SAMPLES NEEDED
Confirmed when we scope your test
TYPICAL TURNAROUND
Depends on the shelf life being simulated
You probably need this if
You need to support a shelf-life or expiration date
You’re validating a new sterile barrier system, pouch, tray or lid
Your regulatory submission calls for aged packaging data
What the test involves
01
Aging plan
We calculate the chamber time from your target shelf life, aging temperature and Q10 factor, per F1980.
02
Chamber aging
Packages are held at the aging temperature with humidity controlled where your materials call for it.
03
Check points
Samples are removed at each time point in your plan to evaluate performance
04
Post-aging testing
Aged packages then go through seal strength, leak and/or distribution testing to show the sterile barrier still holds.
What to send us
Sealed packages built exactly as they ship. We’ll confirm how many for each time point.
Design drawings or a packaging specification, if you have them.
Ship to 9708 Industrial Drive, Bridgeview, Illinois 60455.
Not sure the count is right for your configuration? We confirm it with you before you ship anything.
Related standards
Common questions
How is the aging time calculated?
F1980 uses the Arrhenius approach: aging time equals the desired real time divided by Q10 raised to the power of (aging temperature minus ambient temperature) divided by 10. A Q10 of 2 is the most common choice.
What temperature is used?
Higher temperatures shorten the test but can change packaging materials in ways that don’t happen in real storage, so very high temperatures are generally avoided.
Does accelerated aging replace real-time aging?
No. F1980 treats accelerated aging as a way to support a claim sooner. Real-time aging can be run in parallel, and its results take precedence if the two disagree. Gaynes runs both, so both sets of samples are tested the same way at every time point.
Not certain how to plan your aging study?
Send us an email, give us a call, or schedule time to chat. We can answer your questions and let you know which standard applies for your situation.
