ISO 11607 Validation of Sterile Packaging Processes and Packaging Design for Medical Devices
From Packaging Design to Validation—Protecting Sterility Throughout the Product Lifecycle.
Medical device packaging plays a critical role in maintaining sterility, protecting product integrity, and ensuring patient safety. This training provides a practical understanding of the regulatory and technical requirements governing sterile packaging systems for terminally sterilized medical devices.
Participants will learn how to design, validate, document, and maintain compliant packaging systems according to EN ISO 11607-1:2020/A1:2023, EN ISO 11607-2:2020/A1:2023, and MDR 2017/745. Through practical examples, visual demonstrations, and real-world case studies, attendees will gain the knowledge needed to successfully implement and maintain packaging validation programs.
As participant in this training, you 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.
Testimonial:
- "What I found most valuable was the level of practical detail throughout the course. The concrete examples, photos of real packaging systems, and visual demonstrations made complex validation and packaging requirements much easier to understand and apply in practice."
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This course is intended for:
- Medical Device Manufacturers
- Packaging Engineers
- Product Development Engineers
- Design Engineers
- Product Managers
- Project Managers
- Quality Assurance Professionals
- Quality Engineers
- Validation Engineers
- Regulatory Affairs Professionals
- Sterilization Specialists
- Manufacturing Engineers
- Supplier Quality Engineers
- Technical Documentation Specialists
- Auditors and Compliance Professionals
Introduction to Sterile Packaging
- Sterile barrier systems (SBS)
- Protective packaging
- Packaging systems
- Purpose and functions of sterile packaging
Regulatory and Standard Requirements
- MDR 2017/745 packaging requirements
- EN ISO 11607-1 requirements
- EN ISO 11607-2 requirements
- Recent A1:2023 updates
Packaging Design and Materials
- Packaging system design
- Material selection criteria
- Packaging configurations
- Usability and aseptic presentation
Risk Management
- Packaging risk management requirements
- Foreseeable misuse
- Design controls and risk mitigation
Packaging Validation
- Documentation requirements
- Worst-case rationale
- Sample size considerations
- Validation plans
Qualification Activities
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Packaging Test Methods
- Visual inspection
- Seal strength testing
- Dye penetration testing
- Bubble emission testing
- Burst and creep testing
- Microbial barrier evaluation
Packaging Performance Evaluation
- Transport validation
- ASTM D4169
- ISTA methodologies
- Distribution and environmental conditioning
Shelf-Life Validation
- Accelerated aging
- ASTM F1980
- Real-time aging considerations
Change Management and Revalidation
- Process changes
- Material changes
- Revalidation triggers
Common Validation Pitfalls
- Typical audit findings
- Common industry mistakes
- Best practices
Sterile packaging is a critical component of medical device safety and performance. An effective packaging system must maintain sterility, protect the device throughout distribution and storage, and allow safe aseptic presentation at the point of use. Regulatory authorities and notified bodies increasingly scrutinize packaging validation activities as part of technical documentation and quality management systems.
This intensive one-day training provides a comprehensive overview of the requirements of EN ISO 11607-1:2020/A1:2023 and EN ISO 11607-2:2020/A1:2023, together with relevant MDR 2017/745 requirements. Participants will learn how packaging design, material selection, usability, risk management, and validation activities contribute to maintaining sterile barrier integrity throughout the product lifecycle.
The course explains packaging process validation principles, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Attendees will understand how to establish validation strategies, define worst-case conditions, justify sample sizes, implement risk-based decision-making, and document compliance effectively.
In addition, the training covers common test methods used for sterile packaging evaluation, including visual inspection, seal strength testing, dye penetration testing, bubble emission testing, microbial barrier assessments, transport simulation, and accelerated aging studies. Practical examples demonstrate how test methods support proof of compliance and regulatory expectations.
Through expert instruction, interactive discussions, knowledge checks, photographs, and real packaging examples, participants will develop the confidence to design, validate, maintain, and improve sterile packaging systems while meeting current international standards and regulatory requirements.
Upon completion of this training, participants will be able to:
- Explain the role and function of sterile barrier systems and packaging systems
- Interpret key requirements of EN ISO 11607-1 and EN ISO 11607-2
- Understand MDR requirements related to sterile packaging
- Apply risk management principles to packaging design and validation
- Select appropriate packaging materials and packaging configurations
- Define validation strategies for forming, sealing, and assembly processes
- Execute IQ, OQ, and PQ activities for packaging processes
- Develop worst-case rationales and sampling approaches
- Select appropriate packaging test methods
- Evaluate packaging integrity, seal strength, and microbial barrier performance
- Plan transport validation and shelf-life studies
- Establish documentation required for regulatory submissions and audits
- Assess packaging changes and determine revalidation requirements
Participants will:
- Understand current EN ISO 11607-1:2020/A1:2023 and EN ISO 11607-2:2020/A1:2023 requirements
- Interpret MDR 2017/745 packaging-related requirements
- Learn how to design compliant sterile packaging systems
- Understand packaging material selection criteria
- Implement risk-based packaging validation approaches
- Establish robust IQ/OQ/PQ packaging process validations
- Select and justify appropriate test methods
- Understand transport validation principles
- Develop shelf-life and accelerated aging strategies
- Improve documentation and technical file readiness
- Reduce compliance gaps and audit findings
- Learn from practical examples, visuals, and real-world packaging failures
This instructor-led training combines:
- Expert-led presentations
- Practical industry examples
- Real packaging case studies
- Visual demonstrations and photographs
- Interactive discussions
- Knowledge checks and polls
- Group exercises
- Question-and-answer sessions
The course focuses on practical application and interpretation of standards to support implementation in daily professional activities.
All "in-person" events of this training will be held in:
Location: InterContinental Houston, 6750 Main St, Houston, Texas
All other sessions will be held online as virtual classroom trainings.
- The contents of the training correspond to the current status of revision/harmonization.
- Participants will receive a certificate of attendance from the TÜV SÜD Academy.
No formal prerequisites are required.
However, basic knowledge of:
- Medical device manufacturing
- Quality management systems
- Regulatory requirements
- Sterilization processes
is beneficial but not mandatory.
What standards are covered in this training?
The course covers EN ISO 11607-1:2020/A1:2023 and EN ISO 11607-2:2020/A1:2023, as well as relevant requirements from MDR 2017/745.
Does the course cover both packaging design and packaging validation?
Yes. The training covers packaging system design, material selection, usability, risk management, and process validation activities.
Is transport validation included?
Yes. Transport validation concepts and methodologies, including ASTM D4169 and ISTA approaches, are discussed.
Does the training explain IQ, OQ, and PQ?
Yes. Participants learn the purpose, requirements, and practical implementation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Will packaging testing methods be covered?
Yes. The course reviews visual inspection, seal strength testing, dye penetration testing, bubble emission testing, burst testing, microbial barrier testing, and other commonly used methods.
Does the course address shelf-life validation?
Yes. Accelerated aging (ASTM F1980), real-time aging principles, and shelf-life considerations are covered.
Is risk management included?
Yes. Particular attention is given to the new ISO 11607 A1:2023 risk management requirements.
Does the course include practical examples?
Yes. Participants benefit from numerous real-world examples, photographs, visual demonstrations, and case-based discussions.
Is this course suitable for beginners?
Yes. The course is suitable for newcomers as well as experienced professionals seeking to deepen their knowledge.
Will I receive a certificate?
Participants receive a Certificate of Attendance from TÜV SÜD Academy.
Carsett Webber, Product Expert at TÜV SÜD.
With over six years of experience in sterilization and packaging validation compliance for medical devices, Carsett Webber specializes in helping organizations navigate complex regulatory requirements to ensure safety, quality, and market readiness. Carsett is known for her collaborative approach, working closely with clients to deliver effective, compliant, and practical solutions.
Location for in-person deliveries: InterContinental Houston, 6750 Main St, Houston, Texas