2015 HPC Fall Meeting Friday, November 13, 2015facstaff.cbu.edu/~pong/Packaging/2015HPCFallMeeting.pdf2015 HPC Fall Meeting, November 13, 2015, Memphis, Tennessee, USA Advances in

Active Members

Bayer Consumer Care, Evergreen Packaging, FedEx, GlaxoSmithKline, Medtronic, Memphis Bioworks, MicroPort

Orthopedics, Olympus Surgical Technologies America, Plastic Ingenuity, Smith & Nephew,

Thaddeus Medical Systems, The Pallet Factory, Wright Medical, WS Packaging

2015 HPC Fall Meeting Friday, November 13, 2015

Sabbatini Lounge, 2nd

Floor of Thomas Center, Christian Brothers University

650 East Parkway South, Memphis, TN 38104

8:15 a.m. – 8:45 a.m.

Check-in/Continental Breakfast

8:45 a.m. – 10:15 a.m.

(1.5 hrs) Advances in Medical Device Packaging

Paul Marshall, Smith & Nephew

10:15 a.m. – 10:30 a.m. Break

10:30 a.m. – 12:00 noon

(1.5 hrs) Advances in Pharmaceutical Packaging

Melissa Simpson, GlaxoSmithKline

An Individual Sleeve That Regulates Temperature and Prevents Tampering for

Biological Therapies and Biomedical Samples

Steve Scully, Thaddeus Medical Systems

DEStech Publications, Inc.

Joseph Eckenrode, DEStech

12:00 noon – 1:00 p.m. Lunch

1:00 p.m. – 2:30 p.m.

(1.5 hrs) Medical Device Labeling

Laurie Jordan, Smith & Nephew

2:30 p.m. – 2:40 p.m. Break

2:40 p.m. – 4:10 p.m.

(1.5 hr) Identifying and Validating User Needs during Package Design

Scott Carpenter, Bayer Consumer Care

Applications of Neural Networks in Transport Packaging

Pong Malasri, Christian Brothers University

Campus Map: http://www.cbu.edu/assets/2091/cbumap2015.pdf

http://www.cbu.edu/assets/2091/cbumap2015.pdf

Active Members

Bayer Consumer Care, Evergreen Packaging, FedEx, GlaxoSmithKline, Medtronic, Memphis Bioworks, MicroPort

Orthopedics, Olympus Surgical Technologies America, Plastic Ingenuity, Smith & Nephew,


Meeting Sponsors

Smith & Nephew

(http://www.smith-nephew.com/)

GlaxoSmithKline

(http://www.gsk.com/)

Bayer Consumer Care

(http://www.bayer.com)

Thaddeus Medical Systems

(http://www.thaddeusmed.com/)


(http://www.destechpub.com)

http://www.smith-nephew.com/

http://www.gsk.com/

http://www.bayer.com/

http://www.thaddeusmed.com/

http://www.destechpub.com/

http://www.smith-nephew.com/

http://www.gsk.com/en-gb/home/

Active Members

Bayer Consumer Care, Evergreen Packaging, FedEx, GlaxoSmithKline, Medtronic, Memphis Bioworks,

MicroPort Orthopedics, Olympus Surgical Technologies America, Plastic Ingenuity, Smith & Nephew,


Registered Participants

1. Baker, Chad Christian Brothers University

2. Bell, James Memphis Bioworks (Medical Device Accelerator)

3. Bonner, April Christian Brothers University

4. Byrd, Alana Christian Brothers University

5. Carpenter, Scott Bayer Consumer Care

6. Choudhary, Divya Christian Brothers University

7. Eckenrode, Joseph DEStech

8. Edwards, Evan FedEx

9. Gillman, Jay FedEx

10. Hare, Charlotte Christian Brothers University

11. Howard, Christina Medtronic

12. Jordan, Laurie Smith & Nephew

13. Kapoor, Nipun Wright Medical

14. Kim, Thomas Bayer Consumer Care

15. Koonce, Olivia Christian Brothers University

16. Lin, Louie Christian Brothers University

17. Loving, Benjamin Christian Brothers University

18. Malasri, Pong Christian Brothers University

19. Marshall, Paul Smith & Nephew

20. Mason, Liz Wright Medical

21. Moats, Bob Christian Brothers University

22. Nelson, David FedEx

23. Nguyen, Kim Christian Brothers University

24. Nobes, Geoff Evergreen Packaging

25. Pourhashemi, Ali Christian Brothers University

26. Rainey, Mickey FedEx

27. Ray, Asit Christian Brothers University

28. Rodriguez, Ana Christian Brothers University

29. Russell, Stephen Christian Brothers University

30. Saeteurn, Lai Medtronic

31. Scully, Jr., Steve Thaddeus Medical Systems, Inc.

32. Sheppard, James University of Memphis

33. Simpson, Melissa GlaxoSmithKline

34. Smith, Caleb Medtronic

35. Topinka, Matt Bayer Consumer Care

36. Vazquez, Juan Christian Brothers University

Active Members




37. Ventura, John Christian Brothers University

38. Wadlington, Clark Christian Brothers University

39. Wellford, Brandon Memphis Bioworks

40. Youngblood, Anne Christian Brothers University

41. Yu, Mei Olympus Surgical Technologies America

42. Zheng, Zhihong Christian Brothers University

43. Zhou, Yongquan FedEx

Active Members




Abstracts

2015 HPC Fall Meeting, November 13, 2015, Memphis, Tennessee, USA

Advances in Medical Device Packaging: Sustainability

Paul Marshall1

Abstract: Sustainability is not a new topic, but it is quickly becoming a significant topic within medical device

packaging. Historically sustainability wasn’t a substantial consideration in medical device packaging design

because product functionality and sterile integrity were considered the overriding priority. Now the US is quickly

catching up with the rest of the world where focus on sustainability it has been in place for quite some time. The

world of sustainability is quickly changing as new standards are being introduced to force sustainable considerations

in medical packaging and customers are starting to demand these metrics during the tendering process. As a result,

MDMs must start to adopt these considerations into the packaging designs in order to remain competitive globally.

In this presentation, the following topic will be discussed:

Medical Device Sustainability

Sustainability Reporting and Analysis

o Dow Jones Sustainability Index

o Life Cycle Analysis (LCA)

Regulation Guidelines

o ISO Specifications

o Recycling Claim Requirements

Case Studies

o Packaging Optimization

o Packaging Component Elimination

o Packaging Reuse

Future State

o Tendering and reporting requirements

Keywords: Sustainability, Sterile Medical Device Packaging; Design Control/Compliance, Industry Guidanc;,

Regulatory Requirements.

Presenter:

Paul Marshall – Paul Marshall is a Manager within the Global Packaging Technology group for

Smith & Nephew, Inc. with global responsibility for Packaging Development and Packaging Process

Engineering for the Advanced Surgical Devices (ASD) Division. In addition, he is responsible for

packaging compliance and manages the packaging testing lab. He has worked for Smith & Nephew

for 5 years. Paul has a Bachelor of Science in Packaging Engineering from Michigan State

University and Mechanical Engineering from The University of Cincinnati. He is a Lifetime

Certified packaging Professional (CPPL) and certified Project Manager (PMP). He has over 20+

years of packaging experience including over 14 years within medical and pharmaceutical packaging

application. Paul holds a patent for packaging design and has received multiple industry awards for

medical packaging excellence.

1 Smith & Nephew, Inc., 1450 E. Brooks Road, Memphis, TN 38116, [email protected]

mailto:[email protected]


Advances in Pharmaceutical Packaging

Melissa Simpson1

Abstract: Pharmaceutical packaging has always played a key role in protecting important, life saving drug

products throughout their lifecycle. Pharmaceutical packaging has made major strides since its introduction and is

being required to deliver even more as this industry continues to advance.

With a growing global market, demands for pharmaceutical packaging are expected to increase to $90 billion in

2017 (The Freedonia Group). This will shape the development of materials and material combinations to protect the

new molecules and bio-based therapies in pipelines. This growth will also increase requirements for unit-doses in

various formats and other methods to help ensure compliance with dose amounts and regimens for maintenance of

conditions such as arthritis, multiple sclerosis, and Alzheimer’s.

Counterfeit prevention and serialization efforts continue to increase due to the growing globalization of the industry

and regulatory pressures. Technologies such as RFID, nano-printing, and specialized inks are helping to make

pharmaceutical products more secure through the supply chain. Track and trace technology is allowing for more

information about the product to be shared with the manufacturer or distributor, and, in some cases, allow the

patient more interaction with their product.

The growth predicted for the pharmaceutical packaging market has ignited innovation in this space. From unique

child-resistant/senior-friendly packages for blisters to multi-functional labels for liquid infusion bottles, new

packaging solutions are being developed to support the needs of the manufacturer and the patient or care provider.

Keywords: Pharmaceutical Packaging; Unit-Dose; Counterfeit Prevention; Innovation

Presenter:

Melissa Simpson– Melissa is a Senior Packaging Engineer with GSK in Memphis, Tennessee where she oversees

the packaging activities for various products/product formats. She is a Certified Packaging Professional and

member of IoPP. Melissa received her B.S.M.E from the University of Memphis and has been awarded multiple

patents for innovative packaging designs.

1 GSK, 2149 Harbor Avenue, Memphis, Tennessee 38113, [email protected]



Joseph L. Eckenrode1

Abstract: DEStech Publications, Inc. is a science, technical, medical (STM) book and journal publisher based in

Lancaster, Pennsylvania, with specialty areas in advanced materials, food science, environmental engineering,

nursing, and packaging technology. The company develops and publishes original professional reference and text

books for researchers and students throughout the world. A separate branch of the company produces books and

electronic media for technical societies and conference organizers. DEStech’s packaging book line was developed

from longstanding ties to the Michigan State School of Packaging faculty, as well as past and current collaborative

publishing arrangements with the Institute of Packaging Professionals (IoPP) and the Technical Association of the

Pulp and Paper Industry (TAPPI).

Keywords: Packaging; Publisher, Books; Journals

Presenter:

Joseph Eckenrode - Dr. Joseph L. Eckenrode is a Phi Beta Kappa alumnus of Georgetown University and received

his doctorate from the University of Pennsylvania. After teaching at a number of colleges and universities, including

Rosemont, University of Scranton, Franklin and Marshall and Stanford, he entered the field of publishing in 1984.

During his career he has been instrumental in founding 6 scholarly journals--including the Journal of Intelligent

Systems and Structures, Women in Educational Leadership, and Multifunctional Composite Materials and has

developed over 500 technical books on topics ranging from the human microbiome to bioactive packaging and

nanomaterials, for companies such as Technomic and Blackwell. Dr. Eckenrode is currently an ownership partner

in, and editorial director of, DEStech Publications, Inc.

1 DEStech Publications, Inc., 439 North Duke Street, Lancaster, PA 17602-4967, [email protected]



Medical Device Labeling

Laurie Jordan1

Abstract: Labeling includes any printed or graphic material that is included on the immediate container of a

medical device. For medical devices specifically, labeling includes descriptive information that enables the device

to be properly used to treat a patient. Information included on the label must be clearly legible, accurate, and

compliant from a Regulatory standpoint to ensure that the proper device is selected for use.

In this presentation, the following topics will be discussed:

Packaging levels and labeling

Labeling content

Barcoding

o Standards (GS1 versus HIBCC)

o Barcode verification – ANSI grading

Label Printing

Regulations and Labeling

o CFR Part 11

o Medical Device Directive – Notified Body Standards

o Symbols

o FDA Unique Device Identification (UDI)

Common labeling problems

Keywords: Labeling; Unique Device Identification; barcoding

Presenter:

Laurie Jordan – Laurie Jordan is the Group Manager, Global Packaging Technology for Smith &

Nephew, Inc. with global responsibility for Label Development and Packaging Operations for the

Advanced Surgical Devices (ASD) Division. She has worked for Smith & Nephew for more than 10

years. Laurie has a Bachelor of Science in Biomedical Engineering from Louisiana Tech University,

and a Masters in Business Administration from The University of Mississippi.

1 Smith & Nephew, Inc., 1450 E. Brooks Road, Memphis, TN 38116, [email protected]


Identifying and Validating User Needs during Package Design M. Scott Carpenter

1

Abstract: Package design and in-use functionality are critical factors in the utility of any packaged product.

Incorporating user research-based insights into the early stages of package design can not only increase product

acceptance, but other factors including compliance, ease of use and even emotional connectivity with the product

and/or brand.

This presentation will cover the approaches to the lifecycle of consumer package research. Topics covered will

include understanding the user, approaches to determining external factors on utility, iterative research models, and

validation of acceptance.

Keywords: Package, Insight, Design, Utility, Emotion, Research, Validation

Presenter:

Scott Carpenter - Scott holds the title Associate Director - Packaging Innovation, Research and Development at

Bayer Consumer Care, where he works with a talented group of people to create packaging and products that deliver

on the ideal consumer experience. Though various approaches to authentic consumer research, he and his colleagues

seek to understand the habits, rituals, and heuristics of everyday users in everyday situations to help guide the

design of new products, custom fit to their needs.

Prior to his tenure at Bayer, Scott served in multiple technical and managerial roles at both SC Johnson and Nabisco

with experiences in package design, product development, corporate sustainability, mergers & acquisitions, and

design thinking approaches to establishing cultural change within large organizations. He has served on the board of

the Sustainable Packaging Coalition and holds several US and international patents.

Scott holds a BS in Packaging Science from Clemson University in Clemson, SC and an MBA from Northwestern

University in Evanston, IL.

1 Bayer Consumer Care, 3030 Jackson Avenue, Memphis, TN 38112, [email protected]



An Individual Sleeve That Regulates Temperature and Prevents

Tampering for Biological Therapies and Biomedical Samples

Steve Scully, MD, PhD1

Abstract: In order to better protect vital biomedical samples from adverse temperatures, we have derived a sleeve

to fit around individual tubes that regulates temperature. Last year, the Centers for Disease Control and Prevention

reported that $300 million of vaccines were wasted in 2014 due to improper temperature management. Countless

others were rendered ineffective. Most current cold supply chain solutions are passive technologies that attempt to

maintain temperature but are incapable of adjusting to changing environmental conditions. Moreover, they’re bulky

and made of materials that are not long-lasting and are often discarded and replaced regularly. To combat this

problem, we have developed a small, reusable, temperature-regulated sleeve that preserves biomedical samples and

biological therapies at specific temperatures during transportation. Critical biomedical samples and vaccines are

now protected from variable temperatures along with documented tracking. Ultimately, this means a world where

biomedical samples and vaccines are delivered safely and remain effective and viable for use.

Keywords: Active technology, active device, biologics, vaccines

Presenter:

Steve Scully - Dr. Steve Scully is CEO of Thaddeus Medical Systems. Prior to starting this company that addresses

cold chain issues, he was a research fellow at Mayo Clinic in Rochester, MN. There he saw specific needs for better

temperature regulation of biomedical samples for diagnostic purposes, and started the company.

1 221 First Ave. SW, Suite 202, Rochester MN 55902; 1-978-808-8767, [email protected]


Applications of Neural Networks in Transport Packaging

Siripong Malasri1

Abstract: An artificial neural network is software that is capable of learning from examples. It is modeled after

our brain to some extent. Learning algorithms vary from supervised learning on one extreme to unsupervised

learning on another extreme. In a supervised learning algorithm, training data consists of input and desired output.

The network learns how to map input and desired output. Only input is given to the network without specifying

desired output in an unsupervised learning algorithm. The network learns how to group examples based on their

similarities and differences. Supervised learning algorithms are more common and the Backprogagation algorithm

is the most popular.

Backprogration neural network is a feed-forward network. Typically it consists of an input layer, hidden layer, and

output layer as shown in Figure 1.

Figure 1: Feedforward Neural Network

In this presentation, three applications of artificial neural network related to transport packaging will be discussed:

Estimating temperature in wooden softwood pallet stringer

Determining temperature penetration time into insulated container using rice hull as heat barrier

Predicting compressive strength of corrugated box

Keywords: Artificial Neural Network; Transport Packaging; Wooden Pallets, Rice Hull; Corrugated Box

Presenter:

Siripong Malasri – Dr. Malasri is currently Dean of Engineering and Director of Healthcare Packaging Consortium,

Christian Brothers University. He is an ISTA CPLP (Professional Level) and a registered professional engineer in

Tennessee. His research interests include artificial intelligence applications and packaging.

1 Christian Brothers University, 650 East Parkway South, Memphis, TN 38104, [email protected]


http://www.packcon.org

http://technical.cloud-journals.com/index.php/IJAPT/index

http://www.packcon.org/

http://technical.cloud-journals.com/index.php/IJAPT/index

Documents

2015 HPC Fall Meeting Friday, November 13, 2015facstaff.cbu.edu/~pong/Packaging/2015HPCFallMeeting.pdf2015 HPC Fall Meeting, November 13, 2015, Memphis, Tennessee, USA Advances in