9th Annual Innovations in Medical Device Packaging Conference

May 14-15, 2019 | Chicago, IL

Crowne Plaza Chicago West Loop

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DAY ONE | TUESDAY, MAY 14

8:00 REGISTRATION & WELCOME COFFEE

8:45 CHAIRPERSON’S OPENING REMARKS

9:00 ICE BREAKER: EVOLVING REGULATORY STANDARDS FOR MEDICAL DEVICE PACKAGING
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives on the evolving role of packaging for medical device, recent updates in regulatory standards, and healthcare landscape’s influence on package design. Furthermore, participants in this interactive session are also given the opportunity to directly build contacts with industry peers, kicking off the event networking platform.

Luke Greene, Manager, Packaging Development, SMITH & NEPHEW

 

9:30–11:30 TWO-PART MODULE: NAVIGATING ISO 11607 AND ENSURING COMPLIANCE FOR MEDICAL DEVICE PACKAGING
ISO 11607 remains the core guidance document for the medical device packaging industry, providing standards for validating sterilized medical device packaging, exposing packaged products to a range of conditions that might be encountered during storage and distribution. Packaging engineers are seeking clarity to ISO 11607 requirements, to ensure testing methods meets the regulatory expectations set within the guidance document. Analyzing key aspects of ISO 11607, and supported and applicable ASTM, ISTA and ISO standards will align industry focus for future ISO 11607 compliance.

9:30 PART ONE: INTEGRATION OF ISO 11607 STANDARDS INTO CURRENT OPERATIONS

  • Establishing effective inter-departmental cooperation
  • Insightful feedback from recent FDA inspections
  • Reflections and next steps for ISO 11607 compliance

Stephanie Volk, Senior Corporate Sterilization & Biocompatibility Specialist, CONVATEC

 

10:15 COFFEE AND NETWORKING BREAK

 

10:45 PART TWO: GROUP DISCUSSION: ACTIONS TO ENSURE ISO 11607 COMPLIANCE

  • Key components and updates of ISO 11607
  • Testing methods to support compliance
  • Harmonizing EU MDR and ISO 11607

GROUP 1:
Stephanie Volk, Senior Corporate Sterilization & Biocompatibility Specialist, CONVATEC

GROUP 2:
Britt Jones, Packaging & Chemistry Manager, WUXI APPTEC

 

11:30 ASTM UPDATE: PROJECTS AND UPDATES FOR MEDICAL DEVICE PACKAGING STANDARDS

  • Review of April 2019 ASTM F02 committee meeting agenda and discussion
  • Practical application of ASTM F3263-17 guide for packaging TMV
  • Opportunities for industry collaboration on 2019 proposed standards

Dan Burgess, Chairman, ASTM COMMITTEE F02
Fellow Packaging Engineering, BOSTON SCIENTIFIC

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

TEST METHOD MODULE: DECODING COMPLEXITIES OF PACKAGING VALIDATION STRATEGIES
Ensuring compliance with ISO 11607 and FDA regulation, test method validation (TMV) is an important task for engineers looking to define performance characteristics and limitations, analyze risk and ensure reliability of device packages. With product packages consisting of varying materials and distribution, utilizing test methods that align with device parameters and support validation is key in overall industry compliance. As each testing strategy has individual considerations and challenges to overcome, it is essential for manufacturers to analyze each method in order to ensure optimal implementation during package validation operations.

 

1:30 PART ONE: ASTM D4169 DISTRIBUTION SIMULATION TESTING

  • Analyzing DC 13 and customized cycle options
  • Developing a sequence of hazard elements
    • Shock Testing
    • Drop Testing
    • Vibration Testing
    • Compression Testing
  • Review of ASTM D4169 and ISTA Series 2 and 3
  • Insights and trends from recent quality inspections

Alexea Kouris, Test Engineer II, WESTPAK

 

2:15 PART TWO: ASTM F88 PACKAGE SEAL STRENGTH TESTING

  • Balancing seal strength with easy to open packaging
  • Establishing acceptance criteria benchmarks for testing
  • Analyzing various seal strength testing techniques
    • Overview of Technique A, B and C
    • Determining technique most appropriate
  • Stability concerns with lack of appropriate seal strength

 

3:00 COFFEE AND NETWORKING BREAK

 

3:30 PART THREE: NON-DESTRUCTIVE TEST METHODS FOR DEVICE PACKAGE VALIDATION SMALL GROUPS
Attendees will break into groups discussing various non-destructive methods and techniques, encouraging thoughtful discussion on evaluating flaws without destroying the package at hand.

GROUP 1: Acoustic Emission Method

GROUP 2: Digital Imaging & Communication

GROUP 3: Leak Testing Method

 

4:15 DISTRIBUTION MAPPING: ENSURING PRODUCT QUALITY THROUGHOUT SUPPLY CHAIN
As the medical device industry explores new and innovative strategies to get products to market at an accelerated rate, packaging engineers must ensure that medical devices remain safe, stable and sterile throughout delivery. Validating that the device remains stable through temperature change and distribution requires packaging teams to conduct various test methods aligned with the product’s prospective map of transportation. After review of distribution maps and examining potential hazards or environmental factors a product may face in transit ensures device packaging has the ability to maintain a stable and sterile medical device.

Dannette Casper, Senior Package Development Engineer, OLYMPUS

 

5:00 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on Tuesday, May 14. Please note that dinner expenses must be covered by each participant individually.