medical packaging transition project progress report - dupont · components of dupont medical...

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

Medical Packaging Transition Project -

Progress Report September 2012 2

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



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.



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



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



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





Results show minimal differences

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



Product Stewardship

Cytotoxicity

Endotoxins

Skin irritation and sensitization

Bioburden

U.S. and European Pharmacopeia/Food contact



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).

Final U.S. FDA Transition Protocol Test Matrix



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



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



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



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



Phantom Protocol Test Matrix



Style

EO Coated 1073B

EO Uncoated 1073B

Gamma Coated 1073B

Gamma Uncoated 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


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



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



• Accelerated aging (1, 3, 5 years)



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



• Accelerated aging (1, 3, 5, 7, 10 years)

• Real-time aging (1, 3, 5, 10 years) Medical Packaging Transition Project -


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



Miscellaneous Data Generation – Preliminary Results



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


• U.S. FDA registered

SFDA–Jinan Quality Supervision and Inspection Center for

Medical Devices

• Selected for Transition Protocol material testing


• China’s State Food and Drug Administration (SFDA) authorized



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



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



36 Medical Packaging Transition Project -


37 Medical Packaging Transition Project -


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



A Note of Appreciation

Thank you for your business, your continued support and your

confidence in DuPont.



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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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