Packaging Engineering Support

Oliver’s global packaging team specializes in healthcare packaging across the medical device, diagnostics, pharmaceutical, and biopharmaceutical industries. With over 125 years of combined technical experience, the team provides support through custom packaging design, regulatory compliance of ISO 11607, and troubleshooting with defect analysis. Our packaging engineering support is available virtually, in person at one of our regional technical centers, or at a customer site. Partner with Oliver today to leverage our industry-leading packaging innovations and proven success.

Design & Development

Our expert healthcare packaging team will collaborate with you to create the ideal solution.

Get started with these commonly asked questions:

1. Size, Weight & Geometry: Is the size of the package appropriate for the product? Does the product have any sharp components or rough edges that could damage the packaging and cause a breach in the sterile barrier?
2. Material Selection: Are your materials compatible with the intended sterilization process? Are any specific barrier properties required? Is the product sensitive to light, moisture or oxygen?
3. Aseptic Presentation Method: Does your packaging need to be peelable or tear open to ensure proper aseptic transfer?
4. Packaging Configuration: Will the product be exposed to any climates, altitudes or handling methods that could affect the package during transit? Is your product configuration, including the primary, secondary and tertiary packaging, set up to survive distribution?

DISK Award Winning Design - CleanCut Card

Prototyping

We’ll generate a prototype package for your review, and refine it to meet your exact needs.

Refine your design with these commonly asked questions:

Rightsizing: Have you selected the proper materials to avoid defects like seal creep, channels, punctures, abrasion, and flex cracking?
Design for Manufacturability: Have you carefully evaluated all processes to monitor for efficiency? Is the packaging solution quick and easy to assemble?
Sustainability: Does your solution meet your sustainability initiatives?

Reflow medical cleancut card development

Validation

Your solution is now ready for validation! Our packaging is designed to help you pass sterilization and distribution testing the first time.

Ensure your packaging is ready with these additional commonly asked questions:

Sealing Process: Do you have a repeatable and reproducible heat-sealing process in place to ensure consistency in your end package? If not, do you need to adjust temperature, dwell time, or pressure in your sealing process?
Shelf-Life: Have you validated your sterile barrier system meets the intended shelf life of your device? Have you considered the temperature, humidity and other conditions of where your final product will be stored?
Compliance: What are the specific regional regulatory requirements for your sterile barrier packaging?

Production

When you're ready to go to market, you can trust that your packaging is manufactured in our controlled environments or certified cleanrooms for superior quality—with a reliable partner by you side to help navigate any challenges along the way.

Before you go to market, mitigate your ISO 11607 compliance risk with these 5 considerations:

Worst Case Rationale: Consider weight, geometry, distribution environment and device fragility when writing a worst-case rationale.
Sample Size: Your sampling plan is dependent on many factors including your distribution test method assurance level, risk level from failure mode and effective analyses, and confidence and reliability requirements. What are your organization’s tolerance levels? What sample size plans have you used and justified for previous products?
Conditions for Accelerated and Real Time Aging: Be able to justify your temperature for accelerated aging and temperature and humidity requirements for real time aging/stability. What is your organization’s definition of “ambient”? Can you obtain real time aging data from your supplier?
Minimum Seal Strength Specifications: Minimum specification requirements are dependent on many factors and are continually challenged within the industry. Does your company follow the 1 lb. minimum? What seal strength does the weight of your product require from your packaging?
Label Legibility: Legibility can be subjective, follow a standardized test method or use an in-house test method that has been validated. Have you considered your label legibility after distribution testing?