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WESTPAK ASTM-F1980-21 FAQ v3

The ASTM F1980 standard for accelerated aging of medical devices was updated in 2021. It now recommends controlling humidity during aging if materials in the device degrade with moisture. Most sterile barrier materials are unaffected, but product materials need evaluation. WESTPAK offers accelerated aging chambers at multiple temperatures and humidity levels to meet manufacturers' needs, and real-time aging is still required to set expiration dates. Consult WESTPAK's sales team to determine the best approach.

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560 views2 pages

WESTPAK ASTM-F1980-21 FAQ v3

The ASTM F1980 standard for accelerated aging of medical devices was updated in 2021. It now recommends controlling humidity during aging if materials in the device degrade with moisture. Most sterile barrier materials are unaffected, but product materials need evaluation. WESTPAK offers accelerated aging chambers at multiple temperatures and humidity levels to meet manufacturers' needs, and real-time aging is still required to set expiration dates. Consult WESTPAK's sales team to determine the best approach.

Uploaded by

Brian Wang
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Accelerated Aging Q&A

ASTM F1980-21 Revision


The Accelerated Aging protocol ASTM F1980 was updated in December 2021.
Here, our technical experts address questions that medical device
manufacturers and OEMs will be asking. Please consult with our Sales team to
learn how the changes could impact your medical device and package system.

Environmental Testing What is the background of the ASTM F1980 standard?


at WESTPAK:
The ASTM F1980 standard was initially intended to simulate the aging process of
Accelerated Aging packaging materials for expiration date claims. Based on the Arrhenius equation, the
equivalent real-time aging duration could be accomplished in several months by
Altitude exposing test samples to elevated temperatures. While the standard focused primarily
on the materials used in the sterile barrier system (SBS), the standard was also used for
Environmental
the accelerated aging of products.
Conditioning

ICH What were the general changes to the ASTM F1980 standard?
The F1980-21 revision strongly recommends a thorough understanding of the moisture
Real-Time Aging /
Shelf Life degradation properties of all materials used in the medical device.

Temperature & Accelerated aging studies are typically conducted by elevating the temperature without
Humidity controlling humidity; this works well for SBS materials that do not have moisture
degradation mechanisms. However, there is a potential to degrade the materials used
Temperature in the product with low relative humidity (RH) levels encountered with uncontrolled
humidity during accelerated aging.
Stability

Thermal Cycling
Given the changes, do I need to start conducting Accelerated Aging
Thermal Shock with Controlled Humidity?
The need to use controlled humidity depends almost entirely on the materials used in
your product and how moisture affects them. Fortunately, most SBS materials are
moisture insensitive. However, product material degradation may occur during
exposure to the low RH levels typically observed during accelerated aging with
uncontrolled humidity.

We recommend relying on your material suppliers to provide the moisture degradation


data for materials used in your product and packaging.
Environmental Accelerated Aging ASTM F1980-21 Q&A
Testing Standards

ASTM F1980 What humidity input should I use? Accelerated Aging


Controlled Humidity
ASTM D6653 The manufacturer should determine if humidity should be Decision Flow Chart
controlled during accelerated aging with input from material
ASTM D4332 suppliers. If unknown, a few options exist:

ASTM F2825 1) Business as usual; continue with current testing methods.

ASTM D3103 2) Determine a reasonable humidity input for aging. The


standard's Appendix X3 notes, “When controlling humidity
during an aging study, 45-55% RH should be targeted unless
there is a specific warrant for using other humidity conditions.”

What if I choose uncontrolled humidity?


The critical point of the revised standard is that the
manufacturer should understand the product and packaging
materials and if the accelerated aging conditions are
influencing a potential failure mode in those materials.

Uncontrolled relative humidity (RH) is still acceptable and


should continue to be used for most accelerated aging studies.
Only after evaluating the materials used in the product should
controlled humidity levels be considered. Even then, most
materials will not be sensitive to elevated temperature and
uncontrolled RH conditions. As per the standard, the evaluation
and reasons for the decision should be documented.

What accelerated aging services does WESTPAK offer?


WESTPAK has over 100 environmental chambers providing a variety of customized
Contact Us temperature and humidity input possibilities. The most economical accelerated aging is
conducted at elevated temperatures with uncontrolled RH. We currently have accelerated
westpak.com
aging temperatures of +50°C, +55°C, and +60°C with humidity uncontrolled. Using one of
83 Great Oaks Boulevard these conditions enables the usage of our best economies of scale.
San Jose, CA 95119
408.224.1300
Do I still need to do Real Time Aging?
10326 Roselle Street Yes, accelerated aging is used to specify an expiration date while conducting real-time
San Diego, CA 92121 stability studies in parallel. We recommend using a real-time aging facility such as
858.623.8100
WESTPAK’s, where environmental conditions are monitored, exposure to light is
minimized, and access is controlled.

"WESTPAK has a variety of accelerated aging temperature


and RH conditions available for your needs. Please get in
touch with our Sales team for availability and pricing."

Mark Escobedo,
Senior Sales Engineer

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