ENSURING CONSISTENT ACCURACY:

BULK FILLING SYSTEM

Challenge

Aliquoting is the controlled subdivision of bulk-prepared drug product liquids into smaller containers to ensure accurate dosing, sterility, traceability, and ease of use throughout biopharmaceutical manufacturing. Although the principle is easily understood, the technology to precisely achieve this has proved both challenging and elusive, particularly with larger drug product volumes and the requirement for multiple aliquots.

Solution

We addressed this inefficiency by creating a highly flexible automated bulk filling system that can fill up to 320 containers – bags or bottles – with consistent precision. This has been achieved through a strategic system design of sterile single-use manifolds, aseptic connectors, and disconnectors. The video (below) illustrates the sequence to achieve the filling of 320 containers.

Manufacturing Processes

Multiple and varied as expected from highly complex system

Materials

Multiple and varied

Patents

  • US 11,814,200 B2

Company

Company: Pall/Cytiva

BULK FILLING SYSTEM

"Aliquoting drug product"

Challenge

Aliquoting is the controlled subdivision of bulk-prepared drug product liquids into smaller containers to ensure accurate dosing, sterility, traceability, and ease of use throughout biopharmaceutical manufacturing. Although the principle is easily understood, the technology to precisely achieve this has proved both challenging and elusive, particularly with larger drug product volumes and the requirement for multiple aliquots.

Solution

We addressed this inefficiency by creating a highly flexible automated bulk filling system that can fill up to 320 containers – bags or bottles – with consistent precision. This has been achieved through a strategic system design of sterile single-use manifolds, aseptic connectors, and disconnectors. The video (below) illustrates the sequence to achieve the filling of 320 containers.

Manufacturing Processes

Multiple and varied as expected from highly complex system

Materials

Multiple and varied

Patents

  • US 11,814,200 B2

Company

Company: Pall/Cytiva