Shelf life studies for Sterile Barrier Systems of medical devices

The ASTM F1980 standard provides guidance on conducting accelerated aging testing for medical device Sterile Barrier Systems (SBS) as a whole, with or without devices. These studies help manufacturers assess the effects of time, temperature, and other environmental factors on the integrity of the packaging over its expected lifespan. Aging studies are crucial for many reasons:

Standardization: ASTM F1980 establishes a standardized approach for accelerated aging testing, ensuring consistency and reliability in the testing process. This helps manufacturers, regulatory agencies, and other stakeholders interpret and compare test results reliably.

Assessment of shelf life: Accelerated aging testing allows manufacturers to predict the shelf life of their medical device packages more rapidly than real-time aging studies. By subjecting packages to accelerated aging conditions, manufacturers can estimate how long the packaging will maintain its protective properties under real-world storage and transportation conditions.

Quality assurance: By conducting accelerated aging testing by ASTM F1980, manufacturers can ensure the quality and integrity of their packaging materials. This helps minimize the risk of package failure during storage, transportation, and use, which is crucial for maintaining the sterility and effectiveness of medical devices.

Compliance: ISO 11607-1 states that shelf life studies need to be performed to demonstrate that an SBS is capable of maintaining sterile barrier integrity through claimed expiration dates. Stability testing, using accelerated aging protocols, will be considered sufficient evidence for claimed expiry dates until data from real-time aging studies are available. Many regulatory agencies, such as the FDA in the United States, will allow products to be approved for sale on the market sooner based on the results of accelerated shelf life studies.

In addition, we can provide real-time aging studies in parallel with accelerated aging studies.

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