ASTM F1980 - 16
Standard for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980 is a test standard titled, "Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices" is a testing procedure
that is used to help
with the assessment of the sterile
integrity of a package and product designed for medical use.
In order to
validate a product and package's Sterile Barrier System (SBS) over the intended
storage shelf life, accelerated aging is conducted to evaluate a package and product's long term usability and efficacy. ASTM F1980 is a specific accelerated aging test protocol set forth
by ASTM International (American Standards for Test and Measurement International)
It is also advisable to benchmark the product with Shelf Life Test which is to keep the product at the ambient temperature and humidity conditions for the entire duration of the product's useful life.
ASTM
F1980-21 replaced F1980-16
in December 2021. What changed?
The
revisions' primary change recommends that the use of controlled humidity during accelerated aging be considered, findings documented, and used during testing if warranted. The need for controlled humidity
should be based on the characterization data of
materials used in the medical
device, it's packaging, and the long-term
storage use condition.
Purpose of ASTM F1980
To function safely and effectively, medical devices must maintain their sterile integrity throughout their shelf-life.
However, over time, the physical properties of the materials may degrade in certain environments and, as a result,
may negatively impact the safety and efficacy of the product.
Because they endure so many unique environments while being transported, used, and stored, medical devices must undergo
shelf life testing
in addition
to sterile integrity testing. ASTM F1980 specifically evaluates the aging process of a product
along with its package
and how it impacts sterility and shelf-life. Accelerated aging tests simulate these conditions by exposing the materials to elevated temperatures for shorter periods of
time to represent an equivalent real time shelf life duration. ASTM F1980 testing offers valuable safety and performance insights to manufacturers. With a greater understanding of the aging process on a product and its package system as the result of testing,
manufacturers can make more informed decisions
regarding the handling, storing,
and use of the product.
Additionally, precise aging tests achieved
by tight temperature tolerances offer
enhanced assurance among regulatory agencies and consumers.
Frequently Asked Questions :
What is the procedure for an accelerated aging test for medical devices?
In accelerated
aging tests for medical devices, a material or Sterile Barrier System (SBS)
is exposed to elevated temperatures for a
condensed amount of time. By exposing the testing materials to more extreme conditions during a shorter time frame, researchers can evaluate how a
product will age under normal conditions without waiting for the entire desired duration. Armed with
this knowledge, manufacturers can determine shelf life, storage, in-use,
and transportation parameters more
accurately for their product.
Accelerated aging
is a standard practice in the medical device industry for determining shelf life parameters by accelerating the effects of time on a
Sterile Barrier System (SBS).
The accelerated aging process is based on
the relationship between temperature
and reaction rate, in which the reaction rate
increases as the temperature
rises. The Arrhenius Equation is the
basic formula used for an accelerated
aging test for medical devices is:
Accelerated Aging Time (AAT)= Desired Real Time
(RT) divided by the Accelerated Aging
Factor (AAF)
ln summary
Every 10 C increase in ageing temperature shortens the AAT by half.
Therefore if you have a product
whose expected shelf life is 3 years or 36 months, the device is expected to 'age' or experience :
>
for ambient storage 25 C ; keeping the product
in a chamber at 35 C, the product is
expected to 'age' in 18 months.
>
for ambient storage 25 C ; keeping the product in a chamber at 45 C, the product
is expected to 'age' in 9 months.
>
for ambient storage 25 C ; keeping the product in a chamber at 55 C, the product is
expected to 'age' in 4.5 months.
NOTES
The calculated AAT is typically rounded up to the nearest whole day.
QRA does
not recommend aging packaging materials at temperatures exceeding +65°C. Common Accelerated Aging temperatures (TAA) are
+50°C, +55°C, and +60°C.
Ambient temperature (TRT)
is typically between +20°C to +30°C. A temperature of +25°C is a more conservative approach.
The aging factor is typically between 1.8 - 2.5 with a value
of 2.0 being the most common
accepted value.
To perform ASTM F1980
accelerated aging tests for medical
devices, the laboratory
facility must identify the Q10 value of the testing sample. The Q10 temperature coefficient is a measure of how quickly a
material system changes when the temperature
is increased by
+10 C.
What are some of the parameters for ASTM F1980 testing?
ASTM International
sets forth specific test parameters
to ensure consistent testing across
different lab facilities. The basic parameters
for ASTM F1980 include the following:
1. Accelerated Aging Temperature
2. Humidity (F1980 - 21)
3. The quantity of product testing samples
After the Accelerated Aging Tests, it is advisable to send your medical products
to
a)
Peel Test
b)
Bubble (full immersion) Test
to determine
the Confidence and Reliability Levels. QRA can advise you on these matters.
Arrhenius Equation ; What is it ? Why is it Useful ?
Using the Arrhenius Equation, the TRT should accurately reflect the actual
product storage and in-use conditions, generally between 20°C and 30°C.
Accelerated aging
temperature should be identified prior to testing. This is done by having
in-depth knowledge of your materials,
product, and packaging. It is not
recommended to exceed +65 °C.
The need for controlled humidity during
accelerated aging should be
identified prior to testing; if materials
are subject to moisture degradation, 45% - 55% RH is suggested.
This input should be determined with your material providers' assistance.
A Q10 factor
needs to be determined, which involves
testing materials at various temperatures and
defining the differences in reaction
rate for a 10° change in temperature. A typical Q10 factor used during testing is 2.
Accelerated aging factor should be specified
using the following
equation:
AAF = Q10 (TAA-TRT)/10
QRA's sales professionals can walk you through your product ageing test needs.
What is the best temperature to use for an ASTM F1980 test?
The ASTM F1980 standard
suggests using an accelerated aging temperature below 60°C. Aging your product at a greater temperature provides
the advantage of a faster
simulation of the aging interval, but this comes with risks for particular products and packaging
materials. Medical devices
are often engineered with delicate materials that may drastically
change when exposed to temperatures
exceeding +60°C. Finding out if your medical product or device may be
adversely affected by long periods of high
heat or low humidity is a good place to start when choosing the best accelerated aging temperature.
Westpak's experts can help you define
the ideal temperature parameters for your products and packaging.
Common Accelerated Aging Temperatures: 50 C, 55 C, 57 C or 60 C
Does the F1980-21
version require using controlled humidity during accelerated aging?
In short, humidity is not a required element of accelerated aging. The recent version suggests that humidity conditions in the aging study be defined before starting aging studies. If RH will not be controlled, the rationale for exclusion should be documented.
What is the best humidity
level to use for accelerated aging?
Humidity usage is
dependent on the materials used in your
product and packaging, how moisture impacts them, and other environmental factors. If humidity during accelerated aging is to be controlled, Westpak recommends conferring with our
sales team to determine the RH level to be specified in the test plan. Also, as per F1980-21, the rationale for uncontrolled humidity should be documented.
How do you evaluate
the ASTM F1980 test, post-aging?
After a testing sample has undergone the accelerated aging process, its physical properties and package integrity will be compared against various aging time points.
This includes as per ASTM F1886,
1. Peel Testing
2. Bubble Test
3. Dye Test
My products must comply with the new F1980-21 revision. What do you recommend?
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