Medical Device Packaging Testing

Medical device packaging testing is to verify and test the performance of packaging in a laboratory. Registration data for medical and medical products are required to include the results of packaging studies to demonstrate the safety and effectiveness of the contents after delivery, transportation, storage and until use.

ISO 11607 requires medical device packaging systems to withstand transport and distribution environments, such as vibration, temperature and humidity, without having any effect on the performance and characteristics of medical devices.

About Us

We provide medical device packaging testing services based on regulatory standards to help manufacturers demonstrate that packaging consistently ensures product safety and effectiveness.

Our company provides a range of testing services, including packaging testing, for the premarket application of medical devices to ensure compliance with regulatory requirements. With our medical device packaging testing, manufacturers are able to eliminate safety hazards and medical accidents caused by packaging failures through measurements of material properties, packaging tightness, seal strength, and other factors.

Our accredited laboratory has one-stop medical device packaging testing capability. Our testing experts have extensive medical device industry expertise and are committed to providing comprehensive packaging testing solutions. The final test report we deliver to our customers contains complete, accurate, traceable data, fully demonstrating the compliance of the device and its packaging to withstand stringent environmental challenges. Our testing and validation services are based on ISO 11607 and related ASTM standards and comply with regulatory requirements.

Our Services

• Package Validation Testing

Package validation tests assess the integrity, airtightness, and microbial barrier properties of medical device packaging to ensure its safety and reliability. We provide medical device packaging validation tests to verify that packaging can maintain the required performance throughout its life cycle, protecting the internal product from any external contaminants. The tests we provide include but are not limited to:

• Visual inspection
• Peel strength testing
• Burst testing
• Dye penetration testing
• Creep testing
• Bubble emission testing

• Distribution Simulation Testing

Medical devices encounter various environmental and physical conditions as they move from their manufacturing sites to their final destination. Distributed simulation testing is a widely accepted and reproducible method of assessing the ability of medical device packaging to withstand such conditions. We use laboratory equipment to simulate a range of hazardous elements that packaging systems might encounter in a variety of distribution environments. We provide the following distribution simulation testing services.

• Drop
• Vibration
• Compression
• Concentrated impact
• Vacuum (low pressure)

• Stability Testing

The packaging stability tests for medical devices we provide are divided into accelerated stability tests and real-time stability tests. Our expert team relies on rich testing experience to study packaging materials and their related degradation mechanisms, so as to correctly design test items, test methods and criteria. As an example, we investigate accelerated aging temperature conditions and environmental relative humidity during the test. Stability testing only evaluates the relative properties of the product over time.

With increasingly stringent regulations, manufacturers must follow rigorous medical device packaging testing processes to obtain the required reports for product application. Our company understands the complexity of the medical device industry and we follow regulatory standards to conduct comprehensive packaging testing to help manufacturers achieve compliant medical device packaging systems.

If you need help or have a question, please feel free to contact us for more details.