ASTM F1980-99e1

Standard Guide for Accelerated Aging of Sterile Medical Device Packages

SCOPE
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time and environmental effects on the sterile integrity of packages and the physical properties of their component packaging materials.
1.2 Information obtained using this guide may be used to support expiration date claims for medical device packages.
1.3 The accelerated aging guideline addresses the primary medical package in whole and does not address the package and product interaction or compatibility that may be required for new product development. Package and product compatibility and interactions should be addressed as a material analysis process before package design.
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
1.5 Methods used for package process validation, which include the machine process, the effects of the sterilization process, distribution, handling, and shipping events, are beyond the scope of this guide.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Jan-2002
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: F02 - Primary Barrier Packaging

Relations

• Replaced By: ASTM F1980-02 - Standard Guide for Accelerated Aging of Sterile Medical Device Packages
• Effective Date: 10-Jan-2002
• Referred By: ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 10-Jan-2002

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 1980 – 99
Standard Guide for
Accelerated Aging of Sterile Medical Device Packages
This standard is issued under the fixed designation F 1980; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Editorial changes were made throughout in February 2000.
1. Scope F 1140 Test Methods for Failure Resistance of Unrestrained
and Nonrigid Packages for Medical Applications
1.1 This guide provides information for developing accel-
F 1327 Terminology Relating to Barrier Materials for Medi-
erated aging protocols to rapidly determine the effects, if any,
cal Packaging
due to the passage of time and environmental effects on the
F 1585 Guide for Integrity Testing of Porous Barrier Medi-
sterile integrity of packages and the physical properties of their
cal Packages
component packaging materials.
F 1608 Test Method for Microbial Ranking of Porous Pack-
1.2 Information obtained using this guide may be used to
aging Materials (Exposure Chamber Method)
support expiration date claims for medical device packages.
F 1929 Test Method for Detecting Seal Leaks in Porous
1.3 The accelerated aging guideline addresses the primary
Medical Packaging by Dye Penetration
medical package in whole and does not address the package
2.2 ISO Standard:
and product interaction or compatibility that may be required
ANSI/AAMI/ISO 11607, Packaging for Terminally Steril-
for new product development. Package and product compat-
ized Medical Devices
ibility and interactions should be addressed as a material
analysis process before package design.
3. Terminology
1.4 Real-time aging protocols are not addressed in this
3.1 Definitions—For general definitions of packaging for
guide; however, it is essential that real-time aging studies be
medical devices see ANSI/AAMI/ISO 11607. For terminology
performed to confirm the accelerated aging test results using
related to barrier materials for medical packaging see Termi-
the same methods of evaluation.
nology F 1327.
1.5 Methods used for package process validation, which
3.2 Definitions of Terms Specific to This Standard:
include the machine process, the effects of the sterilization
3.2.1 accelerated aging (AA), n—storage of samples at an
process, distribution, handling, and shipping events, are be-
elevated temperature (T ) in order to simulate real time aging
AA
yond the scope of this guide.
in a reduced amount of time.
1.6 This standard does not purport to address all of the
3.2.2 accelerated aging factor (AAF), n—an estimated or
safety concerns, if any, associated with its use. It is the
calculated ratio of the time to achieve the same level of
responsibility of the user of this standard to establish appro-
physical property change as a package stored at real time (RT)
priate safety and health practices and determine the applica-
conditions.
bility of regulatory limitations prior to use.
3.2.3 accelerated aging temperature (T ), n—the elevated
AA
2. Referenced Documents temperature used to conduct the aging studies, and it is based
on the ambient temperature or the estimated temperature of
2.1 ASTM Standards:
usage, or storage of this package, or both.
D 3078 Test Method for Determination of Leaks in Flexible
3.2.4 accelerated aging time (AAT), n—the length of time at
Packaging by Bubble Emission
which the accelerated aging is conducted.
D 4169 Practice for Performance Testing of Shipping Con-
3.2.5 ambient temperature (T ), n—storage temperature
RT
tainers and Systems
for real-time aging (RT) samples that represents storage con-
D 4332 Practice for Conditioning Containers, Packages, or
ditions.
Packaging Components for Testing
3.2.6 package shelf life, n—the amount of real time that a
F 88 Test Method for Seal Strength of Flexible Barrier
package can be expected to remain in storage at ambient
Materials
conditions, or under specified conditions of storage, and
maintain its critical performance properties.
This guide is under the jurisdiction of ASTM Committee F-2 on Flexible
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
Medical Packaging.
Current edition approved May 10, 1999. Published July 1999. Available from the American National Standards Institute, 11 W. 42nd St., 13th
Annual Book of ASTM Standards, Vol 15.09. Floor, New York, NY 10036.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1980
3.2.7 real-time aging (RT), n—storage time of samples at applied than the normal environmental stress, for a relatively
ambient conditions. short period of time.
3.2.8 real-time equivalent (RTE), n—amount of real-time 5.3 Accelerated aging techniques are based on the assump-
aging to which given accelerated aging conditions are esti- tion that the chemical reactions involved in the deterioration of
mated to be equivalent. materials follow the Arrhenius reaction rate function. This
3.2.9 zero time (t ), n—the beginning of an aging study. function states that a 10°C increase or decrease in temperature
3.3 Symbols: of a homogeneous process results in approximately, a two
times or ⁄2-time change in the rate of a chemical reaction
(Q ) .
Q = an aging factor for 10°C increase or decrease in
5.4 Determining the Q involves testing products at various
temperature.
temperatures and defining the differences in reaction rate for a
T = temperature at which a material melts.
m
10° change in temperature. Modeling the kinetics of material
T = glass transition temperature.
g
deterioration is complex and difficult and is beyond the scope
T = alpha temperature; heat distortion temperature.
a 5
of this guide. For more details on modeling kinetics of
materials.
4. Significance and Use
6. Accelerated Aging Plan
4.1 As package components and adhesives age, they may
break down, become brittle, or lose their bonding capabilities.
6.1 Characterization of Materials—In order to apply AA
This aging characteristic may result in the potential loss of
theory, an understanding of the materials of the package under
package integrity.
investigation is necessary. Items to be considered include the
4.2 The ANSI/AAMI/ISO 11607 states that, “the manufac-
following:
turer shall demonstrate that, under the rigors of distribution,
6.1.1 Processing history;
storage, handling, and aging, the integrity of the final package
6.1.2 Morphology (glassy, amorphous, semi-crystalline,
is maintained at least for the claimed shelf-life of the medical
highly crystalline, % crystallinity, etc.);
device under storage conditions specified by the manufacturer,
6.1.3 Thermal transitions (T ,T ,T );
m g a
as long as the package is undamaged or unopened.”
6.1.4 Chemical structure (aliphatic, aromatic, repeating
4.3 The most valid aging program is to age the package
units, repeating unit sequence, end groups, side chains);
under real-life (ambient) storage conditions for the intended
6.1.5 Molecular weight and molecular weight distribution;
shelf-life. Since such testing would be completed prior to
and,
market release, this approach would delay, unnecessarily in
6.1.6 Additives, processing agents, catalysts, lubricants,
many cases, the introduction of potentially valuable technology
residual solvents, and fillers.
to the market with a loss of benefit to the patient. Avoiding
6.2 Accelerated Aging Plan-Design Guidelines:
unnecessary delays in bringing technology to the market is the
6.2.1 Temperature boundaries, based on the characterization
reason for developing and utilizing accelerated aging pro-
of the device and package materials, must be considered in
grams.
order to assure that initial, conservative aging factors are
4.4 Due to the complexity of aging processes, the use of
applied appropriately.
accelerated aging programs do involve some risk. The manu-
6.2.2 Ambient Temperature (T )—Select an ambient stor-
RT
facturer is exposed to risk of unnecessary product obsolescence
age temperature representative of actual product storage and
from conservative aging programs that predict shelf lives
use conditions.
shorter than reality. In addition, since accelerated aging often is
NOTE 2—This temperature normally is between 20–25°C for normal
on the critical path for market release, overly conservative
hospital type storage. A temperature of 25°C is conservative and may be
aging programs increase the time required to collect aging data,
appropriate when detailed information about the storage environment is
and thereby delay the release of products to the patient.
not available; however, any temperature that represents the normal storage
4.5 Conservative accelerated aging factors (AAFs) must be conditions for the product can be selected, for example, 22°C.
used if little information is known about the package under
6.2.3 Accelerated Aging Temperature (T )—Considering
AA
investigation. With more information about the system under
the characterization of the materials under investigation, select
investigation and with information demonstrating the correla-
a temperature for the accelerated aging testing. As the aging
tion between real time performance and accelerated aging
temperature increases, the aging factor also increases and the
performance, more aggressive and accurate AAFs may be
aging duration decreases; however, the benefits in efficiency
defined.
from raising the aging temperature must be balanced by the
risks involved with extrapolating increasingly high aging
NOTE 1—AAF methods are beyond the scope of this guide.
temperature properties to room temperature properties (see
5. Accelerated Aging Theory
Appendix X1). Guidelines for selecting an aging temperature
are as follows:
5.1 Accelerated aging of materials refers to the accelerated
variation of their properties over time, the properties of interest
Hemmerich, Karl J., “General Aging Theory and Simplified Protocol for
being those related to safety and function of the material or
Accelerated Aging of Medical Devices,” Medical Plastics and Biomaterials,
package.
July/August 1998, pp. 16–23.
5.2 In an aging study, the material or package is subjected to 5
Nelson, Wayne, “Accelerated Testing Statistical Models, Test Plans, and Data
an external stress, which is more severe, or more frequently Analyses,” John Wiley and Sons, New York, 1999.
F 1980
6.2.3.1 Keep T below the temperature at which the however, consideration must be given to maximizing patient
AA
product/package distorts. Consider the thermal transitions of safety since the necessary information to obtain a more
the materials under investigation, for example, the choice of accurate and aggressive shelf-life prediction is not readily
T should be at least 10°C less than T . available.
g
AA
6.2.3.2 Keep T at or below 60°C unless a higher tempera- 6.4 Accelerated Aging Protocol Steps:
AA
ture has been demonstrated to be appropriate. Temperatures 6.4.1 Select the Q value.
higher than 60°C are not recommended due to the higher 6.4.2 Define the desired shelf life of the package, such as,
probability in many polymeric systems to experience nonlinear marketing needs, product needs, etc.
changes, such as percent crystallinity, formation of free radi- 6.4.3 Define aging test time intervals, including time zero.
cals, and peroxide degradation. 6.4.4 Define test conditions, ambient temperature (T ), and
RT
accelerated aging temperature (T ).
AA
NOTE 3—If packages containing liquid or other volatile components are
6.4.5 Calculate the test duration using the Q , T , and T .
10 RT AA
tested, lower temperatures may be required for safety reasons.
6.4.6 Define package material properties, seal strength and
6.2.3.3 When elevated temperature aging is not feasible, for
integrity tests, sample sizes, and acceptance criteria.
example, with materials with very low heat distortion tempera-
6.4.7 Age samples at T . In parallel, age samples at
AA
ture or materials that undergo major morphological changes at
real-life aging conditions (T ).
RT
even slightly elevated temperatures, then real-time aging is the
6.4.8 Evaluate the package performance after accelerated
only option.
aging relative to the initial package requirements, for example,
6.3 Accelerated Aging Factor (AAF) Determination:
package seal strength, package integrity.
6.3.1 It is possible to provide guidance with respect to initial
6.4.9 Evaluate package, or package performance, or both,
conservative estimates of aging factors. These initial estimates
after real time aging relative to the initial package require-
may be used to begin aging programs while real-time data is
ments. The estimated AAF method is a simple and conserva-
being collected in order to verify the initial estimate. The initial
tive technique for evaluating the long-term performance of a
estimates suggested below are conservative in most cases when
package; however, like all accelerated aging techniques, it
applied within the boundaries given.
must be confirmed by real time aging data.
6.3.2 Using the Arrhenius equation with Q equal to 2 is a
6.5 See the example package shelf-life test plan (Appendix
common and conservative means of calculating an aging factor
X2).
for polymeric systems in the moderate aging conditions typi-
cally applied to medical devices and their packaging; however,
7. Post-Aging Testing Guidance
before a particular Q can be applied, the user must show that
7.1 Packages and materials that have been subjected to
the materials of the system do not degrade within the appro-
aging, that is, accelerated and real time, must be evaluated for
priate temperature boundaries. For many polymeric materials,
physical properties and integrity.
the reaction rate coefficient may be higher than 2.0.
7.2 Tests selected should challenge the material or package
6.3.3 An accelerated aging factor (AAF) estimate for a
functionality that is most critical or most likely to fail due to
temperature range greater than 10°C is calculated from a Q
the stresses resulting from aging. Guide F 1585 may be used as
value by means of the following equation:
a testing guide for porous barrier medical packaging.
@~T – T !/10#
AA RT
7.3 Some of the physical strength properties to be consid-
AAF [ Q (1)
ered for selection are flexure, puncture, tensile and elongation,
where:
tear, impact resistance, abrasion resistance, yellowness index,
T [ accelerated aging temperature (°C), and
AA
microbial barrier (Test Method F 1608), seal strength (Test
T [ ambient temperature (°C).
RT
Method F 88), and burst strength (Test Method F 11
...