IoPP Fundamentals of Medical Device Packaging - Day 2

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Event Location

Location: Room 207B


Event Information

Title: IoPP Fundamentals of Medical Device Packaging - Day 2

Event Type: Workshops


Description

Syllabus & Agenda

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 1
  • 9:20 - 9:55 AM: Rotation 2
  • 10:00 - 10:35 AM: Rotation 3

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.

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.

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 - 12:15 PM: 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 - 1:30 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!

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This new course, developed in conjunction with the IoPP Medical Device Packaging Technical Committee, introduces you to the requirements of medical device packaging.

The course consists of three half-day sessions and occurs at MD&M West in Anaheim. The curriculum includes classroom instruction and in-depth discussions, along with demonstrations at participating exhibitor booths of various machinery used to create medical device packaging.

Not technical? No problem. This course is designed for those new to packaging or medical device packaging. It can bring you up to speed on the essential knowledge needed to understand this complex packaging industry segment.


What topics are covered?

  • Materials used for sterile barrier packaging
  • Designing sterile barrier systems
  • Manufacturing packaging for sterile medical devices
  • Qualifying equipment and validating processes
  • Sterilization of medical devices for packaging engineers
  • Regulations, standards, and quality systems for medical device packaging
  • Risk analysis and design assurance
  • CAPA, troubleshooting and remediation strategies

Who should attend?

  • Anyone new to medical device packaging and in need of a broad introduction.
  • Managers who want a wider view of medical device packaging.
  • Sales reps looking to learn the language of medical device packaging.
  • Engineers or technicians with part-time responsibility in packaging.
  • Packaging professionals changing focus and wanting to "come up to speed” in a new area of packaging.
  • Purchasing professionals searching for more technical depth.
  • Students or professionals preparing for IoPP certification.

Professional Instructors

Fundamentals of Medical Device Packaging is taught by a team of packaging professionals vetted and selected by the IoPP Medical Device Packaging Technical Committee.  


CPE credit

Completing the Fundamentals of Medical Device Packaging course earns you 11 Continuing Professional Education (CPE) credit points. You must attend all training days to earn your Certificate of Completion and the CPE credit points. These can be applied toward the requirements for the IoPP Certified Packaging Professional (CPP) program.


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