What exactly is the ASTM F 1980 - 16 (21) ?
It is simply the American Standards for Test and Measurement whereby biomedical products such as endoscopes, contact lenses (for example) must subject these products for 2 types of tests :
a) accelerated aging
b) shelf life testing.
What is Accelerated Aging
The standard (you can purchase it online) gives a detailed 5 page formula derived assertion that IF you wish to know how your products will age during its shelf life, the manufacturer must subject it to a test called accelerated aging.
In essense, if the product's shelf life is 5 years (or 60 months), and it sits idle in the storage facility of the doctor's clinic, the standard asserts the following :
> Temperature (storage) : 25 C
> Humidity (storage) : 50%
The product must be subjected to a 10 C increase in temperature, for it to 'age' by 1/2 or the shelf life shortens by half. In this case, 30 months. So at 35 C, the shelf life is 30 months
If another 10 C increase is added to the storage temperature, then the shelf life shortens another 1/2 or 15 months. At 45 C, the shelf life is 15 months.
If another 10 C increase, the shelf life becomes 7.5 months. At 55 C, the shelf life is 7.5 months.
Now, ordinarily you would think Voila !, increase another 10 or 20 more C and you get 3.75 months and 1.875 months respectively.
Well, most biomedical products have Styvek polymer seals, and it will literally melt above 60 C, so practically it is not advisble to do accelerated aging for biomedical products above 60 C.
Most manufacturers would purchase a stability chamber which can do either of the most common accelerated aging tests.
Temp : 55 C
Humidity : 50%
OR
Temp : 50 C
Humidity : 50%
Want to learn more ?
Speak to the experts at QRA International Pte Ltd.
Email : mark@qra.com.sg (Asia)
reypereira@qra.com.sg (Europe)
We would be happy to discuss your test requirements and advise you in detail.
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