Medical Packaging Transition Project September 2012
Components of DuPont Medical Packaging Transition Project (MPTP) U.S. Food and Drug Administration (FDA) Transition Protocol Product Stewardship Phantom Protocol September 2012 2
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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 2012 4
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 2012 5
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 2012 6
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 2012 7
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 2012 8
Results show minimal differences September 2012 9
Results show minimal differences September 2012 10
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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 2012 17
Product Stewardship Cytotoxicity Endotoxins Skin irritation and sensitization Bioburden U.S. and European Pharmacopeia/Food contact September 2012 18
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 177.1520 Meets Test Requirements ISO 10993-18: 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 2012 19
Final U.S. FDA Transition Protocol Test Matrix Style Pouches/Header Bags Form-Fill-Seal Rigid Trays EO Coated 1073B 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 EO Uncoated 1073B 22 23 24 25 26 27 Gamma Coated 1073B 28 29 30 31 32 33 34 35 36 37 38 39 Gamma Uncoated 1073B 40 41 42 Electron-beam Coated 1073B 43 44 45 Electron-beam Uncoated 1073B 46 47 48 EO Coated 1059B 49 50 51 EO Uncoated 1059B 52 53 54 55 56 57 58 59 60 ~ 50,000 Packages September 2012 20
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 2012 21
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 75 10 x 8 x 3 20 x 24 Sterilization methods EO Gamma Electron-beam September 2012 22
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 2012 23
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 2012 24
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 2012 25
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 75 10 x 9 x 4 22 x 24 Sterilization methods EO Gamma Electron-beam Steam Dry Heat? Low-temperature H 2 O 2 September 2012 26
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 2012 27
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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 2012 30
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 2012 31
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 2012 32
Laboratories for MPTP Testing Nelson Laboratories Selected for U.S. FDA Transition Protocol Selected for Phantom Protocol Third-party accredited to ISO 17025 U.S. FDA registered NAMSA Selected for Phantom Protocol Third-party accredited to ISO 17025 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 17025 China s State Food and Drug Administration (SFDA) authorized September 2012 33
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 2012 34
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 2012 35
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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 2012 39
A Note of Appreciation Thank you for your business, your continued support and your confidence in DuPont. September 2012 40
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