Medical Packaging Transition Project
Progress Report
September 2012
Components of DuPont
Medical Packaging Transition Project (MPTP)
U.S. Food and Drug Administration (FDA) Transition Protocol
Product Stewardship
Phantom Protocol
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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
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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.
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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
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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
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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
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Results show minimal differences
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Results show minimal differences
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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
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Product Stewardship
Cytotoxicity
Endotoxins
Skin irritation and sensitization
Bioburden
U.S. and European Pharmacopeia/Food contact
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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
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Testing results include Pre-Sterilization, EO (2X), Gamma (50 kGy),
Electron-beam (50 kGy), and Steam (127ºC for 30 minutes).
Final U.S. FDA Transition Protocol Test Matrix
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Style
EO Coated 1073B 1 2 3 4 5 6 7 8 9 10 11 12
EO Uncoated 1073B 22 23 24 25 26 27
Gamma Coated 1073B
Gamma Uncoated 1073B
Electron-beam Coated 1073B
Electron-beam Uncoated 1073B
EO Coated 1059B
EO Uncoated 1059B 52 53 54 55 56 57
~ 50,000 Packages
20 21
34 35 36 37 38 39
15 16 17 18 19
58 59 60
13 14
33
43 44 45
49 50 51
Pouches/Header Bags Form-Fill-Seal Rigid Trays
40 41 42
28 29 30
46 47 48
31 32
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
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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
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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
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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
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Phantom Protocol Test Matrix
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Style
EO Coated 1073B
EO Uncoated 1073B
Gamma Coated 1073B
Gamma Uncoated 1073B
Electron-beam Coated 1073B
Electron-beam Uncoated 1073B
Steam Coated 1073B X65 X67
Steam Uncoated 1073B X68? X70
Dry Heat Coated 1073B
Low Temp. H2O2 Coated 1073B
Gamma Coated 1059B
Electron-beam Coated 1059B
X63X62
Pouches/ Header
Bags
X61
Form-Fill-Seal
X75
Rigid Trays
X73
X69
x74
X72
X76
X64
X66
X77?
X71
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 H2O2
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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)
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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)
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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
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Miscellaneous Data Generation – Preliminary Results
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Dimensional shrinkage after steam sterilization (127ºC for 30 minutes)
Flexographic Printing – ACCEPTABLE
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%
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
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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
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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
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®
– Mullen burst
– Hydrostatic head
– Microbial barrier
– Tensile strength, MD/CD
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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
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A Note of Appreciation
Thank you for your business, your continued support and your
confidence in DuPont.
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Stay Informed, Sign Up for Timely Updates
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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.
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