Labelling and Bar Codes
Axicon 15000: a fresh approach to labelling
15500 series 1D/2D barcode verifier ISO/IEC compliant Free licence software Data content checking USB Powered
The Falsification of Medicines Directive and Unique Device Identification for healthcare products require global standards for labelling, with traceability data encoded into easily scannable bar codes. The GS1 general specifications define suitable bar codes and bar code sizes for a particular environment in their Application Specification Tables. The data in the bar codes is encoded in a defined format to allow correct processing. The GS1 system defines a set of fixed length and variable length fields, each labelled by an application identifier. The Axicon 15000 series verifiers from Holfeld Graphics take a fresh approach to labelling standards. The user can select the Application Specifications that they wish to comply with, including different application identifiers for different international markets. A verifier ‘plugin’ can be chosen to check against a particular application specification table in the GS1 General Specifications.
A user-friendly solution The print quality of the code is verified to ISO/IEC 15415 for 2D bar codes or
to ISO/IEC 15416 for linear bar codes. If there is a conflict (e.g. healthcare retail or healthcare distribution), the software will ask you to make a choice. This is a user-friendly way of ensuring that not only is the bar code readable but that it is the correct symbology, the correct size and that the data is properly formatted. The use of the verifier and the recording of data can be controlled in a way that is consistent with 21CFR Part 11. Access to the program is restricted by harnessing the security features of the Windows operating system. To help with Installation Qualification, Operation Qualification and Performance Qualification, Axicon can provide IQ/OQ/PQ protocols and test cards. The software can be updated freeof-charge from the Axicon website as standards are updated and new features are added. Recently released features include the Laetus Pharmacode and audit trial capability to track changes to settings and electronic records, while Axicon are about to add the ability to verify GS1 DataBar Composite Codes as used in the Japanese market.
The Axicon 15000 series allows the user to choose a verifier ‘plugin’ to check against a particular application specification table in the GS1 General Specifications.
2 year warranty
www.holfeldgraphics.com
Irish PharmaChem | Industry Buyers Guide 2021
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