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 |  موضوع: كتاب The Effect of Sterilization on Plastics and Elastomers الإثنين 08 مايو 2023, 9:20 pm | |
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أخواني في الله
أحضرت لكم كتاب
The Effect of Sterilization on Plastics and Elastomers
Third Edition
Laurence McKeen
و المحتوى كما يلي :
Contents
Preafce xi
1. Introduction to Food Irradiation and Medical Sterilization .1
1.1. Pathogens .1
1.1.1. Bacteria .1
1.1.2. Viruses .3
1.1.3. Endospores 3
1.1.4. Other Infectious Agents 4
1.1.4.1. Prions 4
1.1.4.2. Helminthes 4
1.1.4.3. Fungi: Molds and Yeasts 5
1.1.4.4. Protozoans 5
1.1.5. Biofilm 6
1.2. Food-Borne Disease Control .6
1.2.1. The History of Food Preservation 7
1.2.2. The History of Food Irradiation .8
1.2.3. Dosage Measures of Radiation .9
1.2.4. Electron Beam Irradiator 9
1.2.5. Gamma Irradiator 10
1.2.6. X-Ray Irradiator 11
1.2.7. Ultraviolet Germicidal Irradiation 12
1.2.8. Microwave .14
1.2.9. Infrared 14
1.2.10. How Does Irradiation Destroy Bacteria? .15
1.2.11. Doses of Radiation Required 15
1.2.12. Dosimetry 16
1.3. Medical Sterilization 16
1.3.1. Sterilization, Disinfection, and Asepsis .17
1.3.2. Thermal Methods of Sterilization 18
1.3.2.1. Steam Sterilization/Autoclave 18
1.3.2.2. Flash Sterilization .20
1.3.2.3. Dry Heat Sterilization 20
1.3.2.4. Glass Bead Sterilizer 21
1.3.2.5. Microwave 21
1.3.2.6. IR Radiation .21
1.3.3. Chemical Disinfectants e Liquids .22
1.3.3.1. Alcohol 22
1.3.3.2. Chlorine and Chlorine Compounds 23
1.3.3.3. Liquid Formaldehyde 25
1.3.3.4. Glutaraldehyde 26
1.3.3.5. Hydrogen Peroxide .26
1.3.3.6. Iodophors 27
1.3.3.7. Ortho-Phthalaldehyde .27
1.3.3.8. Peracetic Acid .28
1.3.3.9. Peracetic Acid and Hydrogen Peroxide .28
v1.3.3.10. Phenolics .29
1.3.3.11. Quaternary Ammonium Compounds .30
1.3.3.12. Surfacine .30
1.3.3.13. Controlling Biofilm .30
1.3.4. Gas and Vapor Sterilizing .31
1.3.4.1. Ethylene Oxide Sterilization 31
1.3.4.2. Vaporized Hydrogen Peroxide .33
1.3.4.3. Low-Temperature Hydrogen Peroxide Gas Plasma 33
1.3.4.4. Formaldehyde Gaseous Sterilization .34
1.3.4.5. Formaldehyde Steam 34
1.3.4.6. Ozone 35
1.3.4.7. Gaseous Chlorine Dioxide .35
1.3.4.8. Vaporized Peracetic Acid .35
1.3.5. Ionizing Radiation 36
1.3.5.1. UV Radiation .36
1.4. Bioterrorism .36
1.5. Summary 39
References 39
2. Introduction to Plastics and Polymers .41
2.1. Polymerization .41
2.1.1. Addition Polymerization .41
2.1.2. Condensation Polymerization .41
2.2. Copolymers 42
2.3. Linear, Branched, and Cross-Linked Polymers .43
2.4. Polarity .43
2.5. Unsaturation .44
2.6. Steric Hindrance .45
2.7. Isomers .45
2.7.1. Structural Isomers .45
2.7.2. Geometric Isomers 45
2.7.3. Stereosiomers e Syndiotactic, Isotactic, and Atactic 46
2.8. Inter- and Intramolecular Attractions in Polymers .46
2.8.1. Hydrogen Bonding 47
2.8.2. Van der Waals Forces .47
2.8.3. Chain Entanglement .48
2.9. General Classifications .48
2.9.1. Molecular Weight .48
2.9.2. Thermosets vs. Thermoplastics 49
2.9.3. Crystalline vs. Amorphous .49
2.9.4. Orientation 50
2.10. Plastic Compositions 50
2.10.1. Polymer Blends . 50
2.10.2. Elastomers . 51
2.10.3. Additives . 51
2.10.3.1. Fillers, Reinforcement, Composites 51
2.10.3.2. Combustion Modifiers, Fire, Flame Retardants, and Smoke Suppressants .52
2.10.3.3. Release Agents 52
2.10.3.4. Slip Additives/Internal Lubricants 53
2.10.3.5. Antiblock Additives 53
2.10.3.6. Catalysts 53
2.10.3.7. Impact Modifiers and Tougheners 54
2.10.3.8. Radiation Stabilizers .54
2.10.3.9. Optical Brighteners .54
2.10.3.10. Plasticizers .54
vi CONTENTS2.10.3.11. Pigments, Extenders, Dyes, and Mica 55
2.10.3.12. Coupling Agents 55
2.10.3.13. Thermal Stabilizers .55
2.10.3.14. Antistats .55
2.11. Summary 55
References 55
3. Introduction to the Physical, Mechanical, and Thermal Properties of Plastics and Elastomers .57
3.1. Physical Property Testing 57
3.1.1. Specific Gravity or Density 57
3.1.2. Appearance: Color, Haze, and Gloss .58
3.1.2.1. Color .58
3.1.2.2. Gloss Measurement 59
3.1.2.3. Haze Measurement .61
3.1.2.4. Yellowness Index 61
3.2. Mechanical Testing of Plastics 62
3.2.1. Tensile Properties .64
3.2.2. Rigidity of Plastics Materials .67
3.2.3. Shear Properties 68
3.2.4. Flexural Properties 70
3.2.5. Puncture and Impact Properties .70
3.2.5.1. High-Speed Puncture Test 71
3.2.5.2. Drop Dart Impact Test for Plastics Film .72
3.2.5.3. Izod Impact Strength and Charpy Impact Strength .73
3.2.5.4. Gardner and Falling Dart Impact Strength 73
3.2.6. Tear Properties 75
3.2.6.1. Elmendorf Tear Strength 75
3.2.6.2. Trouser Tear Resistance .76
3.2.7. Toughness .76
3.3. Thermal Property Testing of Plastics 77
3.3.1. Melt Flow Index .77
3.3.2. Heat Deflection Temperature 79
3.3.3. Vicat Softening Temperature 79
3.3.4. Melting Point (Tm) 80
3.3.5. Glass Transition Temperature (Tg) .80
3.3.5.1. Mechanical Methods of Estimating Tg 81
3.3.5.2. Thermal Mechanical Analysis .81
3.3.5.3. Thermal Methods of Estimating Tg .82
References 84
4. Styrenic Plastics .85
4.1. AcrylonitrileeButadieneeStyrene Copolymer .85
4.2. MethacrylateeAcrylonitrileeButadieneeStyrene Copolymer .92
4.3. Polystyrene .92
4.3.1. General-Purpose or Crystal Polystyrene 92
4.3.2. High-Heat Crystal Polystyrene .103
4.3.3. Syndiotactic Polystyrene 103
4.3.4. High-Impact Polystyrene 103
4.4. SAN Copolymer .103
4.5. StyreneeButadiene Copolymers .110
References 132
5. Polyesters 133
5.1. Liquid Crystalline Polymers 133
5.2. Polybutylene Terephthalate 135
CONTENTS vii5.3. Polycarbonate .135
5.4. Polyethylene Terephthalate 140
5.5. Polycyclohexylene-Dimethylene Terephthalate 141
5.6. Copolyesters .159
5.7. Polyethylene Naphthalate 166
5.8. Polyphthalate Carbonate 167
References 167
6. Polyimides .169
6.1. Polyamide-Imide 169
6.2. Polyetherimide .170
6.3. Polyimide .174
References 182
7. Polyamides (Nylons) .183
7.1. Polyamide 6 (Nylon 6) 184
7.2. Polyamide 11 (Nylon 11) 185
7.3. Polyamide 12 (Nylon 12) 187
7.4. Polyamide 66 (Nylon 66) 188
7.5. Polyarylamide 188
7.6. Copolymers/Terpolymers .192
References 198
8. Polyolefins .201
8.1. Polyethylene .201
8.1.1. Ultra Low-Density polyethylene 202
8.1.2. Linear Low-Density Polyethylene 202
8.1.3. Low-Density Polyethylene (LDPE) .203
8.1.4. High-Density Polyethylene .203
8.1.5. Ultrahigh Molecular Weight Polyethylene .213
8.2. Polypropylene 215
8.3. Poly-4-Methyl-1-Pentene .221
8.4. Cyclic Olefin Copolymer .225
8.5. Plastomer 225
References 226
9. Polyvinyls and Acrylics .227
9.1. EthyleneeVinyl Acetate Copolymer .227
9.2. EthyleneeVinyl Alcohol Copolymer 228
9.3. Polyvinyl Chloride .231
9.4. Polyvinylidene Chloride 234
9.5. Polyacrylics 239
9.5.1. Homopolymer .240
9.5.2. Acrylic Copolymer .240
9.5.3. Acrylic Terpolymer .240
9.6. AcrylonitrileeMethyl Acrylate Copolymer 253
9.7. Ionomers .253
References 258
10. Fluoropolymers .261
10.1. Polytetrafluoroethylene .262
10.2. Fluorinated Ethylene Propylene .264
10.3. Perfluoroalkoxy .265
10.3.1. PFA . 267
10.3.2. MFA . 268
10.4. Amorphous Fluoropolymer e Teflon AF 268
viii CONTENTS10.5. Polyvinyl Fluoride 269
10.6. Polychlorotrifluoroethylene 270
10.7. Polyvinylidene Fluoride 271
10.8. EthyleneeTetrafluoroethylene Copolymer .274
10.9. EthyleneeChlorotrifluoroethylene Copolymer 275
References .276
11. High-Temperature/High-Performance Polymers 277
11.1. Polyether Ether Ketone .277
11.2. Polyaryletherketone 277
11.3. Polyphenylene Sulfide 282
11.4. Polysulfone 284
11.5. Polyphenylsulfone .285
11.6. Polyethersulfone 292
11.7. Parylene (Poly(p-Xylylene)) .296
11.8. Polyoxymethylene (Acetal Homopolymer)/Polyoxymethylene Copolymer (Acetal Copolymer) 300
11.9. Self-Reinforced Polymers .301
References .304
12. Renewable Resource and Biodegradable Polymers 305
12.1. Polyanhydrides 309
12.2. Cellophane .309
12.3. Nitrocellulose 310
12.4. Ethyl Cellulose (Hydroxyethylcellulose) .311
12.5. Polycaprolactone .311
12.6. Poly Lactic Acid (PLA) and Poly L-Lactic Acid (PLLA) .311
12.7. Poly-3-Hydroxybutyrate .313
12.8. Polyglycolic Acid .315
References .317
13. Elastomers .319
13.1. Thermoplastic Polyether Block Polyamide Elastomers (TPA-ET or PEBA) 320
13.2. Thermoplastic Copolyester Elastomers (TPC-E or COPE) .320
13.3. Olefinic Thermoplastic Elastomers (TPO) .322
13.4. Styrenic Block Copolymer Thermoplastic Elastomers (TPS) .325
13.5. Thermoplastic Polyurethane Elastomers (TPU) .331
13.6. Polysiloxane/Silicone Rubber .339
References .352
Index .
Index
Page references followed by “f” indicate figure, and “t” indicate table.
A
Acetal copolymer, see Polyoxymethylene copolymer
Acetal homopolymer, see Polyoxymethylene
Acrylic copolymer, 240
beta radiation resistance of, 247f, 248f, 249f
EtO resistance of, 245t
gamma radiation resistance of, 245t, 246f, see also Copolymers
Acrylic homopolymer, 240
gamma radiation resistance of, 241t, 242f, 243f
Acrylic terpolymer, 240e249
Acrylonitrileebutadieneestyrene (ABS) copolymer, 85e92
chemical structure of, 85f
electron beam radiation resistance of, 87, 89t, 98f, 99f
EtO resistance of, 87, 89t, 90t, 91t, 92t, 93t, 94t, 99f
gamma radiation resistance of, 86e87, 86t, 87t, 88t, 89t, 95f,
96f, 97f
manufacturers and trade names of, 86
regulatory status of, 87
sterile applications of, 86
uses of, 86, see also Copolymers
Acrylonitrileemethyl acrylate (AMA) copolymer,
253
structure of, 253f, see also Copolymers
Addition polymerization, 41, 42f, see also Polymerization
Additives, 51e55
Adipic acid, chemical structure of, 184f
Alcohol, 22e23
microbiocidal activity of, 23
mode of action, 22e23, 23f
uses of, 23
Alkene, 201
Alkyl didecyl dimethyl ammonium chloride, 30
Alkyl dimethyl benzyl ammonium chloride, 30
Amino acids, chemical structure of, 184f
Aminolauric acid, 194f
chemical structure of, 184f
Aminoundecanoic acid, chemical structure of, 184f
Amylmetacresol, 29, 29f
Antiblock additives, 53, 54f
Antistats, 55
Asepsis, 17e18
Atactic polypropene, 46, 47f, see also Polypropene
Autoclave
gravity displacement steam, 19f
steam, 18e20
advantages of, 20
disadvantages of, 20
mode of action, 19
operating parameters for, 20t
uses of, 20
B
Bacteria, 1e2, 1f
cholera, 2f
classification of, 2
irradiation effects on, 15
morphologies, 2f
Becquerel, Antoine-Henri, 8e9
Benzalkonium chloride compounds, chemical structure of, 30f
Benzene (C6H6), unsaturation of, 44
Benzene-1,3-dicarboxylic acid, chemical structure of, 134f
Benzene-1,4-dicarboxylic acid, chemical structure of, 134f
Benzene-1,4-diol, chemical structure of, 134f
Biofilm, 6
controlling, 30e31
Biopolymers, sterilization of, 308t
Bioterrorism, 36e39
agents, 39
Bipnenol diamine (BPD), chemical structure of, 175f
Bis(p-aminocyclohexyl)methane acid, chemical structure of, 184f
4,4’-Bisphenol A dianhydride (BPADA)
chemical structure of, 174f
-DDS polyetherimide sulfone, chemical structure of, 173f
-MPD polyetherimide, chemical structure of, 174f
-PMDA-MPD copolyetherimide, chemical structure of, 174f
-PPD polyetherimide, chemical structure of, 173f
Bisphenol diamine PMDA polyetherimide, chemical structure of, 173f
Blanching, 8
Branched polymer, 43
“Bruceton Staircase” method, 72e73
C
Canning, 8
Caprolactam, chemical structure of, 184f
Carbothane, 334
Catalysts, 53
Cellophane, 309e310
structure of, 310f
Chain entanglement, 48
Chain-growth polymerization, see Addition polymerization
Charpy impact strength, 73, 74f, 74t, see also Impact strength testing
Chemical pickling, 7
Chloramine-T, 24, 24f
Chlorine, 23e25
Chlorine dioxide (ClO2), 24
gaseous, 35
modes of action, 24
uses of, 24
Chloroxylenol, 29, 29f
Cis-isomers, 46f
Clostridium botulinum, 1
355Cobalt-60, 10e11, 12f
Cold storage, 8
Color, 58e59
Combustion modifiers, 52
Composites, 51e52
Condensation polymerization, 41e42, 42f, see also Polymerization
Copolyesters, 159e160
beta radiation resistance of, 164f, 165f, 166f
chemical sterilization of, 160, 163t
chemical structure of, 160f
electron beam irradiation resistance of, 160, 161t, 162t
EtO resistance of, 160, 162t
gamma radiation resistance of, 160, 161t, 164f
manufacturers of, 160
sterile end uses of, 160
Copolymers, 41
acrylic, 240
acrylonitrileebutadieneestyrene, see
Acrylonitrileebutadieneestyrene copolymer
acrylonitrileemethyl acrylate, 253
alternating, 42, 42f
block, 42, 42f
cyclic olefin, see Cyclic olefin copolymer
ethyleneeacrylic acid, 253, 254f
ethyleneechlorotrifluoroethylene, 275e276, 275f, 276t
ethyleneetetrafluoroethylene, 274e275, 275f
ethyleneevinyl acetate, 227e228, 227f, 228f
ethyleneevinyl alcohol, see Ethyleneevinyl alcohol copolymer
graft, 42f, 43
impact, 215e217
methacrylateeacrylonitrileebutadieneestyrene, 85f, 85t, 92
random, 42, 42f
styreneeacrylonitrile, see Styreneeacrylonitrile copolymer
styreneebutadiene, see Styreneebutadiene copolymers, see also
Polymers
Coupling agents, 55
Critical equipment/device, 18t
Cross-linked polymer, 43
Cryptobia species, 5
Cryptosporidium, 5
Crystal polystyrene, high-heat, 103, see Polystyrene
Curie, Marie, 8e9
Curie, Pierre, 8e9
Cyclic olefin copolymer (COC), 225
film grades of, 225
manufacturers and trade names of, 225
radiation resistance of, 225
sterile applications of, 225
uses of, 225, see also Copolymers
1,4-Cyclohexanedimethanol (CHDM), chemical structure of, 160f
Cyclospora, 5
D
Density, 57
Diacid, chemical structure of, 184f
Dialkyl dimethyl ammonium chloride, 30
Diamines, chemical structure of, 184f
1,4-Diaminobutane, chemical structure of, 184f
Diamino diphenyl sulfone (DDS), chemical structure of, 175f
3,3’-Dimethyl-4,4’-diaminodicyclohexylmethane, 194f
Dipole, 43
Dipole moment, 43, 44t
Disinfection, 17e18
Spaulding’s classification of, 18t
1,12 Dodecanediotic acid, chemical structure of, 184f
Domagk, Gerhard, 16e17
Dosimetry, 16
Drop dart impact test, for plastic films, 72e73, 72f, see also Impact
strength testing
Dry heat sterilization, 20e21
advantages of, 21
disadvantages of, 21
forced-air, 20
mode of action, 21
static-air, 20
timeetemperature relationships for, 20
Drying, 7
Dyes, 55
Dynamic mechanical thermal analysis (DMTA), 81
E
Ehrlich, Paul, 16e17
Elastomer(s), 51, 319e354
olefinic thermoplastic elastomers, 322e325
polysiloxane/silicone rubber, 339e347
styrenic block copolymer thermoplastic elastomers, 325e331
tests, 63t, 64t
thermoplastic copolyester elastomers, 320e321
thermoplastic elastomers, 319, 319f
thermoplastic polyether block polyamide elastomers, 320
thermoplastic polyurethane elastomers, 331e334
Electron beam irradiator, 9e10, 10f, 11f
Elmendorf tear strength, 75, 75f
Elongation to puncture, 71e72
Endospores, 3e4
structure of, 3e4, 3f
Energy to puncture, 72
Enterocytozoon bieneusi, 5
Escherichia coli, 1
Ethyl cellulose, 311
structure of, 310f
Ethylene (C2H4)
chemical structure of, 201f
unsaturation of, 44
Ethyleneeacrylic acid (EAA) copolymer, 253
structure of, 254f, see also Copolymers
Ethyleneechlorotrifluoroethylene (ECTFE) copolymer, 275e276
gamma radiation resistance of, 276t
structure of, 275f, see also Copolymers
Ethylene glycol (EG), chemical structure of, 160f
Ethylene oxide (EtO)
resistance
of acrylic copolymer, 245t
of acrylonitrileebutadieneestyrene copolymer, 87, 89t, 90t, 91t,
92t, 93t, 94t, 99f
of copolyesters, 160, 162t
of high-density polyethylene, 207, 209t, 210t
of linear low-density polyethylene, 203, 204t
of olefinic thermoplastic elastomers, 325t
of polyamide 66 (nylon 66), 189t, 190t
of polyaryletherketone, 281f
of polybutylene terephthalate, 139t
of polycarbonate, 137e138, 147t, 148t, 149t, 150t, 151t, 152t, 153t
of polyether ether ketones, 278f, 279f
of polyetherimide, 170
of poly l-lactic acid, 315f
of polyphenylsulfone, 293f
of polypropylene, 218t, 219t, 221f
of polysiloxane/silicone rubber, 351f, 352f
of polystyrene, 101, 102t, 104t, 105t, 106t, 111t, 112t, 113f, 114f,
115f
of polysulfone, 287f
356 INDEXof polyvinyl chloride, 236t
of self-reinforced polymers, 302f
of styreneeacrylonitrile copolymer, 105, 117t, 118t, 119t, 121f
of styreneebutadiene copolymers, 110, 129t, 130t, 131t
of thermoplastic elastomers, 332t
of thermoplastic polyurethane elastomers, 343t, 344t, 345t
of ultrahigh molecular weight polyethylene, 213, 213t
sterilization, 31e33
advantages of, 32
degassing stage, 32
disadvantages of, 33
modes of action, 32
preconditioning stage, 31
sterilizer stage, 31e32
uses of, 32
Ethyleneetetrafluoroethylene (ETFE) copolymer, 274e275
gamma radiation resistance of, 275f
structure of, 275f, see also Copolymers
Ethyleneevinyl acetate (EVA) copolymer, 227e228
electron beam irradiation resistance of, 228f
structure of, 227f, see also Copolymers
Ethyleneevinyl alcohol (EVOH) copolymer, 228e231
beta radiation resistance of, 231t
formation and structure of, 228f
gamma radiation resistance of, 231t
nonirradiated (NIR), 230t, see Copolymers
Extenders, 55
F
Falling dart impact strength, 73e75, see also Impact strength testing
Fermentation pickling, 7
Fire retardants, 52
Flame retardants, 52
Flash sterilization, 20
Flexural properties, 70, 71f
Fluorinated ethylene propylene (FEP), 264e265
electron beam irradiation resistance of, 266f
gamma radiation resistance of, 266f
structure of, 265f
three-dimensional representation of, 265f
Fluoroplastics, melting point, 262t
Fluoropolymers, 261e276
ethyleneechlorotrifluoroethylene copolymer, 275e276
ethyleneetetrafluoroethylene copolymer, 274e275
fluorinated ethylene propylene, 264e265
perfluoroalkoxy, 265e268
polychlorotrifluoroethylene, 270
polytetrafluoroethylene, 262e264
polyvinyl fluoride, 269e270
polyvinylidene fluoride, 271
poststerilization, performance of, 262t
sterilization capabilities of, 262t
structure of, 261f
Teflon AF, 268
Food-borne disease control, 6e16
dosimetry, 16
electron beam irradiation, 9e10
food irradiation, dosage measures of, 9
food irradiation, history of, 8e9
food preservation, history of, 7e8
gamma radiation, 10e11
infrared heating, 14e15
irradiation effects, on bacteria, 15
microwave sterilization, 14
radiation dose, 15e16
ultraviolet germicidal irradiation, 12e14
X-ray Irradiation, 11e12
Food irradiation
dosage measures of, 9
history of, 8e9
Food preservation, history of, 7e8
Formaldehyde
gaseous sterilization, 34, 34f
liquid, 25e26
alkylation by, 25f
modes of action, 25
uses of, 25e26
steam, 34e35
advantages of, 35
disadvantages of, 35
Fungi, 5
G
Gamma radiator, 10e11, 13f
Gardner impact strength, 73e75, 74f, see also Impact strength testing
Gas and vapor sterilizing, 31e36
Gaseous chlorine dioxide, 35, see also Chlorine dioxide
General-purpose polystyrene (GPPS), 92, see Polystyrene
Geometric isomers, 45e46, 46f
Giardia, 5
Glass bead sterilizer, 21, 21f
Glass transition temperature, 80e84
mechanical estimation methods for, 81
thermal estimation methods for, 82e84
thermal mechanical analysis of, 81e82
Gloss measurement, 59e61
Glutaraldehyde, 26
advantages of, 26
chemical structure of, 26f
disadvantages of, 26
modes of action, 26
uses of, 26
Gram negative bacteria, 2, 2f, see also Bacteria
Gram positive bacteria, 2, 2f, see also Bacteria
Graphite, 53
Gravity displacement steam autoclave, 19f, see Autoclave
Gray and rad units conversion, 9t
Grilamid TR55 amorphous polyamide, 192, 194f
characteristics of, 195
gamma radiation resistance, 195t, 196f, 197f, 198f
manufacturers and trade names of, 195
sterile applications of, 195
uses of, 195
H
Hardness tests, 63t
Haze measurement, 61
Head-to-tail isomers, 46f
Heat deflection temperature, 79
test apparatus, 77f
Helminthes, 4
Hexachlorophene, 29, 29f
1,6-Hexamethylene diamine, chemical structure of, 184f
High-density polyethylene (HDPE), 203e213
beta radiation resistance of, 209t
electron beam irradiation resistance of, 208t, 209t
EtO resistance of, 207, 209t, 210t
gamma radiation resistance of, 206e207, 206t, 207t
manufacturers and trade names of, 204
plasma/hydrogen resistance of, 207e213
steam resistance of, 207
INDEX 357High-density polyethylene (HDPE) (Continued)
sterile applications of, 204
sterilization resistance of, 204e206, see also Polyethylene
High-heat crystal polystyrene, 103, see also Polystyrene
High-impact polystyrene (HIPS), 43, 103
structure of, 114f, see also Polystyrene
Homopolymers, 215, 217, 263
Hookworm parasites, 4f
Hydrochlorofluorocarbon (HCFC), 32
Hydrogen bonding, 47, 47f
Hydrogen peroxide, 26, 28e29
advantages of, 26
disadvantages of, 26
gas plasma, low-temperature, 33e34
advantages of, 34
disadvantages of, 34
effect on polyetherimide sterilization, 177t
modes of action, 34
uses of, 34
modes of action, 26
plus peracetic acid, 28e29, 28f
vaporized, 33
4-Hydroxybenzoic acid (HBA), chemical structure of, 134f
6-Hydroxynaphthalene-2-carboxylic acid, chemical structure of, 134f
4-(4-Hydroxyphenyl)phenol, chemical structure of, 134f
Hypochlorites, 23e24
I
Illuminant, 58
Imide group formation, 169f
Impact copolymers, 215e217, see also Copolymers
Impact modifiers, 54
Impact strength testing, 63t
charpy, 73, 74f, 74t
drop dart, 72e73, 72f
falling dart, 73e75
gardner, 73e75, 74f
izod, 73, 74f, 74t
pendulum-type, 73f
Infrared heating, 14e15
Infrared radiation, 21
Instron Universal Materials Testing Machine, 65e66, 66f, 68e70
Internal lubricants, 53
Iodophors, 27
modes of action, 27
uses of, 27
Ionizing radiation, 8e9
sterilization by, 36
Ionomers, 253e258
electron beam irradiation resistance of, 255t, 256t, 257f, 257t, 258f
gamma radiation resistance of, 254t, 255t
Isomers, 45e46
geometric, 45e46
stereosiomers, 46
structural, 45
Isophthalic acid, 194f
chemical structure of, 160f, 184f
Isospora, 5
Isotactic polypropene, 46, 47f, see also Polypropene
Izod impact strength, 73, 74f, 74t, see also Impact strength testing
K
Koch, Heinrich Hermann Robert, 16e17
Kosan, Idemitsu, 103
L
Lactide dimer, structure of, 312f
Laurolactam, 194f
Light source, 58
Linear low-density polyethylene (LLDPE), 201e203
EtO resistance of, 203, 204t
gamma radiation resistance of, 203, 203t
manufacturers and trade names of, 203
sterile applications of, 203, see also Polyethylene
Linear polymer, 43
Liquid chemical disinfectants, 22e31
alcohol, 22e23
biofilm, controlling, 30e31
chlorine, 23e25
chlorine compounds, 23e25
glutaraldehyde, 26
hydrogen peroxide, 26, 28e29
inhibition of metabolism, 22
iodophors, 27
liquid formaldehyde, 25e26
membrane disruption, 22
nucleic acid damage, 22
ortho-phthalaldehyde, 27
peracetic acid, 28e29
phenolics, 29e30
protein denaturation, 22, 22f
quaternary ammonium compounds, 30
Surfacine, 30
Liquid crystal polymers (LCPs), 133e135
gamma radiation resistance of, 133, 135t
manufacturers and trade names of, 133
regulatory status of, 134e135
steam sterilization resistance of, 134, 136f, 137f
sterile applications of, 133
uses of, 133, see also Polymers
Lister, Joseph, 17, 29
Listeria monocytogenes, 17
Listerine mouthwash, 17
Low-density polyethylene (LDPE), 201, 203
electron beam irradiation resistance of, 205f, 206f
gamma radiation resistance of, 204f, 205f, 206f, see also Polyethylene
Low-temperature hydrogen peroxide gas, beta radiation resistance of,
243f, 244f, 245f
Lucite International, 240
M
Mechanical testing, of plastics, 62e77, 62t, 65t
Medical device packaging
ASTM tests for, 31
goals of, 31
Medical sterilization, 16e36
gas and vapor sterilizing, 31e36
by ionizing radiation, 36
liquid chemical disinfectants, 22e31
thermal methods of, 18e21
Medium-density polyethylene (MDPE), 201, see also Polyethylene
Melt flow index (MFI), 77e79
determination of, recommended conditions for, 78t
test apparatus, 76f
Melting point, 80
Methacrylateeacrylonitrileebutadieneestyrene (MABS) copolymer,
92
electron beam radiation resistance of, 100t
gamma radiation resistance of, 100f
manufacturers and trade names of, 92
358 INDEXsterile applications of, 92, see also Copolymers
Methylene dianiline (MDA), chemical structure of, 175f
4-Methylpentene-1, 201
chemical structure of, 201f
MFA, 268
Mica, 55
Microwave sterilization, 14, 15f, 21
Molar-mass dispersity index, 48e49
Molds, 5
Molecular weight, 48e49
Molybdenum disulfide, 53
m-Phenyne diamine (MPD), chemical structure of, 175f
N
Naegleria fowleri, 5
Naphthalene-2,6-dicarboxylic acid (NDA), chemical structure of, 134f
Nitrocellulose, 310e311
structure of, 310f
Noncritical equipment/device, 18t
Norbornene, chemical structure of, 201f
Nylons, see Polyamides
O
Olefin, see Alkene
Olefinic thermoplastic elastomers (TPO), 322e325
EtO resistance of, 325t
gamma radiation resistance of, 324t, 326f, 327f, 328f
steam resistance of, 325t, 326t, 328f, 329f, 330f
Optical brighteners, 54
Ortho-phthalaldehyde (OPA), 27
advantages of, 27
disadvantages of, 27
modes of action, 27
uses of, 27
Oxydianiline, chemical structure of, 175f
Ozone sterilization, 35
advantages of, 35
disadvantages of, 35
P
Paraformaldehyde, 34, see also Formaldehyde
Parylene, 296e298
sterilization methods of, 299t
structure of, 298f
Pasteur, Louis, 17
Pathogens, 1e6
associated with food-borne illness, 6t, 7t
bacteria, 1e2
biofilm, 6
endospores, 3e4
fungi, 5
helminthes, 4
molds, 5
prions, 4
protozoans, 5
viruses, 3
yeasts, 5
Penicillium, 5f
Peracetic acid (PAA), 28e29
advantages of, 28
disadvantages of, 28
modes of action, 28
plus hydrogen peroxide, 28e29, 28f
vaporized, 35e36
Perfluoroalkoxy (PFA), 265e268
comonomers, 267t
gamma radiation resistance of, 268f
radiation, 267t
structure of, 267f
three-dimensional representation of, 267f
Perfluoropolyether synthetic oil, 53
Phenolics, 29e30
chemical structure of, 29f
modes of action, 30
uses of, 30
2-Phenylphenol, 29, 29f
Physical property testing, 57e62
color, 58e59
density, 57
gloss measurement, 59e61
haze measurement, 61
specific gravity, 57
Pigments, 55
Plasmodium, 5
Plastic films, drop dart impact test for, 72e73, 72f
Plasticizers, 54
Plastics
amorphous, 49e50
compositions, 50e55
crystalline, 49e50
materials, rigidity of, 67e68, 69f
mechanical testing of, 62e77, 62t, 65t
thermal property testing of, 77e84
thermoplastics, 49
thermosets, 49
Plastomers (POP), 225e226
Pleistophora species, 5
Polar bond, 43
Polarity, 43e44
Polyacrylics, 239e249
acrylic copolymer, 240
acrylic homopolymer, 240
acrylic terpolymer, 240e249
Polyamide 6 (nylon 6), 184e185
characteristics of, 185
chemical structure of, 184f
manufacturers and trade names of, 185
properties after EtO sterilization, 185t
sterile applications of, 185
sterilization vs non-sterilization methods, creep compliances of, 186f
tensile strength after autoclave sterilization, 185f
uses of, 185
Polyamide 11 (nylon 11), 185e187
characteristics of, 186
chemical structure of, 186f
dry heat sterilization cycles of
flexural modulus versus, 187f
tensile modulus versus, 187f
manufacturers and trade names of, 187
sterile applications of, 187
uses of, 187
Polyamide 12 (nylon 12), 187e188
characteristics of, 187e188
chemical structure of, 188f
manufacturers and trade names of, 188
sterile applications of, 188
uses of, 188
Polyamide 66 (nylon 66), 188e189
characteristics of, 188
chemical structure of, 188f
electron beam radiation dose
INDEX 359Polyamide 66 (nylon 66) (Continued)
versus elastic modulus retained, 191f
versus elongation at break retained, 191f
versus impact strength, 191f
versus tensile strength retained, 190f
EtO resistance of, 189t, 190t
gamma radiation resistance of, 189t
manufacturers and trade names of, 188
steam resistance of, 190t
sterile applications of, 188
uses of, 188
Polyamide-imides (PAIs), 169e173
chemical structure of, 169f, 170f
gamma radiation resistance, 170f
manufacturers and trade names, 169
polymer units of, 171t, 172t
sterile applications of, 169e170, 174
uses of, 169e170
Polyamides (nylons), 183e200
copolymers/terpolymers, 192e195
generalized reaction of, 183f
polyamide 6 (nylon 6), 184e185
polyamide 11 (nylon 11), 185e187
polyamide 12 (nylon 12), 187e198
polyamide 66 (nylon 66), 188
polyarylamide, 188e192
Polyanhydrides, 309
structure of, 309f
Polyarylamide (PAA), 188
characteristics of, 188e190, 192
chemical structure of, 192f
EtO resistance of, 189f
gamma radiation resistance of, 189t, 195t
heat resistance of, 193f
manufacturers and trade names of, 192
steam resistance of, 194f
sterile applications of, 170
uses of, 192
Polyaryletherketone (PAEK), 277e282
EtO resistance of, 282f
steam resistance of, 283f, 284f
structure of, 281f
Polybutylene terephthalate (PBT), 135
EtO resistance of, 139t
gamma radiation resistance of, 138t
hydrolysis resistance of, 138t
manufacturers and trade names of, 135
sterile applications of, 135
uses of, 135
Polycaprolactone (PCL), 311
irradiation, 311f
structure of, 311f
Polycarbonate, 135e140
beta radiation resistance of, 157f, 158f
chemical structure of, 139f
electron beam resistance of, 145t, 146t, 147t
EtO radiation resistance of, 137e138, 147t, 148t, 149t, 150t, 151t,
152t, 153t
gamma radiation resistance of, 137, 140t, 141t, 142t, 143t, 144t, 145t,
154f, 155f, 156f
manufacturers and trade names of, 137
properties of, 137
regulatory status of, 140
steam sterilization resistance of, 138e139, 158f
sterile applications of, 137
sterilization with hot air, 139e140
sterilization with peracetic acid, 139
uses of, 137
Polychlorotrifluoroethylene (PCTFE), 270
gamma radiation resistance of, 270t
structure of, 270f
Polycyclohexylene-dimethylene terephthalate (PCT), 141e159
autoclave sterilization of, 159
chemical structure of, 160f
gamma radiation resistance of, 141
manufacturers and trade names of, 141
sterile applications of, 141
uses of, 141
Polydispersity, see Molar-mass dispersity index
Polyesters, 133e168
chemical structure of, 133f
Polyether ether ketones (PEEKs), 277
EtO resistance of, 278f, 279f
gamma radiation resistance of, 278t
steam resistance of, 278t, 279f, 280f, 281f
structure of, 277f
Polyetherimide (PEI), 170e174
dry heat resistance of, 174, 180f
EtO resistance of, 170, 175t, 176t, 177t
gamma radiation resistance of, 170, 177f, 178f
manufacturers and trade names of, 170
performance features of, 170
regulatory status of, 174
steam resistance of, 170e174, 177t, 179f, 180f
sterile applications of, 170
Polyethersulfone (PES), 292e296
steam resistance of, 296t, 297f, 298f
structure of, 296f
Polyethylene (PE), 201e213
crystal structure of, 202f
high-density, 203e213
linear low-density, 202e203
low-density, 203
types of, 202f
ultra high molecular weight, 213
ultra low-density, 202
unsaturation of, 44
Polyethylene naphthalate (PEN), 166e167
autoclave sterilization of, 166
chemical structure of, 166f
manufacturers and trade names of, 166
resistance to ionizing radiation, 167
sterile applications of, 166
uses of, 166
Polyethylene terephthalate (PET), 42, 49e50, 135e159
chemical structure of, 159f
electron beam resistance of, 159f
manufacturers and trade names of, 135e140
melting point of, 80f
sterile applications of, 141
uses of, 141
Polyglycolic acid (PGA), 315e317
sterilization methods, 317
structure of, 317
Polyhydroxyalkanoates (PHAs), 313
structure of, 315f
Poly-3-hydroxybutyrate (PH3B), 313e315
gamma radiation resistance of, 316f
Poly(lactic acid) (PLA), 305, 311e313
conversion of lactic acid to, 312f
electron beam irradiation resistance of, 314f
gamma radiation resistance of, 312f, 313f, 314f
360 INDEXPolyimides (PIs), 169e182
chemical structure of, 184f
electrom exposure, 182t
gamma radiation resistance, 181t
manufacturers and trade names, 174
polyamide-imides, 169e170
polyetherimide, 170e174
polyimides, 174e175
sterile applications of, 174
Poly l-lactic acid (PLLA), 311e313
EtO resistance of, 315f
steam resistance of, 315f
Polymerization, 41e42
addition, 41, 42f
condensation, 41e42, 42f
degree of, 48e49
Polymers
additives, 51e55
amorphous, 49e50
blends, 50e51
branched, 43
copolymers, see Copolymers
cross-linked, 43
crystalline, 49e50
elastomers, 51
inter alterations in, 46e48
intermolecular alterations in, 46e48
linear, 43
liquid crystal, see Liquid crystal polymers
molecular weight of, 48e49
orientation, 50
polarity of, 43e44, 44f
steric hindrance of, 45, 45f
unsaturation of, 44e45
Polymethyl methacrylate (PMMA), 239e240
structure of, 240f
Poly-4-methyl-1-pentene (PMP), 221e225
manufacturers and trade names of, 221
sterile applications of, 221
structure of, 222f
uses of, 221
Polyolefins, 201e226
chemical structure of, 201f
cyclic olefin copolymer, 225
plastomers, 225e226
polyethylene, 201e213
high-density, 203e213
linear low-density, 202e203
low-density, 203
types of, 202f
ultra low-density, 202
ultra high molecular weight, 213
poly-4-methyl-1-pentene, 221e225
polypropylene, 215e221
Polyoxymethylene (POM), 300e301
chemical structure of, 300f
copolymer, 300e301
chemical structure of, 300f
Polyphenylene, 301
structure of, 301f
Polyphenylene sulfide (PPS), 282e284
gamma radiation resistance of, 285t, 286t, 287f
steam resistance of, 287f
structure of, 284f
Polyphenylene sulfone (PPS), unsaturation of, 45
Polyphenylsulfone (PPSU), 285e292
EtO resistance of, 293f
low-temperature hydrogen peroxide gas plasma sterilization, 292t,
295f
steam resistance of, 293f, 294f, 295f
structure of, 292f
Polyphthalate carbonate (PPC)
chemical structure of, 166f
electron beam irradiation resistance of, 167t
gamma radiation resistance of, 167t
Polypropene
atactic, 46, 47f
isotactic, 46, 47f
structure of, 46, 46f
syndiotactic, 46, 47f
Polypropylene, 215e221
autoclave sterilization of, 221
EtO resistance of, 218t, 219t, 221f
gamma radiation resistance of, 215t, 216t, 217t, 218e221, 220f, 221f
manufacturers and trade names of, 217
sterile applications of, 217
sterilization resistance of, 218
types of, 215e217
uses of, 217
Polysiloxane/silicone rubber, 339e347
electron beam irradiation resistance of, 349f, 350f, 351f
EtO resistance of, 351f, 352f
gamma radiation resistance of, 347f, 348f, 349f
structure of, 347f
Polystyrene, 92e103
chemical structure of, 101f
electron beam radiation resistance of, 101, 102t, 110t
EtO resistance of, 101, 102t, 104t, 105t, 106t, 111t, 112t, 113f, 114f,
115f
gamma radiation resistance of, 101, 101t, 102t, 107t, 108t, 109t, 112f,
113f, 115f
general purpose, 92
high-heat crystal, 103
manufacturers and trade names of, 101
sterile applications of, 101
syndiotactic, 103
uses of, 101
UV light sterilization resistance of, 101
Polysulfone (PSU), 284e285
EtO resistance of, 288f
gamma radiation resistance of, 288t
steam resistance of, 289f, 290f, 291f, 292f
structure of, 287f
Polytetrafluoroethylene (PTFE), 53, 262e264
amorphous, 263
degradation mechanisms of, 264f
electron beam irradiation resistance of, 265f
gamma radiation resistance of, 264f
structure of, 263f
three-dimensional representation of, 263f
Polyvinyl chloride (PVC), 231e234
classification of, 231e232
degradation, 233, 234f, 237f
EtO resistance of, 236t
gamma radiation resistance of, 234t, 235t, 236t, 237f,
238f, 239f
medical devices, 232
Polyvinyl fluoride (PVF), 269e270
gamma radiation resistance of, 270f
structure of, 269f
Polyvinylidene chloride (PVDC), 234e237
structure of, 239f
INDEX 361Polyvinylidene fluoride (PVDF), 271
electron beam irradiation resistance of, 271t, 274f
gamma radiation resistance of, 272f, 273f, 274f
structure of, 271f
Povidoneeiodine, structure of, 27f
p-Phenyne diamine (PDA), chemical structure of, 175f
Prions, 4
Prokaryotes, 1
Propylene, chemical structure of, 201f
Protozoans, 5
Puncture strength, 72
Puncture test, high-speed, 71e72, 71f
Pyromellitic dianhydride (PMDA), chemical structure of,
175f
Q
Quaternary ammonium compounds, 30
modes of action, 30
uses of, 30
R
Rad and gray units conversion, 9t
Radiation dose, 15e16, 16t
Radiation stabilizers, 54
Random copolymers, 215, 217, see Copolymers
Reinforcing fillers, 51e52
Release agents, 52
Renewable resource and biodegradable polymers, 305e318
Cellophane, 309e310
commercial materials, 306te308t
ethyl cellulose, 311
nitrocellulose, 310e311
poly-3-hydroxybutyrate, 313e315
poly lactic acid, 311e313
poly l-lactic acid, 311e313
polyanhydrides, 309
polycaprolactone, 311
polyglycolic acid, 315e317
Rigidity, of plastic materials, 67e68, 69f
Roentgen, W.K., 8e9
S
Saccharomyces cerevisiae, 5f
Salting, 7
Sarcocystis, 5
Sebacic acid, chemical structure of, 184f
Self-reinforced polymers (SRPs), 301e304
EtO resistance of, 302f
steam resistance of, 302f, 303f
structure of, 301f
Semi-critical equipment/device, 18t
Semmelweis, Ignaz Philipp, 16
Shear properties, 68e70
Slip additives, 53, 53f, see Additives
Smoke suppressants, 52
Smoking, 8
Sodium dichloroisocyanurate, 24, 24f
Solvay Solexis Halar, 275
Specific gravity, 57
Staphylococcus, 1
Steam sterilization, 18e20
advantages of, 20
disadvantages of, 20
immediate-use, see Flash sterilization
mode of action, 19
uses of, 20
Step-growth polymerization, see Condensation polymerization
Stereosiomers, 46
Steric hindrance, 45, 45f
Sterilization, defined, 17e18
Structural isomers, 45, 45f, 46f
Styrene, chemical structure of, 85f
Styreneeacrylonitrile (SAN) copolymer, 85, 103e105
electron beam radiation resistance of, 117t
EtO resistance of, 105, 117t, 118t, 119t, 121f
gamma radiation resistance of, 105, 116t, 117t, 120f,
121f
manufacturers and trade names of, 105
regulatory status of, 105
steam sterilization resistance of, 105
sterile applications of, 105
uses of, 105, see Copolymers
Styreneebutadiene copolymers (SBC), 110
electron beam radiation resistance of, 126t, 127t, 128t
EtO resistance of, 110, 129t, 130t, 131t
gamma radiation resistance of, 110, 122t, 123t, 124t, 125t
manufacturers and trade names of, 110
regulatory of, 110
sterile applications of, 110
structure of, 122f, see Copolymers
Styrenic plastics, 85e132
sterilization capabilities of, 85t
Sugaring, 8
Superoxidized water, 24e25
modes of action, 25
uses of, 25
Surfacine, 30
Syndiotactic polypropene, 46, 47f, see Polypropene
Syndiotactic polystyrene (SPS), 103, see Polystyrene
T
Tear properties, 75e76
Elmendorf tear strength, 75
Trouser tear resistance, 76
Tecoflex, 334
Tecophilic, 334
Tecoplast, 334
Tecothane, 334
Teflon AF, 268
radiation dose, 269f
structure of, 268f
Tensile properties, 64e67, 67f, 67t, 68f, 68t
Terephthalic acid (TPA), chemical structure of, 160f, 184f
Thermal property testing, of plastics, 77e84
glass transition temperature, 80e84
heat deflection temperature, 77f, 79
melt flow index, 76f, 77e79, 78t
melting point, 80
Vicat softening temperature, 79e80, 79f
Thermal stabilizers, 55
Thermal tests, 64t
Thermoplastic copolyester elastomers (TPC-E), 320e321
electron beam irradiation resistance of, 323t
gamma radiation resistance of, 321t, 322t
structure of, 321f
thermal sterilization, 324t
Thermoplastic elastomers (TPEs), 319, 319f, 325e331
EtO resistance of, 332t
gamma radiation resistance of, 331t, 332t
steam resistance of, 332t, 333t
362 INDEXThermoplastic polyether block polyamide elastomers
(TPA-ET or PEBA), 320
Thermoplastic polyurethane elastomers (TPU), 331e334
electron beam irradiation resistance of, 340t, 341t, 342t
EtO resistance of, 343t, 344t, 345t
gamma radiation resistance of, 334t, 335t, 336t, 337t, 338t, 339t, 345f,
346f
structure of, 333f
Thermoplastics, 49
Thermosets, 49
Thymol, 29, 29f
Ticona Vectra A950 LCP, chemical structure of, 135f
Tinuvin-P, 2-(2H-benzotriazol-2-yl)-p-cresol, 233
radiation dose, 233f
structure of, 233f
Tortuous path effect, 52
Tougheners, 54
Toughness, 76e77
Toxins, 1
Toxoplasma, 5
Trans-isomers, 46f
Trichinella spiralis, 4
Trouser tear resistance, 76
U
Ultra high molecular weight polyethylene (UHMWPE), 213
EtO resistance of, 213, 213t
gamma radiation resistance of, 213, 213f, 213t, 214f
sterile applications of, 213, see Polyethylene
Ultra low-density polyethylene (ULDPE), 201e202
manufacturers and trade names of, 202
sterile applications of, 202, see Polyethylene
Ultraviolet germicidal irradiation (UVGI), 12e14, 13f,
14f, 15f
ductwork-installed, 36f
hospital bed air space, 36f
Ultraviolet radiation
types of, 13t
stabilizers, 54
sterilization by, 36
Unsaturation, 44e45
V
Van der Waals forces, 47e48
Vaporized hydrogen peroxide (VHP), 33, see Hydrogen peroxide
Vaporized peracetic acid, 35e36, see Peracetic acid
Very low-density polyethylene (VLDPE), 201, see Polyethylene
Vicat softening temperature, 79e80
test apparatus, 79f
Vinyl benzene. see Styrene
Viruses, 3, 3f
X
X-ray Irradiator, 11e12
Y
Yeasts, 5
Yellowness index (YI), 61e62
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