Medical Packaging Transition Project Progress Report. September 2012

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1 Medical Packaging Transition Project September 2012

2 Components of DuPont Medical Packaging Transition Project (MPTP) U.S. Food and Drug Administration (FDA) Transition Protocol Product Stewardship Phantom Protocol September

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4 More than $30 Million DuPont Investment Raw materials for multiple line and polymer testing Developmental package creation and testing Transition Protocol package creation and testing Third-party laboratory testing Phantom Protocol Product Stewardship September

5 MPTP Developmental Work Collaborators Amcor Flexibles ATMI LifeSciences Beacon Converters, Inc. Bischof + Klein GmbH & Co. E-BEAM Services, Inc. Mangar Medical Packaging NAMSA Nelson Laboratories Nordion Oliver-Tolas Healthcare Packaging PeelMaster Packaging Corporation Perfecseal, Inc. Rollprint Packaging Products, Inc. September

6 MPTP Objective Demonstrate Functional Equivalence Functional equivalence means that the attribute you are measuring may be different, even statistically, but it still meets functional and performance requirements, so that it will perform similarly to current Tyvek in your process and applications September

7 Developmental Material Demonstrates Evidence of Functional Equivalence Specification and miscellaneous properties are trending toward target values Sealing fingerprints are virtually identical Initial response from Sterile Packaging Manufacturers (SPMs) and select Medical Device Manufacturers (MDMs) has been positive September

8 Key Technical Activities Completed as of September 2012 Developmental material feedback Product Stewardship testing defined U.S. FDA Transition Protocol test matrix modified to better reflect industry use of Tyvek Phantom Protocol defined and initiated MPTP cell matrices populated Independent testing laboratories chosen September

9 Results show minimal differences September

10 Results show minimal differences September

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17 Summary Functional Equivalence Specification and miscellaneous properties are trending toward target values Sealing fingerprints are virtually identical Initial response from SPMs and select MDMs has been positive We will use data and feedback to make minor product and process adjustments in creating Transition Protocol material September

18 Product Stewardship Cytotoxicity Endotoxins Skin irritation and sensitization Bioburden U.S. and European Pharmacopeia/Food contact September

19 Product Stewardship Preliminary 1073B Developmental Materials Results Cytotoxicity Meets Test Requirements Bioburden Meets Test Requirements U.S. and European Pharmacopeia/Food contact USP <661> Meets Test Requirements 21 CFR Meets Test Requirements ISO : IR No Major Bands of Interest ICP-MS No Trace Elements; Below Quantification Limits GC-MS No Semi-Volatile Compounds; Below Quantification Limits Testing results include Pre-Sterilization, EO (2X), Gamma (50 kgy), Electron-beam (50 kgy), and Steam (127ºC for 30 minutes). September

20 Final U.S. FDA Transition Protocol Test Matrix Style Pouches/Header Bags Form-Fill-Seal Rigid Trays EO Coated 1073B EO Uncoated 1073B Gamma Coated 1073B Gamma Uncoated 1073B Electron-beam Coated 1073B Electron-beam Uncoated 1073B EO Coated 1059B EO Uncoated 1059B ~ 50,000 Packages September

21 U.S. FDA Transition Protocol Cell Selection Process Two sources Recommendations by SPMs Self-nominations by MDMs Criteria for diversity Package configuration Geography Film and tray type Coating type and methodology Package size MDM size Device type Unique attributes September

22 U.S. FDA Transition Protocol Cell Selection Demographics 38 MDMs Asia Pacific Europe Latin America North America Package configurations 22 pouches and 5 vent/header bags 18 form-fill-seals 15 lids and trays Film and tray types PET, nylon, PE, PS, HIPS, EVA/Surlyn /EVA, and other films PETG, PS, PVC trays Coating methodologies Air knife Hot melt Package size extremes 1 x 4 8 x x 8 x 3 20 x 24 Sterilization methods EO Gamma Electron-beam September

23 Package Creation and Testing Qualified designs and validated processes Sealing conditions Upper Lower Nominal Test environments Pre-sterilization Post-sterilization Accelerated aging (1, 3, 5 years) Real-time aging (1, 3, 5 years) Package testing Visual inspection Package integrity Seal strength Microbial barrier Paired data set comparisons September

24 Phantom Protocol Additional cell matrix to meet expanded industry requirements Effect of sterilization and aging on mechanical and microbial barrier properties Additional sterilization methods Package testing beyond 5-year aging Accelerated aging (7, 10 years) Real-time aging (10 years) Miscellaneous data generation September

25 Phantom Protocol Test Matrix Style Pouches/ Header Bags Form-Fill-Seal Rigid Trays EO Coated 1073B x74 X75 X71 EO Uncoated 1073B X61 Gamma Coated 1073B X62 X63 Gamma Uncoated 1073B X64 Electron-beam Coated 1073B Electron-beam Uncoated 1073B Steam Coated 1073B X65 X66 X67 Steam Uncoated 1073B X68? X69 X70 Dry Heat Coated 1073B X77? Low Temp. H 2 O 2 Coated 1073B X76 Gamma Coated 1059B Electron-beam Coated 1059B X72 X73 September

26 Phantom Protocol Cell Selection Demographics ~10 additional MDMs Europe Latin America North America Package configurations 7 pouches 3 form-fill-seals ~7 lids and trays Film and tray types PET, nylon, autoclavable films and other types PETG, PS, PC trays Coating methodologies Air knife Hot melt Zone Package size extremes 2 x 4 8 x x 9 x 4 22 x 24 Sterilization methods EO Gamma Electron-beam Steam Dry Heat? Low-temperature H 2 O 2 September

27 Effects of Sterilization and Aging on Mechanical and Microbial Barrier Properties Developmental Materials Developmental 1073B and 1059B materials Represent the different manufacturing lines and polymers Control = Tyvek 1073B or Tyvek 1059B Sterilization EO (2X) Gamma (25 kgy, 50 kgy) Electron-beam (25 kgy, 50 kgy) Steam (127ºC for 30 minutes) Test Environments Pre-sterilization Post-sterilization Accelerated aging (1, 3, 5 years) September

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30 Effects of Sterilization and Aging on Mechanical and Microbial Barrier Properties Transition Protocol Materials Transition Protocol 1073B and 1059B materials Represent the different manufacturing lines and polymers Control = Tyvek 1073B or Tyvek 1059B Sterilization EO (2X) Gamma (25 kgy, 50 kgy, 100 kgy) Electron-beam (25 kgy, 50 kgy, 100 kgy) Steam (127ºC for 30 minutes) Low-temperature oxidation Test Environments Pre-sterilization Post-sterilization Accelerated aging (1, 3, 5, 7, 10 years) Real-time aging (1, 3, 5, 10 years) September

31 Miscellaneous Data Generation Requested additional testing under consideration includes Particle generation Chemical resistance (ISO 11607) Bubble leak testing Dimensional stability study Freeze/thaw/warm test DSC, FTIR Surface energy Dynamic/static coefficient of friction Bar code readability Low-intensity UV stability September

32 Miscellaneous Data Generation Preliminary Results Dimensional shrinkage after steam sterilization (127ºC for 30 minutes) MD CD Developmental 1073B Material 2.0% 1.6% Tyvek 1073B 2.2% 1.6% Developmental 1059B Material 2.3% 1.6% Tyvek 1059B 2.3% 1.5% Flexographic Printing ACCEPTABLE September

33 Laboratories for MPTP Testing Nelson Laboratories Selected for U.S. FDA Transition Protocol Selected for Phantom Protocol Third-party accredited to ISO U.S. FDA registered NAMSA Selected for Phantom Protocol Third-party accredited to ISO U.S. FDA registered SFDA Jinan Quality Supervision and Inspection Center for Medical Devices Selected for Transition Protocol material testing Third-party accredited to ISO China s State Food and Drug Administration (SFDA) authorized September

34 Key Regulatory Activities Completed as of September 2012 U.S. FDA Transition Protocol Amendments made and accepted by the Center for Devices and Radiological Health (CDRH) at the U.S. FDA Guidance letters for European compliance received from BSI Assurance UK Ltd SGS United Kingdom Limited TÜV Rheinland LGA Products GmbH TÜV SÜD Product Service GmbH Ministry of Health, Labour and Welfare (MHLW) enlisted the Japan Medical Devices Manufacturers Association (JMED) to work with DuPont to assess Transition Protocol materials and provide guidance for medical devices sold in the Japanese market September

35 Material Property Data Generation for SFDA Part 1: Interlaboratory study of current Tyvek 1073B and Tyvek 1059B materials to assess capabilities Tests conducted at two DuPont R&D facilities (Spruance in Richmond, Va., and DRDM in Shanghai, China) and at SFDA Jinan Tests included Basis weight Delamination Gurley Hill porosity Mullen burst Hydrostatic head Microbial barrier Tensile strength, MD/CD Part 2: SFDA Jinan will perform testing on Transition Protocol materials. Upon completion, SFDA Jinan will provide a report indicating that the Transition Protocol materials are functionally equivalent to current Tyvek September

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39 Looking Ahead to Commercialization Controlled sales of Transition Protocol materials to MDMs for internal testing or independent requalification will begin after Transition Protocol package creation Style names will not change Labeling will include specific identifiers to enable traceability Full commercial launch of Transition Protocol materials will begin after regulatory affirmation of functional equivalence September

40 A Note of Appreciation Thank you for your business, your continued support and your confidence in DuPont. September

41 Stay Informed, Sign Up for Timely Updates September

42 Copyright 2012 DuPont. All rights reserved. The DuPont Oval Logo, DuPont, The miracles of science, and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. September