TY - JOUR
T1 - X-ray imaging
T2 - A potential enabler of automated particulate detection and cake-structure analysis in lyophilized products?
AU - Sacher, Stephan
AU - Poms, Johannes
AU - Dekner, Michael
AU - Wallner-Mang, Sabine
AU - Vogt, Martin
AU - Khinast, Johannes G.
AU - Schennach, Robert
N1 - Funding Information:
This work was funded by the Austrian COMET Program under the auspices of the Austrian Federal Ministry of Transport, Innovation and Technology (bmvit), the Austrian Federal Ministry of Economy, Family and Youth (bmwfj) and by the State of Styria (Styrian Funding Agency SFG) and Baxter AG (part of Takeda). COMET is managed by the Austrian Research Promotion Agency FFG. The authors would like to thank Perkin Elmer for loan of the detector and fruitful discussions, and the Department of Chemical Engineering and Biotechnology, Cambridge University, for execution of the ?CT measurements.
Funding Information:
This work was funded by the Austrian COMET Program under the auspices of the Austrian Federal Ministry of Transport, Innovation and Technology (bmvit), the Austrian Federal Ministry of Economy, Family and Youth (bmwfj) and by the State of Styria (Styrian Funding Agency SFG) and Baxter AG (part of Takeda). COMET is managed by the Austrian Research Promotion Agency FFG.
Publisher Copyright:
© 2021 The Authors
PY - 2021/12
Y1 - 2021/12
N2 - The presence of particulate matter in parenteral products is a major concern since it affects the patients' safety and is one of the main reasons for product recalls. Conventional quality control is based on a visual inspection, which is a labour-intensive task. Limited to clear solutions and the surface of lyophilised products, it cannot be applied to opaque containers. This study assesses the application of X-ray imaging for detecting the particulate matter in a pharmaceutical lyophilized product. The most common types of particulates (i.e., steel, glass, lyo stopper, polymers and organics in different size classes) were intentionally spiked in vials. After optimizing all relevant parameters of the X-ray set-up, all classes of particulates were detected. At the same time, due to contrast enhancement, the inherent structures of lyophilized cake became obvious. This work addresses the potential and limits of X-ray technology in that regard, paving the way for automated image-based particulate matter detection. Moreover, this paper discusses using this approach to predict critical quality attributes (CQAs) of the drug product based on the cake structure attributes.
AB - The presence of particulate matter in parenteral products is a major concern since it affects the patients' safety and is one of the main reasons for product recalls. Conventional quality control is based on a visual inspection, which is a labour-intensive task. Limited to clear solutions and the surface of lyophilised products, it cannot be applied to opaque containers. This study assesses the application of X-ray imaging for detecting the particulate matter in a pharmaceutical lyophilized product. The most common types of particulates (i.e., steel, glass, lyo stopper, polymers and organics in different size classes) were intentionally spiked in vials. After optimizing all relevant parameters of the X-ray set-up, all classes of particulates were detected. At the same time, due to contrast enhancement, the inherent structures of lyophilized cake became obvious. This work addresses the potential and limits of X-ray technology in that regard, paving the way for automated image-based particulate matter detection. Moreover, this paper discusses using this approach to predict critical quality attributes (CQAs) of the drug product based on the cake structure attributes.
KW - Lyophilized cake structure
KW - Lyophilized products
KW - Parenterals
KW - Particulate matter
KW - Particulate matter detection
KW - X-ray imaging
UR - http://www.scopus.com/inward/record.url?scp=85122667331&partnerID=8YFLogxK
U2 - 10.1016/j.ijpx.2021.100101
DO - 10.1016/j.ijpx.2021.100101
M3 - Article
AN - SCOPUS:85122667331
SN - 2590-1567
VL - 3
JO - International Journal of Pharmaceutics: X
JF - International Journal of Pharmaceutics: X
M1 - 100101
ER -