High Alcohol Barrier Films In Antiseptic Packaging


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High Alcohol Barrier Films In Antiseptic Packaging

  1. 1. TOPAS® COCHigh Barrier for Antiseptic Packaging Topas Advanced Polymers A member of Daicel/Polyplastics Group
  2. 2. Cyclic Olefin Copolymer (COC)A New Family of Thermoplastic Materials Olefinic Resin Amorphous, Clear and Colorless High Purity High Moisture Barrier Good Chemical Resistance Easy to Process
  3. 3. TOPAS® COC - Production Plant Production plant on stream since Oct 2000 30 000 tons / year production capacity Backward integrated in Norbornene Largest Cyclic Olefin Copolymer (COC) plant in the world Large scale production enables TOPAS Advanced Polymers to offer a product at competitive pricing
  4. 4. COC - Synthesis and StructureH2 C CH2 + Readily available raw Ethylene Cyclopentadiene Norbornene materials Highly efficient catalyst + H2 C CH2 Low usage Metallocene Catalysis Catalyst removed as part of process ( )( m ) n High purity product Amorphous Crystal clear COC
  5. 5. COC - Basic Properties Glass transition temperatures in [°C] Glass clear, Transparent 70 - 180 Modulus of elasticity in [N/mm2] High UV Transmission 2600 - 3200 Resistant to Alcohols, Acids, Tensile strength in [N/mm2] Bases, Polar Solvents 66 High Purity, Low Extractables Density in [g/cm3] 1.02 Low Water Transmission Rate (WVTR) Water uptake in [%] < 0.01 Biocompatible Water permeability in [g × mm/m2 × day] 0.02 - 0.04 Halogen-free
  6. 6. TOPAS® COC – Regulatory Status FDA Regulation 21 CFR 177.1520 (3.9) TOPAS® COC FDA Food Contact Notification (FCN #75) became effective August 22, 2000, covers films, sheets, and articles made therein from and molded articles for repeated use. TOPAS® COC FDA Food Contact Notification (FCN #405) became effective May 20, 2004, expands #75 to cover all applications, including bottles. FDA Drug Master File, DMF# 12132, established. FDA Device Master File, MAF# 1043, established. The monomers are listed in the EU-Directive 2002/72/EG Norbornene has a SML = 0.05 mg/kg. TOPAS® COC meets all major regulatory requirements for food contact and medical use
  7. 7. COC - Enhancement in ValueCustomized Performance Barrier WVTR – extended shelf life Special barrier (e.g. acetic acid, alcohol, aroma barrier, Iodine, moderate gas-barrier) Mechanical Properties Added stiffness – down-gauging Improved thermoforming Higher temperature resistance Controlled tear Better puncture resistance Seal Properties Low Tg COC can improve seal strength and hot tack
  8. 8. Typical Film Structures (mono/coex) COC Discrete Layer - Films COC monolayer-film laminated with PP, PVC, PAN (Barex®), PVDC, PCTFE, PE/EVOH for blister packaging COC multilayer-film co-extrusion PP / COC / PP blister packaging COC / PE-LLD / COC sleeves, twist wrap extrusion coating cardboard / (LDPE) / COC / LDPE _________ adhesion in co-extrusion • directly to PE-HD, PE-LLD, Plastomer, EVA, (PE-LD) • tie-layer needed for PP, PET, PA, EVOH, HDPE, (PE-LD) => individual cases to be checked
  9. 9. Typical Film Structures (blends) COC / Polyethylene Blend - Films PE-LD, PE-LLD, Plastomer, EVA Semi-compatible blends Increasing compatibility HDPE - LDPE - LLDPE - Plastomer Depending on... crystalline (density, refractive index) side chains, viscosity Typical blend mixes 5 - 30% PE in COC 5 - 30% COC in PE
  10. 10. COC – Market Segments Flexible Packaging Emerging Markets Films for shrink, twist-wrap, sealant, Non-wovens, foams, lidding, easy tear applications Rigid Film compoundsToner Binder Blister packaging forFull-color printers pharmaceutical, personaland copiers care, consumer applications Medical Optics Syringes, vials & Precision lenses, light guides & diagnostic devices optical films COC can substitute traditional products in different growth markets
  11. 11. COC - Chemical ResistancepH < 7 (acidic / aqueous) pH = 7 (neutral / aqueous) pH > 7 (basic / aqueous)hydrochloric acid 36 % Water + + sodium hydroxide 50 % +sulfuric acid 40 % Aqueous solution ammonia (aq. Sol.) 35 %nitric acid 65 % + of soap + +acetic acid > 94 % + saline solution + +Polar organic solvents Aromatic solvents Non-polar organic solventsethanol, methanol, Benzaldehyde Pentane, hexane, -butanol, isopropanol, + Toluene - heptane etc. (alkanes)(short chain alcohols) Benzene - Gasoline (petrol ether) -Acetone, butanone Chlorinated Solvents Norbornene - -(short chain ketones) + Other Oleic Acid - + resistant, increase of weight < 3% or loss of weight < 0,5%, elongation at break not substantially altered - limited resistance, increase of weight 3-8% or loss of weight 0,5-5%, elongation at break reduced by < 50% not resistant, increase of weight > 8% or loss of weight > 5%, elongation at break reduced by > 50% COC is resistant to acids, alcohols, bases and polar solvents
  12. 12. COC - Barrier Properties 10000 LDPE EVA/PE PCL PS 1000 HDPEOxygen Permeability [cm3/m2*d*bar] PVC BOPP PC PP plasticized Cellulose Acetate 100 COC PVC hard PET 10 Starch PEN PA 6 PAN 1 Cellulose PVDC 0,1 EVOH Film thickness: 100 µm LCP 0,01 0,01 0,1 1 10 100 1000 10000 Water Permeability [g/m2*d] COC can extend the shelf life of products due to its very high moisture barrier
  13. 13. Barrier Properties in PE/COC Blends* 7 6 Plastomer [g 100 µm / m² 24h] Water Permeation 5 38°C & 90% r.F. 4 3 LLDPE TOPAS® 8007 2 1 0 0 20 40 60 80 100 [Weight %] COC of Blend*Materials: LLDPE Dow 2035, Plastomer ExxonMobil 3125, TOPAS® 8007F-04
  14. 14. Moisture Barrier of COC WVTR Response to Temperature and Humidity [g 100 µm / m² 24h] g.100 microns / day 1 Water Permeation 2. m 0.1 25% RH 85% RH 0.01 3.61 3.559 3.509 3.46 3.413 3.378 3.333 3.289 3.247 3.215 3.175 1000 / T (kelvin) COC barrier exhibits the normal linear relationship when log transmission is plotted against the reciprocal of absolute temperature. Transmission increases linearly as humidity increases.Data generated by Pauly Permeation Laboratory, 8007F-04
  15. 15. Ethanol Barrier 23°C / saturated Etoh vapor* 5 4.44 4.5 [gg. 100 micron / (m² 2 Ethanol Permeation 4 100 µm / m² 24h] 3.5 3 2.5 2 1.5 1.01 1 0.5 0.124 0 TOPAS 8007 Exxon Mobil Dow 2045 LLDPE HDZ 222 HDPE COC has significantly reduced ethanol permeability as compared to other polyolefins*.* MOCON Test Labs
  16. 16. COC/PE Blends Isopropyl Alcohol Barrier COC / LLDPE-Blends 23°C / saturated IPA vapor* 3.5 g. 100 micron / (m² 24h) [g 100 µm / m² 24h] 3 2.88 2.5 IPA Permeation 2 1.5 1.33 1 0.5 0.2 0.14 0 0 20 40 60 80 100 Wt %wt % Topas 8007 TOPAS 8007 COC / LLDPE blends have significantly reduced IPA permeability as compared to pure LLDPE**.* MOCON Test Labs** Dow 2045
  17. 17. Isopropyl Alcohol Barrier Response to Temperature 10oC 23oC 40oC [g 100 µm / m² 24h] 10 9.2 IPA Permeation 1 1.94 0.52 0.48 0.14 0.1 0.01 0.00675 TOPAS 8007F-04 Dow 2045 LLDPE 0.001 3.53 3.378 3.13 1000 / T (kelvin) COC barrier exhibits the normal linear relationship when log transmission is plotted against the reciprocal of absolute temperature. IPA transmission at room temperature through COC is 14 times less than for LLDPE at 23oC.Data generated by MOCON, saturated vapor
  18. 18. COC/PE Blends Iodine Barrier COC / LLDPE-Blends** 40°C / 7% Tincture of Iodine, water accumulation 6 5.5 mg. 100 micron / (m² 24h) 5 [g 100 µm / m² 24h] Iodine Permeation 4 3 2 1 0.45 0 0.05 0 20 40 60 80 100 wt % Topas 8007 COC / LLDPE blends have significantly reduced Iodine permeability as compared to pure LLDPE*.• MOCON Test Labs** 1018CA LLDPE
  19. 19. Conclusions • COC functions well as a discrete layer combined with polyethylene or in blends. • COC functions as an effective barrier for common antiseptic solutions. At room temperature: – COC has ~5 times the water barrier of LLDPE – COC has ~36 times better ethyl alcohol barrier than LLDPE – COC has ~21 times better isopropyl alcohol barrier than LLDPE – COC has ~110 times better Iodine barrier than LLDPE • COC is in the FDA Drug master-file system
  20. 20. DisclaimerNOTICE TO USERS: To the best of our knowledge, the information contained in this publication is accurate, however we do not assumeany liability whatsoever for the accuracy and completeness of such information. The information contained in this publication should not beconstrued as a promise or guarantee of specific properties of our products. All technical information and services of Topas are intended foruse by persons having skill and experience in the use of such information or service, at their own risk.Further, the analysis techniques included in this publication are often simplifications and, therefore, approximate in nature. More vigorousanalysis techniques and prototype testing are strongly recommended to verify satisfactory part performance. Anyone intending to rely onany recommendation or to use any equipment, processing technique or material mentioned in this publication should satisfy themselvesthat they can meet all applicable safety and health standards.It is the sole responsibility of the users to investigate whether any existing patents are infringed by the use of the materials mentioned inthis publication.Properties molded parts, sheets and films can be influenced by a wide variety of factors including, but not limited to, material selection,additives, part design, processing conditions and environmental exposure. Any determination of the suitability of a particular material andpart design for any use contemplated by the user is the sole responsibility of the user. The user must verify that the material, assubsequently processed, meets the requirements of the particular product or use. The user is encouraged to test prototypes or samples ofthe product under the harshest conditions to be encountered to determine the suitability of the materials.Material data and values included in this publication are either based on testing of laboratory test specimens and represent data that fallwithin the normal range of properties for natural material or were extracted from various published sources. All are believed to berepresentative. These values alone do not represent a sufficient basis for any part design and are not intended for use in establishingmaximum, minimum, or ranges of values for specification purposes. Colorants or other additives may cause significant variations in datavalues.We strongly recommend that users seek and adhere to the manufacturer’s current instructions for handling each material they use, and toentrust the handling of such material to adequately trained personnel only. Please call Topas-hotline +49(0)180-5186727 or visitwww.topas.com for additional technical information and for the appropriate Safety Data Sheets before attempting to process our products.Moreover, there is a need to reduce human exposure to many materials to the lowest practical limits in view of possible adverse effects.To the extent that any hazards may have been mentioned in this publication, we neither suggest nor guarantee that such hazards are theonly ones that exist.The products mentioned herein are not intended for use in medical or dental implants.