Sterile Filtration. A Practical Approach. Theodore H. Meltzer. Maik W. Jornitz. Sartorius AG Gottingen, Germany
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1 Sterile Filtration A Practical Approach Maik W. Jornitz Sartorius AG Gottingen, Germany Theodore H. Meltzer Capitola Consulting Company Bethesda, Maryland MARCEL MARCEL DEKKER, INC. NEW YORK BASEL
2 Contents Foreword (James E. Akers) Preface Acknowledgments v vii ix Chapter 1 Filter Porosity: Its Genesis and Character 1 Introduction 1 Genesis of Porosity 2 Microporous Membranes 9 Comparison of Depth and Membrane Filters 17 Numerical Pore Dimensions 19 Sterilizing Filters 30 Pore Distribution Analysis 46 Implications of Breadth of Pore Size Distribution 48 The Number of Pores 54 Pore Lengths and Tortuosity 58 Pore Shapes 60 Porosity Changes by Particle Accretion 66 xi
3 xii Contents Chapter 2 The Polymeric Matrix and Its Influence 72 Introduction 72 Polymeric Compositions 73 Mechanical Properties 74 Extractables 84 Particle Shedding by Filters 89 Paniculate Matter in Pharmaceuticals 94 Hydrophobic Vent Filters 96 Subtle Incompatibilities 96 Adsorption 108 Blocking Effect 122 Blockage by Surfactant 123 Chapter 3 Membrane Fouling, Cleaning, and Sanitation 125 Membrane Fouling 125 Microporous Membranes 126 Biofoulingof RO Membranes 140 Sanitization 142 Steam 156 Steam Sterilization of Filters 160 Sanitization Summary 163 Chapter 4 Flow and Pressure, Flow Decay, and Filter Sizing 167 Introduction 167 Flow 168 Differential Pressure 168 Parallel Arrangements 170 Pressure Arrangements 172 Prefilter Action 175 Selection of Applied Differential Pressure Level 177 Consumption of Filter Capacity 181 Filter Sizing by Flow Decay 185 System Overdesign 200 Flow Rate Considerations 203 Prefilter and Final Filter Combination 205 Sizing Compressed Gas Systems 210 Sizing Tank Vents 215 Summary 225
4 Contents xiii Chapter 5 Mechanisms of Particle Removal from Liquids Particle Trapping Mechanisms 227 Nature of Adsorption 231 Colloidal Agglomeration 237 Hydrophobic Adsorption 244 Particle Removal from Gas Streams 252 Positively Charged Filters 252 Desorption 256 Finite Number of Adsorption Sites 256 Competition and Selectivity in Adsorption 257 Influence of Polymer Matrix on Organism Adsorption 258 Influence of Suspending Medium on Organism Adsorption 260 Influences on Organism Size 265 Two-Phase Separations 273 Tangential Flow Filtration 275 Minimum Water/Product Bubble Point 276 Absolute Filters and Filter Reliability 278 Surface Filters 279 Organisms Smaller than B. diminuta 280 Maximum Bioburden 291 Filter Retention Additivities 292 Smaller Organism Retention 293 Retention of Latex Spheres 295 Log Reduction Value 301 Chapter 6 Mechanisms of Particle Removal from Air and Other Gases Depth-Type HEPA Filter 302 Historical Development 303 Separation Mechanisms -'04 Van der Waals Forces (Restated) 3 ] 4 Induced Charges 3 ' Superiority of Filter Efficiency in Gases 315 Most Penetrating Particle Size 321 Membrane Filter Compositions 324 Double Membrane Constructions 332 Contaminants Prefiltration 334 Sterilizing Grade Filter Qualities 337 Applications
5 xiv Contents Vent Filters 345 Integrity Testing 346 Validation of Air Filters 352 Chapter 7 Filter Integrity Testing Governing Regulations 361 Sterilizing Membrane Rating 365 Bubble Point Measurement 365 Diffusive Airflow 400 Multipoint Diffusion Testing 417 Pressure Hold Test 426 Water Intrusion Integrity Test 434 Integrity Test Considerations 440 Automated Filter Integrity Testing 445 Troubleshooting 466 Chapter 8 Cartridges, Cartridge Holders, and Their Care 471 General Filter Holder or Housing Design 471 Cartridge Housings 479 Insertion and Removal of Filters from Sealed Housings 497 Cartridge Construction 501 Disposable Filter Devices 513 Installation of Cartridges 516 Filter Handling 518 Contamination Guide 525 Troubleshooting 529 Chapter 9 Validation of Filtrative Sterilization 538 Introduction 538 The Sterilizing Grade Filter 539 Current Approaches 547 Pore Size Considerations 549 Pore Size Designations 549 Pore Numbers and Distributions 550 Organism Sizing 552 Product-Specific Attributes 557 Filtration Conditions 561
6 Contents xv Recovery Method 565 Sterility Testing 566 Direct Transfer Method 567 Microbial Assays 567 Further Validation Aspects 568 Appendix References Index
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