Automated particle inspection of continuously freeze-dried products using computer vision.

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Abstract

The pharmaceutical industry is progressing towards more continuous manufacturing techniques. To dry biopharmaceuticals, continuous freeze drying has several advantages on manufacturing and process analytical control compared to batch freeze-drying, including better visual inspection potential. Visual inspection of every freeze-dried product is a key quality assessment after the lyophilization process to ensure that freeze-dried products are free from foreign particles and defects. This quality assessment is labour-intensive for operators who need to assess thousands of samples for an extensive amount of time leading to certain drawbacks. Applying Artificial Intelligence, specifically computer vision, on high-resolution images from every freeze-dried product can quantitatively and qualitatively outperform human visual inspection. For this study, continuously freeze-dried samples were prepared based on a real-world pharmaceutical product using manually induced particles of different sizes and subsequently imaged using a tailor-made setup to develop an image dataset (with particle sizes from 50μm to 1 mm) used to train multiple object detection models. You Only Look Once version 7 (YOLOv7) outperforms human inspection by a large margin, obtaining particle detection precision of up to 88.9% while controlling the recall at 81.2%, thus detecting most of the object present in the images, with an inference time of less than 1 s per vial.Copyright © 2024 Elsevier B.V. All rights reserved.