Dates
February 5-7, 2024

Location
Anaheim Convention Center
Anaheim, CA
Held during MD&M West

Times
  • Monday, February 5 | 12:30 - 5:30 PM (Light lunch in the classroom at 11:30 AM)
  • Tuesday, February 6 | 8:30 AM - 1:30 PM (Light breakfast in the classroom at 8 AM)
  • Wednesday, February 7 | 8:30 AM - 1:30 PM (Light breakfast in the classroom at 8 AM)
Course setup
Our medical device packaging subject matter experts present this course in a way that encourages effective learning. Here's how 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.

Completing this course earns you 11 CPE credits.
You can apply these toward our Certified Packaging Professional (CPP) requirements. You must attend all training days to earn your CPE credits and Certificate of Completion.
 
  • Elite members: $755
  • Premium members: $845
  • Regular members: $895
  • Affiliates and non-members: $940

    Prices are for all three half-day sessions. We do not offer single half-day registration options. Students receive PDFs for all course slides and any materials distributed by our instructors. On designated days, breakfast, lunch and beverage breaks are included.

    Payments must be completed prior to the course. All attendees are responsible for their own hotel reservations and transportation to and from the class.

This policy covers the liability of cost of a cancellation* or change. Cancellation or rescheduling must be made in writing or by email with confirmation of receipt from IoPP. The following fees apply if you cancel/change your registration or are a no-show to the class:
  • More than 30 days prior to the event is a $75 cancellation/change fee
  • 30 to 14 days prior to the event is a $110 cancellation change fee
  • Less than 14 days prior to the event is a $165 cancellation change fee
  • No-shows to the event are charged a $165 cancellation/charge fee

    *The remaining balance will be issued as a credit toward future IoPP education offerings only. This credit expires after one year. No refunds will be given. Exception: A substitute may attend in place of the original registrant.

Syllabus


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: Light lunch

12 PM: Keynote/Introduction: What Do Medical Device 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.

12:30 PM: Materials Used for Sterile Barrier Packaging—Hands-On Workshop
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 leave this session with a broader understanding of the materials and forms of packaging.

2:30 PM: Break

2:45 PM: Designing Sterile Barrier Systems
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.

4:15 PM: Break

4:30 PM: Sustainability and Medical Device Packaging
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.

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 AM: Light breakfast

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

8:35 AM: Rotations on Show Floor (5 minutes between each rotation)
  • 8:40 AM: Rotation 1 - Processes for Converting and Sealing Pouches
    This session will explain how pouches are made and discussion the qualities of different materials. It also will cover the different sealing technologies, including constant heat sealers, impulse heat sealers, rotary band sealers and form/fill/seal sealers, and explain the advantages and disadvantages of each technology.
  • 9:20 AM: Rotation 2 - Processes for Sealing Trays
    This session will explain how trays are made and the benefits of certain tray features such as interior tack seals.
  • 10 AM: Rotation 3 - Processes for Forming Trays
    This session will cover different types of tray sealers including best practices for tray designs to optimize the tray sealing process such as rolled flanges.

    10:35 AM: Break

    10:50 AM: Qualifying Equipment and Validating Processes Crash Course
    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 PM: Break

    12:30 PM: Sterilization of Medical Devices for Packaging Engineers
    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!

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

8 AM: Light breakfast

8:30 AM: Introduction

8:35 AM: Rotations on Show Floor (5 minutes between each rotation)
  • 8:40 AM: Rotation 1 - 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.
  • 9:20 AM: Rotation 2 - 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.
  • 10 AM: Rotation 3 - Visual Inspection/Dye Testing
    Instructors will demonstrate proper technique for performing visual inspection per ASTM F1886 and dye penetration per ASTM F1929. Discussions will explore common pitfalls and their significance.

    10:05 AM: Break

    10:20 AM: Regulations, Standards and Quality Systems for Medical Device Packaging
    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 PM: Break

    12:15 PM: CAPA, Risk Analysis, Troubleshooting and Remediation Strategies
    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 PM: Course Close-out and Evaluation Survey


FAQs

What will I learn?
  • Materials in sterile barrier packaging: Get to know the materials that are essential for creating effective sterile barrier packaging.
     
  • Designing sterile barrier systems: Learn the intricacies of designing these vital systems.
     
  • Manufacturing medical device packaging: Dive into the manufacturing processes specific to packaging for sterile medical devices.
     
  • Equipment qualification and process validation: Understand how to qualify equipment and validate the processes used in this field.
     
  • Sterilization for packaging engineers: Gain insights into the sterilization methods crucial for medical device packaging.
     
  • Regulations and standards: Familiarize yourself with the regulations, standards, and quality systems governing medical device packaging.
     
  • Risk analysis and design assurance: Explore the methods of conducting risk analysis and ensuring design assurance in this specialized area.
     
  • CAPA, troubleshooting, and remediation: Learn about Corrective and Preventive Actions (CAPA), troubleshooting techniques, and remediation strategies relevant to medical device packaging.

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