Medical Device Shelf Life Testing
Medical devices are labeled with an expiration date that is supported by testing shelf-life data. Medistri performs accelerated aging while performing real-time aging tests to generate shelf-life data for medical device manufacturers. This data is used in the product’s design-history files, technical dossiers and 510(k) submissions.
Establishing the right shelf-life study for your medical device is a complex projects that involves different types of tests.
The United States Pharmacopoeia (USP) defines shelf life as “the extent to which a product retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of manufacture.”
It is the duration in which a product’s characteristics can be expected to remain stable. It is important to separate “shelf-life” from a product’s “useful life”. “Shelf-Life” describes a stability expectancy prior to use. The “Useful-Life” is the duration of a product’s viability during the time of use or the number of uses.
Depending at what development-stage of your products you are before you reach Medistri for shelf-life studies, we typically work with our customers to establish the following criteria that are specificic to our customer’s product.
- Storage Conditions.
- Special Components.
ISO 11607–1 defines requirements for sterile barrier system (SBS) material selection as well as design and testing. ISO 11607–2 defines manufacturing packaging process validation requirements for forming, sealing and cleanroom assembly processes. Too frequently, medical device contract manufacturers do not include assembly process validation as part of the equation.
Get started today ➝
In order to test for accelerated aging, we significantly reduce the evaluation time by agin the materials ate elevated temperatures. Depending on the nature of the product (thermal sensitivity, biological materials, etc…), Medistri will design a more thorough accelerated aging testing plan that considers all aspects of product requirements.
There are multiple risk-areas to consider to asses the shelf life of a medical device. These include:
- Sterility Challenges
- Packaging Integrity Challenges
It is important to design a testing methodology that considers these endpoints. Medistri’s in-house laboratory provides its customers with temperature and humidity controlled chambers for performing accelerated aging tests within a monitored and controlled environment. Our infrastructure allows us to test different product types, materials & sizes. The most common condition for shelf-life studies are 55°C without added humidity but other non-standard temperatures and relative humidities are also available depending on product specifications.
Designing a accelerated aging testing plan to determine the shelf-life of a product depends on the product specifications and product requirements. At Medistri, we consider both internal & external complexities:
- Components interactions (Internal)
- Material Degradation (Internal)
- Manufacturing (External)
- Sterilisation (External)
- Shipping & Storage (External)
At Medistri, we can help preventing any adverse health effects or damage that may occur due to the use of expired devices through shelf life testing, guaranteing the safety and efficacy of medical devices and, ultimately, ensuring that medical devices' quality remains intact and patients are protected.
Medistri's contract Laboratory is located in the heart of Switzerland to continuously serve the countries most innovative universities, research institutes, start-up companies & large enterprises from the Pharmaceutical, MedTech & BioTech industries.
The validation of packaging stems from the need to ensure the quality of products across the many steps in your distribution cycle: from shipping to storage. It is indeed an increasingly common requirement for many product categories, including a strong emphasis on the packaging quality requirements for medical and pharmaceutical industries.
Our Quality Certificates
Explore our list quality certificates and discover why the world's most innovative healthcare companies choose to work with Medistri.
Are you ready to get started?
Contact us and our qualified team will respond.