dupont submission to u.s. fda fast approaching the finish · pdf filedupont submission to u.s....

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

Presenters

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

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

Engage numerous global SPMs and MDMs, test labs and regulatory bodies; build packages; generate data;

demonstrate Functional Equivalence

Journey The

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

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

Regulatory Report Submission Status as of May 2015

  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

  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

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

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

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)

New Reference Library On Our Website

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

*Eleven cells designated for extended accelerated aging (7 and 10 years) and real-time aging (10 years).

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

Timing

Publication of MPTP Test Results in Industry Summary Reports

U.S. FDA Transition Protocol Test Matrix — Nelson Laboratories Testing Status (as of May 13, 2015)

Phantom Protocol Test Matrix — Nelson Laboratories Testing Status (as of May 13, 2015)

Industry Summary: MPTP Test Results after 1-Year Accelerated Aging, Pass/Fail Summary for Seal Strength* — ASTM F88

Industry Summary: MPTP Interim Test Results (75/78 Cells) after 3-Year Accelerated Aging, Pass/Fail Summary for Seal Strength* — ASTM F88

Industry Summary: MPTP Interim Test Results (63/78 Cells) after 5-Year Accelerated Aging, Pass/Fail Summary for Seal Strength* — ASTM F88

Industry Summary: MPTP Interim Test Results (57/78 Cells) after 1-Year Real-Time Aging, Pass/Fail Summary for Seal Strength* — ASTM F88

Industry Summary: MPTP Interim Test Results (4/11 Cells) after 7-Year Accelerated Aging, Pass/Fail Summary for Seal Strength — ASTM F88

  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

Referred to as Transition material or Tyvek® Transition Protocol material

Tremendous amount of data available for Tyvek® sheet material

Material

  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

NEW Transition Protocol Material Data on Our Website

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”

Are You Ready Website – Regulatory Section

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.

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

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

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

Bottom Line The

www.transition.tyvek.com www.areyouready.tyvek.com

Global webcasts FAQs

Tyvek® Rx Newsletter Live seminars

Trade and technical forums Individual meetings

Information The

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

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

Questions?

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 daphne.allen@ubm.com

Or a member of the DuPont team at www.transition.tyvek.com

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