ASTM F 1980 - 16 a summary

 

What exactly is the America Standard for Test and Measurement and why manufacturers need to test according to this and some other standard ? 

The America Standard for Test and Measurement is a standard for the manufacturers who wish to access US marketplace for their products. Products need to be tested according to stringent test conditions ranging from temperature, humidity, transport conditions, aircraft conditions and a whole host of other conditions to either 

- simulate

- stimulate 

the conditions in which the products are being subjected to, during their shelf life or the expected life of product.

The ASTM F 1980 - 16 focusses on Sterile Barrier mainly meant for the Biomedical or Biotech manufacturers. It states that the products must be subjected to ACCELERATED AGING and then sent back to the factory for assessment on product degradation and efficacy compromisation.

> In a nutshell

1. Products must be subjected to temperatures higher that what the operating shelf life of        the product is expected to be. So it is typical to assume that the products should be stored in temperatures normally (in most tropical and temperate) between 20 to 30 C.

2. There is a formula associated with the accelerated aging but I wont go into the fine details.  However, it follows the Arrhenius assumption that for every 10 C rise in temperature setting, the shelf life can shorten by half. There is an Accelerated Aging factor normally set at 2. The formula is a logarithmic function and to the power of the difference between the set temperature in the oven less the actual shelf life temperature divided by 10.

= Shelf life is 3 years 25 C for 36 months, setting in hot oven at 35 C is equal to 18 months,         45 C is 9 months and 55 C is 4.5 months 

= Shelf life is 5 years 25 C for 60 months, setting in hot oven at 35 C is equal to 30 months,         45 C is 15 months and 55 C is 7.5 months

Humidity setting is typically set in the region of 50 to 60%.

If you require more information, please drop me an email at 

mark@qra.com.sg

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www.qra.com.sg 

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