ASTM F1980-07(2011)
(Guide)Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
SIGNIFICANCE AND USE
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 and by subsequent dynamic events during shipping and handling.
ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.”
Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need 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. 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.
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.
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 t...
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 on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 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 sterile barrier systems.
1.3 The accelerated aging guideline addresses the sterile barrier systems in 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.
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 beyond the scope of this guide.
1.6 This guide does not address environmental challenging that stimulates 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 F1327 for a definition of “environmental challenging.”
1.7 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.
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Designation: F1980 − 07(Reapproved 2011)
Standard Guide for
Accelerated Aging of Sterile Barrier Systems for 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 priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 This guide provides information for developing accel-
erated aging protocols to rapidly determine the effects, if any,
2. Referenced Documents
due to the passage of time on the sterile integrity of the sterile
2.1 ASTM Standards:
barrier system (SBS), as defined in ANSI/AAMI/ISO
D4332Practice for Conditioning Containers, Packages, or
11607–1:2006 and the physical properties of their component
Packaging Components for Testing
packaging materials.
E337Test Method for Measuring Humidity with a Psy-
1.2 Information obtained using this guide may be used to
chrometer (the Measurement of Wet- and Dry-Bulb Tem-
supportexpirationdateclaimsformedicaldevicesterilebarrier
peratures)
systems.
F17Terminology Relating to Flexible Barrier Packaging
F1327Terminology Relating to Barrier Materials for Medi-
1.3 The accelerated aging guideline addresses the sterile
cal Packaging (Withdrawn 2007)
barrier systems in whole with or without devices. The sterile
F2097Guide for Design and Evaluation of Primary Flexible
barrier system material and device interaction compatibility
that may be required for new product development or the Packaging for Medical Products
resulting evaluation is not addressed in this guide. 2.2 AAMI Standards:
ANSI/AAMI/ISO 11607–1: 2006,Packaging for Terminally
1.4 Real-time aging protocols are not addressed in this
Sterilized Medical Devices
guide; however, it is essential that real-time aging studies be
AAMITIR22–2007,GuidanceforANSI/AAMI/ISO11607,
performed to confirm the accelerated aging test results using
Packaging for Terminally Sterilized Medical Devices
the same methods of evaluation.
1.5 Methods used for sterile barrier system validation, 3. Terminology
which include the machine process, the effects of the steriliza-
3.1 Definitions—For general definitions of packaging for
tion process, environmental challenge, distribution, handling,
medicaldevices,seeANSI/AAMI/ISO11607.Forterminology
and shipping events, are beyond the scope of this guide.
related to barrier materials for medical packaging see Termi-
nology F17.
1.6 This guide does not address environmental challenging
that stimulates extreme climactic conditions that may exist in
3.2 Definitions of Terms Specific to This Standard:
the shipping and handling environment. Refer to Practice
3.2.1 accelerated aging (AA), n—storage of samples at an
D4332 for standard conditions that may be used to challenge
elevated temperature (T ) in order to simulate real time aging
AA
the sterile barrier system to realistic extremes in temperature
in a reduced amount of time.
and humidity conditions. See Terminology F1327 for a defini-
3.2.2 accelerated aging factor (AAF), n—an estimated or
tion of “environmental challenging.”
calculated ratio of the time to achieve the same level of
1.7 This standard does not purport to address all of the
physical property change as a sterile barrier system stored at
safety concerns, if any, associated with its use. It is the
real time (RT) conditions.
responsibility of the user of this standard to establish appro-
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
This guide is under the jurisdiction of ASTM Committee F02 on Flexible Standards volume information, refer to the standard’s Document Summary page on
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on the ASTM website.
Package Design and Development. The last approved version of this historical standard is referenced on
Current edition approved Aug. 1, 2011. Published November 2011. Originally www.astm.org.
approved in 1999. Last previous edition approved in 2007 as F1980–07. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F1980-07R11. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1980 − 07 (2011)
3.2.3 accelerated aging temperature (T ), n—the elevated documented evidence to show a correlation between real time
AA
temperature at which the aging study is conducted, and it may and accelerated aging.
bebasedontheestimatedstoragetemperature,estimatedusage
4.5 When conducting accelerated aging programs for estab-
temperature, or both.
lishingexpirydatingclaims,itmustberecognizedthatthedata
3.2.4 accelerated aging time (AAT), n—the length of time
obtainedfromthestudyisbasedonconditionsthatsimulatethe
the accelerated aging is conducted.
effects of aging on the materials. The resulting creation of an
expiration date or shelf life is based on the use of a conserva-
3.2.5 ambient temperature (T ),n—storage temperature
RT
tive estimate of the aging factor (for example, Q ) and is
for real-time aging (RT) samples that represents storage con- 10
tentative until the results of real time aging studies are
ditions.
completed on the sterile barrier system.
3.2.6 sterile barrier system shelf life, n—the amount of real
NOTE 1—Determining AAFs are beyond the scope of this guide.
time that a sterile barrier system can be expected to remain in
storage at ambient conditions, or under specified conditions of
5. Apparatus
storage, and maintain its critical performance properties.
5.1 Room (or Cabinet) of such size that samples may be
3.2.7 real-time aging (RT), n—storage time of samples at
individually exposed to circulating air at the temperature and
ambient conditions.
relative humidity chosen.
3.2.8 real-time equivalent (RTE), n—amount of real-time 5.1.1 ControlApparatus,capableofmaintainingtheroomat
aging to which given accelerated aging conditions are esti- therequiredatmosphericconditionswithinthetolerancelimits.
mated to be equivalent.
5.2 Hygrometer—The instrument used to indicate the rela-
3.2.9 zero time (t ), n—the beginning of an aging study.
tive humidity should be accurate to 62% relative humidity.A
psychrometer may be used either for direct measurement of
3.3 Symbols:
relative humidity or for checking the hygrometer (see Test
Q = an aging factor for 10°C increase or decrease in Method E337).
temperature.
5.3 Thermometer—Any temperature-measuring device may
T = temperature at which a material melts.
m
be used provided it can accurately indicate the temperature to
T = glass transition temperature.
g
within 0.1°C or 0.2°F and be properly recorded. The dry-bulb
T = alpha temperature; heat distortion temperature.
α
thermometer of the psychrometer may be used either for direct
measurement or for checking the temperature-indicating de-
4. Significance and Use
vice.
4.1 The loss of sterile barrier system integrity may occur as
6. Accelerated Aging Theory
a result of physical properties of the materials and adhesive or
cohesive bonds degrading over time and by subsequent dy-
6.1 Accelerated aging of materials refers to the accelerated
namic events during shipping and handling.
variationoftheirpropertiesovertime,thepropertiesofinterest
4.2 ISO11607–1:2006, clause 6, states that “the packaging being those related to safety and function of the material or
sterile barrier system.
systemshallprovidephysicalprotectionandmaintainintegrity
of the sterile barrier system. The sterile barrier system shall
6.2 In an aging study, the material or sterile barrier system
maintain sterility to the point of use or until the expiry date.
issubjectedtoanexternalstress,whichismoresevere,ormore
Stabilitytestingshalldemonstratethatthesterilebarriersystem
frequently applied than the normal environmental stress, for a
maintains integrity over time. Stability testing using acceler-
relatively short period of time.
atedagingprotocolsshallberegardedassufficientevidencefor
6.3 Accelerated aging techniques are based on the assump-
claimed expiry date until data from real time aging studies are
tionthatthechemicalreactionsinvolvedinthedeteriorationof
available.”
materials follow the Arrhenius reaction rate function. This
4.3 Real time aging programs provide the best data to
function states that a 10°C increase or decrease in temperature
ensure that sterile barrier system materials and sterile barrier
of a homogeneous process results in, approximately, a two
system integrity do not degrade over time. However, due to
times or ⁄2-time change in the rate of a chemical reaction
market conditions in which products become obsolete in a
(Q ) .
short time, and the need to get new products to market in the
6.4 Determining the Q involves testing materials at vari-
shortest possible time, real time aging studies do not meet this
ous temperatures and defining the differences in reaction rate
objective.Accelerated aging studies can provide an alternative
for a 10° change in temperature. Modeling the kinetics of
means. To ensure that accelerated aging studies do truly
material deterioration is complex and difficult and is beyond
represent real time effects, real time aging studies must be
the scope of this guide.
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.
Hemmerich, K. J., “General Aging Theory and Simplified Protocol for
Accelerated Aging of Medical Devices,” Medical Plastics and Biomaterials,
4.4 Conservative accelerated aging factors (AAFs) must be
July/August 1998, pp. 16–23.
used if little is known about the sterile barrier system material
Nelson, W., “Accelerated Testing Statistical Models, Test Plans, and Data
being evaluated. More aggressive AAFs may be used with Analyses,” John Wiley and Sons, New York, 1999.
F1980 − 07 (2011)
NOTE4—Tolerancesof 62°Cforthetesttemperatureand 65%forthe
6.5 Ahumidityfactortocalculatetheacceleratedagingtime
humidity are acceptable. Since the shelf life of the finished sterile barrier
(AAT) is not applicable for accelerated aging protocols. Unre-
system is based on a conservative aging factor (Q ) of 2.0 for the
alistic or extreme temperature and humidity conditions may be
acceleratedagingprotocol,anylongtermdeviationinthetemperatureless
of interest in overall sterile barrier system performance.
than the specified temperature in the protocol can be compensated for by
However, this must be evaluated in a separate study and is not
increasingthetotaltestdurationtimewithoutinvalidatingtheintentofthe
aging protocol.
related to aging of the materials. See Appendix X3 for more
NOTE 5—Where excursions in the test temperature occur over a long
details on the use of humidity in accelerated aging protocols.
period of time, an assessment on the temperature effects to the packaging
materials and/or the test duration adjustments required to achieve the
7. Accelerated Aging Plan
desired estimate of shelf life must be determined.
7.1 Characterization of Materials—AA theory and its ap-
7.2.3.3 Whenelevatedtemperatureagingisnotfeasibledue
plication are directly related to packaging material composi-
to material characteristics, then real-time aging is the only
tion. Material properties that may affect the results of acceler-
option.
ated aging studies include:
7.1.1 Composition,
7.3 Accelerated Aging Factor (AAF) Determination:
7.1.2 Morphology (glassy, amorphous, semi-crystalline,
7.3.1 Using theArrhenius equation with Q equal to 2 is a
highly crystalline, % crystallinity, and so forth),
common and conservative means of calculating an aging
7.1.3 Thermal transitions (T ,T,T ), as defined in 3.3,
m g α
factor.
7.1.4 Additives, processing agents, catalysts, lubricants,
NOTE 6—Amore aggressive reaction rate coefficient, for example, Q
residual solvents, corrosive gases, and fillers. 10
= 2.2 to 2.5, may be used if the system under investigation is sufficiently
7.2 Accelerated Aging Plan-Design Guidelines:
well characterized in the literature. The level and nature of damage must
7.2.1 Temperatureboundaries,basedonthecharacterization be similar to that reported in the literature to ensure that the reaction rate
coefficient and accelerated aging temperature are maintained within
of the device and sterile barrier system materials, must be
appropriate boundaries.This is the responsibility of the manufacturer. For
considered in order to ensure that initial, conservative aging
more information on this topic see AAMI TIR 22–2007.
factorsareappliedappropriately.Thetemperaturesusedshould
7.3.2 An accelerated aging factor (AAF) estimate is calcu-
bebasedonthecharacterizationofthepackagingmaterialsand
lated by the following equation:
the intended storage conditions. Material characterization and
composition are factors in establishing the accelerated aging @~T 2T !/10#
AA RT
AAF[Q (1)
temperature boundaries. Temperature selection should be lim-
where:
ited to prevent any physical transition of material.
T ≡ accelerated aging temperature (°C), and
7.2.2 Room or Ambient Temperature (T )—Select a tem-
AA
RT
perature that represents the actual product storage and use
T ≡ ambient temperature (°C).
RT
conditions.
7.3.3 The accelerated aging time (AAT) needed to establish
equivalence to real time aging is determined by dividing the
NOTE 2—This temperature is typically between 20 to 25°C.Atempera-
desired (or required) shelf life by the AAF.
ture of 25°C is considered a conservative approach.
7.2.3 Accelerated Aging Temperature (T )—Considering AcceleratedAgingTime AAT [Desired RT /AAF (2)
~ ! ~ !
AA
NOTE 7—See Appendix X1 for a graphical representation of the time
the characterization of the materials under investigation, select
versus temperature. Also, see Appendix X2 for a sample test plan with
a temperature for the accelerated aging testing. The higher the
examples of the calculations using Eq 1 and 2.
accelerated temperature, the greater the AAF and, thus, the
shorter the accelerated aging time. Care must be taken not to 7.3.4 When little information is known about the sterile
elevate aging temperatures solely for the shortest possible barrier system under investigation, the guidance above is
accelerated aging time. Excessively high temperatures may provided for selecting and verifying an appropriately conser-
have an effect on t
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