Plastics in Medical Devices – Properties, Requirements, and Applications

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, 9
    10
    A
    Accelerated Aging Tests, 51
    Acronyms, 295t
    Acrylate styrene acrylonitrile (ASA),
    215
    218, 224t
    Acrylic multipolymers, 122, 123t,
    125
    126
    Acrylics, 121
    126
    applications, 125
    126
    biocompatibility, 125
    chemical resistance, 122
    123
    production and properties, 121
    122
    sterilization, 123
    125
    welding and joining, 125
    Acrylonitrile butadiene styrene (ABS),
    215
    218, 224t
    Acute system toxicity, 46
    Adhesive bonding, 53
    Adhesives, 257
    260
    Advantages of plastics, 21
    Agar diffusion test, 46
    Aging, 50
    51
    American Society for Testing and
    Materials (ASTM)
    ASTM 1428 (pink stain test), 61
    62
    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, 60
    63
    Antioxidants, 70
    Antistatic additives, 63
    64
    Arrhenius Reaction Rate theory, 51
    Atactic polypropylene, 95
    Australia, 15
    16
    Autoclaving, 35t
    B
    Barium sulfate, 60
    Bioburden, 33
    Biocompatibility, 45
    47
    Biodegradable biopolymers, 240
    Biodegradable plastic, 240
    Biodegradation, 47
    Biodegradation of biopolymers,
    251
    252
    Biological indicators, 34
    Biologics master files, 12
    Biomaterials Access Assurance Act
    
    BAAA (HR 872), 16
    17
    Biopolymers, 240
    252
    applications, 252
    biocompatibility, 251
    252
    chemical resistance, 248
    joining and welding, 252
    production, 244
    246
    properties, 246
    248
    sterilization, 248
    250
    Bioresorbable biopolymers, 240
    Biostability of polyurethanes, 143
    144
    Bisphenol A (BPA) polycarbonate, 128,
    134
    135
    Bleaches, 40
    43
    Bottom-up approach, 65
    Bulk molding compounds (BMC),
    254
    257
    C
    Carbon nanotubes, 67
    69
    Carcinogenesis, 46
    CE (Conformite´ Europe´ene) mark, 14
    CE (Conformite´ Europe´ene) marking,
    13
    14
    Ceramics, 20
    21
    Chain scission, 38
    Chemical resistance, 40
    45, 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), 78
    80
    of styrenics, 219
    220
    of thermoplastic elastomers, 237t
    China, 15
    Closed patch test, 46
    Coefficient of friction, 57
    58
    Color additive, 58
    Commodity thermoplastics, 4, 73
    Commodity thermoplastics suppliers, 117
    Conductive additives, 64
    Conductive fillers, 63
    64
    Conductivity spectrum, 63, 63f
    Contract manufacturers and suppliers, 263
    Copolyester thermoplastic elastomers, 230
    Copolyesters, 157
    161
    applications, 161
    biocompatibility, 160
    chemical resistance, 158
    160
    joining and welding, 160
    161
    production and properties, 158
    sterilization, 160
    Copolymers, 29
    30
    Crystal polystyrene, 107
    Crystalline, 27t
    Cyanoacrylates, 255
    Cyclo olefin copolymers, 103
    107
    biocompatibility, 106
    chemical resistance, 106, 107t
    joining and welding, 106
    107
    301Cyclo olefin copolymers (Continued)
    manufacture, 105
    medical applications, 108t
    properties, 105
    106
    sterilization, 106
    Cytotoxicity, 45
    46
    D
    Degradable plastic, 240
    Degradation, 132
    133
    Detergents, 40
    43
    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, 45
    46
    Disadvantages of plastics, 24
    25
    Disinfectants, 40
    43
    Disposables, 3
    Drug Master File (DMF), 12
    Dry heat sterilization, 36
    E
    Elastomers, 28
    29
    Electron-beam (e-beam) radiation, 39
    40
    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), 36
    37
    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,
    13
    14
    Extractables, 43
    45
    F
    Families of plasticizers, 57t
    Families of thermosets, 252
    Fluorinated ethylene-propylene (FEP),
    204t, 205f, 209, 209t
    Fluoropolymers, 57
    58, 202
    209
    applications—examples, 209
    biocompatibility, 209
    chemical resistance, 207
    joining and welding, 209
    production, 204
    206
    properties, 206
    207
    sterilization, 207
    209
    Food and Drug Administration (FDA)
    FDA 21 CFR part 820, 10t
    FDA 21 CFR Part 820 Quality System
    Regulation, 268
    271
    FDA master files, 11
    12
    Food Master Files (FMF), 12
    G
    Gamma and e-beam radiation on
    polycaprolactone (PCL), 251f
    Gamma radiation, 37
    39
    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, 20
    21
    Global Harmonization Task Force
    (GHTF)
    guidance document, 280
    guidance document on inspection of
    purchasing controls, 276
    277
    guidance document on purchasing
    controls, 271
    276
    feedback and communication,
    275
    276
    finalization of controls, 275
    planning, 272
    274
    potential suppliers, selection of,
    274
    supplier evaluation and acceptance,
    274
    Good manufacturing practices (GMP)
    requirements for medical devices,
    9
    10
    Guinea Pig maximization test, 46
    H
    Hardnesses, 74f, 140
    141, 140f
    Heated tool or plate welding, 52
    Hemocompatibility, 46
    High frequency welding, 52
    High impact polystyrene, 107
    High-density polyethylene (HDPE),
    84
    90, 88t
    High-heat polycarbonates, 131f
    High-temperature thermoplastic,
    173
    174
    Homopolymers, 29
    30
    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), 288
    289
    Interfacial polymerization of bisphenol A
    (BPA) polycarbonate, 129f
    International Medical Device Regulators
    Forum (IMDRF), 280
    Intraocular lens, 125
    Irradiation, 37
    40
    Irritation tests, 46
    ISO 10993, 49
    50
    ISO 10993 standards, 47, 48t
    ISO 10993-1, ‘‘Guidance on selection of
    tests’’, 49
    ISO 10993-18, 33
    ISO 13485, 12
    14
    ISO 13485:1996, 9
    10
    ISO 13485:2003, 13t
    ISO 13485 Standard on Purchasing
    Controls, 268
    271
    Isotactic polypropylene, 95, 98
    J
    Japan, 14
    15
    JIS Z 2801/IBRG draft test protocol, 62
    JIS Z 2911/ISO 846 Part B—a fungistatic
    test, 61
    Joining and welding, 51
    53
    K
    Krebs cycle, 248
    K-values, 78
    of polyvinychloride-unplasticized
    (PVC-U), 79t
    L
    Laser marking, 59
    Laser welding, 52
    Leachables, 43
    45
    Linear low-density polyethylene, 84
    87,
    88t, 91
    Lipid resistance of polyetherimides, 185f
    Lipids, 40
    43
    Liquid crystalline polymers (LCPs),
    195
    202
    applications
    examples, 202
    chemical resistance and sterilization,
    200
    202
    joining and welding, 202
    production, 199
    properties, 199
    Low-density polyethylene (LDPE),
    84
    87, 88t, 91
    Lubricious additives, 57
    58
    Lytropic liquid crystalline polymers
    (LCPs), 195
    197
    302 INDEXM
    Master Validation Plan (MVP), 284
    285
    Material characterization, 33
    Maximum dosage (Dmax), 37
    38
    Mechanical fasteners, 51
    52
    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, 279
    280
    automated processes and software
    validation, 292
    293
    installation qualification (IQ),
    288
    289
    manual processes, 292
    Master Validation Plan (MVP),
    284
    285
    operational qualification (OQ),
    289
    290
    performance qualification (PQ),
    290
    291
    process development and engineering
    studies, 286
    288
    processes that require validation,
    282
    283
    process validation and applicable
    regulations and standards, 280
    process validation overview,
    283
    284
    process validation planning and
    master validation plan, 284
    286
    process validation prerequisites, 286
    process validation summary report,
    291
    292
    revalidation, 293
    294
    validation life-cycle, 293
    Validation Plan, 285
    286
    verification, 280
    282
    Melt condensation polymerization of
    bisphenol A (BPA) polycarbonate,
    130f
    Melt process, 129
    MEM Elution method, 46
    Metal injection molding, 20
    Metallocene catalysts, 89
    90, 91f, 98,
    105
    Metallocenes, 89
    90
    Metals, 19
    20
    Methacrylate acrylonitrile butadiene
    styrene (MABS), 215
    218, 224t
    Minimum dosage (Dmin), 37
    38
    Miscible blends, 30
    Murine local lymph node assay, 46
    N
    Nanoadditives, 64
    70
    Nanoclays, nanosilicates, and nanotalcs,
    66
    67
    Nanocomposites, 68t
    Nanometer scale, 65f
    Nanosilver, 70
    Nanotalcs, 66
    67
    Nanotechnology, 64
    Nitinol, 24
    Nondisposables, 3
    Nucleating agents particularly effective in
    polypropylene, 99
    Nylon 11, 164
    165
    Nylon 12, 165
    166
    Nylon 46, 164
    Nylon 610, 164
    Nylon 612, 164
    Nylon 66 and nylon 6, 165
    Nylon 69, 164
    O
    Operational qualification (OQ),
    289
    290
    Ophthalmic lenses, 137
    Oriented polystyrene, 107
    Original equipment manufacturers
    (OEMs), 263
    Overmolding, 234
    235
    Oxidatively degradable plastic, 240
    P
    Parametric release, 34
    Perfluoro alkoxy copolymer (PFA), 204t,
    205t, 209t
    Performance qualification (PQ), 290
    291
    Photodegradable plastic, 240
    Phthalates, 78, 91
    Physical and mechanical properties of
    polyethylenes, 89t
    Physical properties of polyamides, 166t
    Pigment performance requirements, 59t
    Pigments, 58
    59
    Plasticized polyvinychloride (PVC-P), 78t
    Plasticizers, 56
    Plastics resin and processing suppliers and
    purchasing controls, 267
    268
    Poly(3-hydroxybutyrate) (P3HB),
    245
    247, 247t
    Poly(4-hydroxybutyrate) (P4HB), 245,
    247t
    Poly(hydroxybutyrate-cohydroxyvalerate)
    (PHB-co-HV), 249
    Poly(lactide-co-glycolide) (PLGA), 244,
    247t
    Polyacetals, 146
    150
    applications, 150
    chemical resistance, 147
    150
    joining and welding, 150
    or polyoxymethylenes, 146
    production and properties, 147
    sterilization, 150
    Polyamide
    applications, 167
    171
    biocompatibility, 167
    chemical resistance, 166
    joining and welding, 167
    nomenclature, 164f
    production, 162
    166
    sterilization, 167
    thermoplastic elastomers, 230
    Polyamide 6 (Nylon 6), 162, 164
    166
    Polyamide 66 (Nylon 66), 164
    Polyamide-imides (PAIs), 186
    187
    applications, 186
    187
    chemical resistance and sterilization,
    186
    joining and welding, 186
    production, 186
    properties, 186
    Polyaryletherketones
    applications, 195
    biocompatibility, 193
    194
    chemical resistance, 192
    joining and welding, 194
    production, 190
    191
    properties, 192
    sterilization, 193
    Polybutylene terephthalate (PBT),
    151
    156
    and polyethylene terephthalate (PET),
    150
    Polycaprolactone (PCL), 244, 246, 247t
    Polycarbonate (PC)/acrylonitrilebutadiene-styrene (PC/ABS), 137
    Polycarbonate blends, 137
    139
    applications, 139
    joining, 137
    139
    Polycarbonate copolymers, 130
    Polycarbonate-ABS (acrylonitrile
    butadiene styrene), 137
    Polycarbonate-polyester blends, 137
    Polycarbonates, 126
    139
    applications, 136
    137
    biocompatibility, 133
    135
    chemical resistance, 130
    131
    joining and welding, 135
    136
    production, 128
    130
    sterilization, 131
    133
    urethanes, 141
    Polychlorotrifluoro ethylene (PCTFE),
    204t, 205t, 206
    207, 209t
    INDEX 303Polycyclohexylene dimethylene
    terephthalate, 157
    Polycyclohexylene dimethylene
    terephthalate acid (PCTA),
    157
    160
    Polycyclohexylene dimethylene
    terephthalate glycol (PCTG),
    157
    160
    Polydimethylsiloxanes, 222
    Polyesters, 150
    157
    applications, 157
    biocompatibility, 156
    157
    chemical resistance, 156
    joining, 157
    production and properties, 151
    156
    properties, 156t
    sterilization, 156
    urethanes, 141
    Polyether ether ketone (PEEK), 189
    195
    Polyether sulfones (PESs), 175
    176
    Polyetherimides (PEIs), 182
    183
    applications, 186
    biocompatibility, 184
    chemical resistance, 183
    joining and welding, 184
    185
    sterilization, 183
    184
    Polyethylene, 84
    95
    applications, 95
    biocompatibility, 95
    chemical resistance, 91
    92
    during gamma radiation, 93f
    joining and welding, 95
    manufacture, 87
    90
    sterilization, 92
    94
    Polyethylene terephthalate (PET),
    151
    156
    Polyethylene terephthalate glycol (PETG),
    157
    160
    Polyglycolic acid or polyglycolide (PGA),
    244, 247, 247t
    Polyhydroxybutyrate (PHB), 244
    245
    Polyimides, 181
    186
    production, 182
    183
    properties, 183
    Polylactic acid (PLA), 244
    245, 247t
    fibers, 246
    films, 246
    polymers, 244
    Polylactide (PLA), 244
    245
    Poly-L-lactide (PLLA), 240
    243, 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), 187
    189
    applications, 189
    chemical resistance, 187
    188
    joining and welding, 189
    medical device applications, 187t
    production and properties, 187
    sterilization, 188
    189
    Polypropylene, 95
    103
    applications, 102
    103
    biocompatibility, 101
    joining and welding, 101
    102
    manufacture, 95
    98
    properties, 98
    99
    stabilizing, 100
    101
    Polystyrene (PS), 107
    117
    applications, 112
    117, 113t
    biocompatibility, 112
    chemical resistance, 110
    joining and welding, 112
    manufacture, 108
    110
    properties, 110
    sterilization, 111
    112
    Polysulfones, 174
    181
    applications, 181
    biocompatibility, 177
    179
    chemical resistance, 176
    joining and welding, 179
    180
    production, 175
    properties, 176
    sterilization, 176
    177
    Polytetrafluoroethylene (PTFE), 204t,
    205f, 206
    207, 209t
    Polyurethanes, 139
    146, 141f
    applications
    examples, 144
    146
    biocompatibility, 143
    144
    chemical resistance, 142
    joining and welding, 144
    production and properties, 141
    142
    sterilization, 142
    143
    Polyvinyl chloride (PVC), 73
    84
    additives, 75
    78
    biocompatibility, 82
    blends, 83
    chemical resistance, 78
    80
    degradation, 80
    joining and welding, 82
    83
    manufacture, 74
    75
    in medical device applications, 73
    74,
    83
    84
    medical extrusion compounds, 84t
    medical molding compounds, 84t
    plasticized (PVC-P), 78t
    properties, 78
    stabilization, 75
    sterilization, 80
    82
    unplasticized (PVC-U), 78
    80, 78t
    Polyvinylidene difluoride (PVDF), 204t,
    205t, 206
    207, 209t
    Process validation, 279
    280
    life-cycle, 293
    Master Validation Plan (MVP),
    284
    285
    overview, 283
    284
    planning, 284
    286
    prerequisites, 286
    revalidation, 293
    294
    summary report, 291
    292
    Processes that require validation,
    282
    283
    Product, 272
    Production of polyesters, 155f
    Production of poly-L-lactic acid (PLLA),
    244
    245, 244f
    Production of various copolyesters, 158
    Properties and applications of polyvinyl
    chloride (PVC) blends, 84t
    Properties of liquid crystalline polymers,
    199
    200
    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, 59
    60
    Radiopaque materials, 80t
    Requirements for plastics used in medical
    devices, 33
    Restriction of hazardous substances
    (RoHS), 151
    156
    Revalidation, 293
    294
    Rigid polyurethanes, 142
    Ring opening polymerization, 105
    S
    Safe Medical Device Act, 9
    10
    Semicrystalline (or crystalline) polymers,
    27
    Senate bill SR 510, 9
    Sensitization, 46
    Service, 272
    Sheet molding compounds (SMC), 254,
    257
    260
    Shelf life, 50
    51
    Silicone, 57
    58, 222
    230, 236t
    biocompatibility, 229
    230
    chemical resistance, 228
    elastomers, 229t
    fluids, 226
    227
    304 INDEXjoining and welding, 230
    medical device applications, 231t
    production, 223
    224
    properties, 224
    227
    sterilization, 228
    229
    Software validation, 292
    293
    Solvent bonding, 52
    53
    South America, 16
    Spin welding, 52
    Spinal implants, 193
    Stabilizers, 39, 70
    Stainless steels, 19
    Standard polysulfones (PSUs), 175
    176
    Steam and autoclave sterilization
    capability of polysulfones, 177f
    Steam sterilization, 34
    36
    Steam sterilization capability of
    polyetherimides, 185f
    Sterility assurance level, 34
    Sterilization, 33
    40
    of biopolymers, 248
    250
    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), 215
    218,
    224t
    Styrene butadiene styrene (SBS), 230
    Styrene-butadiene copolymers (SBCs),
    218
    219, 224t
    production, 215
    217
    Styrene-ethylene-butylene-styrene
    (SEBS), 230
    Styrenic thermoplastic elastomers, 230
    Styrenics, 215
    222
    biocompatibility, 220
    221
    chemical resistance, 219
    220
    joining and welding, 222
    medical device applications, 225t
    production, 215
    217
    properties, 217
    219
    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, 230
    240
    applications, 240
    biocompatibility, 237
    239
    chemical resistance, 235
    237
    joining and welding, 239
    240
    production, 232
    234
    properties, 234
    235
    sterilization, 237t
    Thermoplastic polyamide elastomer
    (TPA), 233, 235t, 236t
    Thermoplastic polyolefin elastomer
    (TPO), 234, 235t, 236t
    Thermoplastic polystyrene elastomers
    (TPSs), 233
    234, 235t, 236t
    Thermoplastic polyurethane elastomer
    (TPU), 233, 235t, 236t
    Thermoplastics, 4, 25
    27, 28t
    Thermoset elastomer (TPE), 235t
    range of hardness, 232f
    Thermosets, 28, 28t, 252
    257
    applications, 257
    polyurethanes, 254
    production, 252
    254
    properties, 254
    257
    silicone resins, 254
    Thermotropic liquid crystalline polymers
    (LCPs), 195
    197
    Titanium, 19
    Top-down approach, 65
    Transparency of methacrylate acrylonitrile
    butadiene styrene (MABS),
    219f
    Types of additives, 55
    56
    U
    Ultrahigh molecular weight polyethylene
    (UHMWPE), 84
    87, 88t, 92
    93
    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), 78
    80, 78t
    Urethane thermoplastic elastomers,
    230
    V
    Validation Plan, 285
    286
    Verification, 280
    282
    Veterinary Medicine Master Files, 12
    Vibration welding, 52
    W
    Waste electrical and electronic equipment
    (WEEE) directive, 151
    156
    Wear of ultrahigh molecular weight
    polyethylene (UHMWPE),
    93
    Wear-resistant, 57
    58
    Z
    Ziegler
    Natta catalysts, 88
    89, 98
    Zones of inhibition, 61
    62

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