Physical & Packaging Testing

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Comprehensive Physical, Functional & Packaging Testing for Medical Devices & Combination Products and Pharmaceuticals

Accelerate your medical device’s path to market with Cormica’s rigorous Physical & Packaging Testing solutions. Our experts validate your device’s functionality, durability, packaging integrity, and safe transport, ensuring product performance, patient safety, and regulatory compliance throughout development and distribution.

Testing Excellence You Can Trust

Cormica’s Physical & Packaging Testing services are conducted in accordance with ISO 17025 standards. This accreditation underscores our dedication to reliable data, robust testing protocols, and compliance with industry-leading practices.

Request a call back from our team to learn how Cormica can safeguard your product’s success.

Experienced Device Testing and Packaging Validation

Physical & Mechanical Device Testing

Design Verification & Validation Testing

ISO 11608
ISO 11040
ISO 80369
Tensile & Compression Tests
Pressure & Vacuum Tests

Needle Injection Systems

Design Verification Testing
ISO 11608
ISO 11040
ISO 23907-1
ASTM D6653 Air Transport Simulation
ISO 80369

Parental Containers

ISO 11608-3
ISO 8871-5
ISO 11040-8
USP 1207
- Dye Solution Tightness
- Trace Gas Detection

Physical Testing / Mechanical Testing

Tensile & Compression Tests
Pressure & Vacuum Tests
Flow Rate
Attachment & Detachment Forces
Pre-Conditioning
ISO 80369
Safety Feature Confirmation
- Sharps Bins
- ISO 23907-1
Torque & Axial Forces
Penetration Tests

Device Stability Studies

Real Time & Elevated Conditions
ISO 11608
Tensile & Compression Tests
Attachment & Detachment Forces
Torque & Axial Forces

Ageing, Transit and Packaging Testing

Accelerated Ageing & Real Time Ageing:

ASTM F1980 – Standard Guide for Accelerated Ageing of Sterile Barrier Systems and Medical Devices

Transit Simulation Testing:

ASTM D4169 – Performance testing of shipping containers and systems
ASTM D7386 – Performance testing of packages for single parcel delivery systems
ISTA 3A – Packaged products for parcel delivery system shipment (70kg/150lb or less)

Packaging Testing:

ASTM F1886/F1886M – Visual inspection for flexible packaging
ASTM F88/F88M – Seal strength of flexible barrier materials
ASTM F1140/F2054 – Burst testing of flexible package seals
ASTM F1929 – Detecting seal leaks in porous medical packaging by dye penetration

Meeting Global Standards for Medical Device & Packaging Testing

Cormica’s Physical & Packaging Testing services adhere to the most stringent regulatory requirements and industry best practices, including:

Device Performance & Safety Testing Standards:

- ISO 11608 Series (Needle-based injection systems)
- ISO 11040 Series (Prefilled syringes)
- ISO 80369 Series (Small-bore connectors for liquids and gases)
- ISO 7864 (Sterile hypodermic needles)
- ISO 11607-1 and ISO 11607-2 (These critical standards focus on packaging for terminally sterilised medical devices.)
- EU Medical Device Regulation (MDR) (Ensures compliance with the MDR’s stringent requirements for safety, performance, and documentation throughout your device lifecycle.

Investing in standards-based testing is an investment in patient safety and the success of your medical devices.