Micro Computer Tomography for medical device and pharmaceutical packaging analysis

Florine Hindelang; Raphael Zurbach; Yves Roggo

doi:10.1016/j.jpba.2015.01.045

Micro Computer Tomography for medical device and pharmaceutical packaging analysis

J Pharm Biomed Anal. 2015 Apr 10:108:38-48. doi: 10.1016/j.jpba.2015.01.045. Epub 2015 Feb 9.

Authors

Florine Hindelang¹, Raphael Zurbach², Yves Roggo³

Affiliations

¹ Complaint and Counterfeit Department, Quality Control for Commercial Bulk Products, F. Hoffmann-La Roche Ltd, Wurmisweg, CH-4303 Kaiseraugst, Switzerland. Electronic address: florine.hindelang@roche.com.
² Complaint and Counterfeit Department, Quality Control for Commercial Bulk Products, F. Hoffmann-La Roche Ltd, Wurmisweg, CH-4303 Kaiseraugst, Switzerland. Electronic address: raphael.zurbach@roche.com.
³ Complaint and Counterfeit Department, Quality Control for Commercial Bulk Products, F. Hoffmann-La Roche Ltd, Wurmisweg, CH-4303 Kaiseraugst, Switzerland. Electronic address: yves.roggo@roche.com.

PMID: 25710902
DOI: 10.1016/j.jpba.2015.01.045

Abstract

Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner.

Keywords: 3D imaging; Defect detection; Medical device; Quality control; X-ray microtomography.

Publication types

Review

MeSH terms

Drug Packaging / standards*
Equipment and Supplies / standards*
Humans
Quality Improvement
Reproducibility of Results
X-Ray Microtomography / methods