ASTM/ISTA Testing Solutions

Our ASTM/ISTA Testing Solutions Deliver Robust Packaging Data

When you’re preparing to file with regulators, it’s imperative that you can demonstrate your intended packaging is up to the challenges of the biopharma drug supply chain. For packaging qualification, testing to the ASTM and ISTA standards can yield that data.

When ASTM/ISTA Testing is (and Isn’t) the Right Solution

Modality Solutions has helped many biopharmaceutical companies complete the packaging qualification work needed for a successful regulatory filing. Our ASTM/ISTA Testing Solutions help drug developers obtain the robust data required to complete the packaging section of their NDA or BLA filings to regulators’ satisfaction—facilitating the review process and increasing the odds of a successful filing.

For pharmaceutical and biopharma companies that need to test how well their drug formulation will stand up to the environmental hazards they will face in transit, Transport Simulation is much more effective than ASTM or ISTA testing. A transport simulation study goes far beyond test standards like ISTA 3A and other ASTM/ISTA tests that don’t simulate all five environmental hazards concurrently and in the worst-case conditions. When it comes to testing drug formulations for physical and chemical stability at the operating edge of your supply chain, a transport simulation study is the optimal way to obtain accurate, reliable results.