Medical Device Accelerated Aging: ASTM F1980

Ensure Safety, Shelf Life, and Compliance

Accelerated Aging for

Medical Devices & Pharmaceuticals

Ensure Safety & Compliance from Lab to Market

In an industry where safety and efficacy are paramount, you likely face immense pressure to ensure the integrity of your medical devices and pharmaceutical products throughout their shelf life. This pressure to meet regulatory requirements while maintaining product integrity can be overwhelming.

This is where pharmaceutical & medical device accelerated aging, guided by ASTM F1980, comes into play, offering a standardized approach that simulates the effects of time on medical devices. By understanding and implementing these protocols, manufacturers can confidently address concerns about shelf life, durability, and compliance, ultimately ensuring that their products remain safe and effective for patient use.

What is Accelerated Aging?

Accelerated aging is a method used to speed up the aging process of a product by exposing it to elevated temperatures and controlled environmental conditions. Manufacturers can simulate the effects of years of real-time aging in just a matter of weeks or months. This method allows manufacturers to accurately determine shelf life, meet tight production timelines, and bring products to market faster.

Pharmaceutical & Medical Device Accelerated Aging: The Benefits

Improved Product Development

Ensures Regulatory Compliance

Faster Time-to-Market

Cost-Effective

Purple Diamond is your accredited partner in pharmaceutical & medical device package testing, with expertise across ISTA and ASTM standards.

Contact Us

Want to learn more about our accelerated aging solutions? Fill out the form below!

ASTM F1980: The Standard for Accelerated Aging

ASTM F1980 is a standard method for pharmaceutical & medical device accelerated aging under repeated temperature exposure. It provides guidelines to determine the shelf life of products and their performance over time. There are three types of aging conditions based on temperature ranges: moderate, intermediate, and accelerated. These conditions help to identify the worst-case scenario and predict the shelf life of the medical device.

Our team at Purple Diamond offers accelerated aging for medical devices and pharmaceuticals as part of our packaging compliance and validation services.

The Testing Process

At Purple Diamond, our ASTM F1980 accelerated aging testing process for medical devices and sterile barrier systems is meticulously designed to ensure comprehensive and accurate results. This rigorous approach allows us to thoroughly evaluate the physical properties and integrity of the aged samples, providing reliable data to support shelf life and expiration date claims.

Step 1: Determine the Test Parameters

First, we set the accelerated aging temperature (usually below 60°C) and humidity level. Then, we calculate the accelerated aging factor and determine the test duration to simulate the desired real-time aging period.

Step 2: Prepare the Samples

Next, we select the representative product/packaging samples. We also include control samples for comparison.

Step 3: Conduct Accelerated Aging

The samples are placed in temperature and humidity-controlled chambers and exposed to these elevated temperatures for the calculated duration.

Step 4: Perform Post-aging Evaluation

After testing, our experts assess the physical properties and integrity of the aged samples and compare the results to the controlled samples. We may conduct relevant tests like seal strength and burst testing.

Step 5: Analyze Results

Our team analyzes the results to determine if the aging had any adverse effects on the device’s sterile barrier integrity or performance.

Step 6: Document Findings

Finally, our team prepares a detailed report of the test parameters, methods, and results.

Ready to ensure the longevity and reliability of your medical devices? Contact us today to request a quote or a facility tour.

FAQs: Medical Device Accelerated Aging with
ASTM F1980

Want to learn more? Here are some frequently asked questions about accelerated aging for medical devices and pharmaceuticals.

What temperature should be used for accelerated aging?

Standard ASTM F1980 suggests a temperature no more or less than 60°C/140°F.

How is the accelerated aging time calculated?

Accelerated aging time is calculated with the Arrhenius equation. This calculation uses three factors: the desired real-time aging period, the accelerated aging temperature, and the Q10 value (reaction rate).

What is the recommended humidity level if used?

While humidity isn’t required, it is recommended by standard ASTM F1980. The standard suggests a range of 45-55% relative humidity.

What tests are performed after accelerated aging?

Post-aging evaluation may include package integrity tests such as burst, bubble, dye, and peel testing.

Does accelerated aging replace real-time aging studies?

Accelerated aging will never replace real-time aging. It simply provides an estimate. It is recommended to use both accelerated and real-time aging to determine the most accurate shelf-life.

Why Purple Diamond?

Choosing Purple Diamond for your ASTM F1980 accelerated aging testing ensures you partner with an accredited facility that meets ISO/IEC 17025 standards, providing you with reliable and compliant results. Our state-of-the-art humidity and temperature chambers are designed specifically for evaluating medical devices and pharmaceuticals, allowing us to simulate various environmental conditions accurately. We offer a comprehensive suite of testing services, including integrity assessments and detailed reporting, tailored to your unique needs. With a commitment to innovation and customer satisfaction, our expert team is dedicated to helping you optimize your packaging solutions for maximum reliability and market readiness.

Let's Get Started

Request a quote today and discover how our accelerated aging can protect the safety and compliance of your products.

Email us: sales@purple-diamond.com
Call us: 610.264.5080