ASTM F1980-21
(Guide)Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
SIGNIFICANCE AND USE
4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time or by subsequent dynamic events during shipping and handling, or both. Accelerated and real time aging verifies the time-related aspects of potential integrity loss only.
4.2 ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3, states that “the packaging system shall provide physical protection in order to maintain integrity of the sterile barrier system.” Sub-clause 6.1.6 states that, “A terminally sterilized sterile barrier system with its protective packaging, if included, shall be designed to, maintain sterility through exposure to expected conditions and hazards during the specified processing, storage, handling, and distribution until that SBS is opened at the point of use or until the expiry date.” Sub-clause 8.3.1 states, “Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.” Sub-clause 8.3.3 states, “Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.”
4.3 Real time aging programs provide the best data to ensure that sterile barrier system/medical device materials and sterile barrier system/medical device integrity do not degrade over time. However, due to market conditions in which products may become obsolete in a short time, and the desire to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means of screening for possible aging-related failure mechanisms in the SBS or medical device. To ensure that accelerated aging studies represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be perf...
SCOPE
1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.
1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available.
1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
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. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019.
1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide.
1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.”
1.7 The data obtained from accelerated aging studies is no...
General Information
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1980 − 21
Standard Guide for
Accelerated Aging of Sterile Barrier Systems and Medical
Devices
This standard is issued under the fixed designation F1980; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope the shipping and handling environment. Refer to Practice
D4332 for standard conditions that may be used to challenge
1.1 This guide provides information for developing accel-
the sterile barrier system to realistic extremes in temperature
erated aging protocols to model the possible effects of the
and humidity conditions. SeeTerminology F17 for a definition
passage of time on the sterile integrity of the sterile barrier
of “environmental challenging.”
system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019
and the physical properties of their component packaging 1.7 The data obtained from accelerated aging studies is not
materials.Guidancefordevelopingacceleratedagingprotocols to be used as a manner of establishing label storage conditions
may also be used for medical devices and medical device for sterile barrier systems.
materials.
1.8 The values stated in SI units are to be regarded as
1.2 Information obtained using this guide may be regarded standard. No other units of measurement are included in this
as sufficient evidence for expiration date claims for medical standard.
devices and sterile barrier systems until data from real-time
1.9 This standard does not purport to address all of the
aging studies are available.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
1.3 Theacceleratedagingguidelineaddressessterilebarrier
priate safety, health, and environmental practices and deter-
systems as a whole with or without devices.The sterile barrier
mine the applicability of regulatory limitations prior to use.
system material and device interaction compatibility that may
1.10 This international standard was developed in accor-
be required for new product development or the resulting
dance with internationally recognized principles on standard-
evaluation is not addressed in this guide.
ization established in the Decision on Principles for the
1.4 Real-time aging protocols are not addressed in this
Development of International Standards, Guides and Recom-
guide; however, it is essential that real-time aging studies be
mendations issued by the World Trade Organization Technical
performed to confirm the accelerated aging test results using
Barriers to Trade (TBT) Committee.
the same methods of evaluation. Real-time aging (stability) is
the requirement of ANSI/AAMI/ISO 11607–1: 2019.
2. Referenced Documents
1.5 Methods used for sterile barrier system performance
2.1 ASTM Standards:
validation, which include, environmental challenge,
D4332Practice for Conditioning Containers, Packages, or
distribution, handling, and shipping events, are used for pack-
Packaging Components for Testing
ageperformance(event-relatedlossofintegrity)testingandare
E337Test Method for Measuring Humidity with a Psy-
beyond the scope of this guide.
chrometer (the Measurement of Wet- and Dry-Bulb Tem-
1.6 This guide does not address environmental challenging
peratures)
that simulates extreme climactic conditions that may exist in
F17Terminology Relating to Primary Barrier Packaging
F2097Guide for Design and Evaluation of Primary Flexible
This guide is under the jurisdiction of ASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
Package Design and Development. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 15, 2021. Published December 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1999. Last previous edition approved in 2016 as F1980–16. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1980-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1980 − 21
Packaging for Medical Products
T = alpha temperature; heat distortion temperature.
α
2.2 Other Standards:
ANSI/AAMI/ISO 11607–1: 2019Packaging for Terminally
4. Significance and Use
Sterilized Medical Devices
4.1 The loss of sterile barrier system integrity may occur as
ASHRAE 170-2017Ventilation of Health Care Facilities
a result of physical properties of the materials and adhesive or
ISO TS 16775:2014Packaging for terminally sterilized
cohesivebondsdegradingovertimeorbysubsequentdynamic
medical devices — Guidance on the application of ISO
events during shipping and handling, or both.Accelerated and
11607-1 and ISO 11607-2
real time aging verifies the time-related aspects of potential
3. Terminology
integrity loss only.
3.1 Definitions—For general definitions of packaging for
4.2 ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3,
medical devices, see ANSI/AAMI/ISO 11607–1: 2019. For
states that “the packaging system shall provide physical
terminology related to barrier materials for medical packaging
protection in order to maintain integrity of the sterile barrier
see Terminology F17.
system.” Sub-clause 6.1.6 states that, “A terminally sterilized
sterilebarriersystemwithitsprotectivepackaging,ifincluded,
3.2 Definitions of Terms Specific to This Standard:
shall be designed to, maintain sterility through exposure to
3.2.1 accelerated aging (AA), n—storage of samples at an
elevated temperature (T ) in order to simulate real time aging expected conditions and hazards during the specified
AA
processing,storage,handling,anddistributionuntilthatSBSis
in a reduced amount of time.
opened at the point of use or until the expiry date.” Sub-clause
3.2.2 accelerated aging factor (AAF), n—an estimated or
8.3.1 states, “Stability testing shall demonstrate that the sterile
calculated ratio of the time to achieve the same level of
barrier system maintains integrity over time.” Sub-clause 8.3.3
physical property change as a sterile barrier system stored at
states, “Stability testing, using accelerated aging protocols,
real time (RT) conditions.
shall be regarded as sufficient evidence for claimed expiry
3.2.3 accelerated aging temperature (T ), n—the elevated
AA
dates until data from real-time aging studies are available.”
temperature at which the aging study is conducted, and it may
bebasedontheestimatedstoragetemperature,estimatedusage
4.3 Real time aging programs provide the best data to
temperature, or both.
ensure that sterile barrier system/medical device materials and
sterile barrier system/medical device integrity do not degrade
3.2.4 accelerated aging time (AAT), n—the length of time
over time. However, due to market conditions in which
the accelerated aging is conducted.
products may become obsolete in a short time, and the desire
3.2.5 ambienttemperature(T ),n—storagetemperaturefor
RT
togetnewproductstomarketintheshortestpossibletime,real
real-time aging (RT) samples that is typical for storage condi-
time aging studies do not meet this objective. Accelerated
tions. Also, the temperature used to calculate the accelerated
agingstudiescanprovideanalternativemeansofscreeningfor
aging duration.
possible aging-related failure mechanisms in the SBS or
3.2.6 sterile barrier system shelf life, n—the amount of real
medical device. To ensure that accelerated aging studies
time that a sterile barrier system can be expected to remain in
represent real time effects, real time aging studies must be
storage at ambient conditions, or under specified conditions of
conducted in parallel to accelerated studies. Real time studies
storage, and maintain its critical performance properties.
must be carried out to the claimed shelf life of the product and
3.2.7 real-time aging (RT), n—storage time of samples at
be performed to their completion.
ambient conditions.
4.4 Conservative accelerated aging factors (AAFs) must be
3.2.8 real-time equivalent (RTE), n—amount of real-time
used if little is known about the sterile barrier system material
aging to which given accelerated aging conditions are esti-
being evaluated. More aggressive AAFs may be used with
mated to be equivalent.
documented evidence to show a correlation between real time
3.2.9 zero time (t ), n—the beginning of an aging study.
and accelerated aging.
3.3 Symbols:
4.5 When conducting accelerated aging programs for estab-
lishingexpirydatingclaims,itmustberecognizedthatthedata
Q = an aging factor for 10°C increase or decrease in
obtainedfromthestudyisbasedonconditionsthatsimulatethe
temperature.
T = temperature at which a material melts. effects of aging on the materials. The resulting creation of an
m
T = glass transition temperature.
expiration date or shelf life is based on the use of a conserva-
g
tive estimate of the aging factor (that is, Q ) and is tentative
untiltheresultsofrealtimeagingstudiesarecompletedonthe
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
sterile barrier system.
4th Floor, New York, NY 10036, http://www.ansi.org.
4 NOTE 1—Determining AAFs are beyond the scope of this guide.
Available from American Society of Heating, Refrigerating, and Air-
Conditioning Engineers, Inc. (ASHRAE), 1791 Tullie Circle, NE, Atlanta, GA
30329, http://www.ashrae.org.
Available from International Organization for Standardization (ISO), ISO
Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Thor, P., “Humidity as Use Condition for Accelerated Aging of Polymers”
Switzerland, https://www.iso.org. MDDI Online, 2021.
F1980 − 21
5. Apparatus humidly during that accelerated aging. See Appendix X3 for
more details on the use of humidity in accelerated aging
5.1 Room (or Cabinet) of such size that samples may be
protocols.
individually exposed to circulating air at the temperature and
relative humidity chosen. See 7.4.1 for sample configuration
NOTE 2—Degradation mechanisms for most flexible packaging mate-
guidance. rials used as sterile barrier systems do not involve moisture. However,
materials used in medical devices are far more varied, and hydrolytic
5.1.1 ControlApparatus,capableofmaintainingtheroomat
degradationmaybeafactorinsomeofthosematerials.Knowledgeofthe
therequiredatmosphericconditionswithinthetolerancelimits.
materials used in either the SBS or the device, and their relevant
degradation mechanisms, is important in the proper design of an acceler-
5.2 Hygrometer—The instrument used to indicate the rela-
ated aging protocol.
tive humidity should be accurate to 62% relative humidity.A
psychrometer may be used either for direct measurement of
6.6 It is important to consider that humidity will be part of
relative humidity or for checking the hygrometer (see Test
the long-term storage use condition. Controlling humidity
Method E337).
during accelerated aging is intended to compensate for low
relative humidity at intentionally elevated temperatures, nec-
5.3 Thermometer—Any temperature-measuring device may
essary to accelerate the effect of time. The goal of controlling
be used provided it can accurately indicate the temperature to
humidity during accelerated aging is to avoid drying out
within 0.1°C or 0.2°F and be properly recorded. The dry-bulb
materials (primarily polymers) to moisture levels lower than
thermometer of the psychrometer may be used either for direct
typical in the long-term storage use condition. Dry accelerated
measurement or for checking the temperature-indicating de-
aging conditions may cause the user of this practice to miss
vice.
moisture driven degradation that can occur on the shelf in
long-term storage. Appropriate control of relative humidity
6. Accelerated Aging Theory
duringacceleratedagingensuresthatpotentialmoisturedriven
6.1 Aging of materials refers to the study of variation of
degradation mechanisms will be caught during accelerated
theirpropertiesovertime,generallyduetovariousdegradation
aging for moisture sensitive materials. The same relative
mechanisms (for example, thermo-oxidative or hydrolytic)
humidity considerations are not necessary when the tempera-
inherent in the materials. For the purposes of this guide, the
ture is not artificially elevated (for example, real-time aging).
propertiesofinterestarethoserelatedtothesafetyandfunction
Control of relative humidity outside the scope of this standard
of the material or sterile barrier system.
is left to the discretion of the user.
6.2 In an accelerated aging study, the material or sterile
7. Accelerated Aging Plan
barrier system is subjected to conditions which accelerate the
reaction kinetics of possible degradation pathways.
7.1 Characterization of Materials—AA theory and its ap-
plication are directly related to packaging material composi-
6.3 Acceleratedagingtechniquesarebasedontheempirical
tion.Examplesofmaterialpropertiesthatmayaffecttheresults
guidance that chemical reactions (including those involved in
of accelerated aging studies may include:
the deterioration of materials) follow the Arrhenius reaction
rate function, and assume little or no change in reactant
7.1.1 Composition (including laminating adhesives,
concentration(s). This function states that, in general, a 10°C primers, and coatings),
increase in temperature of a homogeneous process results in a
7.1.2 Morphology (glassy, amorphous, semi-crystalline,
two-fold increase in the rate of a chemical reaction (Q ).
10 highly crystalline, % crystallinity, and so forth),
7.1.3 Thermal transitions (T ,T,T ), as defined in 3.3,
6.4 Determining the Q involves testing materials at vari-
m g α
ous temperatures and defining the differences in reaction rate
7.1.4 Additives, processing agents, catalysts, lubricants,
for a 10°C change in temperature. Modeling the kinetics of residual solvents, corrosive gases, and fillers,
material deterioration is complex and difficult and is beyond
7.1.5 Moisture absorption characteristics, and
the scope of this guide.
7.1.6 Known degradation mechanisms (for example,
hydrolysis, metal ion oxidation (MIO), photo-degradation,
6.5 Since sterile barrier systems and medical device are
environmental stress cracking (ESC), corrosion, oxidation).
storedinenvironmentsthatcomprisevaryinglevelsofambient
This can be accomplished by reviewing published literature/
h
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1980 − 16 F1980 − 21
Standard Guide for
Accelerated Aging of Sterile Barrier Systems forand Medical
Devices
This standard is issued under the fixed designation F1980; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to
model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in
ANSI/AAMI/ISO 11607–1:2006 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for
developing accelerated aging protocols may also be used for medical devices and medical device materials.
1.2 Information obtained using this guide may be used to support regarded as sufficient evidence for expiration date claims for
medical device sterile barrier systems.devices and sterile barrier systems until data from real-time aging studies are available.
1.3 The accelerated aging guideline addresses the sterile barrier systems in as a whole with or without devices. The sterile barrier
system material and device interaction compatibility that may be required for new product development or the resulting evaluation
is not addressed in this guide.
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. Real-time aging (stability) is the requirement
of ANSI/AAMI/ISO 11607–1: 2019.
1.5 Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process,
environmental challenge, distribution, handling, and shipping events, are performance validation, which include, environmental
challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing
and are beyond the scope of this guide.
1.6 This guide does not address environmental challenging that stimulatessimulates extreme climactic conditions that may exist
in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile
barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327F17 for a definition of
“environmental challenging.”
1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for
sterile barrier systems.
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
This guide is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved Sept. 15, 2016Dec. 15, 2021. Published September 2016December 2021. Originally approved in 1999. Last previous edition approved in
20112016 as F1980 – 07F1980 – 16.(2011). DOI: 10.1520/F1980-16.10.1520/F1980-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1980 − 21
1.9 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.10 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)
F17 Terminology Relating to Primary Barrier Packaging
F1327 Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
2.2 AAMIOther Standards:
ANSI/AAMI/ISO 11607–1: 2006,2019 Packaging for Terminally Sterilized Medical Devices
ASHRAE 170-2017 Ventilation of Health Care Facilities
AAMI TIR 22–2007,ISO TS 16775:2014 Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical
DevicesPackaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
3. Terminology
3.1 Definitions—For general definitions of packaging for medical devices, see ANSI/AAMI/ISO 11607. 11607–1: 2019. For
terminology related to barrier materials for medical packaging see Terminology F17.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 accelerated aging (AA), n—storage of samples at an elevated temperature (T ) in order to simulate real time aging in a
AA
reduced amount of time.
3.2.2 accelerated aging factor (AAF), n—an estimated or calculated ratio of the time to achieve the same level of physical property
change as a sterile barrier system stored at real time (RT) conditions.
3.2.3 accelerated aging temperature (T ), n—the elevated temperature at which the aging study is conducted, and it may be based
AA
on the estimated storage temperature, estimated usage temperature, or both.
3.2.4 accelerated aging time (AAT), n—the length of time the accelerated aging is conducted.
3.2.5 ambient temperature (T ) , ), n—storage temperature for real-time aging (RT) samples that represents storage conditions.
RT
is typical for storage conditions. Also, the temperature used to calculate the accelerated aging duration.
3.2.6 sterile barrier system shelf life, n—the amount of real time that a sterile barrier system can be expected to remain in storage
at ambient conditions, or under specified conditions of storage, and maintain its critical performance properties.
3.2.7 real-time aging (RT), n—storage time of samples at ambient conditions.
3.2.8 real-time equivalent (RTE), n—amount of real-time aging to which given accelerated aging conditions are estimated to be
equivalent.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from American Society of Heating, Refrigerating, and Air-Conditioning Engineers, Inc. (ASHRAE), 1791 Tullie Circle, NE, Atlanta, GA 30329,
http://www.ashrae.org.
Available from International Organization for Standardization (ISO), ISO Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland,
https://www.iso.org.
F1980 − 21
3.2.9 zero time (t ), n—the beginning of an aging study.
3.3 Symbols:
Q = an aging factor for 10°C increase or decrease in temperature.
T = temperature at which a material melts.
m
T = glass transition temperature.
g
T = alpha temperature; heat distortion temperature.
α
4. Significance and Use
4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive
bonds degrading over time andor by subsequent dynamic events during shipping and handling.handling, or both. Accelerated and
real time aging verifies the time-related aspects of potential integrity loss only.
4.2 ISO 11607–1:2006, clause 6, ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3, states that “the packaging system shall
provide physical protection and in order to maintain integrity of the sterile barrier system. The system.” Sub-clause 6.1.6 states
that, “A terminally sterilized sterile barrier system shall maintain sterility to the with its protective packaging, if included, shall
be designed to, maintain sterility through exposure to expected conditions and hazards during the specified processing, storage,
handling, and distribution until that SBS is opened at the point of use or until the expiry date. Stability date.” Sub-clause 8.3.1
states, “Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing time.”
Sub-clause 8.3.3 states, “Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed
expiry datedates until data from real time real-time aging studies are available.”
4.3 Real time aging programs provide the best data to ensure that sterile barrier system system/medical device materials and sterile
barrier system system/medical device integrity do not degrade over time. However, due to market conditions in which products
may become obsolete in a short time, and the needdesire to get new products to market in the shortest possible time, real time aging
studies do not meet this objective. Accelerated aging studies can provide an alternative means. means of screening for possible
aging-related failure mechanisms in the SBS or medical device. To ensure that accelerated aging studies do truly represent real time
effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the
claimed shelf life of the product and be performed to their completion.
4.4 Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being
evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated
aging.
4.5 When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data
obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of an
expiration date or shelf life is based on the use of a conservative estimate of the aging factor (for example,(that is, Q ) and is
tentative until the results of real time aging studies are completed on the sterile barrier system.
NOTE 1—Determining AAFs are beyond the scope of this guide.
5. Apparatus
5.1 Room (or Cabinet) of such size that samples may be individually exposed to circulating air at the temperature and relative
humidity chosen. See 7.4.1 for sample configuration guidance.
5.1.1 Control Apparatus, capable of maintaining the room at the required atmospheric conditions within the tolerance limits.
5.2 Hygrometer—The instrument used to indicate the relative humidity should be accurate to 62 % relative humidity. A
psychrometer may be used either for direct measurement of relative humidity or for checking the hygrometer (see Test Method
E337).
Thor, P., “Humidity as Use Condition for Accelerated Aging of Polymers” MDDI Online, 2021.
F1980 − 21
5.3 Thermometer—Any temperature-measuring device may be used provided it can accurately indicate the temperature to within
0.1°C or 0.2°F and be properly recorded. The dry-bulb thermometer of the psychrometer may be used either for direct measurement
or for checking the temperature-indicating device.
6. Accelerated Aging Theory
6.1 Accelerated aging Aging of materials refers to the accelerated study of variation of their properties over time, the generally
due to various degradation mechanisms (for example, thermo-oxidative or hydrolytic) inherent in the materials. For the purposes
of this guide, the properties of interest beingare those related to the safety and function of the material or sterile barrier system.
6.2 In an accelerated aging study, the material or sterile barrier system is subjected to an external stress, which is more severe,
or more frequently applied than the normal environmental stress, for a relatively short period of time.conditions which accelerate
the reaction kinetics of possible degradation pathways.
6.3 Accelerated aging techniques are based on the assumption empirical guidance that the chemical reactions (including those
involved in the deterioration of materialsmaterials) follow the Arrhenius reaction rate function. function, and assume little or no
change in reactant concentration(s). This function states that that, in general, a 10°C increase or decrease in temperature of a
homogeneous process results in, approximately, a two times or in a two-fold increase ⁄2-time change in the rate of a chemical
reaction (Q )). .
6.4 Determining the Q involves testing materials at various temperatures and defining the differences in reaction rate for a
10 10
10°10°C change in temperature. Modeling the kinetics of material deterioration is complex and difficult and is beyond the scope
of this guide.
6.5 A humidity factor to calculate the accelerated aging time (AAT) is not applicable for accelerated aging protocols. Unrealistic
or extreme temperature and humidity conditions may be of interest in overall sterile barrier system performance. However, this
must be evaluated in a separate study and is not related to aging of the materials. Since sterile barrier systems and medical device
are stored in environments that comprise varying levels of ambient humidity, and since the properties of some materials may
depend on the level of absorbed moisture (for example, polyamides absorb moisture from the environment and may have
degradation pathways involving moisture, while polyolefins do not), it is important to consider not only the accelerated aging
temperature conditions but also the ambient relative humidly during that accelerated aging. See Appendix X3 for more details on
the use of humidity in accelerated aging protocols.
NOTE 2—Degradation mechanisms for most flexible packaging materials used as sterile barrier systems do not involve moisture. However, materials used
in medical devices are far more varied, and hydrolytic degradation may be a facto
...
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