Cold Chain Consulting Solutions

It takes a data-driven approach to validate your cold chain and ensure it withstands regulatory scrutiny and the rigors of the commercial supply chain. That’s what Modality Solutions provides through our unique Cold Chain Engineering capabilities. We’re the only provider that brings together every discipline needed for accurate, data-driven cold chain validation—combining the required chemical engineering, mechanical engineering, biomedical engineering, and packaging engineering expertise all under one roof.

For drugs transported in pre-filled syringes (PFSs), it is vital to verify plunger movement in transit doesn’t impact the therapeutic’s sterility or efficacy, per ASTM standards D4169-16 and D6653-13. But traditional plunger movement studies have limited accuracy, often require large test quantities, aren’t suitable for some devices, or involve the use of substances (like lactose powder) that can impact later Container Closure Integrity (CCI) testing.

Modality Solutions developed a better way to conduct plunger movement studies—one that’s more accurate, requires fewer syringes, is suitable for use with any device type with a visible plunger, and reduces the use of lactose powder. Testing experts at our Transport Simulation Lab capture real-time video footage of plunger movement under low pressure, simulating transport by aircraft or by truck at high elevations, and use computer software to accurately measure the degree of movement.