Plastics in Medical Devices – Properties, Requirements, and Applications

Plastics in Medical Devices – Properties, Requirements, and Applications
اسم المؤلف
Vinny R. Sastri
التاريخ
12 أغسطس 2023
المشاهدات
322
التقييم
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Plastics in Medical Devices – Properties, Requirements, and Applications
Vinny R. Sastri
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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