Design & Testing Considerations

Whether in our lab or in your facility, our healthcare packaging engineers design solutions that reduce costs, improve material performance, increase productivity, and troubleshoot packaging failures. Our experts can help you navigate through the complexities of ISO 11607 and other global regulations to ensure your product gets to market quickly and safely.

ISO 11607 Part 1: Material Selection

Material selection is crucial when designing for your sterile barrier system. Our experts can help you identify the appropriate material for your unique application. 

Consider the following when selecting your sterile barrier system materials: sterilization method; device profile; necessary barrier properties: uv, oxygen, or microbial biocompatibility; labeling options; aging and shelf life; and aseptic presentation.

ISO 11607 Part 1: Design Considerations

There are countless factors to consider for the successful design and aseptic presentation of your sterile barrier system. With decades of expertise, our packaging experts help you get it right the first time. 

Some factors to consider: environmental considerations, user requirements, device profile, shelf life, sterilization method, distribution and climate conditions, packaging equipment, and aseptic presentation.

ISO 11607 Part 1: Design Performance

Although Oliver doesn’t conduct performance or stability testing, our experts use industry best practices and ASTM standards to design your packaging to pass testing the first time.

Performance testing: vibration and drop testing, compression testing, climate conditioning, concentrated impact testing, bridge impact testing, and altitude testing 

Stability testing: aging testing

Integrity testing: dye penetration testing, and bubble leak testing

Seal strength testing: peel test and seal width measurement


ISO 11607 Part 2

Making sure you have a repeatable and reproduceable sealing process is key to meeting ISO 11607 Part 2. Let our experts help you navigate the challenges of sealing validation for expedited results.

Installation Qualification (IQ): Verifies the equipment is installed according to the equipment manual and manufacturers specifications. Including wiring, safety features, and utilities.

Operational Qualification (OQ): Determines the upper and lower manufacturing operating parameters limits that creates a continuous seal that forms a sterile barrier system. This includes verifying the process achieves seal specifications without defects.

Performance Qualification (PQ): Demonstrates a repeatable and reproduceable process under nominal operating conditions as set in the OQ.

No matter what your healthcare packaging requirements or needs are, Oliver offers a wide variety of innovative and cost-effective solutions that provide high-value and superior performance to get you to market quickly.
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Oliver Stock Packaging Program

Whether you need pouches for testing and validation, are starting a new project, or simply require pouches to help cover inventory, we can help you meet your goals with our DuPont™ Tyvek® Pouches. Available in various sizes.

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Additional Resources

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Struggling to meet your compliance requirements?

Whether in our lab or in your facility, our healthcare packaging engineers tailor solutions that reduce costs, improve material performance, increase productivity, and can help troubleshoot packaging failures.
Learn how we can help you comply with ISO 11607.

Looking for an expert in medical packaging?

With an extensive portfolio and decades of experience, we have the expertise to help you get started by selecting the right packaging solution, as well as anticipating and overcoming any challenges you might face in navigating today’s ever-changing healthcare and regulatory environment.
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Still not sure where to start?

From design, testing, and shipping, to storage and usability, it can be a challenge knowing where to start a packaging project. If you are unsure how to begin, contact our experienced packaging development team for assistance.
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Frequently Asked Questions