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

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 labor-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.