Case Study: Enhancing the Durability of Medical Packaging for a Major Manufacturer

Micom Laboratories offers comprehensive packaging testing services to manufacturers in Canada and the United States. We take pride in contributing to the success of various industries, including the medical sector, by providing tests such as accelerated aging of sterile barrier systems (ASTM F1980) and tests for determining the effects of high altitude on packaging (ASTM F6653) combined with ISTA 3A tests (which simulate the distribution of small packages).

Today, I present you with a case study on the integrity of medical device packaging at high altitude, which was carried out on behalf of a medical device manufacturer.

Client Background

The client is a renowned global medical device manufacturer known for its innovation and high-quality products. Packaging plays a crucial role in this industry as it ensures the sterility and safety of devices during transport and handling.

Problem: The manufacturer needed to ensure that its new packaging met strict regulatory standards. The main challenge was to ensure that the packaging maintained the sterile integrity of the medical devices during transport, particularly in challenging conditions like those encountered at high altitudes. We had to combine this test with the requirements of the ISTA 3A standard, which includes, among other things, drop and vibration tests, all of which could puncture the packaging and cause non-compliance.

Challenge

Main Challenge: With the launch of a new range of medical devices, it was essential to prove that the packaging could withstand various distribution conditions while ensuring sterile protection over a 5-year shelf life.

Specific Conditions: The manufacturer faced difficulties with packaging performance during high-altitude flights, where pressure variations risked compromising product integrity.

Objectives

• Compliance Standards: Ensure that the packaging meets industry standards and the FDA’s stringent requirements.
• Durability: Validate the durability of packaging materials over a 5-year shelf-life by conducting accelerated aging tests and then simulating the distribution environment, including depressurization due to high-altitude flight.
• Damage Reduction: Reduce the damage rate of medical devices during transport, aiming for a decrease from 12% to less than 1%.

Solution Provided by Micom

Micom Laboratories designed a custom testing plan to evaluate the durability of the packaging under extreme conditions.

Collection process: We conducted a series of rigorous tests using climatic chambers to accelerate the aging of products in their primary packaging and simulate extreme transport and storage conditions.

Tests Conducted: Tests included accelerated aging (in accordance with ASTM F1980), high-altitude testing (ASTM D6653), and distribution testing (ISTA 3A). These tests aimed to replicate the real-life conditions the products would experience throughout their lifecycle.

Key Results

The results showed a significant improvement in packaging durability, allowing the manufacturer to validate the sterile protection of its products during transport and over the entire shelf life.

• 25% Improvement: Packaging durability increased by 25%, meeting all regulatory requirements.
• Damage Reduction: The damage rate during transport was reduced from 12% to less than 1%, significantly reducing losses for the client.
• Regulatory Compliance: The packaging met all relevant testing standards for storage and distribution and received accelerated FDA approval, enabling faster time to market.

Evaluation and Recommendations

This project highlighted the importance of a proactive approach to durability testing, particularly for specific transport conditions like high-altitude flights, while considering aging factors due to extended storage.

It was recommended that the client continue monitoring packaging performance under different transport conditions to anticipate any potential new challenges.

Conclusion

Thanks to Micom Laboratories’ expertise, the medical device manufacturer successfully overcame its challenges and ensured that its products reached end-users safely.

To learn more about how Micom Laboratories can help you achieve similar results, contact us today to discuss your packaging testing needs.