Shelf Life and Accelerated Aging - Biomedical and Pharmaceutical Products

Every medical device is required by law to be labelled with an expiration date. The key question to every consumer is this. What exactly is an "expiration date" ? Is the performance of the device guaranteed  to be the same up until that magical date and then falls off dramatically after that ?

How do the manufacturers 'know; that the devices or products can really last that long ?

Thats where the decades long studies and the international standards have been put forth out in the market by top standards bodies such as ASTM (ASTM F 1980 - 21) and ISO (ISO 11607-1) for the US and European markets - the 2 largest consumer markets in the world for such products.

Testing your products and accelerating the aging of your products lends you credibility when you have the product rubber stamped on the box.

The test strategy for any biomedical or pharmaceutical company wanting to attain permission from  the FDA or the European market is to perform these aging tests by either : 

a) procuring accelerated aging chambers 

b) outsourcing these aging tests 

and conducting these tests.

For many biomedical devices that are manufactured from metals and robust plastics, the evaluation time for a product's shelf life  can be significantly shortened by aging the materials at elevated temperatures (as high as 70 C can be set).

Other products, such as biologic materials or products made of thermally sensitive materials, require a more thorough aging study design with environmental chambers relevant to more unique product requirements. 

Choose QRA International - the only Lab in Asia DEDICATED to 

ASTM F 1980 - 21   (for application for FDA approval to sell in USA market)

and ISO 11607 - 1   (for application to sell in the EU market) 

1. Establish product shelf life under both accelerated and real time conditions.QRA offers both test conditions at our 2 State of the Art Laboratories in Singapore and we are exploring setting up new Labs in Australia and USA. 

      An example : 

     Accelerated Aging in Chamber                              Real Life Test in Chamber

    55 C 50%    -  4.5 months         Equivalent to :          25 C 50% - 36 months (3 years)

2. Meet regulatory requirements following the ISO 11607 - 1 and ASTM F 1980 or any custom testing protocol needed to establish your products expiration date.

3. Start, Monthly, Weekly and End Test Reports backed by ISO 9001 : 15 traceability sent to you by email.

4. Additionally, QRA International provides comprehensive post tests, such as Peel and Bubble Tests to determine Sterile Barrier Hermiticity and package integrity

QRA also sells these shelf life testing chambers under our QRA brand. 

For more information, contact :

Tel :(65) 6795 1486

www.qra.com.sg

Email : 1. qrasales@qra.com.sg

            2. mark@qra.com.sg

There is never a better time to improve your products branding. Talk to the experts today. 

                            Laboratory 1 at Toh Guan Centre, 04 -2 Toh Guan Road East

                                                                   Singapore 608609