Handbook for Critical Cleaning: Applications, Processes, and Controls, Second Edition

Contents......Page 5
Preface to the Second Edition......Page 8
Preface to the First Edition......Page 12
About the Second Edition......Page 16
Editors......Page 22
Contributors' Bios......Page 24
Part I: Process Implementation and Control......Page 31
Before Contacting Cleaning Chemistry and Equipment Vendors......Page 33
Record Your Impressions......Page 35
Cleaning Agents......Page 37
Organize and Coordinate......Page 40
Refine and Test......Page 42
References......Page 43
The Quest for the Ideal Cleaning Agent......Page 45
Selectively Aggressive......Page 47
Flash Point and Evaporation Rate......Page 48
Steps in Developing a New Solvent......Page 49
Future of Biobased Cleaning Agents......Page 50
Political Chemistry......Page 51
Green Evolution......Page 52
References......Page 57
Introduction......Page 59
"Not to Worry"......Page 60
The Fun Begins......Page 61
Cleaning Solvent versus Degreasing Solvent versus Vapor Degreasing Solvent, Whatever!......Page 62
A Growth Spurt......Page 63
Kanegsberg, Your Process Stopped Working......Page 64
Metallurgy? Chemistry?......Page 65
The Perfect Cleaning Machine Specification......Page 66
Remedial Physics?......Page 67
Conclusion......Page 68
Overview......Page 69
Good Operating Practices......Page 70
Process Improvements......Page 77
Good Operating Practices......Page 81
Preliminary Treatment......Page 84
Treatment Technologies......Page 85
Tracking Incidental Pollutants......Page 88
Points to Remember......Page 89
References......Page 90
In the Beginning......Page 91
Isolation Technology......Page 93
Preconstruction Design Review......Page 94
Typical Facility File Table of Contents......Page 95
Contamination Control Criteria......Page 96
ISO Standards and Cleanroom Classifications......Page 97
Additional HVAC Considerations......Page 98
Architectural Issues......Page 99
Project Planning......Page 100
Project Delivery......Page 101
Basis of Design Preparation......Page 102
Equipment......Page 103
General......Page 104
Responsibilities......Page 105
Direct Impact Systems......Page 115
Conclusion......Page 116
Further Readings......Page 118
Cleanroom Design......Page 119
Cleanroom Validation......Page 120
So How Does One Determine What Tests Need to Be Performed during a Cleanroom Validation?......Page 121
Validation versus Monitoring......Page 125
Establishing an Environmental Monitoring Program......Page 126
Summary......Page 130
References......Page 131
Introduction......Page 132
Facility Design......Page 133
Protecting Cleanrooms from Human Contamination......Page 135
Behavior......Page 136
Evaluation of Fabrics Using ASTM and AATCC Test Methods at 1×, 50×, and 100×......Page 137
Evaluation of the Cleaning of the Garment System......Page 138
Validation of Gamma Radiation Sterilization of Cleanroom Apparel......Page 139
Certificate of Sterility......Page 140
Sterile Gowning Procedure......Page 141
Housekeeping......Page 143
Ongoing Assessments......Page 144
Standards and Recommended Practices......Page 145
Journal Articles......Page 146
What Is Contamination?......Page 147
How to Remove Contamination from the Cleanroom or Mini-Environment......Page 148
When Do You Clean?......Page 151
Cleaning Validation......Page 152
Cleaning Validation for Pharmaceutical Manufacturing......Page 153
References......Page 154
Visual......Page 156
Standards......Page 157
In Situ versus Extractive Analysis......Page 158
Airborne Molecular Contamination......Page 159
References......Page 160
Introduction......Page 161
Analytical Approach......Page 162
Sample Handling and Packaging Issues......Page 163
Analytical Methods......Page 164
Sample Perturbation......Page 165
Applicability of Different Analytical Approaches......Page 166
Layer Characterization......Page 167
Haze Identification......Page 168
Bibliography......Page 169
Introduction......Page 171
Microbial Contaminants......Page 172
Why Monitor Cleanliness?......Page 173
Factors to Be Considered in the Selection of a Cleanliness Monitoring/Measurement Method.......Page 174
Indirect Methods......Page 175
Indirect Methods......Page 176
Direct Methods......Page 177
Analytical Methods......Page 179
Cost Impact of Cleanliness Levels......Page 180
Controlled Experiment......Page 181
In-Process or On-Line Surface Cleanliness Monitoring......Page 182
Bibliography......Page 185
Validating a Cleaning Process......Page 186
Defining the Validation Scope......Page 187
Defining the Surface......Page 188
Reaction Products......Page 189
Choosing the Test Method......Page 190
Ultraviolet/Visible Spectroscopy......Page 191
Basic Solubility......Page 192
Temperature......Page 193
Spike Recovery......Page 194
Biocompatibility and Other Testing......Page 195
Risk-Based Assessment......Page 196
References......Page 197
Introduction......Page 198
Class III: Noncritical......Page 199
Cleaning and Sterilization Residues......Page 201
Analytical Testing......Page 202
Chromatographic Analysis......Page 203
Biological Safety Assessment......Page 204
References......Page 206
What Is Meant by Compatibility?......Page 208
Preventing Damage to the Hardware......Page 209
Protect the Processing Equipment and Preserve the Processing Fluid......Page 210
Who Should Consider Compatibility?......Page 211
Changing the Cleaning Fluid......Page 212
Finding and Interpreting Good Compatibility Data Can Be a Challenge......Page 213
Examples of Common Compatibility Test Data......Page 214
Compatibility Testing Is Easy......Page 215
Setting Up a Good Test......Page 216
Example of a Successful Compatibility Test......Page 217
References......Page 218
Part II: Applications......Page 219
Overview......Page 221
What Is Critical Cleaning?......Page 222
Cleaning Processes: A Brief Overview......Page 223
Why NOT Cleaning Can Be an Option......Page 224
Why Cleaning Electronics Assemblies Should Be an Option......Page 225
Aerospace......Page 230
Keys to Success in Aerospace and Elsewhere......Page 231
Case Study: Cleaning in an Airless/Vacuum System Prior to Applying Engineered Coatings......Page 232
Inertial Navigation Systems: Complexity and the Team Approach......Page 237
Optics......Page 240
Biomedical Applications......Page 245
Case Studies: Medical Applications......Page 246
Selecting and Improving the Cleaning Process......Page 250
References......Page 251
16. Cleaning Validation of Reusable Medical Devices: An Overview of Issues in Designing, Testing, and Labeling of Reusable Devices......Page 253
Guidance......Page 254
Designing, Testing, and Labeling......Page 255
Compendium......Page 256
Design Considerations......Page 257
Decontamination of Devices Exposed to Transmissible Spongiform Encephalopathy......Page 260
Testing Methodology and Validation Study Design......Page 261
Phenol–Sulfuric Acid Test for Carbohydrates......Page 262
Regulatory Considerations and Labeling......Page 263
Summary and the Future......Page 268
Appendix A.1: Product Families for Cleaning Validation......Page 269
Distractor—Group 1......Page 270
Trial Sizer—Group 4......Page 271
Stain Prevention......Page 272
Simple Instrument Cleaning Steps......Page 273
Autoclave Sterilization......Page 274
Bioburden Recovery: Uncleaned/Cleaned Devices......Page 275
References......Page 277
Overview......Page 279
Selecting Cleaning Agents......Page 280
Selecting Cleaning Agent Suppliers......Page 282
Critical Parameters......Page 283
Equipment Design Considerations......Page 284
Cleaning Method Design......Page 285
Product and Equipment Grouping......Page 286
Recovery Studies......Page 287
Analytical Detection Methods......Page 288
Residue Limits and Acceptance Criteria......Page 289
Cleaning Validation Master Plan and Validation Protocol Design......Page 290
Change Control......Page 291
Biological Contamination......Page 292
Reference......Page 293
Chemistry of Soils......Page 294
Soil Attachment......Page 296
Dairy Soils......Page 297
Brewery Soils......Page 298
Food Processing Soils......Page 300
Standards of Cleanliness......Page 301
Summary......Page 304
Bibliography......Page 305
Introduction......Page 306
Electrochemical Migration Risk......Page 307
Cleaning Challenge......Page 308
Miniaturization......Page 309
Soldering Process Issues Create New Demands on Flux Design......Page 310
Flux Types and Their Impact on Cleaning......Page 311
Building Blocks......Page 312
Semi-Aqueous......Page 316
Aqueous......Page 317
Process Cleaning Rate Theorem......Page 318
Flux Residue Solubility Properties......Page 319
Materials Compatibility......Page 320
Kinetic Energy Effects......Page 322
Semi-Aqueous Cleaning Equipment Considerations......Page 323
Aqueous Batch Spray in Air Cleaning Equipment Considerations......Page 326
Aqueous Inline Cleaning Equipment Considerations......Page 330
Process Validation......Page 335
References......Page 338
Historical Perspective......Page 341
Classification of Surfactants......Page 342
Main Equipment-Process Limitations......Page 344
Attributes of Surfactant-Based Products versus Surfactant-Free Products......Page 347
Process Integration: Controlling the Chemical Wash Fluids......Page 349
Cleaning Agent Technology......Page 351
Acknowledgment......Page 352
References......Page 353
Background......Page 354
Critical Applications......Page 355
Electrochemical Migration......Page 357
Corrosion-Induced Leakage Current and Cutoffs......Page 360
Other Mechanisms......Page 361
Cases......Page 363
Conclusions......Page 364
Bibliography......Page 365
Adhesion Forces......Page 366
Hydrodynamic Removal......Page 368
Ultrasonic Removal......Page 370
Megasonic Removal......Page 371
Brush Cleaning......Page 372
Particle-Removal Mechanism......Page 375
Removal of Nanoparticles......Page 376
References......Page 377
Introduction......Page 380
Basic Operations in Wafer Fabrication......Page 381
Radiation-Sensitive Polymers......Page 382
Negative-Acting Photoresists......Page 384
Positive-Acting Photoresists......Page 385
Photoresist Performance Factors......Page 386
Temperature Effect......Page 389
Sulfuric-Peroxide Chemistry......Page 390
Quaternary Ammonium Hydroxides—Choline-Surfactant Chemistry......Page 391
Ozone—Water Mixtures......Page 392
BEOL Cleaning Processes......Page 393
Chemistry of Post–Plasma Etch Polymer Removers......Page 394
HA/Amine Chemistry......Page 395
Copper Interconnects......Page 396
Low-k Dielectric Material......Page 397
References......Page 398
CMP Primer......Page 399
Post-CMP Clean......Page 400
BEOL Cleaning for Copper Low-k......Page 402
Edge Exclusion......Page 405
Particle Cleaning: An Introduction......Page 407
Cleaning Stationary Particles......Page 408
Cleaning Methods for Removing Strongly Bonded Stationary Particles......Page 409
Weakly Bonded Particles Ionic Bonds or Hydrogen Bonds......Page 410
Cleaning Mobile Particles......Page 411
Simple Blow-Off Using an Inert Gas......Page 412
Laser-Induced Shockwaves......Page 413
Cleaning by Electrolyzed Water: Comparison with SC1 and SC2......Page 414
Cleaning and Rinsing......Page 415
References......Page 416
25. The Cleaning of Paintings......Page 418
Aqueous Cleaning......Page 420
Surface Cleaning......Page 423
Varnish Removal......Page 424
Overpaint or Retouch Removal......Page 427
Introduction......Page 429
Performance-Based Selection......Page 430
Health and Safety Screening Selection......Page 432
On-Site Pilot Plant and Scale-Up Feasibility Studies......Page 434
Acknowledgments......Page 444
References......Page 445
Selective Plating and Masking......Page 446
Cabinet Ovens......Page 447
Vapor Degreasing......Page 448
Aerospace Specifications/Industrial Practices......Page 449
Methods 2 and 3......Page 451
Step 2—Wax Removal......Page 452
Step 3—Water orAlkaline Rinse......Page 453
Step 4—Final Water Rinse......Page 454
References......Page 455
Overview......Page 456
Process......Page 457
Decision-Making Process......Page 459
Definition of Requirements......Page 460
Define Required Performance......Page 461
Engage the User......Page 462
Grow Champions......Page 463
Joint Service Solvent Substitution Working Group......Page 464
Materials Information Management for Sustainable Chemical and Materials Management......Page 467
References......Page 468
Part III: Safety and Regulations......Page 469
Introduction......Page 471
Environmental Regulations versus Worker Safety......Page 472
Tropospheric Ozone VOCs......Page 473
Material Safety Data Sheet et al.......Page 474
Known Hazards versus the Great Unknown......Page 475
Your Input Is Important......Page 476
Communicating with Safety Professionals and Environmental Regulators......Page 477
Conclusion......Page 478
References......Page 479
Introduction......Page 480
Mechanical Hazards......Page 481
Flammable and Reactive Materials......Page 482
Chemical Hazards......Page 483
Defining Hazardous Materials......Page 484
Quantitative Exposure Numbers......Page 485
What Is REACH?......Page 486
Step 1: Collect Information......Page 488
Step 5: Document the Risk Assessment......Page 489
Evaluating and Managing Complex and Proprietary Blends......Page 490
Working Productively and Proactively with the Safety Professional......Page 491
Contact Lenses and Safety Glasses......Page 492
Respiratory Protection......Page 493
Facial Hair......Page 494
Using Personal Protective Equipment......Page 495
References......Page 496
Introduction: The Challenge......Page 498
The 1990s: VOCs and HAPs......Page 499
Workshops......Page 500
After Receiving a Permit......Page 502
Reporting and Record-Keeping Is an Ongoing Activity That Has to Be Maintained......Page 503
Conclusions......Page 504
Introduction......Page 505
After the Montreal Protocol Was Signed, the Industry Changed Direction......Page 506
Military Leadership Was Important......Page 507
No-Clean Soldering Was a Remarkable Team Success......Page 508
The Clean Air Act Amendments of 1990 Set Further Environmental Goals......Page 509
Proactive Companies That Protected the Ozone Layer Are Now Protecting the Climate......Page 510
Conclusions and Climate Leadership Opportunities......Page 511
References......Page 512
Introduction......Page 514
Focus of This Chapter......Page 515
The EPA SNAP Program......Page 516
Good Ozone versus Bad Ozone......Page 518
Air Quality and VOCs......Page 520
Concerns about Stratospheric Ozone: Ozone Depletion Potentials......Page 521
Concerns about Stratospheric Ozone: Equivalent Chlorine Loading......Page 525
Concerns about Climate Change: Global Warming Potentials......Page 527
Reference......Page 530
C......Page 533
M......Page 534
S......Page 535
X......Page 536