Accelerated & Real Time Ageing
Accelerated and Real Time Ageing for Shelf Life Studies
We offer the best in shelf life validation services, including accelerated ageing testing and real time ageing, to support expiry dating, product stability, and regulatory submissions for medical devices, pharmaceuticals, and packaging systems.
Ageing studies are used to evaluate how products perform over time under defined storage conditions. For sterile medical devices, this may include assessment of packaging performance over the claimed shelf life, alongside other material and functional considerations. Ageing data is commonly generated to support shelf-life assignment and risk-based justification in line with recognised standards such as ASTM F1980.
Where ageing studies form part of a wider packaging validation programme, Cormica also provides ISO 11607 packaging validation and sterile barrier system testing.
Ageing and Shelf Life Testing Services
Accelerated Ageing Testing
Standards: ASTM F1980
Accelerated ageing testing exposes products and packaging to elevated temperature and humidity conditions in a controlled environment to simulate the effects of long-term storage over a shorter period. Results are used to support provisional shelf life claims, risk assessments, and formulation or design decisions.
Real Time Ageing
Standards: ASTM F1980
Real time ageing studies evaluate product and packaging performance under defined storage conditions over its intended shelf life. Conducted in parallel with accelerated ageing, real time testing provides definitive evidence of performance and stability over time. This data is essential for final shelf life assignment, regulatory submissions, and ongoing product quality assurance.
Material and Packaging Performance Monitoring
Cormica’s ageing programmes can be integrated with physical and analytical testing to monitor changes in material properties, packaging integrity, and device performance over time. Depending on your product and risk profile.
Reporting and Regulatory Alignment
All ageing studies are supported by comprehensive reporting, including:
- Test protocols aligned to accepted standards
- Clear presentation of results with trend analysis
- Interpretation of performance relative to specification and risk
- Documentation suitable for technical files, regulatory submissions, and quality records
Our ageing testing services are designed to generate evidence that is defensible, traceable, and consistent with regulatory expectations.
What is Accelerated Ageing Testing?
Accelerated ageing testing is used to estimate shelf life by exposing products to elevated environmental conditions, typically increased temperature and humidity, over a defined period. By simulating the effects of long-term storage in a shorter timeframe, accelerated ageing provides early insight into material degradation, performance changes, and potential failure modes.
What is Real Time Ageing?
Real time ageing evaluates how a product, medical device, pharmaceutical, or packaging system performs over its intended shelf life when stored under normal, defined conditions. Real time ageing is typically conducted alongside accelerated ageing to confirm long-term performance and support final shelf-life claims.
Accelerated Ageing Time Calculator
Packaging and Distribution Testing Services
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
