1、Designation: D 3103 071Standard Test Method forThermal Insulation Performance of Distribution Packages1This standard is issued under the fixed designation D 3103; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last rev
2、ision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTERemoved research report footnote from Section 11.2 editorially in September 2008.1. Scope1.1 This test method covers the determinatio
3、n of the thermalinsulation quality of a package and the thermal stability of itscontents when exposed to variable ambient temperature con-ditions. It is suitable for testing packages with various internalenergy sources with or without product payloads.1.2 This standard does not purport to address al
4、l of thesafety 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. Specific precau-tionary statements are given in 5.3.2. Referen
5、ced Documents2.1 ASTM Standards:2D 996 Terminology of Packaging and Distribution Environ-mentsD 4332 Practice for Conditioning Containers, Packages, orPackaging Components for Testing2.2 Other Standards:ISTA 5B Focused Simulation Guide for Thermal Perfor-mance Testing of Temperature Controlled Trans
6、port Pack-aging33. Terminology3.1 DefinitionsGeneral definitions for packaging and dis-tribution environments are found in Terminology D 996.3.2 Definitions of Terms Specific to This Standard:3.2.1 data acquisition unit and associated systemsingle-or multi-channel recorder and its associated softwar
7、e andhardware utilizing thermocouples and thermistor sensors trace-able to NIST (National Institute for Standards and Technology)that collects and date stamps time and temperature.3.2.2 draft-free atmospherean atmosphere where the testspecimens are isolated from direct air currents while surround-in
8、g air temperature is maintained uniformly throughout thechamber.3.2.3 eutectic system, na mixture or compound in whichpure solid phases changes occur at a well-defined specifictemperature.3.2.4 exterior atmospherethe atmosphere surrounding theexterior surface of a package.3.2.5 interior atmosphereth
9、e atmosphere in contact ornear the packaged item.3.2.6 mappingcollecting temperature data at a wide rangeof locations inside a package or chamber to determine thevariability of temperature range in the environment.3.2.7 package systemthe combination of exterior pack-age, interior packaging, refriger
10、ants, and product payload.3.2.8 product payloadthe product and any associatedsecondary packaging that is to be temperature controlled withinthe insulated test package.3.2.9 refrigerantseutectic materials, gel packs, ice, orother material that serves as an energy source or buffer mediumwithin the pac
11、kage system.3.2.10 secondary packagethe package that contains theprimary container/closure system(s).3.2.11 thermal conductivity, homogeneous materialtherate of heat flow, under steady conditions through unit area, perunit temperature gradient in the direction perpendicular to thearea.4. Significanc
12、e and Use4.1 This test method is intended for use for evaluating theperformance of thermal insulated packaging used for high-value, high-risk materials. This test method may also be usedfor any product that requires accurate internal package tem-perature readings while being exposed to a range of ex
13、ternal airtemperatures.4.2 Certain items, such as biological materials, pharmaceu-ticals, diagnostics, and blood products, must be shipped insidetemperature-controlled packages. Factors affecting the rate of1This test method is under the jurisdiction of ASTM Committee D10 onPackaging and is the dire
14、ct responsibility of Subcommittee D10.23 on NaturalEnvironment Test Methods.Current edition approved May 1, 2007. Published June 2007. Originallyapproved in 1972. Last previous edition approved in 1999 as D 3103 99.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM
15、Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from International Safe TransitAssociation (ISTA), 1400Abbott Rd.,Suite 160, East Lansing, MI 488231900, http:/www.ista.org.1Copyright
16、ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.heat transfer of the package include the insulation of theexterior package, the energy source, and the product payload.4.3 Because of the variety of factors affecting the perfor-mance of a thermal
17、ly insulated package, testing should beconducted with the actual package whenever possible. Whensimulated packages are used, special care must be exercised sothat the simulated payload and coolant will be as close aspossible to the actual packages in temperature and otherrelevant physical properties
18、.5. Test Conditions and Apparatus5.1 Temperature Profile of Exterior AtmosphereThe time-temperature test profile should be established prior to testingbased on actual field data, compendial or regulatory require-ments, or contractual requirements.5.1.1 Field Data Time-Temperature ProfileIt is recom-
19、mended that the test profile represent actual worst casedistribution conditions as closely as possible. The test profile ofexterior package temperatures should be based on actualambient air data accumulated during package handling andtransit whenever possible. Any published test cycle or cycledevelo
20、ped using ISTA 5B may also be used as applicable.When using a method based on actual data or developed inaccordance with ISTA 5B, the rate of temperature changebetween trip segments should reflect, as closely as possible,actual transit conditions. Should other than worst case condi-tions be used, in
21、dicated the percentile of the data pool that theprofile represents.5.1.2 Regulatory RequirementsWhen using a time-temperature test profile from a regulatory or compendialsource, such as the WHO, cite the source and its application.5.1.3 Contractual RequirementsShould the time-temperature test profil
22、e be stipulated by contract, cite thesource and, where available, the rationale for the profile.5.1.4 Constant TemperatureA constant temperature pro-file may be used, especially to determine relative performanceof insulating materials. Constant temperatures do not reflectactual transit conditions bu
23、t may be useful for comparativetesting or for research.5.2 Test ChamberTests must be performed in one or morerooms or cabinets (chambers) for which test samples can beindividually placed with adequate space around all surfaces forair circulation at the desired temperature.An access port shouldbe ava
24、ilable for leading thermocouple wires out of the chamberfor hook-up to the data acquisition unit (DAU). A temperatureindicator should be placed 10 in. from the test package torecord the temperature of the exterior atmosphere during theentire test duration.5.3 Test Chamber ControllerThe room or cabin
25、et mustmaintain a uniform temperature around the test specimen. Thetest chamber control apparatus must be capable of maintainingthe desired temperature to within 63C. It may be desirable toincorporate a programmable controller with the capability ofperforming temperature profiles (for example, multi
26、ple tem-perature changes over time). However, the temperature cabinetheating and cooling mechanisms must have the capability tochange temperature at the desired ramp rates of the profile.(WarningGaseous CO2is colorless, odorless, and noncom-bustible. In well-ventilated uses they present few problems
27、, butevaporation or sublimation in airtight enclosures for prolongedperiods (for example, 12 h) can produce sprung doors andasphyxiation of operating personnel. Usually these CO2can beused if provisions are made to evacuate the built-up gasperiodically.)5.3.1 Single or Multi-Channel Data Acquisition
28、 Unit(DAU):5.3.1.1 The recording capability should be as an electronicdatalogger by sensor number with date and time of reading thatcan be presented in a continuous graph form as a secondarypresentation. Resolution of the device shall be 0.1C or greater.Accuracy over the range tested should be 60.5C
29、. The printeror associated computer datafile shall be activated by a voltagefrom an insulated copper-constantan wires, Type T, or othersuitable sensor for the temperature range to be measured thatare specified by the manufacturer to be accurate to 0.1C. Thewires may be single or multi-strand and sho
30、uld be flexibleenough to be run through repeated bends in the package. Anytips or probes added to the wire should be noted and should notchange the accuracy or response time of the thermocouple.5.3.2 Thermistor-RecorderA thermistor sensor may beused, instead of a thermocouple, for sensing interior t
31、empera-tures of the package. The thermistor may be attached torecording equipment, as described in 5.3.1, with supplementaryelectrical circuitry as needed, or it may be a wireless, batteryoperated, computer programmable unit that stores digitaltemperature readings at specified time intervals. Progra
32、mmingand data downloading of the units is done through a suitablecomputer interface with appropriate software. System accuracyover the range tested should be 60.5C with minimumresolution to 0.1C. Response time over range should bedetermined prior to use and suitable for the reading interval ofthe te
33、st.5.4 Calibration Reference StandardA NIST-traceable de-vice used in conjunction with a constant temperature bath whencalibrating and verifying accuracy pre- and post-test. Theresolution and accuracy must be equal to or better than thesensors used in testing.5.5 Constant Temperature BathA device or
34、 method thatproduces a stable and consistent reference temperature within61C of a desired set point used in the calibration andverification of temperature sensors. The bath may produce thetemperature reference point by means of an electronic signal ortemperature controlled liquid bath (the type of l
35、iquid may varydepending of system and temperature). A bath in which thetemperature is both stable and consistent within 61C of thedesired set-point and is used in the calibration and verificationof thermocouples. The bath solution may vary depending onthe desired set-point.6. Sampling6.1 Experimenta
36、l package designs (prototypes) shall bemade as close to the specifications and methods as possible thatwill be used during actual production.6.2 A minimum of three samples must be tested to ensurereproduceability.D310307127. Test Specimens7.1 In designing a package system it is suggested that thepay
37、load contents within the insulated container is mapped todetermine hot and cold locations throughout.7.2 The packaging system and its components, mass, con-figuration, and locations shall have identical assemblies. Thepackage system shall be closed, taped, or sealed in the samemanner as will be used
38、 for actual shipment.8. Conditioning8.1 Condition all materials in accordance with PracticeD 4332 or in accordance with the instructions provided in thetest protocol for a minimum of 24 h or until stable at theconditions expected during actual production packing.8.2 Pre-conditioningSpecific test pro
39、cedures may requirecertain pre-conditioning of components just prior to assem-bling the test packages. Pre-conditioning, if any, should bedone in accordance with individual test requirements.9. Procedures9.1 The desired test packaging configuration will be docu-mented in such a way to identify all c
40、omponents, theirlocations, thermocouple locations, test equipment, test condi-tions, and test start time.9.2 Calibrate the sensors using the NIST-traceable referencestandard. Place sensors in stable temperature bath along withthe reference standard. Record temperatures from the sensorsand reference
41、standard independently for a minimum of threetemperature points. The overall system difference between thereference standard and each sensor should be within 60.5C. Ifusing a thermistor, ensure the equipment is certified as cali-brated to a NIST-traceable source.9.3 Test Package Assembly:9.3.1 Pre-c
42、ondition all packaging materials, refrigerants,and products at specified pre-test temperatures for the packageassembly to be tested. Pre-conditioning should be for at least24 h, or as specified. Be sure to allow sufficient time for allmaterials to reach desired temperature, that is, frozen solid.Rec
43、ord all pre-conditioning temperatures.9.3.1.1 If feasible, attach probes directly to the wall of theprimary product package and/or inside the package in directcontact with the product, prior to pre-conditioning. Whenattaching probes, avoid covering the sensor area with tape orother material that cou
44、ld inhibit the sensors ability to readtemperatures at the specified speed and accuracy.9.3.1.2 The number of probes per package will be depen-dent on the size and number of the primary containers in thepayload. In general, when first evaluating a thermal package, aminimum of 5 to 10 probes should be
45、 used on payloads of upto 25 primary packages. Record the probe placements in thepackage assembly.NOTE 1It may be desirable to use wireless data recorders, if possible,on smaller units to minimize air exchange caused by leaks at thethermocouple insertion site. If thermocouples are used, a small port
46、 can beopened through the wall of the carton as far away from the ice as possible,the thermocouples inserted into the carton, and the port sealed to preventleaking of air. Do not place battery operated recorders in packagescontaining dry ice as the units will be damaged and nonfunctional at thesetem
47、peratures. Units with remote probes may be placed outside the cartonwhere the battery and microchip will not be exposed to dry ice conditions.9.3.2 When a cooling or heat source is used, place aweighed and measured quantity of refrigerant or phase changematerial in the package as specified in the te
48、st protocol. Whenwater, ice, or refrigerant bottles, gel, or bricks are used,measure and record the temperature of the conditioning cham-ber before removal. Any pre-conditioning prior to package thetest assemblies should be monitored during pre-conditioningby ambient air probes.9.3.3 The quantity of
49、 energy source or eutectic system maybe varied. However, when materials and designs of similarinside dimensions are being evaluated, the quantity by mass,configuration, and total surface area must be constant for theseries for accurate evaluation of performance. When crushed orchopped dry ice is used, the fragments should be of the samegeneral size for each package tested and should be free of dryice dust.9.3.4 If wires are not ported through the wall of theinsulated carton, place the cover on the package with the sensorwires arranged so that
