Additional Information can be found on the ISTA website.
Advanced Tests

Links to tests: ISTA 7D, ISTA 7E

ISTA 7-Series  tests are package development tests with test elements coming from ISTA 1, 2 or 3 tests and they may or may not evaluate the protection afforded packaged products.
There are three sections to the ISTA Series 3 test protocols: Overview, Testing and Reporting.
ISTA Series 3 Overview provides general information required before testing in the laboratory.
ISTA Series 3 Testing presents the instructions required for laboratory testing.
ISTA Series 3 Reporting indicates the data that shall be reported to ISTA.

Two systems of weights and measures are always used in ISTA testing. The English system uses inches and pounds and the international system SI is metric. Inch/Pound units are shown first with Metric units in brackets. Tables will show the two systems separately. In the case of temperatures C (Celsius) is shown first and F (Fahrenheit) is shown in brackets.

Key to Metric and English units and symbols:

  • For measuring weight, metric units include kilograms (kg) or grams (gm). For measuring weight, English units include pounds (lb).
  • For measuring distance, metric units include meters (m) or millimeters (mm). For measuring distance, English units include feet (ft) or inches (in).
  • For measuring volume, metric units include cubic centimeters (cm3). For measuring volume, English units include cubic inches (in3).
  • For measuring density, metric units include kilograms per cubic meter (kg/m3). For measuring density, English units include pounds per cubic inch (lb/in3).
  • For measuring temperature, metric units include centigrade (C). For measuring temperature, English units include Fahrenheit (F).
  • For measuring absolute pressure, metric units include kilopascal (kPa). For measuring volume, English units include pounds per square inch (psi).

Either system may be used as the standard unit of measure; however, the standard unit should remain consistent throughout testing and reporting. Units are converted to significant figures, not exact equivalents.

Use of ISTA 7E over ISTA 7D
In cooperation with the Pharmaceutical Cold Chain Interest Group (PCCIG), ISTA has completed an extensive survey or temperature ranges found in the U.S. parcel delivery distribution environment.

The data collected has been used to develop ISTA 7E Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment. This Data should be considered for use in lieu of Procedure 7D. 7E is not available in the Resource book but is available for a separate purchase from ISTA. Details can be found on the ISTA website.

Overview of ISTA Series Test Procedure 7D

The ISTA Series 7D is a development test to evaluate the effects of external temperature exposures of individual packaged products. It can be used for the development of temperature-controlled transport packages. ISTA 7D can also be used for individual or comparative performance analysis of standard or insulated transport packages in normally encountered conditions.

It is designed to measure the ability of a package to protect a product exposed to cycles of temperature conditions.

The product and package are considered together – not separately.

This test is not intended to evaluate the protection afforded products from shock, vibration or compression.

Caution: The cycle profiles in 7D are simulations not intended to represent “worst case” exposure to temperature. Variables affect the thermal and distribution performance of packages and the exposure profile extremes found in the distribution environment for each situation.

If testing  is for specific government compliance, industry, lab, validation or regulatory standard or guideline that would add to this procedure, it is the user’s responsibility to know and understand those requirements and to use the proper procedure.

ISTA encourages the use of ISTA 7E over ISTA 7D because 7E is the most current simulation of the thermal environment.

Other ISTA procedures may be right for different conditions or objectives.

ISTA recommends that once a package demonstrates acceptable thermal performance, that general simulation tests be conducted to simulate the extremes likely to be encountered in transit.

Consider ISTA 7E for thermal testing of insulated shipping containers in the parcel delivery system.

The shipper must determine the exact product temperature limits, high and low for the product and the acceptable time limits above and below the temperature limits.

Samples for ISTA Series Test Procedure 7D

Samples for Test Procedure 7D should be untested actual packages and actual products. If one or both are not available, be sure that the substitute product and packaging are as close as possible to the actual items.

Substituted products should be as close as possible in terms of content, composition, thermal mass, consistency and other physical properties and be packaged in the product specific primary package. It is also recommended that the simulated packaged product be as close as possible in its specific heat to the actual product so that temperature changes will occur at the same rates.

One sample is required for tests in the ISTA Series Test 7D Procedure.

To allow for proper testing of package and product durability, ISTA requires that the test procedure be performed one time, but due to variability of packaging and product characteristics recommends that fragile and liquid products have two or more packaged product samples tested.

ISTA suggests performing the testing procedure five or more times using new samples with each test to improve statistical significance for all package tests.

Test Sequence for ISTA 7 D

The tests shall be performed on each sample in the sequence indicated below:

Sequence 1: Temperature Preconditioning  A temperature test type. Storage conditions for the product and each package element for 24 hours minimum. This sequence is optional.
Sequence 2: Atmospheric Test A temperature test type. 1st Cycle Period of selected test profile. This sequence is required.
Sequence 3: Atmospheric Test A temperature test type. 2nd Cycle Period of selected test profile.This sequence is required.
Sequence 4: Atmospheric Test  A temperature test type.Remaining Cycle Periods of selected Test Profile. This sequence is required.

Equipment Required for Atmospheric Conditioning.

Temperature Conditioning:
Draft-free room or chamber and control apparatus complying with the apparatus section of ASTM D 3103
Temperature indicators complying with the apparatus section of ASTM D 3103

 


ISTA 7E Usage Modes

The ISTA 7 Series tests are a combination of thermal profile simulations and procedure protocols.

This new test, ISTA 7E is different. It is a set of standard profiles based on exhaustive real world measurements made in the parcel shipping environment. ISTA 7E is designed to be used with a companion testing procedure, Standard 20.

7E may be used alone as a profile set for proprietary testing procedures or if the user want the tested package to be certified by ISTA in the context of 7E, Standard 20 must be acquired and followed.

No testing procedures are part of this 7E document.

Overview of ISTA Series Test Procedure 7E & Standard 20

ISTA Standard 7E evaluates the effects of external temperature exposure of individual packaged products shipped through a parcel delivery system. It can be used as a standalone profile standard.

When it is used in conjunction with ISTA Standard 20 it is enhanced.

It can be used for developing controlled packages made of any material. It can also be used for individual or comparative analysis of transport packages. It can measure the ability of a package to protect a product throughout a range of temperature conditions. And, it allows the testing lab to submit results to ISTA that a package conforms to testing according to Standard 20 using the 7E profiles. Thus, packages can legally bear the ISTA 7E Thermal Certification Mark.

Elements of ISTA Standard 20

Qualification of design requires the following three elements:

  1. Training – One certified thermal professional levels 1 and 2 must be active in the testing. ISTA provides testing and training for this element.
  2. Lab Protocols – Documentation of testing protocols is required. The Standard 20 document provides everything needed for compliance.
  3. Lab Audit – An onsite lab audit by a Certified ISTA Thermal Transport Lab Auditor is required.

 

Important Notes about Standard 20

The Standard 20 does not evaluate packaged products protection from shock, vibration or compression. The ISTA 7E profiles are not intended to represent the worst case exposure in the small parcel shipment environment. Contact ISTA for the availability of lane-specific profiles. Other ISTA procedures might be appropriate for different conditions and objectives.

Applicability and Use of ISTA 7E and Standard 20

Applicacability:

ISTA 7E and Standard 20 as well as Standard 14 are recommended to support FDA-regulated compliance related to the Center for Drug Evaluation and Research (CDER) guidelines as applied to insulated shipping containers’ thermal performance.

Use:

The ISTA documents provide the means to comply with internal and external quality system requirements through individual certification, thermal transport laboratory certification and ISC design qualification.

The ISTA documents provide the user with a standardized methodology for demonstrating performance of an insulated shipping container to create a thermal profile.

Benefits of ISTA 7E and Standard 20

The benefits of the new thermal profile and qualification process are as a qualification tool but not customized shipping lane data nor customized worst case shipping qualification.

The end user benefits as well as the supplier of ISC designs and products and the contract test labs.

The end result is that ISTA reviews qualification results and issues the certification mark for the ISC designs. This provides consistency to the approach and the documentation.

Certification using Standard 20

Users seeking ISTA 7E Certification must use 7E profiles as required by Standard 20. Without compliance packages will not qualify for certification. Contact ISTA for specifics at https://ista.org

Test Sequence for ISTA 7 E & Standard 20

Design Testing: Affirms the design performs according to requirements using ISTA 7E profiles.
Thermal Qualification:  Lab testing affirms accuracy and repeatability of design testing using ISTA 7E profiles.
Physical Qualification: Lab testing  to affirm package integrity assuring thermal performance using ISTA testing standards.
Thermal Qualification Verification: Field Testing to affirm lab thermal testing results are repeatable is performed using sensor placement.

Contents of the Standard 20 Document

Standard 20  Main Document – STD-0020:  A complete set of instructions for lab procedures, equipment, calibration and data handling requirements.
Design Protocol – APPX-0023: Outline of the protocol for Design Thermal Testing.
Design Report – APPX-0024: Form and requirements for reporting results of Design Thermal Testing.
Design Data Package Example – APPX-0026: Complete example illustrating requirements of Design Data Package.
Thermal Qualification Protocol – APPX-0027: Outline of protocol document for Thermal Qualification Testing.
Thermal Qualification Report – APPX-0028: Form and requirements for reporting results of Thermal Qualification Testing.
Physical Qualification Protocol – APPX-0031: Outline of protocol document for Physical Qualification Testing.
Physical Qualification Report – AAPX-0032: Form and requirements for reporting results of Physical Qualification Testing.
Thermal Verification Protocol – AAPX-0035: Outline and protocol document for Thermal Qualification Testing.
Thermal Verification Report – AAPX-0036: Form and requirements for reporting results of Design Thermal Testing.
Document History File Template – APPX-0039: Outline of user document presenting testing results to Standard 20.
ISC Qualification Program Worksheet – FORM-0046: Worksheets that are part of the Data Packages.
Significant Figures and Rounding – SOP-0039: Explanation of data handling techniques for figures and results of quantitative user requirements.
Good Documentation Practice –  SOP-0044: Explanation of standards for signatures, approvals and exceptions handling.

Testing Using 7E Standalone

If users do not determine a need for Standard 20, the following guidelines are recommended.

Samples for Test Procedure 7E should be untested actual packages and actual products. If one or both are not available, be sure that the substitute product and packaging are as close as possible to the actual items.

Substituted products should be as close as possible in terms of content, composition, thermal mass, consistency and other physical properties and be packaged in the product specific primary package. It is also recommended that the simulated packaged product be as close as possible in its specific heat to the actual product so that temperature changes will occur at the same rates.

If refrigerant or temperature stabilizer are used, it must be the exact type used by shipper. To determine representative performance  of packaged product, ISTA recommends procedures be performed minimum of once, but preferably three or more times using new samples with each test.

Packages already subjected to transit cannot be assumed to  represent standard conditions. Packages shipped to labs should be overpackaged or re-packaged at the lab.

Temperature Conditioning:

A draft free room and control apparatus complying with ASTM D 3103 and temperature indicators complying with ASTMD 3103 are required.

It is important to measure and document the package gross weight in pounds (kg) and outside dimensions of the packaged product.