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DuPont Submission to U.S. FDA Fast Approaching the Finish Line
May 21, 2015
Michael H. Scholla, Ph.D. Global Director, Regulatory and Standards; Medical Packaging Fellow
Karen Polkinghorne Packaging Engineer and MDM Specialist
Bruce A. Yost, Ph.D. Global Technical Director
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Presenters
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
A materials science company makes a manufacturing change, impacting a material used in a highly regulated industry.
How can this be accomplished without triggering a revalidation?
Challenge The
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Build a matrix of packages, of all shapes and sizes, material combinations & sterilization methods; demonstrate Functional Equivalence between
“Transition Protocol material” and “Current material”; work with regulatory bodies around the world;
the entire industry leverages the data…
Plan The
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Engage numerous global SPMs and MDMs, test labs and regulatory bodies; build packages; generate data;
demonstrate Functional Equivalence
Journey The
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Prove Functional Equivalence, not statistical equivalence, of
6 line/polymer combinations used in packaging applications for more
than 75,000 different end uses
Functional Equivalence
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Oct 18, 2012: We have completed our review of the documentation….we are in agreement
with the study design and testing proposed…. FDA will not routinely require Sponsors to
amend either their 510(k)s or PMAs
In addition, we have worked with regulatory entities from EU, Japan, China and Canada
U.S.FDA The
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Regulatory Report Submission Status as of May 2015
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Guidance from Intertek has been received and posted to our website
Japan minor change notification (Keibi Henko Todoke)
We intend to publish ISO 11607 compliance document for Transition Protocol material in June, which industry can reference for their submissions
We intend to publish two letters this summer: • The first at the end of May or early June to indicate all data through
1-year real-time aging is in and the results indicate Functional Equivalence. Be Ready
• The second in July to notify the industry that all reports, through 1-year real-time aging, have been submitted to the U.S. FDA, Health Canada and 5 other Notified Bodies
– Following this notification and submission, you can reference our regulatory report in your submissions to Notified Bodies
Regulatory News
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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After the U.S. FDA issues their guidance, MDMs should place letter(s) in their files before they begin using Transition Protocol material
MDMs should not submit information to Health Canada prior to
receiving the template from Health Canada
Amendments to 510(k)s, PMAs or Health Canada licences should only be made if the device is clearly outside the scope of the study or when using your own data
Helpful Hints
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Sterilization and Ethylene Oxide (EO) Residual Testing
The Gurley porosity and MVTR ranges are the same for Current and Transition Protocol materials Are the gases getting into the package during the gaseous
sterilization process?
Are the gases getting out of the package? EO residual testing was conducted on 27 cells exposed to EO sterilization; all valid test results met the acceptance criteria for EO residuals established by the MDM
MDMs who have questions or concerns regarding Transition Protocol material and EO residuals may choose to perform their own EO residual testing
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Requirements for
Interchangeability Allows MDMs to use either Current Tyvek® or
Transition Protocol material interchangeably, provided that:
1) MDM has considered this in their change control, risk management and regulatory submission processes
2) Specifications for the device package do not restrict the
use of Current Tyvek® or Transition Protocol material
3) There were no changes to the packaging or sterilization process conditions
4) Any required regulatory submissions for the transition are structured
and approved to allow both products to be used, if applicable
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Considerations Each company has its own change control and risk assessment
processes that must be conducted
DuPont is providing data and results summaries backed by extensive statistical analysis to determine Functional Equivalence
Each company must then decide:
1) How to use this information within your organization and processes 2) Whether interchangeability is acceptable in your process
3) What additional work must be performed by your company (Function of risk assumption at each company)
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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New Reference Library On Our Website
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Cell | noun | \’sel\: a validated, commercially available SBS,
produced using 3 lots of Transition Protocol material and 3 lots of Current material,
sealed at Upper, Lower & Nominal conditions, contains ~1200 to 1500 individual packages
Cell The
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
*Eleven cells designated for extended accelerated aging (7 and 10 years) and real-time aging (10 years).
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Pre-sterilization and Post-sterilization
Accelerated Aging (1 Year)
Accelerated Aging (3, 5 and 7 Years) and Real-time Aging (1 Year)
Accelerated Aging (3 Years)
Accelerated Aging (5 Years)
Real-time Aging (1 Year)
Accelerated Aging (7 and 10 Years)*
October 2014
February 2015
PARTIAL TODAY!
June 2015
July 2015
August 2015
2016
Timing
Publication of MPTP Test Results in Industry Summary Reports
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U.S. FDA Transition Protocol Test Matrix — Nelson Laboratories Testing Status (as of May 13, 2015)
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Phantom Protocol Test Matrix — Nelson Laboratories Testing Status (as of May 13, 2015)
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Industry Summary: MPTP Test Results after 1-Year Accelerated Aging, Pass/Fail Summary for Seal Strength* — ASTM F88
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Industry Summary: MPTP Interim Test Results (75/78 Cells) after 3-Year Accelerated Aging, Pass/Fail Summary for Seal Strength* — ASTM F88
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Industry Summary: MPTP Interim Test Results (63/78 Cells) after 5-Year Accelerated Aging, Pass/Fail Summary for Seal Strength* — ASTM F88
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Industry Summary: MPTP Interim Test Results (57/78 Cells) after 1-Year Real-Time Aging, Pass/Fail Summary for Seal Strength* — ASTM F88
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Industry Summary: MPTP Interim Test Results (4/11 Cells) after 7-Year Accelerated Aging, Pass/Fail Summary for Seal Strength — ASTM F88
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Publication error for Pre- and Post-Sterilization and 1-Year Accelerated Aging microbial barrier data in Industry Summary Reports
Discovered during generation of Regulatory Summary Reports
NO CHANGE IN FUNCTIONAL EQUIVALENCE
Conclusion? Transition Protocol material performance is even better
Publication Correction posted at www.areyouready.tyvek.com
Note on Industry Summary Reports
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Referred to as Transition material or Tyvek® Transition Protocol material
Tremendous amount of data available for Tyvek® sheet material
Material
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The
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Effects of sterilization and 5-year accelerated aging and 1-year real-time aging on: – material puncture strength
– material tensile strength – material microbial barrier (ASTM F2638)
Effects of sterilization and 5-year accelerated aging on:
– cytotoxicity
Effects of sterilization on: – extractables and leachables
Printing assessment: – Flexography and thermal transfer – Barcode readability tests – Reminder: print on smooth side and seal to rough side
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NEW Transition Protocol Material Data on Our Website
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All of this and more can be found on our website at: www.areyouready.tyvek.com A few helpful hints: • It’s a long list, scroll down
• Summary information and reports at the top, followed by technical data, followed by regulatory guidance
• As new data and documents are added, we will indicate this with “UPDATED” or “NEW”
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Are You Ready Website – Regulatory Section
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
DuPont 2015 Commercialization Plan
May MDMs continue planning with their SPMs and Notified Body(s)
June – August MDMs complete their risk assessments, any additional testing and
required regulatory notifications (Notified Body for Class III devices, minor change notification in Japan)
July DuPont completes submission to U.S. FDA, Health Canada and Notified Bodies August DuPont publishes 1-Year Real-Time Industry Summary Report September Expected U.S. FDA Affirmation of Functional Equivalence (Submission + 8 weeks)
DuPont begins to confirm new orders with Tyvek® Transition material October SPMs begin to receive Tyvek® Transition material (U.S. FDA Affirmation + 4 weeks) December DuPont expects to transition the majority of manufacturing
to Tyvek® Transition material* *Note: Complete transition may take up to 12-18 months as inventories throughout the value chain are depleted.
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Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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Functional Equivalence will allow you to accept Current Tyvek® and Transition Protocol material interchangeably
U.S. FDA affirmation of Functional Equivalence is expected September 2015
Ensures continuity of supply during the transition period
Eliminates the need to segregate inventories throughout the value
chain, enabling flexibility in converting and end-user processes
Allows for depletion of inventories of Current Tyvek® roll goods and converted products throughout the entire value chain
Interchangeability The Benefits of
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ü Status of risk assessments and testing ü Controlled sales material ordered ü Class III device(s) sold in EU?
ü Engage regulatory & supply chain ü Discuss plans with SPM
Ready? Are You
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Data continues to indicate Functional Equivalence
U.S. FDA affirmation of Functional Equivalence is expected September 2015
Transition Protocol material interchangeable with Current Tyvek® material following U.S. FDA affirmation of Functional Equivalence
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Bottom Line The
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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www.transition.tyvek.com www.areyouready.tyvek.com
Global webcasts FAQs
Tyvek® Rx Newsletter Live seminars
Trade and technical forums Individual meetings
Information The
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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June 9: MDM East Lunch and Learn Sept 15: Technical Seminar, Boston, MA
Sept 24: Next MPTP Webinar Oct 20: Technical Seminar, Dallas, TX
Nov 10: Technical Seminar, East Lansing, MI
With additional events around the world. Look for updates from DuPont and our media partners on how to register.
Calendar The
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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A Note of Appreciation
Thank you for your business, your continued support and your confidence in DuPont
We are committed to support you throughout this transition
Together, we can continue to meet the needs of a growing population for safe and sustainable medical packaging
www.transition.tyvek.com www.areyouready.tyvek.com
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
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www.transition.tyvek.com www.areyouready.tyvek.com
Questions?
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Thank you!
Thank you for attending today’s Webcast: DuPont Submission to U.S. FDA Fast Approaching the Finish Line— Are You Ready?
Today’s webcast will be archived for one year for on-demand viewing within this environment.
For any additional questions, please contact us: Daphne Allen, Editor, Pharmaceutical & Medical Packaging News at [email protected]
Or a member of the DuPont team at www.transition.tyvek.com
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. (05/15)
Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo, DuPont™ and Tyvek® are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates.
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