In the medical device industry, where the stakes are high and patient safety is paramount, ensuring the quality and reliability of products is crucial. From pacemakers to surgical instruments, the integrity of these devices can directly impact patient outcomes. Testing laboratories like Purple Diamond have implemented various testing methodologies to assess the shelf life of these medical devices and ensure their efficacy when they reach the end user. One such method that has gained popularity among industry professionals is Accelerated Shelf-Life Testing (ASLT), a critical tool for predicting the performance and safety of these life-saving devices over time.
What is Accelerated Shelf-Life Testing?
Accelerated Shelf-Life Testing, defined by the ASTM F1980 standard, is a scientific technique that accelerates the aging of a medical device or its packaging material in a controlled environment, simulating the real-time degradation process. The purpose of ASLT is to predict the product’s shelf-life based on accelerated aging and subsequently determine the applicability, effectiveness, and safety of the device.
Accelerating Shelf-Life Testing: The Process
To conduct an accurate ASLT for medical devices, manufacturers must follow a systematic approach:
- Sample Selection: Representative samples of medical devices or packaging materials are selected, considering their diversity, manufactured batches, and potential exposure to various environmental conditions during their shelf-life.
- Accelerated Aging Conditions: Parameters such as temperature, humidity, and light exposure are carefully determined to create accelerated aging conditions. These conditions should reflect and simulate real-world scenarios that the medical device might encounter during its lifespan.
- Testing Durations: Based on the desired shelf-life of the product, testing durations are determined. Accelerated aging can compress several years of real-time aging within a few months, significantly reducing the testing time.
- Monitoring and Evaluation: Throughout the testing process, the samples undergo regular analysis and testing to assess various performance characteristics, such as mechanical strength, material integrity, sterility, or chemical stability. This helps evaluate the product’s quality and safety throughout its shelf-life.
- Data Analysis and Extrapolation: The collected data is analyzed to predict the shelf-life of the medical device under real-time conditions. Statistical models and algorithms are used to extrapolate the accelerated aging data, providing valuable insights into the product’s performance and integrity.
The Benefits
Accelerated shelf-life testing is preferred by manufacturers for a variety of reasons, including compliance, risk assessment, and cost reduction.
Accelerated shelf-life testing for medical devices isn’t a “nice to have.” It is required by ISO 11607 for packaging and ISO 13485 for quality management systems. ASLT enables manufacturers to provide the necessary data to demonstrate compliance with these standards.
ASLT also aids in assessing potential risks associated with the product’s shelf-life, such as deterioration of mechanical or electrical components, loss of sterility, or degradation of packaging integrity. By identifying potential risks, manufacturers can implement appropriate measures to mitigate them and ensure patient safety.
Finally, by employing ASLT, medical device manufacturers can shorten the testing duration and avoid the need for long-term clinical trials. This saves both time and resources, allowing manufacturers to bring their products to market faster and more efficiently.
Accelerate Success with Purple Diamond
With the ever-growing demand for innovative medical devices, ASLT provides manufacturers with the means to bring their products to market faster, without compromising on quality or patient safety. By investing in ASLT, manufacturers can demonstrate the longevity and efficacy of their products and instill confidence in healthcare professionals and patients alike.
Ready to get started? Our team at Purple Diamond offers accelerated shelf-life testing for medical devices within our ISO-certified lab. With over 20 environmental chambers, a team of experts with decades of experience, and certifications in both ISTA and ASTM testing standards, we have the knowledge and skills to help ensure the safety and sterility of your product. Contact us to request a free quote or consultation.
