ASTM F1980-2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices《医疗器械用无菌屏障系统加速老化的标准指南》.pdf

1、Designation: F1980 16Standard Guide forAccelerated Aging of Sterile Barrier Systems for MedicalDevices1This standard is issued under the fixed designation F1980; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revi

2、sion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides information for developing accel-erated aging protocols to rapidly determine the effects, if any,due to the

3、 passage of time on the sterile integrity of the sterilebarrier system (SBS), as defined in ANSI/AAMI/ISO116071:2006 and the physical properties of their componentpackaging materials.1.2 Information obtained using this guide may be used tosupport expiration date claims for medical device sterile bar

4、riersystems.1.3 The accelerated aging guideline addresses the sterilebarrier systems in whole with or without devices. The sterilebarrier system material and device interaction compatibilitythat may be required for new product development or theresulting evaluation is not addressed in this guide.1.4

5、 Real-time aging protocols are not addressed in thisguide; however, it is essential that real-time aging studies beperformed to confirm the accelerated aging test results usingthe same methods of evaluation.1.5 Methods used for sterile barrier system validation,which include the machine process, the

6、 effects of the steriliza-tion process, environmental challenge, distribution, handling,and shipping events, are beyond the scope of this guide.1.6 This guide does not address environmental challengingthat stimulates extreme climactic conditions that may exist inthe shipping and handling environment

7、. Refer to PracticeD4332 for standard conditions that may be used to challengethe sterile barrier system to realistic extremes in temperatureand humidity conditions. See Terminology F1327 for a defini-tion of “environmental challenging.”1.7 This standard does not purport to address all of thesafety

8、concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D4332 Practice for Conditioning Con

9、tainers, Packages, orPackaging Components for TestingE337 Test Method for Measuring Humidity with a Psy-chrometer (the Measurement of Wet- and Dry-Bulb Tem-peratures)F17 Terminology Relating to Flexible Barrier PackagingF1327 Terminology Relating to Barrier Materials for Medi-cal Packaging (Withdraw

10、n 2007)3F2097 Guide for Design and Evaluation of Primary FlexiblePackaging for Medical Products2.2 AAMI Standards:ANSI/AAMI/ISO 116071: 2006, Packaging for TerminallySterilized Medical Devices4AAMI TIR 222007, Guidance forANSI/AAMI/ISO 11607,Packaging for Terminally Sterilized Medical Devices43. Ter

11、minology3.1 DefinitionsFor general definitions of packaging formedical devices, seeANSI/AAMI/ISO 11607. For terminologyrelated to barrier materials for medical packaging see Termi-nology F17.3.2 Definitions of Terms Specific to This Standard:3.2.1 accelerated aging (AA), nstorage of samples at anele

12、vated temperature (TAA) in order to simulate real time agingin a reduced amount of time.3.2.2 accelerated aging factor (AAF), nan estimated orcalculated ratio of the time to achieve the same level ofphysical property change as a sterile barrier system stored atreal time (RT) conditions.1This guide i

13、s under the jurisdiction of ASTM Committee F02 on PrimaryBarrier Packaging and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved Sept. 15, 2016. Published September 2016. Originallyapproved in 1999. Last previous edition approved in 2011 as

14、 F1980 07(2011).DOI: 10.1520/F1980-16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved vers

15、ion of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,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 State

16、s13.2.3 accelerated aging temperature (TAA), nthe elevatedtemperature at which the aging study is conducted, and it maybe based on the estimated storage temperature, estimated usagetemperature, or both.3.2.4 accelerated aging time (AAT), nthe length of timethe accelerated aging is conducted.3.2.5 am

17、bient temperature (TRT),nstorage temperaturefor real-time aging (RT) samples that represents storage con-ditions.3.2.6 sterile barrier system shelf life, nthe amount of realtime that a sterile barrier system can be expected to remain instorage at ambient conditions, or under specified conditions ofs

18、torage, and maintain its critical performance properties.3.2.7 real-time aging (RT), nstorage time of samples atambient conditions.3.2.8 real-time equivalent (RTE), namount of real-timeaging to which given accelerated aging conditions are esti-mated to be equivalent.3.2.9 zero time (t0), nthe beginn

19、ing of an aging study.3.3 Symbols:Q10= an aging factor for 10C increase or decrease intemperature.Tm= temperature at which a material melts.Tg= glass transition temperature.T= alpha temperature; heat distortion temperature.4. Significance and Use4.1 The loss of sterile barrier system integrity may o

20、ccur asa result of physical properties of the materials and adhesive orcohesive bonds degrading over time and by subsequent dy-namic events during shipping and handling.4.2 ISO 116071:2006, clause 6, states that “the packagingsystem shall provide physical protection and maintain integrityof the ster

21、ile barrier system. The sterile barrier system shallmaintain sterility to the point of use or until the expiry date.Stability testing shall demonstrate that the sterile barrier systemmaintains integrity over time. Stability testing using acceler-ated aging protocols shall be regarded as sufficient e

22、vidence forclaimed expiry date until data from real time aging studies areavailable.”4.3 Real time aging programs provide the best data toensure that sterile barrier system materials and sterile barriersystem integrity do not degrade over time. However, due tomarket conditions in which products beco

23、me obsolete in ashort time, and the need to get new products to market in theshortest possible time, real time aging studies do not meet thisobjective. Accelerated aging studies can provide an alternativemeans. To ensure that accelerated aging studies do trulyrepresent real time effects, real time a

24、ging studies must beconducted in parallel to accelerated studies. Real time studiesmust be carried out to the claimed shelf life of the product andbe performed to their completion.4.4 Conservative accelerated aging factors (AAFs) must beused if little is known about the sterile barrier system materi

25、albeing evaluated. More aggressive AAFs may be used withdocumented evidence to show a correlation between real timeand accelerated aging.4.5 When conducting accelerated aging programs for estab-lishing expiry dating claims, it must be recognized that the dataobtained from the study is based on condi

26、tions that simulate theeffects of aging on the materials. The resulting creation of anexpiration date or shelf life is based on the use of a conserva-tive estimate of the aging factor (for example, Q10) and istentative until the results of real time aging studies arecompleted on the sterile barrier

27、system.NOTE 1Determining AAFs are beyond the scope of this guide.5. Apparatus5.1 Room (or Cabinet) of such size that samples may beindividually exposed to circulating air at the temperature andrelative humidity chosen.5.1.1 Control Apparatus, capable of maintaining the room atthe required atmospheri

28、c conditions within the tolerance limits.5.2 HygrometerThe instrument used to indicate the rela-tive humidity should be accurate to 62 % relative humidity. Apsychrometer may be used either for direct measurement ofrelative humidity or for checking the hygrometer (see TestMethod E337).5.3 Thermometer

29、Any temperature-measuring device maybe used provided it can accurately indicate the temperature towithin 0.1C or 0.2F and be properly recorded. The dry-bulbthermometer of the psychrometer may be used either for directmeasurement or for checking the temperature-indicating de-vice.6. Accelerated Aging

30、 Theory6.1 Accelerated aging of materials refers to the acceleratedvariation of their properties over time, the properties of interestbeing those related to safety and function of the material orsterile barrier system.6.2 In an aging study, the material or sterile barrier systemis subjected to an ex

31、ternal stress, which is more severe, or morefrequently applied than the normal environmental stress, for arelatively short period of time.6.3 Accelerated aging techniques are based on the assump-tion that the chemical reactions involved in the deterioration ofmaterials follow the Arrhenius reaction

32、rate function. Thisfunction states that a 10C increase or decrease in temperatureof a homogeneous process results in, approximately, a twotimes or12-time change in the rate of a chemical reaction(Q10)5.6.4 Determining the Q10involves testing materials at vari-ous temperatures and defining the differ

33、ences in reaction ratefor a 10 change in temperature. Modeling the kinetics ofmaterial deterioration is complex and difficult and is beyondthe scope of this guide.65Hemmerich, K. J., “General Aging Theory and Simplified Protocol forAccelerated Aging of Medical Devices,” Medical Plastics and Biomater

34、ials,July/August 1998, pp. 1623.6Nelson, W., “Accelerated Testing Statistical Models, Test Plans, and DataAnalyses,” John Wiley and Sons, New York, 1999.F1980 1626.5 Ahumidity factor to calculate the accelerated aging time(AAT) is not applicable for accelerated aging protocols. Unre-alistic or extre

35、me temperature and humidity conditions may beof interest in overall sterile barrier system performance.However, this must be evaluated in a separate study and is notrelated to aging of the materials. See Appendix X3 for moredetails on the use of humidity in accelerated aging protocols.7. Accelerated

36、 Aging Plan7.1 Characterization of MaterialsAA theory and its ap-plication are directly related to packaging material composi-tion. Material properties that may affect the results of acceler-ated aging studies include:7.1.1 Composition,7.1.2 Morphology (glassy, amorphous, semi-crystalline,highly cry

37、stalline, % crystallinity, and so forth),7.1.3 Thermal transitions (Tm,Tg,T), as defined in 3.3,7.1.4 Additives, processing agents, catalysts, lubricants,residual solvents, corrosive gases, and fillers.7.2 Accelerated Aging Plan-Design Guidelines:7.2.1 Temperature boundaries, based on the characteri

38、zationof the device and sterile barrier system materials, must beconsidered in order to ensure that initial, conservative agingfactors are applied appropriately. The temperatures used shouldbe based on the characterization of the packaging materials andthe intended storage conditions. Material chara

39、cterization andcomposition are factors in establishing the accelerated agingtemperature boundaries. Temperature selection should be lim-ited to prevent any physical transition of material.7.2.2 Room or Ambient Temperature (TRT)Select a tem-perature that represents the actual product storage and usec

40、onditions.NOTE 2This temperature is typically between 20 to 25C. A tempera-ture of 25C is considered a conservative approach.7.2.3 Accelerated Aging Temperature (TAA)Consideringthe characterization of the materials under investigation, selecta temperature for the accelerated aging testing. The highe

41、r theaccelerated temperature, the greater the AAF and, thus, theshorter the accelerated aging time. Care must be taken not toelevate aging temperatures solely for the shortest possibleaccelerated aging time. Excessively high temperatures mayhave an effect on the material that may never occur during

42、realtime or at room temperature (see Appendix X1). Guidelines forselecting an aging temperature are as follows:7.2.3.1 TAAshould be below any material transitions orbelow where the sterile barrier system distorts. Consider thethermal transitions of the materials under investigation. (Formore informa

43、tion on this topic, see AAMI TIR 222007.)7.2.3.2 Keep TAAat or below 60C unless a higher tempera-ture has been demonstrated to be appropriate. Temperatureshigher than 60C are not recommended due to the higherprobability in many polymeric systems to experience nonlinearchanges, such as percent crysta

44、llinity, formation of freeradicals, and peroxide degradation. (For more information onthis topic, see AAMI TIR 222007.)NOTE 3If sterile barrier systems containing liquid or other volatilecomponents are tested, lower temperatures may be required for safetyreasons.NOTE 4Tolerances of 62C for the test

45、temperature and 65 % for thehumidity are acceptable. Since the shelf life of the finished sterile barriersystem is based on a conservative aging factor (Q10) of 2.0 for theaccelerated aging protocol, any long term deviation in the temperature lessthan the specified temperature in the protocol can be

46、 compensated for byincreasing the total test duration time without invalidating the intent of theaging protocol.NOTE 5Where excursions in the test temperature occur over a longperiod of time, an assessment on the temperature effects to the packagingmaterials and/or the test duration adjustments requ

47、ired to achieve thedesired estimate of shelf life must be determined.7.2.3.3 When elevated temperature aging is not feasible dueto material characteristics, then real-time aging is the onlyoption.7.3 Accelerated Aging Factor (AAF) Determination:7.3.1 Using the Arrhenius equation with Q10equal to 2 i

48、s acommon and conservative means of calculating an agingfactor.NOTE 6A more aggressive reaction rate coefficient, for example, Q10= 2.2 to 2.5, may be used if the system under investigation is sufficientlywell characterized in the literature. The level and nature of damage mustbe similar to that rep

49、orted in the literature to ensure that the reaction ratecoefficient and accelerated aging temperature are maintained withinappropriate boundaries. This is the responsibility of the manufacturer. Formore information on this topic see AAMI TIR 222007.7.3.2 An accelerated aging factor (AAF) estimate is calcu-lated by the following equation:AAFQ10TAA2TRT!/10#(1)where:TAA accelerated aging temperature (C), andTRT ambient temperature (C).7.3.3 The accelerated aging time (AAT) needed to establishequivalence to real time aging is determined