Top Considerations To Meet FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies

US Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.

Packaging and shipper rack design can play a significant part in either maintaining or interfering with correct handling and temperature requirements, in addition to adding inefficiencies.