ASTM D3103-20

Standard Test Method for Thermal Insulation Performance of Distribution Packages

SIGNIFICANCE AND USE
4.1 This test method is intended for use for evaluating the performance of thermal insulated packaging used for high-value, high-risk materials. This test method may also be used for any product that requires accurate internal package temperature readings while being exposed to a range of external air temperatures.  
4.2 Certain items, such as biological materials, pharmaceuticals, diagnostics, and blood products, must be shipped inside temperature-controlled packages. Factors affecting the rate of heat transfer of the package include the insulation of the exterior package, the energy source, and the product payload.  
4.3 Because of the variety of factors affecting the performance of a thermally insulated package, testing should be conducted with the actual package whenever possible. When simulated packages are used, special care must be exercised so that the simulated payload and coolant will be as close as possible to the actual packages in temperature and other relevant physical properties.
SCOPE
1.1 This test method covers the determination of the thermal insulation quality of a package and the thermal stability of its contents when exposed to variable ambient temperature conditions. It is suitable for testing packages with various internal energy sources with or without product payloads.  
1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in 5.3.  
1.3 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.

General Information

• Status: Published
• Publication Date: 31-Mar-2020
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: D10 - Packaging
• Drafting Committee: D10.21 - Shipping Containers and Systems - Application of Performance Test Methods

Relations

• Replaces: ASTM D3103-14 - Standard Test Method for Thermal Insulation Performance of Distribution Packages
• Effective Date: 01-Apr-2020
• Refers: ASTM E177-14 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-May-2014
• Refers: ASTM E177-13 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-May-2013
• Refers: ASTM E691-13 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-May-2013
• Refers: ASTM D4332-13 - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
• Effective Date: 15-Mar-2013
• Refers: ASTM E691-11 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Nov-2011
• Refers: ASTM D996-10a - Standard Terminology of Packaging and Distribution Environments
• Effective Date: 01-Dec-2010
• Refers: ASTM E177-10 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Oct-2010
• Refers: ASTM E691-08 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Oct-2008
• Refers: ASTM E177-08 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Oct-2008
• Refers: ASTM E177-06b - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 15-Nov-2006
• Refers: ASTM E177-06a - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Nov-2006
• Refers: ASTM D4332-01(2006) - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
• Effective Date: 01-Nov-2006
• Refers: ASTM E691-05 - Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• Effective Date: 01-Nov-2005
• Refers: ASTM E177-04e1 - Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• Effective Date: 01-Nov-2004

Overview

ASTM D3103-20: Standard Test Method for Thermal Insulation Performance of Distribution Packages establishes a reliable procedure for evaluating the thermal insulation quality and thermal stability of package contents when subjected to variable ambient temperature conditions. Developed by ASTM International, this standard is critical for assessing how well temperature-controlled packaging maintains internal conditions, ensuring the safe transport of high-value and high-risk materials. It supports accurate temperature monitoring of internal package contents as they experience external air temperature changes, providing vital data for industries that rely on precise thermal control.

Key Topics

• Thermal Insulation Evaluation: The standard outlines methods to determine the insulation quality of packaging, considering factors such as package construction, insulation, and energy sources (e.g., refrigerants, gel packs, ice).
• Temperature-Controlled Packaging Requirements: It emphasizes the necessity for temperature-controlled distribution of items like pharmaceuticals, biological materials, blood products, and diagnostics.
• Test Procedures and Apparatus: Procedures address everything from package conditioning and calibration of temperature sensors to test chamber requirements and data acquisition, specifying the use of NIST-traceable sensors to ensure accuracy and traceability.
• Performance Influencers: The method identifies variables that affect thermal performance, including package insulation, product payload, type and amount of refrigerant, and package design.
• Data Recording and Reporting: Detailed instructions are provided for documenting test configurations, calibration procedures, package assembly, sensor locations, temperature profiles, test durations, and the physical state of contents post-test.
• Precision and Reproducibility: The standard includes precision statements established through interlaboratory studies, supporting test repeatability and comparability.

Applications

ASTM D3103-20 is widely used in industries where maintaining a controlled thermal environment during transportation is crucial to product integrity and regulatory compliance. Typical applications include:

• Pharmaceuticals and Healthcare: Ensuring cold chain packages can reliably transport temperature-sensitive drugs, vaccines, and blood products without compromising efficacy or safety.
• Biological and Diagnostic Materials: Certifying the performance of insulated distribution packaging for sensitive biological samples, laboratory specimens, and diagnostic kits.
• Food Industry: Evaluating the effectiveness of packaging for perishable food items or specialty foods requiring strict thermal protection.
• Logistics and Distribution: Supporting packaging engineers, logistics managers, and quality assurance professionals in selecting and validating packaging solutions that meet client and regulatory requirements for temperature control.
• Comparative Packaging Design: Providing a standardized method for comparing the thermal performance of competing packaging materials and configurations.

Related Standards

ASTM D3103-20 is part of a network of standards supporting packaging and thermal testing. Key related documents include:

• ASTM D996: Terminology of Packaging and Distribution Environments - defines key terms used throughout ASTM packaging standards.
• ASTM D4332: Practice for Conditioning Containers, Packages, or Packaging Components for Testing - specifies pre-test conditioning requirements.
• ASTM E177: Practice for Use of the Terms Precision and Bias in ASTM Test Methods - guides the interpretation of repeatability and reproducibility data.
• ASTM E691: Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method - used in establishing D3103’s precision and reproducibility.
• ISTA 5B and ISTA 7D: International Safe Transit Association guides for thermal performance testing of temperature-controlled transport packaging.

Practical Value

Implementing ASTM D3103-20 ensures that thermal packaging systems are rigorously tested and validated under real-world and worst-case conditions, helping companies:

• Minimize risk of product degradation due to temperature excursions
• Meet regulatory demands for temperature-sensitive shipments
• Confidently select or compare insulated packaging solutions
• Maintain product safety, quality, and customer trust during cold chain or controlled-temperature distribution

In summary, ASTM D3103-20 is an essential tool for organizations involved in the shipment of temperature-sensitive goods, promoting best practices and compliance throughout the supply chain.

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: D3103 − 20
Standard Test Method for
Thermal Insulation Performance of Distribution Packages
This standard is issued under the fixed designation D3103; 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* 2.2 Other Standards:
ISTA 7D Temperature Test for Transport Packaging
1.1 Thistestmethodcoversthedeterminationofthethermal
insulation quality of a package and the thermal stability of its 3. Terminology
contents when exposed to variable ambient temperature con-
3.1 Definitions—General definitions for packaging and dis-
ditions. It is suitable for testing packages with various internal
tribution environments are found in Terminology D996.
energy sources with or without product payloads.
3.2 Definitions of Terms Specific to This Standard:
1.2 This standard does not purport to address all of the
3.2.1 data acquisition unit and associated system—single-
safety concerns, if any, associated with its use. It is the
or multi-channel recorder and its associated software and
responsibility of the user of this standard to establish appro-
hardware utilizing thermocouples and thermistor sensors trace-
priate safety, health, and environmental practices and deter-
able to NIST(National Institute for Standards andTechnology)
mine the applicability of regulatory limitations prior to use.
that collects and date stamps time and temperature.
Specific precautionary statements are given in 5.3.
3.2.2 draft-free atmosphere—an atmosphere where the test
1.3 This international standard was developed in accor-
specimens are isolated from direct air currents while surround-
dance with internationally recognized principles on standard-
ing air temperature is maintained uniformly throughout the
ization established in the Decision on Principles for the
chamber.
Development of International Standards, Guides and Recom-
3.2.3 eutectic system, n—a mixture or compound in which
mendations issued by the World Trade Organization Technical
pure solid phases changes occur at a well-defined specific
Barriers to Trade (TBT) Committee.
temperature.
3.2.4 exterior atmosphere—the atmosphere surrounding the
2. Referenced Documents
exterior surface of a package.
2.1 ASTM Standards:
3.2.5 interior atmosphere—the atmosphere in contact or
D996 Terminology of Packaging and Distribution Environ-
near the packaged item.
ments
3.2.6 mapping—collecting temperature data at a wide range
D4332 Practice for Conditioning Containers, Packages, or
of locations inside a package or chamber to determine the
Packaging Components for Testing
variability of temperature range in the environment.
E177 Practice for Use of the Terms Precision and Bias in
3.2.7 package system—thecombinationofexteriorpackage,
ASTM Test Methods
interior packaging, refrigerants, and product payload.
E691 Practice for Conducting an Interlaboratory Study to
Determine the Precision of a Test Method 3.2.8 product payload—the product and any associated
secondarypackagingthatistobetemperaturecontrolledwithin
the insulated test package.
This test method is under the jurisdiction of ASTM Committee D10 on 3.2.9 refrigerants—eutectic materials, gel packs, ice, or
Packaging and is the direct responsibility of Subcommittee D10.21 on Shipping
othermaterialthatservesasanenergysourceorbuffermedium
Containers and Systems - Application of Performance Test Methods.
within the package system.
Current edition approved April 1, 2020. Published June 2020. Originally
approved in 1972. Last previous edition approved in 2014 as D3103 – 14. DOI:
3.2.10 secondary package—the package that contains the
10.1520/D3103-20.
primary container/closure system(s).
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Available from International SafeTransitAssociation (ISTA), 1400Abbott Rd.,
the ASTM website. Suite 160, East Lansing, MI 48823–1900, http://www.ista.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D3103 − 20
3.2.11 thermal conductivity, homogeneous material—the aircirculationatthedesiredtemperature.Anaccessportshould
rateofheatflow,understeadyconditionsthroughunitarea,per beavailableforleadingthermocouplewiresoutofthechamber
unit temperature gradient in the direction perpendicular to the for hook-up to the data acquisition unit (DAU).Atemperature
area. indicator should be placed 10 in. from the test package to
record the temperature of the exterior atmosphere during the
4. Significance and Use
entire test duration.
4.1 This test method is intended for use for evaluating the
5.3 Test Chamber Controller—The room or cabinet must
performance of thermal insulated packaging used for high-
maintain a uniform temperature around the test specimen. The
value, high-risk materials. This test method may also be used
test chamber control apparatus must be capable of maintaining
for any product that requires accurate internal package tem-
the desired temperature to within 63°C. It may be desirable to
peraturereadingswhilebeingexposedtoarangeofexternalair
incorporate a programmable controller with the capability of
temperatures.
performing temperature profiles (for example, multiple tem-
4.2 Certain items, such as biological materials,
perature changes over time). However, the temperature cabinet
pharmaceuticals, diagnostics, and blood products, must be
heating and cooling mechanisms must have the capability to
shipped inside temperature-controlled packages. Factors af-
change temperature at the desired ramp rates of the profile.
fecting the rate of heat transfer of the package include the
(Warning—Gaseous CO is colorless, odorless, and noncom-
insulation of the exterior package, the energy source, and the
bustible.Inwell-ventilatedusestheypresentfewproblems,but
product payload.
evaporation or sublimation in airtight enclosures for prolonged
periods (for example, 12 h) can produce sprung doors and
4.3 Because of the variety of factors affecting the perfor-
asphyxiation of operating personnel. Usually these CO can be
mance of a thermally insulated package, testing should be
used if provisions are made to evacuate the built-up gas
conducted with the actual package whenever possible. When
periodically.)
simulated packages are used, special care must be exercised so
that the simulated payload and coolant will be as close as 5.3.1 Single or Multi-Channel Data Acquisition Unit
possible to the actual packages in temperature and other (DAU):
relevant physical properties.
5.3.1.1 The recording capability should be as an electronic
dataloggerbysensornumberwithdateandtimeofreadingthat
5. Test Conditions and Apparatus
can be presented in a continuous graph form as a secondary
5.1 Temperature Profile of Exterior Atmosphere—The time-
presentation.Resolutionofthedeviceshallbe0.1°Corgreater.
temperature test profile should be established prior to testing
Accuracy over the range tested should be 60.5°C. The printer
based on actual field data, compendial or regulatory
or associated computer datafile shall be activated by a voltage
requirements, or contractual requirements.
from an insulated copper-constantan wires, Type T, or other
5.1.1 Field Data Time-Temperature Profile—It is recom-
suitable sensor for the temperature range to be measured that
mended that the test profile represent actual worst case
are specified by the manufacturer to be accurate to 0.1°C. The
distributionconditionsascloselyaspossible.Thetestprofileof
wires may be single or multi-strand and should be flexible
exterior package temperatures should be based on actual
enough to be run through repeated bends in the package. Any
ambient air data accumulated during package handling and
tips or probes added to the wire should be noted and should not
transit whenever possible. Any published test cycle or cycle
change the accuracy or response time of the thermocouple.
developed using ISTA 7D may also be used as applicable.
5.3.2 Thermistor-Recorder—A thermistor sensor may be
When using a method based on actual data or developed in
used, instead of a thermocouple, for sensing interior tempera-
accordance with ISTA 7D, the rate of temperature change
tures of the package. The thermistor may be attached to
between trip segments should reflect, as closely as possible,
recordingequipment,asdescribedin5.3.1,withsupplementary
actual transit conditions. Should other than worst case condi-
electrical circuitry as needed, or it may be a wireless, battery
tions be used, indicated the percentile of the data pool that the
operated, computer programmable unit that stores digital
profile represents.
temperature readings at specified time intervals. Programming
5.1.2 Regulatory Requirements—When using a time-
and data downloading of the units is done through a suitable
temperature test profile from a regulatory or compendial
computerinterfacewithappropriatesoftware.Systemaccuracy
source, such as the WHO, cite the source and its application.
over the range tested should be 60.5°C with minimum
5.1.3 Contractual Requirements—Should the time-
resolution to 0.1°C. Response time over range should be
temperature test profile be stipulated by contract, cite the
determined prior to use and suitable for the reading interval of
source and, where available, the rationale for the profile.
the test.
5.1.4 Constant Temperature—A constant temperature pro-
5.4 Calibration Reference Standard—A NIST-traceable de-
file may be used, especially to determine relative performance
viceusedinconjunctionwithaconstanttemperaturebathwhen
of insulating materials. Constant temperatures do not reflect
calibrating and verifying accuracy pre- and post-test. The
actual transit conditions but may be useful for comparative
resolution and accuracy must be equal to or better than the
testing or for research.
sensors used in testing.
5.2 Test Chamber—Tests must be performed in one or more
rooms or cabinets (chambers) for which test samples can be 5.5 Constant Temperature Bath—A device or method that
individually placed with adequate space around all surfaces for produces a stable and consistent reference temperature within
D3103 − 20
61°C of a desired set point used in the calibration and 9.3.1.1 If feasible, attach probes directly to the wall of the
verification of temperature sensors. The bath may produce the primary product package and/or inside the package in direct
temperature reference point by means of an electronic signal or contact with the product, prior to pre-conditioning. When
temperature controlled liquid bath (the type of liquid may vary attaching probes, avoid covering the sensor area with tape or
depending of system and temperature). A bath in which the other material that could inhibit the sensor’s ability to read
temperature is both stable and consistent within 61°C of the temperatures at the specified speed and accuracy.
desired set-point and is used in the calibration and verification
9.3.1.2 The number of probes per package will be depen-
of thermocouples. The bath solution may vary depending on dent on the size and number of the primary containers in the
the desired set-point.
payload. In general, when first evaluating a thermal package, a
minimum of 5 to 10 probes should be used on payloads of up
6. Sampling
to 25 primary packages. Record the probe placements in the
package assembly.
6.1 Experimental package designs (prototypes) shall be
madeasclosetothespecificationsandmethodsaspossiblethat
NOTE 1—It may be desirable to use wireless data recorders, if possible,
will be used during actual production.
on smaller units to minimize air exchange caused by leaks at the
thermocoupleinsertionsite.Ifthermocouplesareused,asmallportcanbe
6.2 A minimum of three samples must be tested to ensure
opened through the wall of the carton as far away from the ice as possible,
reproduceability.
the thermocouples inserted into the carton, and the port sealed to prevent
leaking of air. Do not place battery operated recorders in packages
containing dry ice as the units will be damaged and nonfunctional at these
7. Test Specimens
temperatures. Units with remote probes may be placed outside the carton
7.1 In designing a package system it is suggested that the
where the battery and microchip will not be exposed to dry ice conditions.
payload contents within the insulated container is mapped to
9.3.2 When a cooling or heat source is used, place a
determine hot and cold locations throughout.
weighed and measured quantity of refrigerant or phase change
7.2 The packaging system and its components, mass,
material in the package as specified in the test protocol. When
configuration, and locations shall have identical assemblies.
water, ice, or refrigerant bottles, gel, or bricks are used,
The package system shall be closed, taped, or sealed in the
measure and record the te
...

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: D3103 − 14 D3103 − 20
Standard Test Method for
Thermal Insulation Performance of Distribution Packages
This standard is issued under the fixed designation D3103; 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 Scope*
1.1 This test method covers the determination of the thermal insulation quality of a package and the thermal stability of its
contents when exposed to variable ambient temperature conditions. It is suitable for testing packages with various internal energy
sources with or without product payloads.
1.2 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. Specific precautionary statements are given in 5.3.
1.3 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:
D996 Terminology of Packaging and Distribution Environments
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
2.2 Other Standards:
ISTA 5B 7D Focused Simulation Guide for Thermal Performance Testing of Temperature Controlled Temperature Test for
Transport Packaging
3. Terminology
3.1 Definitions—General definitions for packaging and distribution environments are found in Terminology D996.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 data acquisition unit and associated system—single- or multi-channel recorder and its associated software and hardware
utilizing thermocouples and thermistor sensors traceable to NIST (National Institute for Standards and Technology) that collects
and date stamps time and temperature.
3.2.2 draft-free atmosphere—an atmosphere where the test specimens are isolated from direct air currents while surrounding air
temperature is maintained uniformly throughout the chamber.
3.2.3 eutectic system, n—a mixture or compound in which pure solid phases changes occur at a well-defined specific
temperature.
3.2.4 exterior atmosphere—the atmosphere surrounding the exterior surface of a package.
3.2.5 interior atmosphere—the atmosphere in contact or near the packaged item.
3.2.6 mapping—collecting temperature data at a wide range of locations inside a package or chamber to determine the
variability of temperature range in the environment.
This test method is under the jurisdiction of ASTM Committee D10 on Packaging and is the direct responsibility of Subcommittee D10.21 on Shipping Containers and
Systems - Application of Performance Test Methods.
Current edition approved Oct. 1, 2014April 1, 2020. Published December 2014June 2020. Originally approved in 1972. Last previous edition approved in 20072014 as
ε1
D3103 – 07D3103 – 14. . DOI: 10.1520/D3103-14.10.1520/D3103-20.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from International Safe Transit Association (ISTA), 1400 Abbott Rd., Suite 160, East Lansing, MI 48823–1900, http://www.ista.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D3103 − 20
3.2.7 package system—the combination of exterior package, interior packaging, refrigerants, and product payload.
3.2.8 product payload—the product and any associated secondary packaging that is to be temperature controlled within the
insulated test package.
3.2.9 refrigerants—eutectic materials, gel packs, ice, or other material that serves as an energy source or buffer medium within
the package system.
3.2.10 secondary package—the package that contains the primary container/closure system(s).
3.2.11 thermal conductivity, homogeneous material—the rate of heat flow, under steady conditions through unit area, per unit
temperature gradient in the direction perpendicular to the area.
4. Significance and Use
4.1 This test method is intended for use for evaluating the performance of thermal insulated packaging used for high-value,
high-risk materials. This test method may also be used for any product that requires accurate internal package temperature readings
while being exposed to a range of external air temperatures.
4.2 Certain items, such as biological materials, pharmaceuticals, diagnostics, and blood products, must be shipped inside
temperature-controlled packages. Factors affecting the rate of heat transfer of the package include the insulation of the exterior
package, the energy source, and the product payload.
4.3 Because of the variety of factors affecting the performance of a thermally insulated package, testing should be conducted
with the actual package whenever possible. When simulated packages are used, special care must be exercised so that the simulated
payload and coolant will be as close as possible to the actual packages in temperature and other relevant physical properties.
5. Test Conditions and Apparatus
5.1 Temperature Profile of Exterior Atmosphere—The time-temperature test profile should be established prior to testing based
on actual field data, compendial or regulatory requirements, or contractual requirements.
5.1.1 Field Data Time-Temperature Profile—It is recommended that the test profile represent actual worst case distribution
conditions as closely as possible. The test profile of exterior package temperatures should be based on actual ambient air data
accumulated during package handling and transit whenever possible. Any published test cycle or cycle developed using
ISTA 5BISTA 7D may also be used as applicable. When using a method based on actual data or developed in accordance with
ISTA 5B,ISTA 7D, the rate of temperature change between trip segments should reflect, as closely as possible, actual transit
conditions. Should other than worst case conditions be used, indicated the percentile of the data pool that the profile represents.
5.1.2 Regulatory Requirements—When using a time-temperature test profile from a regulatory or compendial source, such as
the WHO, cite the source and its application.
5.1.3 Contractual Requirements—Should the time-temperature test profile be stipulated by contract, cite the source and, where
available, the rationale for the profile.
5.1.4 Constant Temperature—A constant temperature profile may be used, especially to determine relative performance of
insulating materials. Constant temperatures do not reflect actual transit conditions but may be useful for comparative testing or for
research.
5.2 Test Chamber—Tests must be performed in one or more rooms or cabinets (chambers) for which test samples can be
individually placed with adequate space around all surfaces for air circulation at the desired temperature. An access port should
be available for leading thermocouple wires out of the chamber for hook-up to the data acquisition unit (DAU). A temperature
indicator should be placed 10 in. from the test package to record the temperature of the exterior atmosphere during the entire test
duration.
5.3 Test Chamber Controller—The room or cabinet must maintain a uniform temperature around the test specimen. The test
chamber control apparatus must be capable of maintaining the desired temperature to within 63°C. It may be desirable to
incorporate a programmable controller with the capability of performing temperature profiles (for example, multiple temperature
changes over time). However, the temperature cabinet heating and cooling mechanisms must have the capability to change
temperature at the desired ramp rates of the profile. (Warning—Gaseous CO is colorless, odorless, and noncombustible. In
well-ventilated uses they present few problems, but evaporation or sublimation in airtight enclosures for prolonged periods (for
example, 12 h) can produce sprung doors and asphyxiation of operating personnel. Usually these CO can be used if provisions
are made to evacuate the built-up gas periodically.)
5.3.1 Single or Multi-Channel Data Acquisition Unit (DAU):
5.3.1.1 The recording capability should be as an electronic datalogger by sensor number with date and time of reading that can
be presented in a continuous graph form as a secondary presentation. Resolution of the device shall be 0.1°C or greater. Accuracy
over the range tested should be 60.5°C. The printer or associated computer datafile shall be activated by a voltage from an
insulated copper-constantan wires, Type T, or other suitable sensor for the temperature range to be measured that are specified by
D3103 − 20
the manufacturer to be accurate to 0.1°C. The wires may be single or multi-strand and should be flexible enough to be run through
repeated bends in the package. Any tips or probes added to the wire should be noted and should not change the accuracy or
response time of the thermocouple.
5.3.2 Thermistor-Recorder—A thermistor sensor may be used, instead of a thermocouple, for sensing interior temperatures of
the package. The thermistor may be attached to recording equipment, as described in 5.3.1, with supplementary electrical circuitry
as needed, or it may be a wireless, battery operated, computer programmable unit that stores digital temperature readings at
specified time intervals. Programming and data downloading of the units is done through a suitable computer interface with
appropriate software. System accuracy over the range tested should be 60.5°C with minimum resolution to 0.1°C. Response time
over range should be determined prior to use and suitable for the reading interval of the test.
5.4 Calibration Reference Standard—A NIST-traceable device used in conjunction with a constant temperature bath when
calibrating and verifying accuracy pre- and post-test. The resolution and accuracy must be equal to or better than the sensors used
in testing.
5.5 Constant Temperature Bath—A device or method that produces a stable and consistent reference temperature within 61°C
of a desired set point used in the calibration and verification of temperature sensors. The bath may produce the temperature
reference point by means of an electronic signal or temperature controlled liquid bath (the type of liquid may vary depending of
system and temperature). A bath in which the temperature is both stable and consistent within 61°C of the desired set-point and
is used in the calibration and verification of thermocouples. The bath solution may vary depending on the desired set-point.
6. Sampling
6.1 Experimental package designs (prototypes) shall be made as close to the specifications and methods as possible that will
be used during actual production.
6.2 A minimum of three samples must be tested to ensure reproduceability.
7. Test Specimens
7.1 In designing a package system it is suggested that the payload contents within the insulated container is mapped to determine
hot and cold locations throughout.
7.2 The packaging system and its components, mass, configuration, and locations shall have identical assemblies. The package
system shall be closed, taped, or sealed in the same manner as will be used for actual shipment.
8. Conditioning
8.1 Condition all materials in accordance with Practice D4332 or in accordance with the instructions provided in the test
protocol for a minimum of 24 h or until stable at the conditions expected during actual production packing.
8.2 Pre-conditioning—Specific test procedures may require certain pre-conditioning of components just prior to assembling the
test packages. Pre-conditioning, if any, should be done in accordance with individual test requirements.
9. Procedures
9.1 The desired test packaging configuration will be documented in such a way to identify all components, their locations,
thermocouple locations, test equipment, test conditions, and test start time.
9.2 Calibrate the sensors using the NIST-traceable reference standard. Place sensors in stable temperature bath along with the
reference standard. Record temperatures from the sensors and reference standard independently for a minimum of three
temperature points. The overall system difference between the reference standard and each sensor should be within 60.5°C. If
using a thermistor, ensure the equipment is certified as calibrated to a NIST-traceable source.
9.3 Test Package Assembly:
9.3.1 Pre-condition all packaging materials, refrigerants, and products at specified pre-test temperatures for the package
assembly to be tested. Pre-conditioning should be for at leas
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