Entstehung, Klassifizierung und Vermeidung von Rissen in Fertigspritzen
Originale
key words Fehler – Risse, Beschädigungen, Kratzer | Fehlerklassifizierung | Fehlervermeidung | Inspektionstechnologie | Qualitätsmanagement | Sterile Fertigspritzen
Abstract
Emergence, Classification and Prevention of Cracks in Ready-to-fill Syringes
In the production and processing of ready-to-fill syringes, a multitude of defects with varying levels of severeness can occur. The spectrum includes cracks that penetrate the glass body completely and are classified as critical errors due to their risk for patients, checks that penetrate the glass body only partially and are classified as major errors, and superficial scratches that are classified as cosmetic errors. Each production or processing stage produces a specific range of potential defects that are typically located at a certain part of the syringe. For an efficient quality management it therefore makes sense to classify defects by location and cause so that appropriate measures for the optimization of the corresponding processes can immediately be derived. This requires a multi-level classification process for the precise identification of defects and the discrimination of cracks from less severe types of defects. Due to improved production processes and automated quality control defect rates at low ppm levels are reached. In filling technology and the design of ready-to-fill syringe-based drug delivery devices, however, there is a potential for further optimization to be exploited in close cooperation of glass and pharmaceutical industry.
· 2 Method Validation & Intercalibration, Gerresheimer Bünde GmbH, Bünde
· 3 Hinsch-Consulting, Dr. Bernhard Hinsch, Hamburg
Korrespondenz:
Dr. Andrea Behrenswerth, Gerresheimer Bünde GmbH, Erich-Martens-Str. 26-32, 32257 Bünde, Germany; e-mail a.behrenswerth@gerresheimer.com
ZUSAMMENFASSUNG
Bei der Herstellung und Weiterverarbeitung von Fertigspritzen kann eine Vielzahl unterschiedlicher Fehlertypen auftreten. Das Spektrum reicht vom durchgängigen Riss, der aufgrund seines Patientenrisikos als kritischer Fehler eingestuft wird, über als
