Sicherheitsetiketten für Pharmaschachteln
Anforderungen, Besonderheiten und Herausforderungen
Fachthemen
Abstract
Security labels for pharmaceutical folding boxes – requirements, special requirements and challenges
The delegated EU Regulation 2016/161 requires individual product marking with a data matrix code in combination with an anti-tampering device to increase protection against counterfeiting. This device intends to unmistakably indicate whether the folding box, as the outer casing of the medicine, has been opened or tampered and thus prevent the contents of the coded folding box from being exchanged or otherwise tampered with in the supply chain. The tamper-evident labels represent a technical implementation of the requirements for the delegated EU Regulation 2016/161. They can be applied to a variety of existing folding box designs manually up to fully automatic. In addition, labels are used across all industries as a security seal and therefore recognized by consumers. However, they have to meet very high and different requirements from the point of view of protection against manipulation, but also from the perspective of materials and process technology. They have to withstand various climatic conditions (especially for cooled medicines) and meet the durability indirectly required by EU Regulation 2016/161. This article takes a closer look at these requirements. It evaluates the performance of the labels in different climates according to the ICH guidelines (International Council of Technical Requirements for Pharmaceuticals for Human Use) as well as the shelf life after accelerated aging.
 | Philip Falkenstein studierte Druck- und Medientechnologie an der Bergischen Universität Wuppertal und schrieb seine Masterarbeit über die Umsetzung der EU-Fälschungsschutzrichtlinie 2011/62. Bei dem pharmazeutischen Packmittellieferanten Bähren Pharma-Packaging unterstütze er, als Produktmanager, Pharmaunternehmen bei der Umsetzung von Fälschungsschutzmaßnahmen. Zuletzt war er dort für die Leitung des Produktmanagements Serialisierung & Tamper-Verification verantwortlich. Seit Ende 2020 ist er |
