The Effects of Sterilization Methods on Plastics and Elastomers

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
- Acetal (Polyoxymethylene) . 17
Tabular Information 17vi Contents
ABS - Acrylonitrile-Butadiene-Styrene (ABS) . 19
Tabular Information 22
Graphical Information . 33
Acrylic Resins - Acrylic 39
Tabular Information 40
Graphical Information . 43 - Acrylic Copolymer . 47
Tabular Information 48
Graphical Information . 49 - Acrylic Terpolymer 55
Graphical Information . 56
Fluoroplastic - Fluoropolymer . 61
Tabular Information 61 - Polychlorotrifluoroethylene (PCTFE) 63
- Polyvinylidene Fluoride (PVDF) . 65
Tabular Information 65
Graphical Information . 66
Polyphenylene - Polyphenylene Ether (PPE) 67
Nylon - Nylon or Polyamide (PA) 69
Tabular Information 70
Graphical Information . 73
Polycarbonate - Polycarbonate (PC) 81
Tabular Information 83
Graphical Information . 103
Polyester - Polyester . 111
Tabular Information 111 - Polyester – PBT 113
Tabular Information 113Contents vii - Polyester – PETG and PCTG . 117
Tabular Information 118
Graphical Information . 120 - Liquid Crystal Polymer (LCP) . 123
Tabular Information 124
Graphical Information . 124
Polyketone - Polyetherimide (PEI) . 127
Tabular Information 128
Graphical Information . 133 - Polyetheretherketone (PEEK) 137
Tabular Information 138
Graphical Information . 138
Polyolefin - Linear Low Density Polyethylene (LLDPE) 141
Tabular Information 141 - High Density Polyethylene (HDPE) 143
Tabular Information 144 - Ultra High Molecular Weight Polyethylene (UHMWPE) 149
- Ethylene Vinyl Acetate (EVA) . 151
- Ethylene Vinyl Alcohol (EVOH) 153
Tabular Information 153
Polypropylene - Polypropylene (PP) . 155
Tabular Information 156
Graphical Information . 159 - Metallocene Polyolefin (MPO) Foam . 161
Graphical Information . 161
Polyphenylene Sulfide - Polyphenylene Sulfide (PPS) . 163
Tabular Information 163
Polystyrene - General-Purpose Polystyrene (GPPS) . 165
Tabular Information 166
Graphical Information . 173viii Contents - Syndiotactic Polystyrene (SPS) 175
Tabular Information 176
Graphical Information . 176 - High Impact Polystyrene (HIPS) . 179
Tabular Information 180
Graphical Information . 185 - High Heat Crystal Polystyrene . 187
Tabular Information 187
Polysulfone - Polysulfone (PSu) . 189
Tabular Information 190
Graphical Information . 191 - Polyethersulfone (PES) 195
Graphical Information . 196 - Polyphenylsulfone (PPSu) 199
Polyurethane - Thermoplastic Polyurethane (TPUR) . 201
Tabular Information 202
Graphical Information . 212
Styrene Acrylonitrile - Styrene Acrylonitrile (SAN) . 215
Tabular Information 216
Graphical Information . 222
Styrene Butadiene Copolymer - Styrene Butadiene Copolymers (SBC) . 225
Tabular Information 226
Graphical Information . 227
Vinyl Resin - Polyvinyl Chloride (PVC) 229
Tabular Information 231
Graphical Information . 234
Thermoplastic Alloy - Acrylonitrile-Butadiene-Styrene Polycarbonate Alloy (ABS PC) . 237
Tabular Information 237
Graphical Information . 239Contents ix - Acrylic Polycarbonate Alloy (Acrylic PC) 241
Graphical Information . 241
Thermoplastic Elastomer - Thermoplastic Elastomer (TPE) . 245
Tabular Information 246
Graphical Information . 247 - Thermoplastic Polyester Elastomer (TP) CoPolyester Ether Elastomer (COPE) . 249
Tabular Information 250 - Styrenic Thermoplastic Elastomer (Styrenic TPE) . 253
Tabular Information 254 - Thermoplastic Polyurethane Elastomer (Polyurethane TP) 257
Tabular Information 258
Silicone Rubber - Silicone 265
Additional Materials - 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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