Sunday, February 6, 2022

Accelerated Aging Tests for Medical Products




This is the video of QRA International Test Laboratory. The company provides accelerated aging for all kinds of test devices including medical products. Here is a view of one of our 2 Laboratories located in western part of Singapore.

Products manufactured in factories will normally have an expiry date set on their packaging. How do the manufacturers know whether their products can actually perform as well as when the day they were made in the factory ? They use stress screening techniques which are basically elevated temperatures and controlled humidities with some reference to the Arrhenius equation. The 'aging' of a product is essentially halves the expiry date for every 10 deg increase in temperature. So if the product is designed to last for 3 years, then for an expected storage life of 3 years, then if it is designed to sit in the store or clinic at 30 deg C (average), the elevated temperature of 40 will mean that the test needs to run for 36 /2 (divide by 2) or 18 months to achieve the same 'aging' than if it was at 30 deg C. At 50 deg C (or 20 deg C above 30), that same aging 'result' will only take 9 months or 18 / 2.

The 'aging' using elevated temperatures and humidities are well documented and recorded in ASTM standards for medical, electronic and pharmaceutical products and devices.

The subsequent tests to determine the extent of the 'aging' is company proprietary and the Lab has no stake in determining those effects.

 

 

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