Privatsphäre-Einstellungen

Codieren und Lesen der Codierung von Behältnissen aus Glas für pharmazeutische und diagnostische Produkte / Teil 1

Albert Wohland¹, Sylvain Houy¹, Simone Voldrich³, Robert Hormes³, Sabine Lehnicke⁴, André Witzmann⁵, Ulla Trinks⁵, Oliver Berger⁶, Volker Wedershoven⁶, Sergej Toedtli⁷, Stefanie Hub¹, Marcus S. Kern¹, Stephan Knittel¹, Jörn Köhler², Thomas Wetzel²

¹ Roche Diagnostics GmbH, Mannheim
² F. Hoffmann-La Roche AG, Basel (Schweiz)
³ SCHOTT forma vitrum ag, St. Gallen (Schweiz)
⁴ SCHOTT AG, Mainz
⁵ SCHOTT-Rohrglas GmbH, Mitterteich
⁶ Seidenader Vision GmbH, Markt Schwaben
⁷ Vesdo AG, Wollerau (Schweiz)

Corresponding author: Sylvain Houy, Dipl.-Ing. Werkstofftechnik, Roche Diagnostics GmbH, Packmittelentwicklung Pharma, Sandhofer Str. 116, 68305 Mannheim (Germany), e-mail: sylvain.houy@roche.com

Encoding and Reading of Codes on Glass Containers for Pharmaceutical and Diagnostic Products

The purpose of this study was to mark glass containers for pharmaceutical and diagnostic products unambiguously with an individual code, and establish proof of concept for largescale production. Identification at the level of the primary packaging should thus be possible, thereby preventing crosscontamination as well as enabling each individual packing to be tracked and traced.
A special laser process and corresponding scanning method were developed for individually coding the barrels of the glass syringes. For this purpose, a data matrix barcode was engraved onto the glass barrel while still hot. This marking left an intact glass matrix with no microcracks and was characterized by a high degree of abrasion resistance. The data matrix barcode was read with image-processing and camera systems before and after the pharmaceutical filling process, thereby enabling mechanical registration of the code.
After reading, the glass barrel underwent standard quality testing. No significant differences to non-coded glass barrels were ascertained.
Controls were conducted to test the quality and readability of the barcode for the proof of concept. A one-hour run of a total of 17 019 coded and filled syringes with 1 474 syringes deliberately intermixed, the latter were clearly identified and rejected. Avoidance of mix-ups and the suitability of this process for large-scale production are therefore guaranteed.

Key words Pharmazeutische Verpackungen • Pharmazeutische und diagnostische Glasverpackungen • Vorfüllbare Spritze • Track & Trace • E-Pedigree • Lasermarkierung • Data Matrix Code