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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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أخواني في الله أحضرت لكم كتاب 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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