Perspectives In Aseptic Manufacturing: Start Packaging Development Early: De-Risk Before You Build

By Eric Kurtz, Manager Technical Product Development

In aseptic manufacturing, the sequence of decisions matters as much as the decisions themselves. When packaging development is treated as a downstream activity, teams often discover late-stage misalignments between primary components and filling equipment, constraints around isolator integration or automated introduction technologies, and limited options for scaling to commercial volumes.

Eric Kurtz, Manager of Technical Product Development, makes the case that packaging strategy should inform fill/finish line selection, not follow it. Early coordination across container suppliers, OEM partners, and drug developers clarifies requirements for format parts, transport mechanisms, pump technologies, and in-process controls before fabrication begins. It also positions teams to address EU GMP Annex 1 expectations as a coherent system rather than a late-stage checklist.

The article examines how timing shapes not only line configuration but also dosing accuracy, automation capability, and long-term format flexibility. Explore the full perspective to see where these decisions intersect.