The video above shows the Lab (No. 1) in Singapore running 10 test chambers 24 hours 7 days a week for key biomedical 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. QRA has been operating its Labs for over 15 years now, successfully serving many top MNC corporations from Japan, Singapore, Australia, Thailand and USA.
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 up, it is infinitely better to rectify the products in factory rather than endanger the client's patients in the field. The cost of refining or reworking the products' reliability and long term efficacy has proven to save companies millions of dollars in brand reputation and perception.
This is many times the difference between success and failure.
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 - 16
For example, if you have a finished product (say daily contact lenses) stored in a box, which has a shelf life of 3 years or 36 months. The ASTM F 1980 - 16 states that for every 10 C increase in storage temperature is equivalent to halving the shelf life. So in essence, if your storage temperature for your box is 25 C, you can send these box samples to a Laboratory like QRA, we will advise you to do accelerated aging for up to 30 C above the storage temperature (that is IF the products inside the boxes can withstand such high temperatures without melting or having immediate material characteristic change) for shorter durations.
The end result of these accelerated agings would be
Shelf Life Temp End of Life Accelerated Aging Temp Equivalent End of Life
25 C 36 months 35 C 18 months
45 C 9 months
55 C 4.5 months
It is NOT RECOMMENDED to stress test or accelerate age test above 60 C for polymer products due to rapid degradation due to melting.
QRA performs BOTH Accelerated Aging and Shelf Life Testing
Lab No. 1 and Lab No. 2
Shelf Life Testing
Storage RHDurationWhat is Simulates
25 C 60%5 Years Real Time Storage
5 C No. 5 Years Real Time Storage (Temperate Climate Countries)
Talk to the Professionals : We have over 15 Years Experience Globally in Accelerated Aging Tests (since 2009)
Let me give my viewpoint on the issue of 'chopeing' of empty tables at food courts and hawker centres in Singapore.
Look at this picture above, I am sure you are familiar with this scene. People in Singapore who work in downtown central CBD, or in town like Orchard have the habit of booking or reserving (called 'chopeing' in Singlish) the table for themselves first, and then they go and make an order of their chicken rice, hor fun (dry noodles), wanton mee or nasi bryani.
I think this behavior while it is a solution, is not ideal. I have travelled to many countries in the West and East and I do not see this kind of behavior. Perhaps, in Singapore, we always 'MUST WIN' and having the table at our disposal when and wherever we want before we dine is a necessity.
On the one hand, I think the use of paper tissues wrapped in plastic packets is very unfriendly to the environment, and we have massive amounts of waste to dispose daily, that I will put up in a separate post another day.
On the other hand, maybe if we reduce our 'kiasuness' and stop fighting to 'win all the time' we can actually be a more gracious society in the overall scheme of things.
Let empty tables lie. At the very least, get one person to sit at the table and book the table for the others in that party of (say) 4 or 5.
Secondly, bring back the handkerchief !
(I am hearing howls of protest from the Gen Z and even Millenials).
At the ripe young old age of mine, I firmly believe that if I invest in my health, eyes, ears, internal health, I (God willing) will be able to complete 3 more (at least) marathons.
There are numerous examples of people in their 70s and 80s who run like the wind.
Medical device packaging must maintain integrity
over its claimed shelf-life under the storage conditions specified by the
manufacturer. Real time aging programs provide the best data to ensure that
packaging performance is maintained over the claimed shelf life, although due
to time constraints in the product development process, QRA International also
offers accelerated aging.
These 2 tests are run concurrently so as to provide
accelerated aging results validated by real time benchmarks.
QRA has 16 Chambers available at short notice
Shelf Life Testing
QRA International performs
testing on products at specific intervals over real time storage to provide
accurate shelf life conclusions. However, the drive to get new products to the
market often means that accelerated aging tests are often run in conjunction
with real time aging to validate the product shelf life claims.
Accelerated Aging Testing (ASTM F 1980 and ISO 11607-1)
Our experts will tailor an accelerated aging test
program to your particular requirements. We perform benchmark testing on
products from the same batch before simulated aging to allow comparative
post-aging testing at specified time intervals; a testing process which
includes burst tests, dye penetration assessments, and peel strength testing.
Standards Complied by QRA International’s Labs
QRA International performs accelerated aging
according to ASTM F1980 “Standard Guide for Accelerated Aging of Sterile
Medical Device Packaging” and BS EN 868-8 “Packaging materials and systems for
medical devices which are to be sterilized.”
Additionally, QRA International's labs also test according to ISO 11607 - 1 so we comply with all these international standards, so that your certification is made so much easier.
Here are 2 videos explaining WHY acclerated aging and shelf life testing is SO IMPORTANT now, where customers demand product efficacy, peformance and functionality throughout the entire shelf life of the product, be it 3 years, 5 years of even 8 years.
In this age of recycling and circular economy, we are encouraged to REUSE, RECYCLE AND REFUSE throwing out stuff, hence manufacturers are mindful of :
a) Reusing unused products (off the shelf and not used up to date of expiry) ; the purpose of these accelerated aging studies and shelf life testing then falls on the designer of these products to
> replace the material which has degraded during the shelf life, and implant into the product and ideally REUSE the unsold product at a cheaper price. This way there is no waste.
> RECYCLE also follows the same logic as reuse.
The ultimate goal of the manufacturers is to offer products with the longest shelf life spans, so that there will be much less wastage year on year.
When that happens, losses due to waste is reduced tremendously adding to bottom line savings.
For more consultancy videos, watch this blog AND / OR email to :
Intraocular Lens of all types need to have sterile barrier testing. QRA International provides prompt, cost competitive testing with ISO approved test reports and upholding the highest standards of test protocols for International markets. We do the accelerated aging tests according to :
ASTM F 1980 - 16 (21)
ISO 11607 - 1
for many opthalmic manufacturers worldwide. These tests are standard requirements for biomedical manufacturers of international standing and have been practised and approved by many standards bodies for compliance to international markets like the USA, Europe and Asia.
For more information and consultancy, please email to :
Asia
mark@qra.com.sg
Europe
reypereira@qra.com.sg
USA
tim@qra.com.sg
Australia
clifford@qra.com.sg
and a specialist will be happy to guide you through your test essentials and requirements.
