CS Analytical is one of the unique service providers that offers Package Distribution Testing in an FDA regulated, cGMP laboratory. Testing is based upon ASTM D4169 “Performance Testing of Shipping Containers and Systems” that is designed to evaluates the ability of shipping units to withstand the distribution environment. Other ISTA test methods can also be performed. The CS Analytical team understands the challenges that package distribution can present and the experienced laboratory technicians can help clients identify the most optimal approach and test program for their specific package system to ensure regulatory compliance is met.
The assignment and scope of an ASTM D4169 Package Testing Program will depend on the objectives of the testing, the type of package system and the intended mode of distribution. In many cases, package distribution testing can be part of a more comprehensive test program to include routine qualification of individual package components or part of a container closure integrity leak testing program as outlined under USP <1207> integrity test requirements. Key steps in the testing process include:
- Define the shipping unit in terms of size, weight and form of construction.
- Establish the assurance level or level of test intensity. The level is based on the product value and desired level of anticipated damage to be tolerated. The number of units to be shipped and knowledge of the shipping environment should also be considered.
- Determine the acceptance criteria for the shipping container test. The acceptance criteria for package validation of ASTM D4169 testing must be established prior to testing.
- Select the most appropriate ASTM D4169 distribution cycle. The selection of the cycle is based on the various distribution paths a package could experience.
- Draft a formal test plan based upon the expected hazards the package may have to endure. Specific hazards are defined as follows:
- Schedule A: Handling, manual and mechanical. Manual handling includes loading, unloading, stacking, sorting or palletizing. The main hazards from these activities are the impacts caused by dropping or throwing. Several test method options are permitted. These include SSTM D4169 free-fall and simulated drop test using shock machines.
- Schedule B: Warehouse stacking test method determines the ability of the shipping unit to withstand compressive loads. These loads occur during warehouse storage or vehicle transport.
- Schedule C: Vehicle stacking test requires that the loading must consider the effects of the length of time in storage. Other considerations include container stacking pattern, container strength variability, method of load transport and vibration. Environmental impacts such as moisture content and temperature must also be considered.
- Schedule D: Stacked vibration. This test method determines the ability to withstand vertical vibration and the compression resulting from vehicle stacking as simulated by an ASTM vibration test.
- Schedule E: Vehicle vibration. This vibration does not include the compression from vehicle stacking. Acceptable vibration testing can include sine vibration and random vibration.
- Schedule F: Load testing services such as loose load vibration. This simulates the repetitive shocks that occur during transportation of bulk or loose loads.
- Schedule G: Rail switching. There are various acceleration levels and compression forces that occur during rail switching operations.
- Schedule H: Environmental hazard. This schedule accounts for the rapid changes in ambient conditions. These are most associated with the military distribution of material. These conditions include moisture, temperature shock, solar radiation and water spray. This type of testing is also known as environmental testing.
- Schedule I: Low pressure hazard testing. The reduction in pressure when packaged products are transported via certain methods must be accounted for. These methods include feeder aircraft or by ground over mountain passes.
- Schedule J: Concentrated impact. Packages often experience numerous impacts during sorting operations and in transit. This package test schedule simulates those impacts.
The CS Analytical team are experts when it comes to distribution testing for Pharmaceutical, Medical Device and Biotechnology products and package systems. The team has the experience to understand all aspects of the ASTM D4169 and ISTA test programs and how they apply to these unique, and often sensitive, product types. All work is performed in a strict, FDA regulated environment that operates under a GMP quality system.