Validation of Sterile Packaging Processes and Packaging Design for Medical Devices

Instructor-led Training1.5 Days if In-Person or 1 Day if Online​AdvancedInstructor-led or Virtual Classroom

With this seminar, participants will:

  • Acquire sound knowledge of the requirements for sterile packaging in accordance with EN ISO 11607:
    • You will be familiarized with the standards and will be able to apply them specifically in your work.
  • Receive practical know-how for validating your packaging processes:
    • Our experts share proven methods to optimize your packaging processes.
  • Ensuring aseptic packaging:
    • You will learn how to ensure the sterility of your medical devices through effective packaging processes.

This seminar is aimed at:

  • Manufacturers and operators of medical devices
  • Developer
  • Product manager
  • Project manager
  • Employees in quality management
  • Employees in the Regulatory Affairs department

The following topics will be covered during the seminar:

DAY 1:

  1. Definitions and definitions of terms:
    • Clear definition of the relevant terms in the context of sterile packaging.
  2. Requirements of EN ISO 11607-1:2020:
    • In-depth insights into the basic requirements for sterile packaging.
    • Understanding the standard to ensure the safety and integrity of medical devices.
  3. Basic requirements for sterile packaging:
    • Practical implementation of the standard specifications.
    • Selection of suitable materials and processes to ensure sterility.
  4. Basics of the packaging process:
    • Understanding of processes and best practices in the packaging of medical devices.
  5. Requirements from the MDR regarding sterile packaging
  6. Decision criteria for the selection of packaging materials:
    • Criteria for selecting materials for sterile packaging.
  7. Test methods for packaging materials:
    • Methods for checking material quality and integrity.
  8. Validation of the packaging process (OQ/PQ) in accordance with EN ISO 11607-2:2020:
    • Procedure for compliant validation.
    • Practical examples
  9. Transport validation:
    • Ensuring packaging integrity during transportation.

DAY 2: (Only if attending "In-person" training delivery in New Brighton, MN)

  • Half-day Lab Demonstration/Tour (OPTIONAL)

In this seminar, you will learn in a practical way all about the standard EN ISO 11607-1:2020, EN ISO 11607-2:2020 and their requirements for the validation of sterile packaging design and processes for terminally sterilized medical devices. Implementing these standards precisely is essential for medical device manufacturers but is often a challenge. Through the expertise of our specialists, participants will gain a deep insight into the core requirements of these standards and learn how to effectively design validation processes according to specific specifications. In addition, we provide clarity on regulatory requirements for conducting validation studies, including risk analysis and documentation of results. The seminar is designed to be interactive, with lectures, discussions, and exercises to promote successful application in everyday working life. It is aimed at newcomers and experienced professionals in the medical device industry who wish to expand their knowledge of validating sterile packaging.

You will get a basic overview of the essential contents of the standard and the requirements for the validation of packaging processes.

This 1-day training will teach you how to ensure Medical Device Sterility.

This is an instructor-led training. Please note that we do offer this training program either as "In-person" training or as "Virtual classroom" training. Be sure to select the correct type of training to which you would like to register for in the booking table below.

All "in-person" events of this training, scheduled in our upcoming Public Calendar of events, will be held in our new state-of-the-art laboratory in New Brighton, Minnesota.
The new laboratory is accredited to ISO 17025 for the biological and chemical testing of medical devices and is part of TÜV SÜD’s ongoing commitment to providing high-quality medical device services that deliver precision with purpose to its customers.

TÜV SÜD America Inc.
141 14th ST NW
New Brighton, MN 55112

All other sessions will be held online as virtual classroom trainings.

FURTHER INFORMATION on the New Brighton Lab:

  • The contents of the seminar correspond to the current status of revision/harmonization.
  • Participants will receive a certificate of attendance from the TÜV SÜD Academy.
Net Price (excl. TAX)
from$ 995.00

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Book Now: Validation of Sterile Packaging Processes and Packaging Design for Medical Devices
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From 17.Sep.2024
New Brighton, MN
$ 995.00 excl. TAX

Event No.

1.5 Days if In-Person or 1 Day if Online​

Show Schedule

New Brighton, MN


Net price
$ 995.00
0% TAX
$ 0.00

Price (excl. TAX):
$ 995.00

Event No.

1.5 Days if In-Person or 1 Day if Online​

Show Schedule



Net price
$ 995.00
0% TAX
$ 0.00

Price (excl. TAX):
$ 995.00

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