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 |  موضوع: كتاب Plastics in Medical Devices - Properties, Requirements, and Applications السبت 12 أغسطس 2023, 4:05 am | |
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Plastics in Medical Devices - Properties, Requirements, and Applications
Vinny R. Sastri
و المحتوى كما يلي :
Table of contents
1. Introduction to Plastics in Medical Devices
2. Regulations of Medical Devices and Application to Plastic Suppliers
3. Materials used in Medical Devices
4. Material Requirements for Plastics used in Medical Devices
5. Commodity Thermoplastics PVC, POE, PS for Medical Devices
6. Engineering Thermoplastics Acrylics, PC, PC, PU, Polyacetals, Polyesters, Polyamides for Medical Devices
7. High Temperature Engineering Thermoplastics for Medical Devices
8. Other Polymers: Styrenics, Silicones, TPEs, Biopolymers and Thermosets for Medical Devices
9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications
10. Materials used for Coatings, Adhesives and 3-D Printing in Medical Devices
11. Purchasing Controls and Supplier Controls in Plastics for Medical Devices
12. Process Validation in Plastics for Medical Devices13. Risk Management and Biocompatibility in Plastics for Medical Devices
Index
Note: Page numbers followed by “f ” and “t” refer to figures and tables respectively.
1,1-bis(4-hydroxyphenyl)-3,3,5-trimethyl
cyclohexane (bisphenol TMC), 130
21 CFR (Code of Federal Regulations)
Parts, 58
21 CFR (Code of Federal Regulations)
Parts 820, 910
A
Accelerated Aging Tests, 51
Acronyms, 295t
Acrylate styrene acrylonitrile (ASA),
215218, 224t
Acrylic multipolymers, 122, 123t,
125126
Acrylics, 121126
applications, 125126
biocompatibility, 125
chemical resistance, 122123
production and properties, 121122
sterilization, 123125
welding and joining, 125
Acrylonitrile butadiene styrene (ABS),
215218, 224t
Acute system toxicity, 46
Adhesive bonding, 53
Adhesives, 257260
Advantages of plastics, 21
Agar diffusion test, 46
Aging, 5051
American Society for Testing and
Materials (ASTM)
ASTM 1428 (pink stain test), 6162
ASTM 2180-01/ASTM G22/ISO 846,
62
ASTM D3045-92 (2003), 50
ASTM D543 and ISO 4599, 43
(ASTM) F 1980-02, 50
ASTM G21/ISO 846 Part A—a
fungicidal test, 61
ASTM G22/ISO 846 Part C—an
antibacterial agar test, 61
American type culture collection (ATCC),
62
Amorphous, 26, 27t
Amorphous plastics, 40
Amorphous thermoplastics, 26
Antimicrobials, 6063
Antioxidants, 70
Antistatic additives, 6364
Arrhenius Reaction Rate theory, 51
Atactic polypropylene, 95
Australia, 1516
Autoclaving, 35t
B
Barium sulfate, 60
Bioburden, 33
Biocompatibility, 4547
Biodegradable biopolymers, 240
Biodegradable plastic, 240
Biodegradation, 47
Biodegradation of biopolymers,
251252
Biological indicators, 34
Biologics master files, 12
Biomaterials Access Assurance Act
BAAA (HR 872), 1617
Biopolymers, 240252
applications, 252
biocompatibility, 251252
chemical resistance, 248
joining and welding, 252
production, 244246
properties, 246248
sterilization, 248250
Bioresorbable biopolymers, 240
Biostability of polyurethanes, 143144
Bisphenol A (BPA) polycarbonate, 128,
134135
Bleaches, 4043
Bottom-up approach, 65
Bulk molding compounds (BMC),
254257
C
Carbon nanotubes, 6769
Carcinogenesis, 46
CE (Conformite´ Europe´ene) mark, 14
CE (Conformite´ Europe´ene) marking,
1314
Ceramics, 2021
Chain scission, 38
Chemical resistance, 4045, 297t
of acetals, 152f
of acrylonitrile butadiene styrene
(ABS), 220f
of biopolymers, 248
of engineering thermoplastics, 124f
of high-temperature engineering
thermoplastics, 176t
of polyesters, 156
of polyphenylene sulfide, 192
of polyurethanes, 145f, 145t
of polyvinyl chloride (PVC), 7880
of styrenics, 219220
of thermoplastic elastomers, 237t
China, 15
Closed patch test, 46
Coefficient of friction, 5758
Color additive, 58
Commodity thermoplastics, 4, 73
Commodity thermoplastics suppliers, 117
Conductive additives, 64
Conductive fillers, 6364
Conductivity spectrum, 63, 63f
Contract manufacturers and suppliers, 263
Copolyester thermoplastic elastomers, 230
Copolyesters, 157161
applications, 161
biocompatibility, 160
chemical resistance, 158160
joining and welding, 160161
production and properties, 158
sterilization, 160
Copolymers, 2930
Crystal polystyrene, 107
Crystalline, 27t
Cyanoacrylates, 255
Cyclo olefin copolymers, 103107
biocompatibility, 106
chemical resistance, 106, 107t
joining and welding, 106107
301Cyclo olefin copolymers (Continued)
manufacture, 105
medical applications, 108t
properties, 105106
sterilization, 106
Cytotoxicity, 4546
D
Degradable plastic, 240
Degradation, 132133
Detergents, 4043
Device Master Files (MAF), 12
Device Master Record (DMR), 280
Devices classification, 3
Di-(2-ethyl hexyl phthalate) (DEHP), 56,
75
Diethylene glycol (DEG), 264
Diisocyanates, 141
Direct contact test, 4546
Disadvantages of plastics, 2425
Disinfectants, 4043
Disposables, 3
Drug Master File (DMF), 12
Dry heat sterilization, 36
E
Elastomers, 2829
Electron-beam (e-beam) radiation, 3940
Engineering thermoplastics, 121
Engineering thermoplastics suppliers, 170t
Environmental stress cracking (ESCR), 40
Epoxy resins, 254
Ethylene chlorotrifluroethylene (ECTFE),
204t, 205t, 209t
Ethylene copolymers, 88t
Ethylene oxide (EtO), 3637
and gamma sterilization on poly
(lactide-co-glycolide) (PLGA),
250f
sterilization, of thermoplastic polyolefin
elastomer (TPO), 238f
sterilization, on properties of
polyethylene, 93f
Ethylene tetrafluoroethylene (ETFE),
204t, 205t, 209t
European Union medical device directive,
1314
Extractables, 4345
F
Families of plasticizers, 57t
Families of thermosets, 252
Fluorinated ethylene-propylene (FEP),
204t, 205f, 209, 209t
Fluoropolymers, 5758, 202209
applications—examples, 209
biocompatibility, 209
chemical resistance, 207
joining and welding, 209
production, 204206
properties, 206207
sterilization, 207209
Food and Drug Administration (FDA)
FDA 21 CFR part 820, 10t
FDA 21 CFR Part 820 Quality System
Regulation, 268271
FDA master files, 1112
Food Master Files (FMF), 12
G
Gamma and e-beam radiation on
polycaprolactone (PCL), 251f
Gamma radiation, 3739
of polysulfones, 178f
Gamma radiation stability
of liquid crystalline polymer, 201f
of polyphenylene sulfide, 191f
Gamma sterilization capability of
polyetherimides, 186f
Gamma sterilization of thermoplastic
polyester elastomer, 239f
Genotoxicity, 46
Glass, 2021
Global Harmonization Task Force
(GHTF)
guidance document, 280
guidance document on inspection of
purchasing controls, 276277
guidance document on purchasing
controls, 271276
feedback and communication,
275276
finalization of controls, 275
planning, 272274
potential suppliers, selection of,
274
supplier evaluation and acceptance,
274
Good manufacturing practices (GMP)
requirements for medical devices,
910
Guinea Pig maximization test, 46
H
Hardnesses, 74f, 140141, 140f
Heated tool or plate welding, 52
Hemocompatibility, 46
High frequency welding, 52
High impact polystyrene, 107
High-density polyethylene (HDPE),
8490, 88t
High-heat polycarbonates, 131f
High-temperature thermoplastic,
173174
Homopolymers, 2930
Hydrolytic stability of polysulfones, 177f
Hydrolytically degradable plastic, 240
Hydroxyapatite, 20
I
Immiscible polymer blends, 30
Implantation, 46
India, 16
Infrared welding, 52
Installation qualification (IQ), 288289
Interfacial polymerization of bisphenol A
(BPA) polycarbonate, 129f
International Medical Device Regulators
Forum (IMDRF), 280
Intraocular lens, 125
Irradiation, 3740
Irritation tests, 46
ISO 10993, 4950
ISO 10993 standards, 47, 48t
ISO 10993-1, ‘‘Guidance on selection of
tests’’, 49
ISO 10993-18, 33
ISO 13485, 1214
ISO 13485:1996, 910
ISO 13485:2003, 13t
ISO 13485 Standard on Purchasing
Controls, 268271
Isotactic polypropylene, 95, 98
J
Japan, 1415
JIS Z 2801/IBRG draft test protocol, 62
JIS Z 2911/ISO 846 Part B—a fungistatic
test, 61
Joining and welding, 5153
K
Krebs cycle, 248
K-values, 78
of polyvinychloride-unplasticized
(PVC-U), 79t
L
Laser marking, 59
Laser welding, 52
Leachables, 4345
Linear low-density polyethylene, 8487,
88t, 91
Lipid resistance of polyetherimides, 185f
Lipids, 4043
Liquid crystalline polymers (LCPs),
195202
applications examples, 202
chemical resistance and sterilization,
200202
joining and welding, 202
production, 199
properties, 199
Low-density polyethylene (LDPE),
8487, 88t, 91
Lubricious additives, 5758
Lytropic liquid crystalline polymers
(LCPs), 195197
302 INDEXM
Master Validation Plan (MVP), 284285
Material characterization, 33
Maximum dosage (Dmax), 3738
Mechanical fasteners, 5152
Mechanical methods of joining materials,
51
Medical device
Amendments of 1976, 9
applications of
copolyesters, 163t
polyamides, 169t
polyethylenes, 96t
polypropylene, 104t
polystyrenes, 113t
polysulfones, 180t
polyvinyl chloride (PVC), 85t
thermoplastic elastomers, 241t
thermosets and adhesives, 258t
definition, 3
manufacturers and suppliers, 279280
automated processes and software
validation, 292293
installation qualification (IQ),
288289
manual processes, 292
Master Validation Plan (MVP),
284285
operational qualification (OQ),
289290
performance qualification (PQ),
290291
process development and engineering
studies, 286288
processes that require validation,
282283
process validation and applicable
regulations and standards, 280
process validation overview,
283284
process validation planning and
master validation plan, 284286
process validation prerequisites, 286
process validation summary report,
291292
revalidation, 293294
validation life-cycle, 293
Validation Plan, 285286
verification, 280282
Melt condensation polymerization of
bisphenol A (BPA) polycarbonate,
130f
Melt process, 129
MEM Elution method, 46
Metal injection molding, 20
Metallocene catalysts, 8990, 91f, 98,
105
Metallocenes, 8990
Metals, 1920
Methacrylate acrylonitrile butadiene
styrene (MABS), 215218, 224t
Minimum dosage (Dmin), 3738
Miscible blends, 30
Murine local lymph node assay, 46
N
Nanoadditives, 6470
Nanoclays, nanosilicates, and nanotalcs,
6667
Nanocomposites, 68t
Nanometer scale, 65f
Nanosilver, 70
Nanotalcs, 6667
Nanotechnology, 64
Nitinol, 24
Nondisposables, 3
Nucleating agents particularly effective in
polypropylene, 99
Nylon 11, 164165
Nylon 12, 165166
Nylon 46, 164
Nylon 610, 164
Nylon 612, 164
Nylon 66 and nylon 6, 165
Nylon 69, 164
O
Operational qualification (OQ),
289290
Ophthalmic lenses, 137
Oriented polystyrene, 107
Original equipment manufacturers
(OEMs), 263
Overmolding, 234235
Oxidatively degradable plastic, 240
P
Parametric release, 34
Perfluoro alkoxy copolymer (PFA), 204t,
205t, 209t
Performance qualification (PQ), 290291
Photodegradable plastic, 240
Phthalates, 78, 91
Physical and mechanical properties of
polyethylenes, 89t
Physical properties of polyamides, 166t
Pigment performance requirements, 59t
Pigments, 5859
Plasticized polyvinychloride (PVC-P), 78t
Plasticizers, 56
Plastics resin and processing suppliers and
purchasing controls, 267268
Poly(3-hydroxybutyrate) (P3HB),
245247, 247t
Poly(4-hydroxybutyrate) (P4HB), 245,
247t
Poly(hydroxybutyrate-cohydroxyvalerate)
(PHB-co-HV), 249
Poly(lactide-co-glycolide) (PLGA), 244,
247t
Polyacetals, 146150
applications, 150
chemical resistance, 147150
joining and welding, 150
or polyoxymethylenes, 146
production and properties, 147
sterilization, 150
Polyamide
applications, 167171
biocompatibility, 167
chemical resistance, 166
joining and welding, 167
nomenclature, 164f
production, 162166
sterilization, 167
thermoplastic elastomers, 230
Polyamide 6 (Nylon 6), 162, 164166
Polyamide 66 (Nylon 66), 164
Polyamide-imides (PAIs), 186187
applications, 186187
chemical resistance and sterilization,
186
joining and welding, 186
production, 186
properties, 186
Polyaryletherketones
applications, 195
biocompatibility, 193194
chemical resistance, 192
joining and welding, 194
production, 190191
properties, 192
sterilization, 193
Polybutylene terephthalate (PBT),
151156
and polyethylene terephthalate (PET),
150
Polycaprolactone (PCL), 244, 246, 247t
Polycarbonate (PC)/acrylonitrilebutadiene-styrene (PC/ABS), 137
Polycarbonate blends, 137139
applications, 139
joining, 137139
Polycarbonate copolymers, 130
Polycarbonate-ABS (acrylonitrile
butadiene styrene), 137
Polycarbonate-polyester blends, 137
Polycarbonates, 126139
applications, 136137
biocompatibility, 133135
chemical resistance, 130131
joining and welding, 135136
production, 128130
sterilization, 131133
urethanes, 141
Polychlorotrifluoro ethylene (PCTFE),
204t, 205t, 206207, 209t
INDEX 303Polycyclohexylene dimethylene
terephthalate, 157
Polycyclohexylene dimethylene
terephthalate acid (PCTA),
157160
Polycyclohexylene dimethylene
terephthalate glycol (PCTG),
157160
Polydimethylsiloxanes, 222
Polyesters, 150157
applications, 157
biocompatibility, 156157
chemical resistance, 156
joining, 157
production and properties, 151156
properties, 156t
sterilization, 156
urethanes, 141
Polyether ether ketone (PEEK), 189195
Polyether sulfones (PESs), 175176
Polyetherimides (PEIs), 182183
applications, 186
biocompatibility, 184
chemical resistance, 183
joining and welding, 184185
sterilization, 183184
Polyethylene, 8495
applications, 95
biocompatibility, 95
chemical resistance, 9192
during gamma radiation, 93f
joining and welding, 95
manufacture, 8790
sterilization, 9294
Polyethylene terephthalate (PET),
151156
Polyethylene terephthalate glycol (PETG),
157160
Polyglycolic acid or polyglycolide (PGA),
244, 247, 247t
Polyhydroxybutyrate (PHB), 244245
Polyimides, 181186
production, 182183
properties, 183
Polylactic acid (PLA), 244245, 247t
fibers, 246
films, 246
polymers, 244
Polylactide (PLA), 244245
Poly-L-lactide (PLLA), 240243, 246,
247t
Polymers, 27
acronyms, 295t
additives, 55
alloys, 30
blends and alloys, 30
sterilization of, 299t
Polymethyl methacrylate (PMMA), 121
Polyphenyl sulfones (PPSUs), 175
and polyether sulfones (PESs), 176
Polyphenylene sulfide (PPS), 187189
applications, 189
chemical resistance, 187188
joining and welding, 189
medical device applications, 187t
production and properties, 187
sterilization, 188189
Polypropylene, 95103
applications, 102103
biocompatibility, 101
joining and welding, 101102
manufacture, 9598
properties, 9899
stabilizing, 100101
Polystyrene (PS), 107117
applications, 112117, 113t
biocompatibility, 112
chemical resistance, 110
joining and welding, 112
manufacture, 108110
properties, 110
sterilization, 111112
Polysulfones, 174181
applications, 181
biocompatibility, 177179
chemical resistance, 176
joining and welding, 179180
production, 175
properties, 176
sterilization, 176177
Polytetrafluoroethylene (PTFE), 204t,
205f, 206207, 209t
Polyurethanes, 139146, 141f
applicationsexamples, 144146
biocompatibility, 143144
chemical resistance, 142
joining and welding, 144
production and properties, 141142
sterilization, 142143
Polyvinyl chloride (PVC), 7384
additives, 7578
biocompatibility, 82
blends, 83
chemical resistance, 7880
degradation, 80
joining and welding, 8283
manufacture, 7475
in medical device applications, 7374,
8384
medical extrusion compounds, 84t
medical molding compounds, 84t
plasticized (PVC-P), 78t
properties, 78
stabilization, 75
sterilization, 8082
unplasticized (PVC-U), 7880, 78t
Polyvinylidene difluoride (PVDF), 204t,
205t, 206207, 209t
Process validation, 279280
life-cycle, 293
Master Validation Plan (MVP),
284285
overview, 283284
planning, 284286
prerequisites, 286
revalidation, 293294
summary report, 291292
Processes that require validation,
282283
Product, 272
Production of polyesters, 155f
Production of poly-L-lactic acid (PLLA),
244245, 244f
Production of various copolyesters, 158
Properties and applications of polyvinyl
chloride (PVC) blends, 84t
Properties of liquid crystalline polymers,
199200
Properties of polyetherimides, 183t
Properties of polyphenylene sulfide, 192
Properties of polysulfones, 174t
Properties of silicone fluids, 229t
Properties of some thermoplastic
elastomers, 235t
Properties of typical polyurethanes, 144t
Properties of unfilled and reinforced
polyamide-imides, 189t
Property comparison of various adhesives,
257f
Pyrogens, 33
Q
(Q10) factor, 51
R
Radiopaque additives, 5960
Radiopaque materials, 80t
Requirements for plastics used in medical
devices, 33
Restriction of hazardous substances
(RoHS), 151156
Revalidation, 293294
Rigid polyurethanes, 142
Ring opening polymerization, 105
S
Safe Medical Device Act, 910
Semicrystalline (or crystalline) polymers,
27
Senate bill SR 510, 9
Sensitization, 46
Service, 272
Sheet molding compounds (SMC), 254,
257260
Shelf life, 5051
Silicone, 5758, 222230, 236t
biocompatibility, 229230
chemical resistance, 228
elastomers, 229t
fluids, 226227
304 INDEXjoining and welding, 230
medical device applications, 231t
production, 223224
properties, 224227
sterilization, 228229
Software validation, 292293
Solvent bonding, 5253
South America, 16
Spin welding, 52
Spinal implants, 193
Stabilizers, 39, 70
Stainless steels, 19
Standard polysulfones (PSUs), 175176
Steam and autoclave sterilization
capability of polysulfones, 177f
Steam sterilization, 3436
Steam sterilization capability of
polyetherimides, 185f
Sterility assurance level, 34
Sterilization, 3340
of biopolymers, 248250
capabilities of styrenics, 221t
capability of polyvinyl chloride (PVC),
80t
of high-temperature engineering
thermoplastics, 176t
matrix, 42t
of polyamides, 167
of polyesters, 156
of polymers, 299t
resistance, of acetals, 152t
resistance, of polycarbonates, 133t
of thermoplastic elastomers, 237t
of thermoplastic polyurethane
elastomer, 238f
Styrene acrylonitrile (SAN), 215218,
224t
Styrene butadiene styrene (SBS), 230
Styrene-butadiene copolymers (SBCs),
218219, 224t
production, 215217
Styrene-ethylene-butylene-styrene
(SEBS), 230
Styrenic thermoplastic elastomers, 230
Styrenics, 215222
biocompatibility, 220221
chemical resistance, 219220
joining and welding, 222
medical device applications, 225t
production, 215217
properties, 217219
sterilization, 220
Subchronic toxicity, 46
Supplier, 272
Supplier Corrective Action Report
(SCAR), 275
Surface properties of fluoropolymers, 205f
Surface resistivity, 63
Syndiotactic polypropylene, 95
Syndiotactic polystyrene, 108
T
Thermoplastic copolyester elastomer
(TPC), 233, 236t
Thermoplastic elastomers, 230240
applications, 240
biocompatibility, 237239
chemical resistance, 235237
joining and welding, 239240
production, 232234
properties, 234235
sterilization, 237t
Thermoplastic polyamide elastomer
(TPA), 233, 235t, 236t
Thermoplastic polyolefin elastomer
(TPO), 234, 235t, 236t
Thermoplastic polystyrene elastomers
(TPSs), 233234, 235t, 236t
Thermoplastic polyurethane elastomer
(TPU), 233, 235t, 236t
Thermoplastics, 4, 2527, 28t
Thermoset elastomer (TPE), 235t
range of hardness, 232f
Thermosets, 28, 28t, 252257
applications, 257
polyurethanes, 254
production, 252254
properties, 254257
silicone resins, 254
Thermotropic liquid crystalline polymers
(LCPs), 195197
Titanium, 19
Top-down approach, 65
Transparency of methacrylate acrylonitrile
butadiene styrene (MABS),
219f
Types of additives, 5556
U
Ultrahigh molecular weight polyethylene
(UHMWPE), 8487, 88t, 9293
Ultrasonic welding, 52
Ultraviolet (UV)- or light-curing
adhesives, 255
United States Pharmacopoeia (USP)
classification table, 47t
Class VI, 47
XXII, Part 88, 47
Unplasticized PVC (PVC-U), 7880, 78t
Urethane thermoplastic elastomers,
230
V
Validation Plan, 285286
Verification, 280282
Veterinary Medicine Master Files, 12
Vibration welding, 52
W
Waste electrical and electronic equipment
(WEEE) directive, 151156
Wear of ultrahigh molecular weight
polyethylene (UHMWPE),
93
Wear-resistant, 5758
Z
ZieglerNatta catalysts, 8889, 98
Zones of inhibition, 6162
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