Accurate Aliquoting Of Bulk Drug Substance Over A Range Of Product Viscosities And Target Weights

By Natasha Kelly

Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy. The Allegro Connect Bulk Fill System offers a solution as it can accurately fill up to 320 single-use biocontainer bags or bottles in an automated and sterile manner.

This system significantly reduces the risk of operator error and overall process time. It offers four configurations based on the type of filling container and quantity of containers needed. Moreover, the system allows for process flexibility to accommodate bioburden or sterile filtration in various configurations—single, serial, parallel, or none.

An automated 'recipe' controls the filling of each container, and adjusts the filling speed in a stepwise manner based on real-time container weight, eliminating the need for manual intervention during the filling process.

Here, we present bulk filling performance data generated from a series of application tests to demonstrate the reliability and consistency of the filling accuracy of the Allegro Connect Bulk Fill System within acceptable tolerances.