Single Polymer HDPE Solution

Transcription

1 Single Polymer HDPE Solution March 8, 2012 Darrel Blocksom Director of Operations 0

2 AGENDA March 8 th 8:15 9:00 AM The Challenge HPRC Guidelines Single Polymer HDPE Solution Q&A 1

3 THE MEDICAL PACKAGING CHALLENGE Hospitals and medical facilities in the US produce more than 5.9 million tons of waste annually, with plastics representing a very large portion of this waste. However, due to a variety of factors, very little is recycled. 2

4 HEALTHCARE PLASTICS RECYCLING COUNCIL In response to this challenge, the Healthcare Plastics Recycling Council (HPRC) was formed. This private technical coalition of industry peers across healthcare, recycling and waste management industries exists to improve the recyclability of plastic products within healthcare. 3

5 HPRC DESIGN GUIDELINES As part of this effort, the HPRC developed a set of Design Guidelines for Optimal Hospital Plastics Recycling offering useful product and packaging design tips. The HPRC found that one of the biggest obstacles to recycling Sterile Barrier System (SBS) materials is that fact that they most often consist of more than one material, and hospital staff simply don t have the time or interest in separating lids and trays for recycling. Accordingly, the HPRC has tasked manufacturers with reducing or eliminating the use of multiple plastic types within one discrete healthcare product. 4

6 ENVIRONMENTAL IMPACTS OF PLASTICS There is less environmental impact utilizing recycled materials but they lack resin lot traceability. Therefore, TEQ recommends utilizing materials like virgin High-Density Polyethylene (HDPE) which the HPRC has identified as having less environmental impact than other virgin materials such as HIPS or PET. 5

7 THE HDPE RECYCLE STREAM Not only does HDPE have a lower environmental impact, but it is also the most often recycled plastic. HDPE is the most widely used resin for plastic bottles In the US, million pounds were recycled in 2009 a 4.9% increase over billion pounds were recycled worldwide in 2009 In addition to being recycled, HDPE is often down cycled into plastic lumber Every ton of recycled HDPE bottles has the greenhouse gas equivalent of about 4 barrels of oil 6

8 MATERIAL COMPARISON HDPE has also proven to be a cost effective option for medical packaging - with Resin Cost significantly below that for PETG, Part Cost well below that for PETG and HIPS and a Yield far greater than PETG or HIPS. Resin Cost Part Cost Yield HDPE PETG HIPS HDPE PETG HIPS HDPE PETG HIPS 7

9 MATERIAL CHARACTERISTICS Additionally, HDPE scores well on the physical characteristics of Impact Resistance, Tear Resistance, Chemical Resistance, Denestability, Temperature Resistance and Surface Uniformity - making it a durable solution as well. HDPE PET HIPS Impact Resistance High Medium Medium Tear Resistance High Medium Low Chemical Resistance High Medium Low Denestability Excellent Denest Denest Agent Required Fair Denest Sterilization Options ETO/E-beam/Gamma & Some Autoclave ETO/E-beam/Gamma ETO/E-beam/Gamma Temperature Resistance -60 to to to 185 Custom Color Better Good Best (lower cost) Tensile Strength Medium High High Sunlight Resistance Medium Medium Low 8

10 MATERIAL CHARACTERISTICS Additionally, HDPE scores well on the physical characteristics of Impact Resistance, Tear Resistance, Chemical Resistance, Denestability, Temperature Resistance and Surface Uniformity - making it a durable solution as well. HDPE PET HIPS Impact Resistance Tear Resistance Chemical Resistance Denestability Sterilization Options Temperature Resistance Custom Color Tensile Strength Sunlight Resistance 9

11 SINGLE POLYMER HDPE SOLUTION Of course, as with any material, HDPE does have some limitations. Specifically, depending on the manufacturer, HDPE does not always fair well when it comes to dimensional stability, clarity or formability. HDPE PET HIPS Dimensional Stability High Shrink High Medium Clarity Contact Clarity Excellent Opaque/ Limited Contact Clarity Formability Difficult Well Established Process Easy 10

12 SINGLE POLYMER HDPE SOLUTION Seeing the potential of HDPE as a viable solution for sterile barrier systems, TEQ worked with its suppliers to develop a better HDPE blend/ tray to combat these known issues. The result was a material with: Better clarity over conventional HDPE for improved product visibility and seal inspection Better processing and dimensional control 11

13 HPRC IMPACT ON THERMOFORMING Used in combination with adhesive coated TYVEK HDPE, the most widely used lid material, we can provide: A mono-polymer sterile barrier system (SBS) No need to dissemble lid from tray for recycling Lidding stock adhesive, while not HDPE based, that is negligible in recycling A cost effective, durable medical packaging solution in alignment with the HPRC Design Guidelines 12

14 HDPE STABILITY DATA While our single polymer HDPE solution is very strong, changing SBS thermoformed tray materials usually necessitates the execution of a stability study to demonstrate the maintenance of strength and integrity over time. SBS Stability Studies can present a major roadblock to changing MDM s in term of time and cost For this reason, TEQ has decided to be proactive, by conducting stability studies with 3 adhesives and 3 sterilization materials (ETO, gamma, and E-Beam) to help customers meet the requirements of ISO I:2006 for Stability Testing 13

15 REQUIREMENTS FOR STABILITY TESTING While ISO :2006 requires that stability testing demonstrate that the SBS maintains integrity over time, the source of the aging data does not have to be the MDM. When it is demonstrated that the device does not interact with the SBS materials over time, previously documented data for stability testing shall be sufficient to be in accordance with Clause of :2006 In other words, if you know that the device and packaging materials do not interact a part of the material selection process, the source of the aging data does not have to be the MDM Therefore, SBS materials suppliers can provide stability data 14

16 HDPE STABILITY STUDY: TESTS Tests conducted on the SBS tray / lid samples: Visual Integrity Examination of the SBS seals per ASTM International F1886 / F1886M-09 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection Integrity test on the SBS seals per ASTM International F (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and Committee F02 WK23814 Seal Tensile Strength per ASTM International F88 / F88M-10 Standard Test Method for Seal Strength of Flexible Barrier Materials 15

17 HDPE STABILITY STUDY: TESTS Tests conducted on the flat sheets of HDPE: Tensile strength per ASTM International D 882 Test Method of Tensile Properties of Thin Plastic Sheeting Elongation per ASTM International D 882 Test Method of Tensile Properties of Thin Plastic Sheeting Modulus of Elasticity per ASTM International D Test Method of Tensile Properties of Thin Plastic Sheeting Puncture per ASTM International D Standard Test Method for High Speed Puncture Properties of Plastics Using Load and Displacement Sensors Impact Resistance per ASTM D Standard Test Method for Impact Resistance of Flat, Rigid Plastic Specimen by Means of a Striker Impacted by a Falling Weight (Gardner Impact) 16

18 HDPE STABILITY STUDY: REPORTING At the conclusion of the stability testing and post aging sample evaluation will be available to customers using TEQ s single polymer HDPE trays. Rationale for the HDPE stability testing project based on the requirements of ISO :2006 Description of the SBS materials and configurations tested Listing of the tests conducted on the samples Test data for each configuration at each test interval Biocompatibility data on the materials used in the study Summary which provides an analysis of the test data and a conclusion regarding the stability attributes for each SBS configuration and the SBS materials The report can be used to provide support for regulatory submissions and to demonstrate compliance with ISO :2006 Data for Tyvek is readily available on the Dupont website 17

19 CONCLUSION TEQ s Single Polymer HDPE Solution can offer: A cost effective, mono polymer durable medical packaging solution in alignment with the HPRC Design Guidelines Stability data eliminating costly, time-consuming studies typically necessary to be in compliance with the stability requirements of ISO :

20 QUESTIONS? 19

21 THANK YOU! 20