Medical devices need to reach patients in the most pristine condition to ensure safety and reduce the risk of unintended infection. Testing the integrity of medical device packaging is a crucial step in ensuring devices are transported and stored without being compromised, and two regulatory standards are the gatekeepers to making sure this is done as thoroughly as possible.
The ASTM F1980-21 standard is the cornerstone of these efforts. It gives manufacturers the methodologies to simulate the aging process affecting their products and packaging, allowing them to predict the product’s shelf life.
ASTM D4169-23, revised in 2023, plays the same role for final packaging systems, ensuring medical devices can withstand the rigorous transportation process. Complying with these two standards helps the medical device manufacturing industry adhere to the strictest safety levels. Manufacturers must understand and meet these standards.
What are accelerated and real-time aging studies?
Accelerated aging studies examine the longevity and effectiveness of medical device packaging and allow manufacturers to evaluate the impact of time on the integrity of packaging materials and their ability to maintain a sterile barrier.
The studies mimic the effects of natural aging in a shortened period. They expose packaging materials to elevated temperatures and humidity levels to simulate the passing of time. ASTM F1980-21 outlines the controlled stress conditions required to determine how a product will stand the test of time.
The specific testing conditions are chosen based on the characteristics of the packaging material, and they can vary greatly. They are designed to accelerate the materials’ reaction rate, giving manufacturers a snapshot of how the product might age over weeks, months, or years.
Although accelerated aging tests give manufacturers a quick analysis of how materials behave under stress, they can’t wholly replicate actual aging. This is why it’s crucial to conduct real-time aging studies concurrently to validate the long-term integrity of the packaging.
How humidity impacts accelerated aging studies
Humidity affects various packaging materials and medical devices, especially polymers, which are widely used because of their versatility and durability.
Polymers exhibit varying behaviors under different humidity conditions. For example, high humidity can lead to hydrolysis, where water molecules interact with polymer chains, potentially causing a loss of mechanical strength, changes in color, and other physical alterations.
Manufacturers must fully understand the material-specific reactions to humidity. This helps set appropriate accelerated aging conditions, simulating a product’s challenges during its market life. Precise humidity controls in accelerated aging protocols enable manufacturers to accurately predict the performance of packaging in the real world, leading to safer and more reliable medical devices.
The crucial role of ASTM D4169-23
ASTM D4169-23 is the sister standard to ASTM F1980-21 and regulates how packaging systems perform. The tests required by the standard simulate a variety of physical factors that affect packages when they’re being transported. These factors reflect the real-world challenges faced during transportation, including:
- Compression
- Vibration
- Impact
- Exposure to different climatic conditions
ASTM D4169-23 seeks to guarantee the packaging system maintains its integrity and protective capabilities no matter what they encounter during the distribution process. Like ASTM F1980-21, this standard can also change, so manufacturers need to stay current with requirements to mitigate risks associated with distribution and ensure their products reach patients in optimal condition.
Staying ahead of change
To ensure they stay ahead of regulatory changes, device manufacturers should remain vigilant and proactive by engaging with regulatory bodies, staying updated through professional development, and participating in industry workshops.
Regulatory changes often focus on maximizing patient safety and product reliability, which can require manufacturers to revise their existing testing protocols or follow entirely new ones. Keeping ahead of these adjustments can help minimize potentially costly and frustrating disruptions and ensure regulatory compliance.
For example, ASTM D4169-23 was last revised in 2023, and the change increased the default shipping density factor to 12 lbs./ft3 from 10 lbs./ft3. This increases the vehicle stacking top load required for a shipper configuration. The latest change to ASTM F1980-21 recommends introducing relative humidity to accelerated aging protocols.
A final word
Both standards are crucial in ensuring medical devices reach patients safely. When regulations change, manufacturers can find it tricky to navigate the new landscape, especially if they don’t have extensive facilities or expertise in regulatory compliance. Trusted lab partners offer specialized testing services and help manufacturers interpret and implement updated standards. This ensures that medical devices remain compliant and competitive in a market where safety and durability are paramount.
