Pharmaceutical Particulate Matter
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1 Pharmaceutical Particulate Matter Analysis and Control Thomas A. Barber Baxter Healthcare Illustrations by John G. Williams Photomicrography Section by Damian S. Neuberger Interpharm Press Buffalo Grove, IL
2 Vll Preface Acknowledgements xv xvii I. Introduction 1 GMP Principles l Compendial Requirements 4 Particle Distribution 5 Particulate Matter Control 6 Standards 8 Summary 19 References 19 II. Visual Inspection 22 Visual Inspection 23 Manual Inspection 24 Reproducibility of Visual Inspection 33 Automated (Machine) Inspection 34 Application of Automated Systems 44 Compendial Requirements 44 Summary 46 References 47 III. Instrumental Particle Counting 50 The Coulter Principle 51 Light Extinction Counting 54 Laser Versus White Light Extinction Sensors 59 Error Sources 70 Recent Developments 73 Spectrex (Phototron) System 75 Particle Size Standards 77 Emulsion Polymerization 78
3 Vlll Suspension Polymerization 79 Swollen Emulsion Process 80 Storage and Handling of Standard Particles 81 Use of Commercial Standards 82 USP Particle Count Reference Standard 84 Alternative Count Standards 85 Autornated Light Extinction Counting 87 Validation of the Robotic Assay 89 Operational Validation 92 Validation of Data Collected 93 Summary 96 References 96 IV. Microscopy 100 Structure of the Compound Microscope 102 Lens Aberrations 103 Objective Lenses 107 Working Distance of Objectives 109 Resolving Power 110 Oculars (Eyepieces) 111 Condenser Lens 111 Reflected Illumination 112 Dark-Field Microscopy 112 Refractive In dex 114 Polarized Ligh t Microscopy 115 Interference 116 Birefringence and Extinction 118 Refractive Index Determinations 121 Dispersion Staining 122 Isolation and Handling of Particles 123 Hot Stage Methods 125 Microscope Calibration 126 Measurement of Particle Size 127 Techniques for Microscopic Particle Counting 129 Enumeration of Particles in Parenteral Products 134 Summary 139 References 139
4 IX V. Instrumental Analysis for Particle Identification 143 Particle Identification Electron Microscopy 145 Transmission Electron Microscopy 146 Electromagnetic Lenses 149 Scanning Electron Microscopy 152 Application of X-Ray Spectroscopy 160 Elemental Composition Analysis 162 Infrared Microspectrophotometry 165 Mass Spectrometry 169 LAMMA 169 Secondary Ion Mass Spectrometry 172 X-Ray Diffraction Crystallography 177 Summary 183 References 183 VI. Environmental Particulate Matter Monitoring and Control 187 Applicable Standards 189 Principles of HEP A Filtration 192 HEPA Filter Particle Retention Characteristics 197 In-Use Testing of HEPA Filters 197 Environmental Particle Monitoring 201 Laser Versus White Light Counters 203 Remote Particle Monitoring 208 Application of Federal Standard 209-D 212 Federal Standard 209-E 215 Isokinetic Sampling 219 Sampling of Compressed Gases 223 Tubing Transport of Particulate Matter Samples 226 Large Particle Monitoring 229 Personnel Monitoring 231 Summary 232 References 233
5 VII. Process- and Product-Related Particles 237 Packaging Materials 240 Solution and Formulation Components 243 Dry Powder Drug Materials 246 Product-Container Interactions 248 Process Point-Generated Particulates 249 Particulate Matter Problem Solving 253 Philosophical Considerations 255 Sampling for Large Particles 259 Summary 260 References 261 VIII. Particle Population Analysis 266 Particle Size 268 Particle Shape 271 Particle Size Distributions (Particle Number) 281 Distribution of Extraneous Particle Counts 294 Average Diameters 294 Instrumentation and Methods 298 Nephelometry 303 Laser Diffraction 306 Photon Correlation Spectroscopy 309 Microscopy and Image Analysis 312 Sieving 318 Light Extinction Counting 323 Sedimentation 328 Adsorption and Porosimetry 330 Porosimetry 334 Application of Adsorption and Porosimetry 337 Aerosol Population Analysis 338 Summary 344 References 345
6 XI IX. Collection and Isolation of Particulate Matter 350 Filter Structure and Application 352 Retention Ratings, Pore Size, and Porosity 359 Mechanism of Liquid Filtration 361 Determination of Retention Ratings 364 Wettability and Refractive Index 365 Filtration Apparatus 366 Collection of Particles for Analysis 367 Isolation of Particles for Identification 368 Powder Sampling 371 Collection of Particles from Environmental Air 376 Microscopic Analysis of Airborne Particles 379 Monitoring of Components and Parts 385 Sampling of Clean Room Garments 386 Testing of Clean Room or Surgical Gloves 389 Summary 390 References 390 X. Process Control of Particulate Matter 393 Process Design 394 Process Control 398 Statistical Process Control 399 Process Stability and Capability 403 Control Charting 407 Batch Sampling 420 Summary References XL Medical Devices Parenteral-Type Devices Sources and Control of Particulate Matter in Devices 434 Process Design 437 Patient Concerns
7 Xll Analysis of Particulate Matter in Devices 442 Autologous Transfusion Devices 448 Blood Filters 449 Choice of Particle Counting Methods 449 GMP Control of Device Particulates 450 Current Regulatory Issues 453 Device-Related 483s 459 Device Specific Particulate Matter Issues 460 Consideration Regarding Particulate Matter Requirements 461 Safe Medical Devices Act of Summary 465 References 466 XII. Patient Issues Related to Particulate Matter 470 Circulatory Transport 471 Human Injury by Particles 4 73 Animal Studies 474 Liposome Research 476 Infusion of Rlood-Related Materials 478 Phlebitis and Particles 479 Conclusions Regarding Patient Risk 480 Summary 480 References 482 Appendices Photomicrography of Particulate Matter 487 Sample Preparation 488 Instrumentation 489 Film 493 Light Balancing Filters 495 Color Compensating Filters 496 Polarized Light Techniques 497 Illustrations 498
8 Xlll 2. Vendor and Equipment Information 504 Particle Counters (Airborne and Solution) 504 Light Extinction Counter Sensors 505 Counter Calibration Software 505 Calibration Materials 505 Visual Inspection Systems 506 Image Analysis 506 Electrical Zone Sensing Counters 507 Laser Diffraction Particle Analyzers 507 Lamma Instrumentation 507 Light Microscopes 507 X-Ray Spectrometers 508 Electron Microscopes 508 Photon Correlation Spectrophotometers 509 Laser Light Scattering Liquid Counters 509 Micro (Submicron) Particle Samplers 509 Microfiltration Supplies 509 Clean Room Supplies 509 Particle Analysis Equipment (General) 510 Powder Analysis Equipment 510 Secondary Ion Mass Spectrometers 511 Laboratory Robots 511 Additional Sources of Supplemental Information and Standards 511 Software for Data Reduction Trademarks 514 Index 519 Name 519 Subject 524 The color photomicrographs found near the middle of this text are described on pages 498 to 503 in Appendix I.
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