Fundamentals of Medical Device Packaging
Course Setup

Our medical device packaging subject matter experts present this course in a way that encourages effective learning. 

Here are some of the ways we do it:

• The class is informal, encouraging discussion and interaction with instructors and classmates.
• Students get to view and discuss actual medical device package samples.
• Instructors use presentations and videos to illustrate the latest packaging materials, containers, components, techniques and advancements. 
• Students see demonstrations of actual machinery at MD&M West, with an opportunity to ask questions.
• Students take away a complete set of slides (provided in PDF format), to serve as a handy reference tool for the future.

Syllabus & Agenda

DAY ONE: Designing Packaging for Sterile Medical Devices
Objectives: Students will learn the basics of sterile packaging material selection, sterile barrier system design and sustainability considerations relating to medical device packaging.

11:30 AM - 12 PM: Light lunch

12 - 1 PM: Keynote/Introduction: What Do Medical Device Packaging Engineers Do?
Instructor: Jen Benolken
The course will kick off with an inspirational call to students in medical device packaging, giving them an idea of the dynamic opportunities available to medical device packaging engineers.
  
1 - 2:45 PM: Materials Used for Sterile Barrier Packaging—Hands-On Workshop
Instructor: Dhuanne Dodrill
The myriad of material choices and packaging forms available to packaging professionals when designing a medical device package can be overwhelming. This section will focus on considerations that drive the selection of packaging materials and format to deliver the best user value. Flexible, semi-rigid and rigid packaging forms will be discussed, with attention given to key materials and design criteria for each form type, whether a flexible pouch, formed tray, or molded tube or case. Examples of specific packaging forms will be shared, along with pragmatic suggestions. Attendees will gain a broader understanding of the materials and forms of packaging.

2:45 - 3 PM: Break

3 - 4:30 PM: Designing Sterile Barrier Systems
Instructor: Art Castronovo
Design inputs and subsequent outputs form the basis for developing designs in medical device packaging. They are essential requirements and building blocks to ensure the sterile barrier system design maintains its integrity through the end-to-end life cycle while ensuring customer requirements and usability are met.

Students will gain an overall understanding of critical inputs and what goes into developing them, taking into account such factors as the device weight, geometric features, light and moisture sensitivity, sterilization method and customer requirements.

4:30 - 5:30 PM: Sustainability and Medical Device Packaging
Instructors: Zach Muscato, Anna Thomas
The need for sustainable medical device packaging solutions is more important than ever. This session will provide a foundational understanding of sustainability principles, including the drivers of change; guidance on how packaging designs can be optimized to reduce material, increase the likelihood of recovery or reuse; and how to maximize the use of recycled materials. The session will include a deep dive into mechanical and advanced recycling techniques with an emphasis on the challenges faced in medical device packaging. Students will learn what tools are available, including Life Cycle Assessments and design guides, to engrain sustainability principles into their future packaging development efforts.

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DAY TWO: Manufacturing Packaging for Sterile Medical Devices
Objectives: Students will be exposed to hands-on training on using sealing equipment, along with education on practical skills relating to medical device packaging and manufacturing processes.

8 - 8:30 AM: Light breakfast

8:30 AM: Introduction
Explain exhibitor booth rotations on MD&M West show floor, divide into groups, travel to rotation areas.

8:35 - 10:35 AM: Rotation Stations on Show Floor

• 8:35 - 8:40 AM: Travel time to Rotation Stations

• 8:40 - 9:15 AM: Rotation A

• 9:20 - 9:55 AM: Rotation B

• 10 - 10:35 AM: Rotation C

11-11:15 AM: Travel time back to classroom

10:35 - 10:50 AM: Break

10:50 AM - 12:15 PM: Qualifying Equipment and Validating Processes Crash Course
Instructors: Charlie Webb, Sean Thompson, Sarah Rosenblum
Learn how to properly install and validate sealing equipment. From tray sealers to pouch sealers, this section will cover proper techniques for DOE, IQ, OQ and PQ, including developing sealing recipes tips and tricks, testing plans and common faults. The second half of this section will cover how to ensure that processes and machinery are operating properly over time, and include an introduction on in-process testing techniques, different strategies used and why, and how to ensure that equipment is set up for success.

12:15 AM: Break

12:30 - 1:30 PM: Sterilization of Medical Devices for Packaging Engineers
Instructor: Dan Floyd
This session will focus on medical device sterilization fundamentals, providing an overview of prevalent sterilization modalities in the industry—ethylene oxide, radiation (X-ray, Gamma, E-beam), moist heat and dry heat. Packaging material selection, design and compatibility considerations will be discussed. Current and future trends in sterilization, and their impact on medical packaging, will be addressed. Come prepared with your questions!

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DAY THREE: Quality/Regulatory Requirements for Medical Device Packaging
Objectives: Students learn about quality and regulatory requirements for medical device packaging.

The day begins with a workshop on testing methods for medical packaging and then proceeds through classroom instruction on regulations and quality systems. The day ends with a session on assessing root cause analysis, with advice and perspective on what to do when confronted with the unexpected.

8 - 8:30 AM: Light breakfast

8:30 - 8:35 AM: Introduction
Class welcome.
Instructor: Amy Stewart

8:35 -10 AM: Testing
Instructors: Sarah Rosenblum, Sean Thompson

Tensile Strength and/or Burst Testing
Instructors will demonstrate proper technique for performing tensile testing per ASTM F88 and burst strength per ASTM F2054. Tips and tricks will be shared for performing each method and their significance for packaging validation.

Whole Package Integrity Testing
Students will observe a demonstration of the proper technique for performing ASTM F2096 and learn when this method is most applicable.

Visual Inspection/Dye Testing
Instructors will demonstrate proper technique for performing visual inspection per ASTM F1886 and dye penetration per ASTM F1929. Discussion will explore common pitfalls and their significance.

10:05 -10:20 AM: Break

10:20 AM - 12 PM: Regulations, Standards and Quality Systems for Medical Device Packaging
Instructors: Jan Gates
Regulations and standards are fun—keep telling yourself that. This session will show the essential regulations and standards to know and how to use them, with some interpretations provided. Remember that the primary concern is the product remains safe for use; next is to document the work that needs to be completed or was completed with a robust rationale—which could be repeated in five years (by someone else). This section will conclude with a discussion around the point that while practically no one reading the work will understand packaging like you, auditors and management usually can spot dubious information easily.

12 -12:15 PM: Break

12:15 - 1:15 PM: CAPA, Risk Analysis, Troubleshooting and Remediation Strategies
Instructor: Elon Goldbaum
What is a CAPA? How are root cause analysis tools and DMAIC methodology used? How are the problem statement and scope properly defined? This section will provide insights on how to address packaging engineering failure modes through CAPA using real cases by applying DMAIC principles.

1:15 - 1:30 PM: Course Close-out and Evaluation Survey