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Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes.

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New sensors accurately measure low-volume parenteral filling (<200 µL), addressing aseptic manufacturing challenges. Capacitive sensors show the most promise for reliable in-process control in pharmaceutical filling lines.

Keywords:
IPCIn-process controlLow-volume fillingMicrodosingcapacitancegravimetric IPCsensor concepts

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Analytical Technology (PAT)
  • Aseptic Processing

Background:

  • Aseptic filling of low-volume parenterals (<200 µL), especially for monoclonal antibodies and intravitreal drugs, presents significant manufacturing challenges.
  • Existing gravimetric fill-volume control methods lack accuracy and robustness for these small volumes.
  • Developing reliable in-process controls is crucial for ensuring product quality and process efficiency.

Purpose of the Study:

  • To evaluate novel, contact-free sensor technologies for accurate and precise measurement of fill volumes below 200 µL.
  • To identify suitable alternatives to traditional gravimetric fill-volume control in aseptic filling lines.
  • To assess sensor performance under conditions mimicking aseptic manufacturing environments, considering factors like airflow and vibrations.

Main Methods:

  • Five distinct sensor concepts were tested: airflow, capacitive pressure, light obscuration, and capacitive measurements.
  • Sensors were evaluated for their performance in the 10-150 µL fill volume range.
  • Accuracy and precision of novel sensors were compared against a high-precision gravimetric balance.

Main Results:

  • All tested sensor types demonstrated functionality within the target low-volume range (10-150 µL).
  • Remarkable accuracy and precision were observed across all sensor types when compared to gravimetric measurements.
  • A sensor based on capacitance measurement exhibited superior sensitivity and precision compared to other evaluated technologies.

Conclusions:

  • Novel sensor technologies, particularly capacitance-based sensors, can effectively address the challenges of low-volume aseptic filling (<200 µL).
  • These sensors offer a promising solution for accurate and precise 100% in-process fill volume verification, even at high machine speeds.
  • Implementation of these advanced sensors has the potential to revolutionize aseptic filling processes in the pharmaceutical industry.