Low-Volume Aseptic Filling Using a Linear Peristaltic Pump.

Area of Science:

• Pharmaceutical Technology
• Bioprocessing
• Drug Delivery Systems

Background:

• Aseptic filling of parenterals faces challenges with low-volume fills (<200 µL) for advanced therapies like monoclonal antibodies and ophthalmologic drugs.
• Microliter doses are increasingly required for highly concentrated formulations, cell therapies, and gene therapies, demanding high accuracy and precision.

Purpose of the Study:

• To investigate the applicability of a linear peristaltic pump as a novel filling system for low-volume parenteral applications.
• To compare the linear peristaltic pump's performance against current state-of-the-art filling systems in pharmaceutical production.

Main Methods:

• Characterization of the linear peristaltic pump's working principle.
• Evaluation of the pump's accuracy and precision for a target fill volume of 50 µL.
• Assessment of filling stability over an 8-hour operational period.

Main Results:

• The linear peristaltic pump demonstrated suitability for fill volumes ranging from 12 µL to 420 µL.
• For a 50 µL fill volume, a typical intravitreal dose, the filling accuracy remained stable over 8 hours with a standard deviation of +/-4.4%.
• The system maintained accuracy and precision for microliter fills.

Conclusions:

• The linear peristaltic pump technology can overcome challenges in reliable aseptic filling of volumes <1 mL.
• This innovation has the potential to transform aseptic filling methods by expanding the range of fillable volumes while ensuring high accuracy and precision for microliter doses.