ISTA 7D Testing
ISTA 7D is a development test to evaluate the effects of external temperature exposures of individual packaged products.
Certain products, like pharmaceuticals and biologics, must be shipped inside temperature regulated packages.
ISTA 7D Cold Chain
ISTA 7D is a test method that’s used by medical devices, pharmaceuticals, biologics, and food and beverage products to test the thermal performance of their packaging. Cold chain is done to ensure that the packaging can maintain a specific internal temperature as to maintain efficacy in the product/device or to ensure perishable goods do not perish.
ISTA 7D Test Conditions
- Determine the product’s temperature sensitivity (upper/lower limits and allowable excursion times) and the packaging design(s) to be compared.
- Use the actual packaged product. A substitute should be avoided, but, if necessary, it should closely match in thermal mass and composition of the actual packaged product.
- The package and product are brought to ambient or specified storage/conditioning temperatures for a minimum period (per the procedure).
- The packaged product is subjected to one or more temperature cycle profiles. The Temperature profiles range from hot, cold, and ramp conditions.
- Internal package temperatures are monitored using thermocouples or similar technology.
- Based on performance relative to defined limits and design objectives, determine if the packaging design is acceptable or needs redesign.
Cold Chain ISTA 7D
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Frequently Asked Questions
Does ISTA 7D also include distribution simulation?
7D addresses thermal hazards, it does not address mechanical hazards (shock, vibration, compression) that are inherent in distribution. If your shipping scenario has significant mechanical hazard exposure, you may need to supplement 7D with an appropriate mechanical-simulation procedure.
How do I know which cycle profile is correct for my distribution path?
Because the cycle profiles are general, you should assess whether your specific distribution environment may require a more targeted test or a higher-fidelity procedure.