Determining the exact shelf-life of a medical device is not an estimation; it is a strict regulatory requirement. You must prove that your product remains safe, sterile, and fully functional from the day it is manufactured until its labeled expiration date.
Qualitech International offers comprehensive stability testing programs. By subjecting your devices to precisely controlled environmental extremes, we help you generate robust, data-driven evidence to establish and defend your product’s expiration dating in global markets.
At Qualitech International, our state-of-the-art microbiology laboratories provide rigorous testing for bioburden, sterility, and endotoxins. We deliver precise, undeniable data that ensures your products meet the strictest global regulatory requirements before they ever reach a patient.
Data-Driven Shelf-Life Determination
We remove the guesswork from expiration dating. Our advanced climatic chambers and engineering expertise ensure your stability data is accurate and unconditionally accepted by Notified Bodies.
- Full compliance with ASTM F1980 and ICH guidelines.
- Synchronized accelerated and real-time aging programs.
- Customized testing parameters based on material properties.
- Continuous monitoring with redundant backup systems.
- Integrated post-aging physical and functional testing.
What We Offer ?
Expose products to elevated temperatures to simulate the effects of time rapidly, allowing you to launch products faster with justified initial shelf-life claims.
Store products under actual ambient conditions to run parallel with accelerated studies, providing the ultimate definitive proof of shelf-life over the long term.
Evaluate how exposure to light (UV and visible) affects your device materials, packaging, and active components over time.
Subject devices to rapid extreme temperature shifts to simulate harsh environmental changes during global transport and storage.
After aging, we perform rigorous mechanical and functional tests to prove the device still operates exactly as intended.
Combine stability studies with package validation to ensure the sterile barrier remains uncompromised at the end of its shelf-life.
Why Choose Qualitech International ?
High-Capacity Chambers
Our facility houses massive, highly calibrated walk-in and reach-in chambers capable of accommodating projects of any scale.
Uninterrupted Monitoring
24/7 continuous data logging with backup generators and alarm systems ensures your multi-year studies are never compromised.
Strategic Planning
We don't just run machines; we help you design the most efficient Arrhenius equation models and testing matrices to save time and budget.
Frequently Asked Questions
Have questions about regulatory compliance, market access, or our services?
Here are answers to the most common inquiries from Medical Device and IVD manufacturers.
Can I use accelerated aging data to get market approval?
Yes. Regulatory bodies like the FDA and Notified Bodies accept accelerated aging data for initial market clearance, provided that you run a real-time aging study in parallel to confirm the accelerated results eventually.
How is the accelerated aging time calculated?
We utilize the Arrhenius equation (typically based on ASTM F1980), which uses a Q10 aging factor to correlate elevated temperature exposure to equivalent real-time duration.
Do you test the device itself or just the packaging?
We must test both. A proper stability study evaluates the degradation of the device materials and functionality, as well as the integrity of the sterile packaging over time.
