How long is your shelf life? Just curious because in my experience 1 month of accelerated aging is almost equal to 1 year of real time aging. As such, if your shelf life is 3 years you should still be able to comply with the standard. I'm not sure what type of device you are working on but at my company, for single use medical devices, we usually submit marketing applications with 6 months - 12 months as our shelf life while simultaneously conducing additional accelerated and real time studies to justify a longer shelf life.
Alternatively, you could put 2x the amount of product required for the accelerated aging study and pull one batch out at some intermediate time (say after 1-2 years equivalent) and see how things are going. If the testing is good, you could continue testing with the second set and start your real time aging with more confidence.
Our in house test lab can perform this testing for you and help answer any additional question you may have.
------------------------------
Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Company Website:
www.biotexmedical.comTest Lab Website:
https://www.biotexmedical.com/criterion/------------------------------
Original Message:
Sent: 20-Dec-2022 09:43
From: Dan O'Leary
Subject: Aging Studies - Accelerated vs Real time aging
Thank you for the text.
I think it provides an answer to the question.
Start real-time aging before commercialization. I take this mean the first pre-market authorization from any regulatory region. (You could get the US before the EU, for example.)
Begin accelerated aging within three months of real-time aging.
This must mean "Begin accelerated aging within three months of the start of real-time aging"
Within doesn't mean after the start of real-time aging. It establishes a plus/minus three-month window.
In your design plan, lay out a timeline for the start and end of real-time aging. Also lay out a timeline for the start and end of accelerated aging. These timelines need to support the project and not be arbitrary.
If the two starts are within three months of each other, you are done.
If the two starts are not within three months of each other develop and document an alternate rationale.
I have no clue as to why the authors would create such an arbitrary rule. The good news is there is an escape hatch, so you don't need to follow it if it interferes with the project.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 19-Dec-2022 22:09
From: Anonymous Member
Subject: Aging Studies - Accelerated vs Real time aging
This message was posted by a user wishing to remain anonymous
I can share BS EN ISO 11607‑1:2020 clause 8.3.4: "If accelerated aging is conducted, it shall begin within three months of real-time aging, unless an alternative rationale has been developed. Real-time aging shall be started prior to commercialization."
Original Message:
Sent: 19-Dec-2022 09:44
From: Dan O'Leary
Subject: Aging Studies - Accelerated vs Real time aging
It would be great if somebody were to post the text of ISO 11607-1:2019, 8.3.4.
The discussion seems to hinge on "within" three months. This looks like a 6-month window ± 3-months and doesn't state the order in which the studies start.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 15-Dec-2022 05:49
From: Anonymous Member
Subject: Aging Studies - Accelerated vs Real time aging
This message was posted by a user wishing to remain anonymous
Hi,
we are having an intense discussion right now regarding of aging studies. ISO 11607-1:2019 requires in 8.3.4 that, if accelerated aging is conducted, it shall be started within 3 months of the RT study. But what is the background for this requirement? Is it also possible to begin with accelerated aging? I mean, if you fail here, you wouldn't start RT anymore. Or am I seeing this requirement too strict?
Best Regards