Every year more upcoming drugs are Biotech ones, complex and highly sensible.
Many of them are sensible to water, oxygen etc.
Lyophilization is not a new technique and quite frequently is the only way to solve the above issues.
Given the complexity of managing Sterility, building a Sterile suite is already a complicated project and adding a Freeze Dryer between the Filling Line and the Capping machine add another challenge.
After filling vials are partially stoppered, the final stoppering happens in the Freeze Dryer after the Lyophilization cycle completion. Between the filler and the Lyo, the vial is partially open with sterility risk. For this reason, managing a Sterile project with Lyo requires a deep understanding of the GMP as well as a consolidated Manufacturing experience and HVAC knowledge.
Sterile Freeze Dryers Projects include several other challenges such as the Compounding which frequently requests additional challenges or large Laminar Air Flow which if not properly designed may generate issues during validation.