Three Critical Items You

Must Know to Plan and

Start Accelerated Aging for
Medical Devices
John Baumwoll
Production Manager

June 2023
Summary
Medical device manufacturers must provide adequate documentation that confirms their product and
packaging will maintain efficacy and sterility during its shelf-life or expiration period. While this length
of real-time aging testing can take years, manufacturers can utilize accelerated aging to get their
products to market in a significantly shorter timeframe. However, before the accelerated aging
planning process can begin, these three critical elements must be identified:

Document the market's Understand how the

shelf-life storage product and packaging Determine the test sample
1 2 3
requirements for the may be affected by quantity.
product, temperature and humidity,

Once these three elements have been answered, the manufacturer is ready to begin the accelerated
aging planning process.

Background and Introduction

In the United States, the Food and Drug Administration (FDA) requires medical device manufacturers
to establish the product's expiration date before entering the market using real-time aging data,
which would take years, time that manufacturers do not have with new product introductions.
Fortunately, the FDA allows accelerated aging data to establish a tentative expiration date for product
labeling, provided the manufacturer also initiates shelf-life studies to determine the actual shelf life
and supporting expiry date. After the real-time aging completes, test samples are compared to
accelerated aging samples. Hopefully, the two sets compare favorably, thus confirming that
accelerated aging's test results supported real-time testing.
Additionally, medical device developers
and manufacturers must fully
understand how handling,
transportation, environmental
conditions, and time affect product
sterility and efficacy. A compromised
sterile barrier system can potentially
jeopardize the effectiveness and safety
of the product.

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Regulatory Requirements
Medical device manufacturers offering products for sale in the US must adhere to at least two test
protocols affecting aging: ASTM F1980 and ISO 11607-1.

ASTM F1980-21, Standard Guide for ISO 11607.1, Packaging for Terminally
Accelerated Aging of Sterile Barrier Sterilized Medical Devices, specifies the
Systems and Medical Devices, specifies the requirements for sterile products and
methodology for planning and conducting packaging to ensure the safety of sterilized
accelerated aging studies. medical devices up to the point of use.

Both documents allow accelerated aging test results and data to be used temporarily until real-time or
shelf-life studies have been completed.

Accelerated Aging Definition and Use

Accelerated aging, also called accelerated shelf-life, is an artificial representation of real-time. It is a
test procedure that determines the effects of time by exposing samples to relatively high
temperatures for a defined period. A test sample subjected to accelerated aging experiences the
dynamic relationship between temperature and chemical reaction rate, where the reaction rate
increases as the temperature rises. This testing is standard practice in various industries, including
medical device manufacturing and food.

Three crucial things that must be known

before accelerated aging can be planned or started:
The manufacturer must know and understand three crucial things before the accelerated aging
planning and testing can begin.

1. Document the market's shelf-life storage requirements for the product

You must fully understand and document the shelf-life storage requirements for the medical
device. The market's shelf-life is the period during which the device must remain suitable until its
sterile package is opened at the point-of-use. The shelf-life storage requirements should identify
the time (months) and environmental conditions the product would be exposed to during
distribution, in a storage facility, and storage near its end point of use.
The total time (months) will be used as the Desired Real time (RT) factor in the Accelerated Aging
Time formula.

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2. Understand how the product and packaging may be affected by temperature
and humidity
Per ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical
Devices, the Accelerated Aging Temperature (TAA) and humidity levels must be determined before
calculating Accelerated Aging Time (AAT).
However, it's essential first to understand the effects that exposure to heat and humidity will have
on the items to be tested. For example, would a lengthy exposure at +60OC degrade the product?
Excessive heat has been known to harm certain plastics, adhesives, and components, often included
in a medical device's construction.
Regarding relative humidity, if the product or packaging materials could be affected by moisture
degradation, a 45% to 55% relative humidity level is suggested as a starting point (depending on
the temperature chosen). Still, checking with your material provider or in-house material expert to
understand your product and package's limits is essential. Note that controlled relative humidity
may not be required to be controlled if the product is not affected by moisture degradation. Also,
relative humidity is not included in the Arrhenius equation (defined below).

3. Determine the test sample quantity

Sample size determination must be completed before accelerated aging can begin, therefore,
should be an input to accelerated aging test planning. First, what is the purpose of the testing and
how will the test results be used? The answers to these questions will be helpful inputs in the
sample size decision-making process.
Secondly, the number of samples available for testing should be known. It's important to note that
the purpose of testing may affect the selection of samples. For example, if the test results and data
are submitted to the FDA as part of a 510(k) premarket submission demonstrating that the device
is safe and effective, the test samples should be randomly pulled from production lots.
WESTPAK offers Sample Size Calculators on our website that you should find helpful.

Applying the Arrhenius Equation for Accelerated Aging

Accelerated aging planning can commence once the Three Critical Items above are understood and
documented. ASTM F1980 incorporates the Accelerated Aging Factor (AAF) in the Arrhenius equation
below to determine the Accelerated Aging Time (AAT).

Desired Real Time (RT)

Accelerated Aging Time (A AT) =
Q10 [(TAA-TRT) /10]

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The four variables used in the above equation are as follows:

♦ Desired Real Time (RT)

The shelf-life or real-time duration in months that will be simulated through Accelerated Aging.

♦ Aging Factor (Q10)

The chemical reaction rate; the factor by which the rate of spoilage increases when temperature
increases by 10OC. The aging factor is typically between 1.8 – 2.5, with 2.0 being the most common
O
value; 2.0 means the rate of spoilage doubles every 10 C.

♦ Accelerated Aging Temperature (TAA)

The short-term storage temperature during the Accelerated Aging process. Commonly
recommended temperatures are +50OC, +55OC, and +60OC dependent on product and package
material.

♦ Ambient Temperature (TRT)

The Ambient Temperature is the temperature expected in the long-term storage environment,
O O O O
typically between +20 C to +25 C, with +25 C falling on the more conservative side and +23 C
typically chosen.
The equation calculates the Accelerated Aging Time (AAT), which is the length of time, in days,
the accelerated aging test must run at the given Accelerated Aging Temperature (TAA).

Example: Accelerated Aging Time (AAT)

Desired Real Time (RT)
Accelerated Aging Time (A AT) =
Q10 [(TAA-TRT) /10]

O
♦ Desired Real Time (RT): 12 months ♦ Ambient Temperature (TRT): +23 C
Variables O
♦ Aging Factor (Q10): 2.0 ♦ Accelerated Aging Temperature (TAA): +55 C

Result ♦ Accelerated Aging Time (AAT): 39.7 days (round up to 40 days)

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Using the four factors above and WESTPAK's Accelerated Aging Calculator,
Calculator a sterile barrier system
O
(SBS) that undergoes an Accelerated Aging test over the course of 40 days at +55 C, displays aging
properties estimated to be the equivalent of a one-year-old real-time sample placed in ambient
storage with a temperature averaging 23OC.

Evaluating a Product During and Post-Aging

During the Accelerated Aging process, the test laboratory will remove test samples and evaluate the
product and package integrity at various aging time points, especially what is noted on the product
expiry or shelf-life label. These evaluations may include the following:

♦ Visual inspections (ASTM F1886)

♦ Sterile integrity testing

Gross Leak Dye Penetration

Seal Strength
Burst Testing Detection Testing (ASTM
(Peel) Testing
(ASTM F2054) (Bubble) Testing F1929 & ASTM
(ASTM F88)
(ASTM F2096) F3039)

Testing in Advance of Accelerated or Real-Time Aging

Conditioning and distribution testing is often performed on medical device products before
accelerated or real-time aging. Distribution testing is transit simulation tests conducted in the test
laboratory that evaluate how a package system performs when exposed to hazards commonly found
in the distribution environment.
The package system that will undergo distribution testing must be subjected to conditioning before
distribution testing. Conditioning at prescribed temperature and humidity levels for a specific time
ensures that the package system materials will reach standard conditions and be ready for transit
testing.

♦ Conditioning (ASTM D4332) ♦ Distribution Testing (ASTM D4169)

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The Test Report
A comprehensive test report will be documented
once all the testing has been completed. The
report will include test sample descriptions,
photos, test failure details, test standards
utilized, the aging conditions, all equipment and
instrumentation used, instrument calibration
status, notes, and more.

The report will also detail post-aging evaluation

results and whether the test has passed or failed
per pre-established acceptance criteria.

The report and results can uncover the underlying issue of most performance problems and may
recommend what to retest after the issues have been addressed.

Working with Us
WESTPAK strives to be your ultimate test services partner and works diligently as a team to earn your
trust. Our ISTA-certified laboratories and ISO 17025 accredited testing back our Quality
Management System (QMS). The outstanding customer service we provide to all customers is
recognized throughout the industry.
Are you ready to get started with accelerated aging? Request a quote or ask a question now or
contact us directly.
We look forward to the possibility of working with you on your upcoming tests.

About WESTPAK
As a third-party, independent test laboratory
that specializes in product and package testing
solutions, our facilities are ISO/IEC 17025
accredited by the American Association for
Laboratory Accreditation (A2LA) as well as the
International Safe Transit Association (ISTA).
Learn more about our range of
Service offerings.
offerings

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 John Baumwoll has served as Production Manager at WESTPAK, Inc.'s
accredited testing laboratory in San Diego, California, since graduating
in 2010 from Cal Poly, San Luis Obispo, with a bachelor's degree in
Industrial Technology with a minor in Packaging.
In nearly 13 years, John and his production team have increased
production volume while maintaining consistently high-quality levels for
customers from Medical Device, Pharmaceuticals, Aerospace, Defense,
Computers & Electronics, Cold Chain, Consumer Goods, and others.
John is a member of ASTM Committees D10 on Packaging and F02 on
Primary Barrier Packaging. He is an active Cal Poly Packaging Advisory
Board member and represents WESTPAK at ASTM conferences twice
John Baumwoll annually.
John's passions and interests include providing customers with the
highest level of safety, quality, and customer service. He enjoys helping
customers improve their products, Packaging, and efficiency, ultimately
improving people's lives.
During his free time, John enjoys San Diego's coastline and traveling,
scuba diving, hiking, exploring, and enjoying nature.

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 TRUST · FOCUS FORWARD · UNIQUE CULTURE

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