ASTM versus ISTA for Distribution Simulation Testing
By Scott Levy, Packaging Engineer, DDL, Inc.
May 24, 2013
Many medical device manufacturers struggle with what they need to do in order to comply with ISO 11607
and which procedure to utilize for performance testing, ASTM or ISTA. This paper will help the reader look
at both procedures from the outside in.
What is Distribution Simulation Testing?
Distribution simulation testing is a uniform and repeatable way to evaluate packaging systems by utilizing
laboratory equipment, subjecting the system to specific hazards that may occur in the anticipated
distribution environment. The primary goal is to have an effective shipping configuration that protects the
product during transit and complies with ISO 11607-1.
Distribution simulation testing can be thought of as a conditioning element for the test specimens. It is the
tests that are carried out after distribution testing that determine whether the specimens pass or fail as
there is no variable or attribute data associated with simulation testing. The post-distribution tests can
include:
1. Evaluation of Product/Package Interaction (Sterility Maintenance)
2. Evaluation of Product Functionality
3. Regulatory Compliance
When conducting distribution simulation testing there are two different procedures that can be utilized:
ASTM International (American Society of Testing Materials)
• D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems”
• D7386, “Standard Practice for Performance Testing of Packages for Single Parcel Delivery
Systems”
•
ISTA (International Safe Transit Association)
• 2 Series, “Partial Simulation Performance Tests”
• 3 Series, “General Simulation Performance Tests”
The tables below briefly describes some of the differences between ASTM versus ISTA
–
–
–
–
ASTM
Public association
Employs a democratic process:
• Task Group development and approval
• Subcommittee review and approval
• Main Committee review and approval
All comments and negative ballots must be
resolved before approval
Full ASTM membership reviews prior to
standards approval and publication
–
–
–
–
ISTA
Private industry association (membership
required to participate)
Board of Directors generates new ideas for
standards
Standards are reviewed and approved
through “test series groups” and the ISTA
Technical Council ultimately has final approval
No formal ballot process including outside
organizations or non member industry experts
© 2013 DDL, Inc. ISTA 1 Series: Non-Simulation Integrity
Performance Tests
No comparable ASTM performance
standard.
-
-
-
ASTM D4169-09 DC 13
ISTA 2 Series: Partial Simulation Performance
Tests
- “Standard Practice for Performance
Testing of Shipping Containers and
Systems”
- DC 13: “Air (intercity) and motor freight
(local, single package Up to 150 lbs.”
- This single standard is predominately used
for regulatory compliance.
- FDA Recognized Consensus Standard
-
-
Challenges the strength and robustness of the
product and package combination
Not designed to simulate environmental
occurrences. Useful as screening tests,
particularly when used as a consistent
benchmark over time.
This procedure was developed as a quick and
easy way to evaluate a shipping configuration
for drop testing and repetitive shock vibration
only.
This procedure does not take into account
random vibration or atmospheric preconditioning and is not truly a ‘simulation’. It is
meant strictly for domestic shipment.
Test with at least one element of a 3 Series
type General Simulation Performance Test
The ISTA Procedure 2A procedure is a widely
utilized test procedure to evaluate sterile barrier
system through dynamics.
Pro’s
• Comparable to ASTM D4169-05
• Atmospheric Conditioning
• Fixed Displacement Vibration and/or
Random Vibration
Con’s
• Does not address effects of low pressure
high altitude on non-porous packaging.
• Alternative methods
© 2013 DDL, Inc. ASTM D7386-08
ISTA Standards (Procedure 3A)
- “Standard Practice for Performance Testing
of Packages for Single Parcel Delivery
Systems”
- Generally developed for ALL types of packages
moving through the single parcel shipping system
(UPS, FedEx, etc.)
- This standard is dependent on the package type
that is under evaluation.
Small Packaged-Product Bagged for Transport
(TS-1)
Large Flat Packaged Product (TS-2)
Long Narrow Packaged Products (TS-3)
All Other Packaged Product (TS-4) (Most Typical)
- Example: Standard shipper, 12”x12”x12”
Containing Single Barrier Poly/Tyvek Pouch
- This would follow into the classification of “TS-4”
- This procedure can be strenuous due to the
vibration under compressive load.
*This test procedure is used sparingly by Medical
Device Manufacturers, as it is severe due to the
utilization of the top load vibration. MDM’s may
encounter damage that does not occur in the
normal distribution environment.
-
-
Test Procedure 3A is a general simulation test
for individual packaged products shipped
through a parcel delivery system.
Appropriate for four different package types
commonly distributed as individual packages,
either by air or ground:
1. Standard packages
2. Small packages
3. Flat packages
4. Elongated packages
Basic Requirements:
- Atmospheric pre-conditioning
- Shock
- Random vibration with and without top load
- Shock testing
- This procedure is comparable to ASTM D738608
*This test procedure is used sparingly by Medical
Device Manufacturers, as it is severe due to the
utilization of the top load vibration. MDM’s may
encounter damage that does not occur in the
normal distribution environment.
-
Problems in using standards with top load vibration sequences
ASTM D7386 and ISTA Procedure 3A
Medical device packages are not typically designed for the interior packaging or products to
withstand compressive loads.
Field observations from MDM customers do not indicate a significant shipping box crushing
problem. Test results do not correlate to actual field observations.
Top load weights may exceed that which is applied during actual shipments. Other boxes
designed to contribute interior and/or product compressive strengths to the overall shipping system
compression strength may be able to pass this test more readily than medical device packages
that only use the shipping box strength in design considerations.
Conclusion
Below are some tips to consider before making decisions on distribution simulation testing:
1. Work with your testing lab to understand the specific test procedures that will be used to evaluate
the shipping configuration for validation.
2. Perform feasibility testing prior to executing a full-blown performance test (shipping/environmental
study).
© 2013 DDL, Inc. 3. Work with your testing lab to ensure that the test procedure best simulates the intended distribution
environment.
4. Understand the percent of defects acquired in shipping the sterile samples to the customer / end
user.
5. Plan ahead and provide adequate time to perform a thorough validation.
If you have any further questions regarding your package testing or would like help evaluating your next
distribution simulation project, please don’t hesitate to contact me.
Scott R. Levy
Packaging Engineer
952-941-9226 ext. 115
scott.levy@testedandproven.com
© 2013 DDL, Inc.