HEALTHCARE SOLUTIONS TECHNICAL POLYMERS

HEALTHCARE SOLUTIONS TECHNICAL POLYMERS

FROM 2015 TO 2050 THE NUMBER OF PEOPLE OVER 80 YRS OLD WILL TRIPLE Society will need to accommodate this shift with new ways of providing medical care. Medical device manufacturers have a key role to play by developing innovative, more capable devices, making improved care accessible to an ever greater number of people. The world is becoming more extreme

CHALLENGES FOR HEALTHCARE APPLICATIONS & REQUIREMENTS RANGE OF SOLUTIONS

AN EVOLVING HEALTHCARE LANDSCAPE More Aggressive Chemical Interactions New Material Restrictions Advancement of Technology 4 HEALTHCARE SOLUTIONS

AN EVOLVING HEALTHCARE LANDSCAPE Equipment wiped down more frequently Preventing spread of infections More Aggressive Chemical Interactions Plastics being used in new applications 5 HEALTHCARE SOLUTIONS

AN EVOLVING HEALTHCARE LANDSCAPE BPA-free PVC-free Need for variety of compliant materials New Material Restrictions 6 HEALTHCARE SOLUTIONS

AN EVOLVING HEALTHCARE LANDSCAPE Need smaller, more capable devices Need for more advanced materials e.g. wearable devices, foams Advancement of Technology 7 HEALTHCARE SOLUTIONS

CHALLENGES FOR HEALTHCARE APPLICATIONS & REQUIREMENTS RANGE OF SOLUTIONS

A VARIETY OF APPLICATIONS WITH UNIQUE REQUIREMENTS Catheters Bags Masks Garments Drug Delivery, Instruments, & Equipment 9 HEALTHCARE SOLUTIONS

BRIEF ON: CATHETERS Catheters R E Q U I R E S Low hysteresis (torque transfer) Chemical resistance Burst resistance 10 HEALTHCARE SOLUTIONS

BRIEF ON: BAGS Bags R E Q U I R E S Chemical resistance Flexibility Easy processing 11 HEALTHCARE SOLUTIONS

BRIEF ON: MASKS Masks R E Q U I R E S Transparency Flexibility, Comfort Chemical resistance 12 HEALTHCARE SOLUTIONS

BRIEF ON: DRUG DELIVERY, INSTRUMENTS, & EQUIPMENT Drug Delivery, Instruments, & Equipment R E Q U I R E S Chemical resistance Mechanical strength Sterilization compatible 13 HEALTHCARE SOLUTIONS

BRIEF ON: GARMENTS Garments R E Q U I R E S Breathable Lightweight Tear resistance 14 HEALTHCARE SOLUTIONS

NEED A RANGE OF MATERIALS TO SUPPORT HEALTHCARE Catheters Bags Masks Drug Delivery, Instruments, & Equipment Garments 15 HEALTHCARE SOLUTIONS

CHALLENGES FOR HEALTHCARE APPLICATIONS & REQUIREMENTS RANGE OF SOLUTIONS

TECHNICAL POLYMERS HEALTHCARE SOLUTIONS Thermoplastic Elastomers Transparent Polyamides Polyamide 11 Polyamide 12 Polyvinylidene fluoride (PVDF) & flexible fluoropolymers 17 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS Lowest hysteresis among TPE s Chemical resistance Breathable Fatigue resistance Easy processing (higher yields) Kink resistance Lightweight Consistent performance at high and low temperature USP VI 18 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS A WIDE RANGE More flexible Flexibility modulus (MPa) More rigid 500 510 400 390 300 285 200 170 100 77 86 0 12 21 2533 3533 4033 4533 5533 6333 7033 7233 USP VI 19 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS A WIDE RANGE Styrenics Rubber TPO Pebax elastomers TPU Polyester elastomers Save time in material selection Rilsan polyamides Shore D 72D 70D 63D 55D 45D 35D 25D Shore A 90A 85A 75A 50A 10A USP VI 20 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS STERILIZABLE Sterilization by: Gamma (up to 10Mrads) ETO Steam (*55D and above) USP VI 21 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS LOW HYSTERESIS Energy Loss Factor (ELF) L o a d Theoretical ELF = 0 ELF = 0.4 0.5 ELF = 0.1-0.2 TPU (80 shore A) Pebax TPE (80 shore A) Elongation USP VI 22 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS LIGHTWEIGHT 1.4 Density (g/cm3) 1.3 1.2 1.1 1 0.9 0.8 0.7 Pebax TPE TPU COPE Soft grades Rigid grades USP VI 23 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS AT VARYING TEMPERATURE 0.5 Energy Loss Factor vs. Temperature 0.4 E L F 0.3 0.2 TPU (40D) 0.1 COPE (40D) Pebax TPE (40D) 0-20 0 20 40 60 Temperature C USP VI 24 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS AT VARYING TEMPERATURE 600 Modulus of rigidity (MPa) vs. Temperature (ASTM D 1043) 400 TPU COPE 200 Pebax TPE -40-20 0 20 40 60 80 Temperature C USP VI 25 HEALTHCARE SOLUTIONS

Impact Strength (kj/m 2 ) PEBAX MED ELASTOMERS AT VARYING TEMPERATURE Impact resistance ISO 179 (V-notched Charpy impact test) 30 No Break 20 10 0 23-30 Temperature (ºC) TPU 64 Shore D Pebax 6333 SA 01 MED USP VI 26 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS BREATHABLE Water droplets RH- Fabric Pebax monolithic membrane Hydrophilic group on polymer chain PEG grades (not PTMG) Fabric Water vapor molecules RH+ Pebax MV1074 SA01 MED: High MVTR Monolithic, non-porous, non-woven Good barrier to blood and other liquids Lightweight, low-noise One step extrusion lamination process USP VI 27 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS ANTISTATIC Surface Resistivity ( /square) Surface Resistance ( ) Geometric Factor (depends on electrode type) Represents ability of charges to move to the surface (dissipate) Surface Resistivity Conductivity Ability for charges to move USP VI 28 HEALTHCARE SOLUTIONS

Surface Resistivity ( /sq) PEBAX MED ELASTOMERS ANTISTATIC 10 6 10 10 10 14 Conductive Static Dissipative Antistatic Insulative 1,E+16 1,E+14 1,E+12 1,E+10 1,E+08 0 ABS + Chemical Agent ABS + Pebax MV1074 1 2 3 4 5 6 7 8 9 10 Pebax additive Forms 3D network in the matrix Does NOT migrate to surface Produces immediate & permanent antistatic effect Maintains antistatic effect at high/low humidity Is much less sensitive to humidity than chemical agents (agents can be very inefficient) *Compatible additive for a wide variety of polymer matrices Time (months) USP VI 29 HEALTHCARE SOLUTIONS

PEBAX MED ELASTOMERS COMMON APPLICATIONS Catheters PVC-Free Tubing Films & Others Angioplasty Intravenous Gowns & caps Balloon Peristaltic pump Trans-dermal patches Stent-delivery Multi-lumen Monofilament, floss, brushes 30 HEALTHCARE SOLUTIONS

TECHNICAL POLYMERS HEALTHCARE SOLUTIONS Thermoplastic Elastomers Transparent Polyamides Polyamide 11 Polyamide 12 Polyvinylidene fluoride (PVDF) & flexible fluoropolymers 31 HEALTHCARE SOLUTIONS

RILSAN CLEAR POLYAMIDES Transparent Chemical resistance Bio-based (most grades) & BPA-free Lightweight Re-grind recyclable Flexible Fatigue resistance Easy processing (higher yields) High temperature performance USP VI 32 HEALTHCARE SOLUTIONS

RILSAN CLEAR POLYAMIDES LIGHTWEIGHT Density (g/cm 3 ) 1.3 1.2 1.19 1.24 1.1 1 1.01 1.05 1.09 0.9 0.8 0.7 G850 MED G170 MED PMMA PC PSU USP VI 33 HEALTHCARE SOLUTIONS

RILSAN CLEAR POLYAMIDES TRANSPARENCY Transmittance (%) 94 92 90 90 90.8 91.5 92 88 88 86 85 84 82 80 PSU PC Glass G170 MED G850 MED PMMA USP VI 34 HEALTHCARE SOLUTIONS

RILSAN CLEAR POLYAMIDES FLEXIBILITY Flexural Modulus (MPa) 3500 3000 2690 2900 2500 2000 1500 1600 1980 2250 1000 500 0 G850 Rnew MED G170 MED PC PSU PMMA USP VI 35 HEALTHCARE SOLUTIONS

RILSAN CLEAR POLYAMIDES IMPACT STRENGTH Charpy Impact (kj/m 2 ) 25 20 NO BREAK 15 10 11 13 13 9 5 0 Notched 23ºC Notched -30ºC Unnotched 23ºC Unnotched - 30ºC G850 Rnew MED G170 MED USP VI 36 HEALTHCARE SOLUTIONS

RILSAN CLEAR POLYAMIDES CHEMICAL RESISTANCE Chemicals: G850 Rnew MED G170 MED Ethanol p Isopropanol p Acetone Premium Gasoline (60ºC) Diesel fuel 60ºC ASTM reference oil 3 (IRM 903) 23ºC ASTM reference oil 3 (IRM 903) 90ºC Ethanol fuel E85 (23ºC) p Ethanol fuel E85 (60ºC) p p p Not resistant: might be used for just short exposure Limited resistance: changes in weight or dimensions after long periods, transparency drop Resistant: very little change in weight or dimensions, no influence on transparency Resistant: no change in weight or dimensions, no influence on transparency USP VI 37 HEALTHCARE SOLUTIONS

RILSAN CLEAR POLYAMIDES PROCESSING Wide injection molding window T m = 250-300ºC No oxidation after 2hr injection @ 290ºC Improved flow Fewer bubbles Shorter cycle times USP VI 38 HEALTHCARE SOLUTIONS

TECHNICAL POLYMERS HEALTHCARE SOLUTIONS Thermoplastic Elastomers Transparent Polyamides Polyamide 11 Polyamide 12 Polyvinylidene fluoride (PVDF) & flexible fluoropolymers 39 HEALTHCARE SOLUTIONS

RILSAN PA11 & RILSAMID PA12 Chemical resistance Dimensional stability Bio-based (PA11), BPA-free High temperature performance Sterilizable Gamma, ETO, Steam Lightweight Easy processing (higher yields) Abrasion resistant low friction Flexible USP VI 40 HEALTHCARE SOLUTIONS

POLYAMIDE PERFORMANCE PYRAMID PA11 Long-Chain Chemical resistance Low moisture absorption Lower density Better flexibility PA12 PA10.10 PA6.12 PA6.10 PA6.6 PA6 Short-Chain Barrier to fuels Thermal resistance Non-renewable resources Renewable resources 41 HEALTHCARE SOLUTIONS

TECHNICAL POSITIONING 1.16 1.14 1.12 1.1 1.08 1.06 1.04 1.02 1.13 1.14 1.08 Density (g/cm 3 ) 1.06 1.04 1.03 1.02 1.03 121 101 81 61 41 21 Renewable carbon (%) 100 62 45 100 1 PA6 PA6.6 PA6.10 PA6.12 PA10.10 PA10.12 PA12 PA11 1 PA6 PA6.6 PA6.10 PA6.12 PA10.10 PA10.12 PA12 PA11 10 9 8 9 8 Water absorption (14 days @ 23ºC) 7 6 5 4 3 2 3.3 3 2.1 2.15 1.6 1.9 1 PA6 PA6.6 PA6.10 PA6.12 PA10.10 PA10.12 PA12 PA11 42 HEALTHCARE SOLUTIONS

TECHNICAL POLYMERS HEALTHCARE SOLUTIONS Thermoplastic Elastomers Transparent Polyamides Polyamide 11 Polyamide 12 Polyvinylidene fluoride (PVDF) & flexible fluoropolymers 43 HEALTHCARE SOLUTIONS