Certification and Registration
ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems
Category:
Package
ASTM D4169 provides a guideline for evaluating shipping units in accordance with a uniform system. By using established test methods, it allows us to simulate a wide range of shipping and handling environments, thereby assessing the level of protection that transport packaging provides to products. SATISFY offers comprehensive ASTM D4169 testing services, as well as improvement recommendations and corrective measures.
ASTM D4169 is currently cited as a mandatory requirement by the U.S. Food and Drug Administration (FDA) for medical pharmaceutical and device products, which are required to comply with the ASTM D4169 test standard. When medical device manufacturers bring a new device to market, one of the three data points they must submit to the FDA under 510(k) is the results of ASTM D4169 transport testing. The data generated from transport simulation must demonstrate that the sterile barrier system can withstand the most extreme and severe distribution environments. For medical pharmaceutical and device products intended for non-U.S. markets, ISTA 1 and 2 Series testing may be conducted; for domestic transport testing within China, testing may be performed in accordance with the GB/T 4857 Series.
Test kit
Medical equipment
ASTM D4169 - Factors to consider
For ASTM D4169 testing, you need to identify the distribution cycle (DC) you wish to simulate and the assurance level that must be achieved. Each DC simulates a different shipping environment and a different level of transportation hazard. Meanwhile, each assurance level provides a different test intensity.
ASTM D4169 Distribution Cycles and Test Schedules
ASTM D4169 defines 18 distinct distribution cycles, 10 different test schedules, and 3 assurance levels. Selecting the correct combination of distribution cycle (DC), test schedule, and assurance level is critical to ensuring that your shipping containers can withstand the distribution process and arrive at the customer's location safely and intact. Our technical specialists can assist you in determining the appropriate distribution cycle and test schedule for your specific application.
Three Assurance Levels
The three assurance levels are designated as Level I, Level II, and Level III. Level I represents the highest test intensity, corresponding to a relatively low probability of occurrence in real-world conditions. Level III represents the lowest test intensity, corresponding to a relatively high probability of occurrence. Level II falls between these two extremes.
10 Test Schedules
|
Program |
Hazardous factors |
Test Content |
|
A |
Manual and mechanical operation |
Drop, impact, and stability |
|
B |
Warehousing and Palletizing |
Compression |
|
C |
Carrying and stacking |
Compression |
|
D |
Stacking vibration |
Vibration |
|
E |
Vehicle Vibration |
Vibration |
|
F |
Bulk Load Vibration |
Repetitive Shock |
|
G |
Railcar Switching / Classification |
Horizontal impact, inclined-plane impact |
|
H |
Environmental hazard |
Loop Condition Handling ( Simulated exposure ) |
|
I |
Low-pressure hazards |
Vacuum |
|
J |
Concentrated Impact |
Impact |
18 Distribution Cycles
|
DC |
Distribution Scenario Description |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
1 |
General Cycle – Undefined Logistics System |
A |
D |
F |
G |
J |
A |
|
|
2 |
Specially Defined Logistics System – User-Specified |
Choose from A to J. |
||||||
|
3 |
Single packaging without pallets or slip sheets, less-than-truckload (LTL) trucking. |
A |
D Or C plus E |
F |
J |
A |
|
|
|
4 |
Single packaging, with pallet or slip sheet, less-than-truckload (LTL) trucking |
A |
D Or C plus E |
F |
J |
A |
|
|
|
5 |
Freight motor vehicle (TL) transport, non-unitized packaging |
A |
D |
E |
J |
A |
|
|
|
6 |
Freight motor vehicle (TL) or LTL transportation, unitized packaging |
A |
D Or C plus E |
J |
A |
B |
|
|
|
7 |
Railway only, bulk cargo |
A |
D |
G |
A |
|
|
|
|
8 |
Railway only, combined unit packaging |
A |
D |
G |
A |
B |
|
|
|
9 |
Rail and road freight, non-combined unit load packaging |
A |
C |
E |
G |
F |
J |
A |
|
10 |
Rail and road freight, unitized packaging |
A |
D |
G |
J |
A |
B |
|
|
11 |
Rail, flatbed trailers (TOFC), and container trailers (COFC) |
A |
G |
D |
F |
A |
|
|
|
12 |
Air freight (intercity) and truck freight (local), over 150 pounds (68.1 kg), combined unit packaging |
A |
D |
I |
E |
J |
A |
|
|
13 |
Air freight (intercity) and motor vehicle (local) single-package shipments, with a maximum weight of 150 pounds (61.8 kg). |
A |
C |
F |
I |
E |
J |
A |
|
14 |
Warehousing |
A |
B |
|
|
|
|
|
|
15 |
Import and export transportation of intermodal containers or Ro-Ro trailers |
A |
C |
A |
|
|
|
|
|
16 |
Import and export cargo of palletized vessels |
A |
C |
A |
|
|
|
|
|
17 |
Import and export shipments of bulk cargo vessels |
A |
C |
A |
|
|
|
|
|
18 |
Non-commercial government shipment compliant with MIL-STD-2073 |
Reference Standard Appendix A1 |
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ASTM D 4169 - Testing Procedure
Cycle 13 is applicable to individual packaged products weighing less than 150 lb that are shipped via intercity air or freight transport. The test sequence is designed to simulate the actual shipping process. Through this series of tests, an assessment is made as to whether the packaging can adequately protect the product during actual transit
1) Define the shipping unit. The shipping unit is defined based on dimensions, weight, and construction type. It must also be determined whether the container is handled manually or mechanically.
2) Establish the test intensity level. The intensity level is established based on product value, the acceptable level of anticipated damage, the number of units to be shipped, knowledge of the shipping environment, or other applicable criteria.
3) Determine the acceptance criteria for shipping container testing. Acceptance criteria for ASTM D4169 packaging validation must be established prior to testing. The criteria should take into account the condition of the product upon receipt. The organization conducting the test may select any acceptance criteria suitable for its purposes. In most cases, acceptance criteria may include:
Criterion 1 : Product shows no damage
Criterion 2 : Packaging shows no damage
Criterion 3 : Both product and packaging show no damage
4) Select the Distribution Cycle (DC). The distribution cycle is a sequential list of hazard elements expected to occur along the specific route from production to the user. Once the DC is selected, the required test items are essentially determined.
5) Develop the test plan. ASTM D4169 outlines a number of hazard elements and test schedules to choose from. These include both dynamic and climatic test types.
6) Conduct testing. Taking the most common example, DC 13 applies to individual packaged products weighing less than 150 lb and shipped via intercity air or freight transport. Testing is conducted at Assurance Level I.
|
Test sequence |
Test Name |
Test Item Interpretation |
Test Method (DC 13 ， Level I) |
|
Preprocessing |
Temperature and humidity preconditioning |
Condition test samples to room temperature equilibrium | Place in ambient room conditions for 24 hours |
|
Temperature and Humidity Testing |
Temperature and Humidity Testing |
Assess the impact of temperature and humidity on packaged products during transportation and storage. |
(23±1) °C ， (50±2)% Processing 72 hour |
|
Schedule A |
Manual Handling Test |
Damage caused by the mannequin accidentally dropping the product during handling. |
According to the table 1 Determine the drop height, according to Table. 2 Determine the drop direction and number of drops. |
|
Schedule C |
Stress test |
Simulated damage caused by stacking during transportation |
Calculate the pressure value according to the following formula, apply the specified pressure to the package, and then release it once the target pressure is reached. |
|
Schedule F |
Bulk vibration |
The process by which simulated products endure repeated impacts during bulk transportation. |
Fixed-frequency low-frequency vibration, vibration duration 60 Minutes, amplitude: 1 Inches, frequency: approximately at 2-5HZ A certain frequency between them. Vibration trajectory: vertical vibration or circular vibration. |
|
Schedule I |
Low-pressure test |
Simulated air transport is primarily intended for packaging materials that are highly sensitive to low atmospheric pressure, such as… : A sealed, non-porous, flexible package, a liquid container, or one that is empty. Container, but packaging that exhibits a reverse‑inflation phenomenon under low‑pressure conditions. |
According to elevation, 4267 Pressure test at room temperature 60 minute |
|
Schedule E |
Freight vibration |
The vibration mode is random vibration, simulating the vibration risks that products experience during transportation. |
60 Minute truck mode, 120 Minute air transport mode, no payload |
|
Schedule J |
Concentrated Impact Test |
Assess the process by which packaging is subjected to impacts from other obstacles during transportation. Primarily addresses the structural weaknesses of shipping containers. Suitable for lightweight single-wall corrugated shipping containers and plastic film packaging. |
The cylindrical test weight is dropped vertically, with a distance of 32 inch (0.8 rice ) |
|
Schedule A |
Manual Handling Test |
Damage caused by the mannequin accidentally dropping the product during handling. |
Consistent with the first drop test. |
Table 1
Table 2
7) Evaluate results to determine compliance with acceptance criteria. Results are generally evaluated against the following non-conformance indicators:
◉ Any part of the product has punctured through the shipping container
◉ The shipping container has cracked or split
◉ Severe corner deformation or damage to the inner packaging material and retail packaging
◉ Visible damage such as cracking, chipping, scratching, etc.
◉ Any dents, scuffs, or abrasions
◉ Any corner deformation or cracking
◉ Obvious surface wear or scratching
| Shipping container rupture or tearing | Product abrasion or wear |
SATISFY offers professional packaging transport testing consultation, develops customized test plans based on each client's specific circumstances, and issues authoritative test reports. Please contact SATISFY Customer Service to learn more about ASTM D4169.
ASTM Transport Packaging-Related Standards
ASTM D642 Test Method for Determining the Compressive Strength of Shipping Containers, Components, and Unit Loads
ASTM D880 Test Methods for Impact Testing of Transport Containers and Systems
ASTM D951 Test method for determining the waterproofness of containers using the spray method
ASTM D996 Packaging and Distribution Environmental Terminology
ASTM D999 Test Method for Vibration Testing of Transport Containers
ASTM D4003 Test method for programmable horizontal impact testing of containers and systems
ASTM D4332 The practice of adjusting containers, packaging, or packaging components for testing purposes.
ASTM D4728 Test Method for Random Vibration Testing of Transport Containers
ASTM D5265 Bridge Impact Testing
ASTM D5276 Method for Free-Fall Drop Testing of Freight Containers
ASTM D5277 Test method for performing horizontal impact tests using an inclined impact tester.
ASTM D5487 Test method for simulating container drop impacts using an impact tester
ASTM D6055 Test Method for Mechanical Handling of Combined Loads and Large Transport Boxes and Crates
ASTM D6179 Test Method for Rough Handling of Combined Loads and Large Transport Containers and Crates
ASTM D6344 Test Method for Simulated Transport Shock on Packaging
ASTM D6653 Test Method for Determining the Effects of High Altitude on Packaging Systems Using the Vacuum Method
ASTM D7386 Practical Testing of Package Performance in a Single-Package Delivery System
ASTM F1327 Terms related to barrier materials for medical packaging
MIL-STD-810F Environmental Testing Methods
MIL-STD-2073 – 1 DOD Military Packaging Standards in Practice
Related Information
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