The Effects of Sterilization Methods on Plastics and Elastomers
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Liesl K. Massey
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The Effects of Sterilization Methods on Plastics and Elastomers
Second Edition
The Definitive User’s Guide and Databook
Liesl K. Massey
Contents
Preface iii
Introduction to Sterilization Methods 1
1.0 Plastics in Sterile Applications 1
2.0 Sterilization Methods 1
2.1 Irradiation Sterilizing 1
2.1.1 Gamma Sterilization . 2
2.1.2 Electron Beam (E-beam) . 2
2.2 Gas Sterilization, Ethylene Oxide (EtO) . 3
2.3 Steam Sterilization . 3
2.4 Dry Heat Sterilization . 3
2.5 LTHPGP Sterilization . 3
2.6 Disinfectants and Other Fluids for Cleaning . 3
3.0 Sterilization Stability of Materials 4
4.0 Comparative Radiation Stability . 4
5.0 The Effects of Ionizing Radiation on Polymers 8
5.1 Mechanical Properties . 8
5.2 Oxidation Induction Temperature . 8
5.3 Crosslinking . 9
5.4 Yellowness Index . 9
5.5 Package Seal Strength and Hot Tack Performance . 9
6.0 Radiation Stabilizers . 9
7.0 The Effects of Gamma Sterilization on Color Change . 9
8.0 Regulatory Status . 9
8.1 FDA . 12
8.2 USDA 12
8.3 NSF . 12
8.4 3A-Dairy 12
8.5 Canada AG 13
8.6 USP Class VI . 13
Acetal Resins

  1. Acetal (Polyoxymethylene) . 17
    Tabular Information 17vi Contents
    ABS
  2. Acrylonitrile-Butadiene-Styrene (ABS) . 19
    Tabular Information 22
    Graphical Information . 33
    Acrylic Resins
  3. Acrylic 39
    Tabular Information 40
    Graphical Information . 43
  4. Acrylic Copolymer . 47
    Tabular Information 48
    Graphical Information . 49
  5. Acrylic Terpolymer 55
    Graphical Information . 56
    Fluoroplastic
  6. Fluoropolymer . 61
    Tabular Information 61
  7. Polychlorotrifluoroethylene (PCTFE) 63
  8. Polyvinylidene Fluoride (PVDF) . 65
    Tabular Information 65
    Graphical Information . 66
    Polyphenylene
  9. Polyphenylene Ether (PPE) 67
    Nylon
  10. Nylon or Polyamide (PA) 69
    Tabular Information 70
    Graphical Information . 73
    Polycarbonate
  11. Polycarbonate (PC) 81
    Tabular Information 83
    Graphical Information . 103
    Polyester
  12. Polyester . 111
    Tabular Information 111
  13. Polyester – PBT 113
    Tabular Information 113Contents vii
  14. Polyester – PETG and PCTG . 117
    Tabular Information 118
    Graphical Information . 120
  15. Liquid Crystal Polymer (LCP) . 123
    Tabular Information 124
    Graphical Information . 124
    Polyketone
  16. Polyetherimide (PEI) . 127
    Tabular Information 128
    Graphical Information . 133
  17. Polyetheretherketone (PEEK) 137
    Tabular Information 138
    Graphical Information . 138
    Polyolefin
  18. Linear Low Density Polyethylene (LLDPE) 141
    Tabular Information 141
  19. High Density Polyethylene (HDPE) 143
    Tabular Information 144
  20. Ultra High Molecular Weight Polyethylene (UHMWPE) 149
  21. Ethylene Vinyl Acetate (EVA) . 151
  22. Ethylene Vinyl Alcohol (EVOH) 153
    Tabular Information 153
    Polypropylene
  23. Polypropylene (PP) . 155
    Tabular Information 156
    Graphical Information . 159
  24. Metallocene Polyolefin (MPO) Foam . 161
    Graphical Information . 161
    Polyphenylene Sulfide
  25. Polyphenylene Sulfide (PPS) . 163
    Tabular Information 163
    Polystyrene
  26. General-Purpose Polystyrene (GPPS) . 165
    Tabular Information 166
    Graphical Information . 173viii Contents
  27. Syndiotactic Polystyrene (SPS) 175
    Tabular Information 176
    Graphical Information . 176
  28. High Impact Polystyrene (HIPS) . 179
    Tabular Information 180
    Graphical Information . 185
  29. High Heat Crystal Polystyrene . 187
    Tabular Information 187
    Polysulfone
  30. Polysulfone (PSu) . 189
    Tabular Information 190
    Graphical Information . 191
  31. Polyethersulfone (PES) 195
    Graphical Information . 196
  32. Polyphenylsulfone (PPSu) 199
    Polyurethane
  33. Thermoplastic Polyurethane (TPUR) . 201
    Tabular Information 202
    Graphical Information . 212
    Styrene Acrylonitrile
  34. Styrene Acrylonitrile (SAN) . 215
    Tabular Information 216
    Graphical Information . 222
    Styrene Butadiene Copolymer
  35. Styrene Butadiene Copolymers (SBC) . 225
    Tabular Information 226
    Graphical Information . 227
    Vinyl Resin
  36. Polyvinyl Chloride (PVC) 229
    Tabular Information 231
    Graphical Information . 234
    Thermoplastic Alloy
  37. Acrylonitrile-Butadiene-Styrene Polycarbonate Alloy (ABS PC) . 237
    Tabular Information 237
    Graphical Information . 239Contents ix
  38. Acrylic Polycarbonate Alloy (Acrylic PC) 241
    Graphical Information . 241
    Thermoplastic Elastomer
  39. Thermoplastic Elastomer (TPE) . 245
    Tabular Information 246
    Graphical Information . 247
  40. Thermoplastic Polyester Elastomer (TP) CoPolyester Ether Elastomer (COPE) . 249
    Tabular Information 250
  41. Styrenic Thermoplastic Elastomer (Styrenic TPE) . 253
    Tabular Information 254
  42. Thermoplastic Polyurethane Elastomer (Polyurethane TP) 257
    Tabular Information 258
    Silicone Rubber
  43. Silicone 265
    Additional Materials
  44. Biodegradable or Organic . 267
    Graphical Information . 267
    Appendices
    Appendix I: Chemical Resistance to Cleaning Solutions . 269
    Graphical Information . 269
    Tabular Information 270
    Appendix II: Chemical Resistance 271
    A2.1 Introduction to Chemical Resistance Tables 271
    A2.2 PDL Resistance Rating 271
    A2.3 Chemical Resistance Tables 272
    ABS 273
    ABS Nylon Alloy . 275
    ABS PU Alloy . 275
    Acetal Resin . 275
    ASA 277
    Acrylic Resin 278
    Acrylic Copolymer/Terpolymer . 282
    Acrylonitrile Copolymer 282
    Aromatic Polyamide . 283
    Cellulose Acetate . 283
    Cellulose Acetate Butyrate . 283
    Cellulose Propionate 284x Contents
    Ethylene Vinyl Alcohol Copolymer . 284
    Ethylene Chlorotrifluoroethylene Copolymer 285
    Ethylene Tetrafluoroethylene Copolymer . 287
    Fluorinated Ethylene Propylene Copolymer . 288
    Perfluoroalkoxy Resin 289
    Polychlorotrifluoroethylene . 290
    Polytetrafluoroethylene 290
    Polyvinylidene Fluoride 291
    Ionomer 292
    Modified Polyphenylene Ether . 293
    Nylon 11 . 295
    Nylon 46 . 296
    Nylon 12 . 296
    Nylon 6 . 298
    Nylon 610 . 299
    Nylon 612 . 300
    Nylon 66 . 301
    Nylon MXD6 . 304
    Amorphous Nylon . 304
    Polybenzimidazole . 305
    Polybutadiene 305
    Polycarbonate 305
    Polycarbonate Copolymer 306
    Polyethylene Terephthalate . 307
    Polybutylene Terephthalate . 307
    Polycyclohexylenedimethylene Terephthalate . 310
    Glycol Modified Polycyclohexylenedimethylene Terephthal . 310
    Polycyclohexylenedimethylene Ethylene Terephthalate 310
    Liquid Crystal Polymer . 311
    Polyimide 311
    Polyamideimide 312
    Polyetherimide . 312
    Polyketone . 314
    Polyetherketone . 314
    Polyetheretherketone . 314
    Low Density Polyethylene 314
    Medium Density Polyethylene 316
    High Density Polyethylene . 316
    Polyethylene Copolymer 320
    Polypropylene 320
    Polyallomer 323Contents xi
    Fluorinated Polyethylene 323
    Polymethylpentene . 323
    Polyphenylene Sulfide 324
    Polyphenylene Sulfide Sulfone 325
    Polyphthalamide . 325
    General Purpose Polystyrene 325
    Impact Polystyrene . 327
    Polysulfone . 329
    Polyethersulfone 330
    Polyurethane 332
    Rigid Thermoplastic Urethane 333
    Styrene Acrylonitrile Copolymer . 334
    Styrene Butadiene Copolymer . 337
    Styrene Maleic Anhydride Copolymer 337
    Polyvinyl Chloride . 338
    Chlorinated Polyvinyl Chloride . 340
    Polyvinylidene Chloride 340
    Acrylic PVC Alloy . 343
    ASA PVC Alloy . 343
    Polycarbonate ABS Alloy . 343
    Polycarbonate Acrylic Resin Alloy 343
    Polycarbonate Polyester Alloy . 343
    Polycarbonate Polyester Copolymer Alloy . 344
    Polycarbonate Polyester PCTG Alloy 344
    SMA PC Alloy . 345
    Olefinic Thermoplastic Elastomer 345
    Polyamide Thermoplastic Elastomer 346
    Polyester Thermoplastic Elastomer . 346
    Styrenic Thermoplastic Elastomer . 347
    Urethane Thermoplastic Elastomer 347
    Thermoplastic Polyester Urethane Elastomer 348
    Polyvinyl Chloride Polyol 349
    Butyl Rubber 350
    Chlorosulfonated Polyethylene Rubber 351
    Epichlorohydrin Rubber 352
    Ethylene Acrylate Rubber 352
    Ethylene Propylene Diene Methylene Terpolymer . 352
    Natural Rubber . 354
    Fluoroelastomer . 356
    Tetrafluoroethylene Perfluoromethyl Vinyl Ether Copolymer . 356
    Vinylidene Fluoride Hexafluoropropylene Copolymer 357xii Contents
    Neoprene Rubber . 358
    Nitrile Rubber . 360
    Polysulfide Rubber . 361
    Tetrafluoroethylene Propylene Copolymer . 362
    Silicone . 362
    Methylsilicone . 363
    Methylphenylsiticone 363
    Methylphenylvinylsilicone . 363
    Methylvinylfluorosilicone 363
    Methylvinylsilicone . 364
    Fluorosilicone . 364
    Styrene Butadiene Rubber . 365
    Polyvinyl Alcohol 365
    Endnotes to Tables . 367
    Glossary of Terms . 381
    References . 407
    Index . 415Index
    Index terms Links
    A
    Advanced Elastomer Systems
    Santoprene Chapter 38
    AlphaGary Chapter 35
    Atofina
    Kynar Chapter 8
    Kynar Flex Chapter 8
    AtoHaas
    Plexiglas Chapter 3
    B
    BASF
    Polystyrol Chapter 26
    Styrolux Chapter 34
    Terlux Introduction
    Ultradur Chapter 13
    Ultramid Chapter 10
    Ultrason E Chapter 31
    Ultrason S Chapter 30
    Basell
    Pro-fax Chapter 23
    Baxter
    Healthcare Chapter 35
    Bayer
    Lustran Chapter 33
    Makrolon Introduction Chapter 11
    C
    Chevron Phillips
    K-Resin Chapter 34
    Ryton R-4 Chapter 25
    Consolidated Polymer Technologies
    C-Flex Chapter 40416
    Index terms Links
    Cyro Industries
    Acrylite Chapter 3
    Acrylite Plus Chapter 3
    Cyrolite Introduction Chapter 5
    Cyrex Chapter 5
    Cyrolite Chapter 5
    Cyrex Chapter 5
    XT/Cyrolite Chapter 3
    D
    Dow Chemical
    Dowlex Chapter 18
    Magnum Chapter 2
    Pellethane Chapter 41
    Questra Chapter 27
    Styron Chapter 26 Chapter 28
    Dow Corning
    Silastic RX Chapter 42
    Dow Engineering Plastics
    Isoplast Chapter 32 Chapter 41
    Dow Plastics
    Calibre Chapter 11
    Pulse Chapter 36
    Tyril Chapter 33
    DuPont
    Hytrel Chapter 39
    Tyvek Chapter 19
    Zytel 101 Chapter 10
    E
    Eastman
    Durastar Introduction Chapter 12
    Eastar Introduction Chapter 12
    Chapter 14
    Eastalloy Introduction
    Ecdel elastomers Chapter 39
    Tenite Introduction
    EMS
    Grilamid Chapter 10
    ExxonMobil
    Exact Chapter 23417
    Index terms Links
    G
    Gamma-10 Plastics Chapter 23
    GE Plastics
    Cycolac Chapter 2
    Lexan Chapter 11
    Noryl Chapter 9
    Ultem Chapter 16
    Valox Chapter 13
    H
    Honeywell
    Aclar Chapter 7
    K
    Kraton Polymers
    Kraton Chapter 40
    L
    LNP, A GE Company
    Lubricomp p Chapter 1
    N
    Nova Chemicals
    NAS 90 Chapter 4
    Zylar 93-546 Chapter 4
    Zylar 94-568 Chapter 4
    High Heat Crystal Polystyrenes Chapter 29
    High Impact Polystyrene Chapter 28
    S
    Saint-Gobain
    Silmedic Chapter 42
    Solvay Advanced Polymers
    Radel Chapter 31
    Udel Chapter 30
    T
    Thermedics
    Tecoflex Chapter 41418
    Index terms Links
    Ticona
    Polyphenylene Sulfide Chapter 25
    Vectra Chapter 15
    V
    Victrex
    Polyetheretherketone (PEEK) Chapter 17

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