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. 

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ISO 11607 Part 1

Material Selection
Design Considerations
Design Performance
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

Aseptic Presentation

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.
Environmental Considerations
User Requirements

Device Profile

Shelf Life
Sterilization Method
Distribution and Climate Conditions
Packaging Equipment
Aseptic Presentation
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

Altitude Testing

Stability Testing

Aging Testing

Integrity Testing

Dye Penetration Testing

Bubble Leak Testing 

Seal Strength Testing

Peel Test

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.
 
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