix; membrane filtering, cleaning, and sanitation; flow and pressure, flow decay, and filter sizing; mechanisms of particle removal from liquids; mechanisms of particle removal from gases; filter integrity testing; cartridges, cartridge holders, and their care; and, validation of filtration sterilization. Jornitz and Meltzer work for private companies in the pharmaceutical industry. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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.Recenzijas
" 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
Foreword v James E. Akers Preface vii Acknowledgments ix Filter Porosity: Its Genesis and Character 1(71) Introduction 1(1) Genesis of Porosity 2(7) Microporous Membranes 9(8) Comparison of Depth and Membrane Filters 17(2) Numerical Pore Dimensions 19(11) Sterilizing Filters 30(16) Pore Distribution Analysis 46(2) Implications of Breadth of Pore Size Distribution 48(6) The Number of Pores 54(4) Pore Lengths and Tortuosity 58(2) Pore Shapes 60(6) Porosity Changes by Particle Accretion 66(6) The Polymeric Matrix and Its Influence 72(53) Introduction 72(1) Polymeric Compositions 73(1) Mechanical Properties 74(10) Extractables 84(5) Particle Shedding by Filters 89(5) Particulate Matter in Pharmaceuticals 94(2) Hydrophobic Vent Filters 96(1) Subtle Incompatibilities 96(12) Adsorption 108(14) Blocking Effect 122(1) Blockage by Surfactant 123(2) Membrane Fouling, Cleaning, and Sanitation 125(42) Membrane Fouling 125(1) Microporous Membranes 126(14) Biofouling of RO Membrances 140(2) Sanitization 142(14) Steam 156(4) Steam Sterilization of Filters 160(3) Sanitization Summary 163(4) Flow and Pressure, Flow Decay, and Filter Sizing 167(304) Introduction 167(1) Flow 168(1) Differential Pressure 168(2) Parallel Arrangements 170(2) Pressure Arrangements 172(3) Prefilter Action 175(2) Selection of Applied Differential Pressure Level 177(4) Consumption of Filter Capacity 181(4) Filter Sizing by Flow Decay 185(15) System Overdesign 200(3) Flow Rate Considerations 203(2) Prefilter and Final Filter Combination 205(5) Sizing Compressed Gas Systems 210(5) Sizing Tank Vents 215(10) Summary 225(2) Mechanisms of Particle Removal from Liquids Particle Trapping Mechanisms 227(4) Nature of Adsorption 231(6) Colloidal Agglomeration 237(7) Hydrophobic Adsorption 244(8) Particle Removal from Gas Streams 252(1) Positively Charged Filters 252(4) Desorption 256(1) Finite Number of Adsorption Sites 256(1) Competition and Selectivity in Adsorption 257(1) Influence of Polymer Matrix on Organism Adsorption 258(2) Influence of Suspending Medium on Organism Adsorption 260(5) Influences on Organism Size 265(8) Two-Phase Separations 273(2) Tangential Flow Filtration 275(1) Minimum Water/Product Bubble Point 276(2) Absolute Filters and Filter Reliability 278(1) Surface Filters 279(1) Organisms Smaller than B. diminuta 280(11) Maximum Bioburden 291(1) Filter Retention Additivities 292(1) Smaller Organism Retention 293(2) Retention of Latex Spheres 295(6) Log Reduction Value 301(1) Mechanisms of Particle Removal from Air and Other Gases Depth-Type HEPA Filter 302(1) Historical Development 303(1) Separation Mechanisms 304(10) Van der Waals Forces (Restated) 314(1) Induced Charges 314(1) Superiority of Filter Efficiency in Gases 315(6) Most Penetrating Particle Size 321(3) Membrane Filter Compositions 324(8) Double Membrane Constructions 332(1) Contaminants 332(2) Prefiltration 334(3) Sterilizing Grade Filter Qualities 337(5) Applications 342(3) Vent Filters 345(1) Integrity Testing 346(6) Validation of Air Filters 352(9) Filter Integrity Testing Governing Regulations 361(4) Sterilizing Membrane Rating 365(1) Bubble Point Measurement 365(35) Diffusive Airflow 400(17) Multipoint Diffusion Testing 417(9) Pressure Hold Test 426(8) Water Intrusion Integrity Test 434(6) Integrity Test Considerations 440(5) Automated Filter Integrity Testing 445(21) Troubleshooting 466(5) Cartridges, Cartridge Holders, and Their Care 471(67) General Filter Holder or Housing Design 471(8) Cartridge Housings 479(18) Insertion and Removal of Filters from Sealed Housings 497(4) Cartridge Construction 501(12) Disposable Filter Devices 513(3) Installation of Cartridges 516(2) Filter Handling 518(7) Contamination Guide 525(4) Troubleshooting 529(9) Validation of Filtrative Sterilization 538(39) Introduction 538(1) The Sterilizing Grade Filter 539(8) Current Approaches 547(2) Pore Size Considerations 549(1) Pore Size Designations 549(1) Pore Numbers and Distributions 550(2) Organism Sizing 552(5) Product-Specific Attributes 557(4) Filtration Conditions 561(4) Recovery Method 565(1) Sterility Testing 566(1) Direct Transfer Method 567(1) Microbial Assays 567(1) Further Validation Aspects 568(9) Appendix 577(4) References 581(28) Index 609
MAIK W. JORNITZ is Director of Product Management at Sartonus Headquarters, Gottingen, Germany. With over 10 years of experience in separation technologies, Mr. Jornitz supports the biopharmaceutical industry worldwide in validation, integrity testing, and air and water filtration. A member of the Parenteral Drug Association and the International Society of Pharmaceutical Engineers, among others, he is the author, coauthor, or coeditor of numerous professional papers on membrane filters, integrity testing, and validation studies, including Filtration in the Biopharmaceurical Industry (Marcel Dekker, Inc.). Mr. Jornitz received the Diploma in Engineering from the Technical University of Hamburg, Germany. THEODORE H. MELTZER, based in Bethesda, Maryland, is a consultant on filtration and high- purity water preparation to the pharmaceutical and semiconductor industries. With over 40 years of experience in membrane separations, Dr. Meltzer holds four patents, and is the author, coauthor, or coeditor of Filtration in the Pharmaceutical Industry, Filtration in the Biopharmaceutical Industry (both titles, Marcel Dekker, Inc.), High Purity Water Preparation for the Semiconductor, Pharmaceutical and Power Industries, and Phar,naceutical Water Systems as well as many professional papers and book chapters that reflect his research interests in the structureproperty relationships in membrane filters, filter systems, and their validation. A member of the American Chemical Society, the Parenteral Drug Association, and the Filtration Society, Dr. Meltzer received the Ph.D. degree in physical- organic chemistry from the University of Chicago, Illinois. He pursued postdoctoral work in polymer mechanical properties at Princeton University, Princeton, New Jersey.
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