Sunday, May 5, 2024

Biomedical Manufacturers ; Your Products must be Accelerated Aged Tested for ASTM F 1980 - 21

 




The video above shows the Lab (No. 1) in Singapore running 10 test chambers 24 hours 7 days a week for key biomdeical customers from Singapore, USA and Thailand. Accelerated aging is a process in which finished biomedical products are aged in test cabinets called chambers for months for simulate the actual shelf life of the product in their client's storage facility.

If after the aging tests (for every one year of aging test represents 8 years of shelf life in the storage area of hospitals or clinics) defects show it, it is infinitely better to rectify the products in factory rather than endanger the client's patients in the field.

Think of the damage to the brand's reputation if this batch of new (for example) contact lenses causes a major eye defect once the product is sold and distributed globally !

Screening = Accelerated Aging 

The calculation is simple. According to ASTM F 1980 -21 

Storage Temp                    End of Life                             Aging Duration (set at 55 C)    rH

25 C                                    36 months                                    4.5 months                        50%

25 C                                    60 months                                    7.5 months                        50%








QRA performs BOTH Accelerated Aging and Shelf Life Testing 

Lab No. 1 and Lab No. 2

Shelf Life Testing 

Storage                 RH                                Duration

25 C                      60%                                5 Years


5 C                        No.                                 5  Years



Talk to the Professionals : We have over 15 Years Experience Globally in Accelerated Aging Tests (since 2009) 


Email : mark@qra.com.sg

             evalyn@qra.com.sg


Website : www.qra.com.sg





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