Accelerated Aging 2017-04-01T05:55:33+00:00

Accelerated aging

Accelerated Aging follows the well-characterised Arrhenius relationship that states that the rate of a chemical reaction is dependent upon the temperature at which it occurs.
Ageing of polymers is due to slow reactions proceeding slowly over time. Therefore, conditioning a plastic product (e.g. Packaging) at a temperature higher than the usual baseline storage temperature can be used to demonstrate the effect of time on the product in a short duration.

ASTM 1980 Accelerated Ageing of Sterile Barrier Systems for Medical Devices presents an approximation calculation to account for the ageing of plastics when the actual reaction kinetics are not known. These ageing studies are used to bring your product to market sooner than allowed by depending on real time studies alone.

Ageing studies should be assessed in the context of a full package validation, as transport simulations at the beginning and end of the shelf life may also need to be demonstrated.

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Real time aging room

Sabre Medical has a number of controlled conditioning chambers. The standard chamber runs at a temperature of 55°C/ 50% RH. A chamber may also run at 30°C/ 75% humidity for real time tropical ageing. We also maintain a real time ageing room which is controlled at 19-25°C.

real-time-aging-room
We also have policies and validated refrigeration for handling 2-8°C cold chain samples before and after any conditioning of your temperature-sensitive product.

Custom temperatures can be accommodated, so please contact us to see what our chamber availability is as we have quite a few possible chambers.

Typical aging time-points

Tp Time of production
T0 Time immediately after packaging & sterilisation
T1, T2, T3, T5 & T10 1,2,3,5 & 10 years aged equivalent after packaging / sterilisation
R1, R2, R3, R5 & R10 1,2,3,5 & 10 years real time ageing after packaging / sterilisation

Considerations with Accelerated Ageing :

  • What is your baseline storage temperature? 21°C or 25°C are common, but how will you justify this based on your intended storage conditions.
  • Will you calculate shelf life from date of sealing or date of sterilisation? Practically, many companies have an imposed time-limit between manufacture and sterilisation to remove this conundrum.
  • Is the package or product going to be adversely affected by a high temperature? Eg, ageing at 70°C might seem fast, however it is above the glass transition temperature of most polymers.
  • , All test articles for accelerated ageing should be sterilised at least once. The sterilisation date should be included in the test reports. In many cases it is wise to perform a double sterilisation to 55kGy or 2 x ETO Cycles to give confidence in the case of a failed cycle.

Our clients

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Testimonials

“Quality of pouches is critical…The engineers at Sabre Medical are able to provide us with excellent sealing validation testing and data to ensure our packaging validation programs are complete and robust.” More…

Ken Logan, Managing Director, Logikal Health Products Pty. Ltd.

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“They understood our requirements quickly and responded to our timelines immediately. Sabre went over and above to get things to us in a timely manner, meeting all of our quality requirements.” More…

Simone von Fircks, Vice President of Operations, Aroa Biosurgery

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