Real-time and Accelerated Ageing Testing

What Is Real-Time and Accelerated Ageing Testing?

Real-time and accelerated ageing testing are processes used to determine and verify the shelf life of products, particularly for sterile barrier systems (SBS). Accelerated ageing simulates the effects of time on a product in a shorter period by exposing it to controlled environmental conditions, such as elevated temperature and humidity. This is crucial for expediting the process of getting products, especially medical devices, to market.

Why Is Real-Time and Accelerated Ageing Testing Important?

Alongside accelerated studies, real-time ageing tests are mandatory to confirm the results obtained from the accelerated process, ensuring the expiry dates claimed by manufacturers are accurate and reliable. These tests are fundamental for regulatory compliance, such as for FDA 510k pre-market notification in the United States and CE marking (MDR 2017/745) in Europe, using methodologies following standards such as ASTM F1980.

What Real-Time and Accelerated Ageing Do We Perform?

At Applus+ Laboratories, we conduct comprehensive real-time and accelerated ageing tests to validate the claimed shelf life of your products. Our services are designed to meet the stringent requirements of standards such as ISO 11607-1, the primary document for validating sterile barrier systems.

Our testing process includes:

• Parameter Validation: We begin by validating the appropriate ageing parameters, primarily temperature and humidity, ensuring they are as high as possible to shorten test duration without damaging the packaging or the device itself.
• Controlled Environment Testing: Tests are performed in state-of-the-art climatic chambers equipped with metrological monitoring, ensuring continuous and precise control of temperature and humidity throughout the study.
• Visual Inspections: We conduct thorough visual inspections of the packaging before, during (through intermediate sample extraction), and after the ageing process.
• Integrity Validation: Our studies allow for intermediate samples of sterile packaging to be taken, enabling the assessment of packaging integrity at various ageing points within a single study.
• Functional Checks: While our primary mission is to inspect sterile packaging, clients can also retrieve their medical devices post-ageing to perform functional checks and validate device performance.
• Monitoring: We perform daily monitoring of temperature and % RH.
• Detailed Reporting: Our experts provide systematic technical feedback and detailed reports to the customer.

We also offer a comparison with natural ageing (conducted at 23°C / 50% RH) to provide a comprehensive understanding of product stability. All tests are carried out under our ISO 17025 accreditation (COFRAC).

What Are the Benefits of Real-Time and Accelerated Ageing?

Engaging in real-time and accelerated ageing testing offers several critical benefits:

• Market Access: Expedites the process of bringing new products, particularly sterile medical devices, to market by providing evidence for shelf-life claims required for regulatory approvals like FDA 510k and CE marking.
• Compliance: Ensures adherence to international standards such as ISO 11607-1 and ASTM F1980, along with other regulatory requirements, demonstrating product safety and efficacy over its intended shelf life.
• Risk Mitigation: Helps identify potential issues with packaging integrity or device functionality over time, allowing manufacturers to address these before commercialisation, thus reducing the risk of product recalls or failures.
• Cost Efficiency: While real-time ageing is essential, accelerated ageing provides quicker insights, potentially saving time and resources in the product development cycle.
• Data-Driven Expiry Dates: Provides robust scientific data to support the expiry dates claimed for products, enhancing consumer trust and safety.
• Product Quality Assurance: Validates that the sterile barrier system maintains its integrity and that the medical device within remains functional throughout its stated shelf life.
• Support for Changes: Essential for when manufacturers make changes to their packaging processes or materials, ensuring these changes do not negatively impact product stability.

Why Choose Applus+ Laboratories for Real-Time and Accelerated Ageing Testing?

Choosing Applus+ Laboratories for your real-time and accelerated ageing testing needs provides you with a partner dedicated to quality, precision, and customer satisfaction.

• Accredited Expertise: Our laboratories operate under ISO 17025 accreditation (COFRAC), ensuring the highest standards of testing and calibration, providing results you can trust. Our expertise extends to commonly used standards like ASTM F1980 and ISO 11607-1.
• Regulatory Knowledge: We have extensive experience with regulatory requirements such as FDA 510k, MDR 2017/745, and CE marking, helping you navigate the complexities of product validation for different markets.
• State-of-the-Art Facilities: Our climatic chambers are equipped with precise temperature and humidity controls and continuous metrological monitoring, ensuring reliable and repeatable test conditions.
• Comprehensive Service: Beyond standard ageing tests, we offer comparative natural ageing studies and facilitate functional checks of your devices post-ageing.

By partnering with Applus+ Laboratories, you gain access to a wealth of experience and a commitment to helping you ensure your products meet the highest standards of safety and efficacy.