ISTA Standard 3A
General Simulation Performance Tests
Test Procedure 3A is for packaged-products weighing 150 lb. (70 kg) or less, and is a general simulation test for individual packaged-products shipped through a parcel delivery system. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. Characteristics will include simple shaped random vibration, different drop heights applied to the sample package, and/or atmospheric conditioning (complies with ASTM D4332) such as tropical wet or winter/frozen.
3A tests are appropriate for four different types of packages commonly distributed as individual packages, either by air or ground. The types include standard, small, flat, and elongated packages. Standard packaged-products maybe such as traditional fiberboard cartons, as well as plastic, wooden or cylindrical containers. Small, Flat, and Elongated packaged-products all have to meet a strict set of dimensions and criteria. However, if a packaged-product is both Flat and Elongated, the package should be tested as Elongated.
3A includes an optional test combining Random Vibration Under Low Pressure (simulated high altitude). This tests the container’s (whether primary package or transport package) ability to hold a seal or closure and the retention of contents (liquid, powder or gas) without leaking. This test procedure is used sparingly by Medical Device Manufacturers as it is very severe with the utilization of top load vibration. MDMs may encounter damage that does not happen in the normal distribution environment. This procedure is comparable to ASTM D7386-08. This procedure does not address effects of low pressure High Altitude for non-porous packaging.
When properly executed, ISTA 3A procedures will provide tangible benefits of:
- Product to market time reduction
- Confidence in product launch
- Reduction in damages and product loss
- Balanced distribution costs
- Customer satisfaction contributing to increased market share
|1||Atmospheric Preconditioning||ASTM D4332||Ambient Temperature and Humidity|
|2||Atmospheric Conditioning||ASTM D4332||Controlled Temperature and Humidity|
|4||Vibration||D4728||Random with and without load|
|5||Vibration||D4728||Random Vibration under Low Pressure|