The EU FMD Anti-Counterfeiting Drug Directive has made a rigid requirement for drug traceability, and CYCJET has participated in the formulation and implementation of the FMD labeling regulations. Since the introduction of the regulations, it has provided a comprehensive solution for the compliance of many pharmaceutical companies, introducing you to the solutions adopted by TechWorld in the United States.
With more than 120 years of history, TechWorld has been committed to the cause of human health and has always kept pace with the times. Nowadays it has to face the challenge of the new EU FMD regulations, to achieve online tracking of drug tracking retrospective QR code, and can not reduce the efficiency of the production line.
CYCJET T6040 at TechWorld
To ensure traceability throughout the entire process from production to retail to patient, each product requires an effective compliance code. In the high-speed medical production line, the code requirements of the traceability code are concentrated in the stable, accurate and fast three-words, that is, stable operation for a long time, high-speed code assignment and accurate reading.
The CYCJET Small Character Inkjet Printer T Series is highly experienced in helping pharmaceutical companies to comply with global regulatory compliance, and is well versed in the three-word approach:
TechWorld USA has long experience in using CIJ coding technology, so a CYCJET T6040 version of the small character printer is the first choice. The CYCJET T6040 version used by TechWorld is an easy-to-integrate product developed by CYCJET for high-speed production line systems and traceability applications.
We urgently need to complete the high-speed and high-quality code of DM QR code, and can not reduce the output of the production line. This fully meets our requirements. It is very easy to integrate, we integrate it into METTLER TOLEDO’s XS2MV checkweigher, and it is easy to operate through the checkweigher’s user interface and complete the transfer of coded data.
–TechWorld Technical Manager
QR code level is crucial
The US TechWorld will assign the coded link to the carton pack for blister packaging and assign it to the side of the carton pack. The printed DM QR code contains the product’s GTIN code, lot number and shelf life. The lot number and shelf life are printed in clear text on the right side of the QR code. After the CYCJET T6040 completes the assignment, it is verified by a PCE vision that the data it contains is correct.
If the test results are correct, the carton continues to be transported, wrapped in 12 boxes after weighing and placed in the outer box. If the test is not correct, the tray will be removed from the production line.
The DM two-dimensional code is determined by the printing level of the two-dimensional code, and this level depends on several different factors. Techworld Production Director explained:
An important factor in achieving a good rating is the quality of the carton and the performance of the assigned ink, in addition to the stable transport of the carton on the conveyor. The maximum speed of our weighing machine is 60-80 meters per minute. At this speed, with the cooperation of CYCJET T6040, we can successfully obtain the QR code between B and C. If the speed is slower, we can even achieve the A and B codes.
Note: According to the EU FMD regulations, the level of the 2D DM code on the drug needs to be above C or C.
EU Regulation No. 2016/161 (FMD) on drug traceability codes was fully implemented on February 9, 2019, requiring prescription drugs to have a unique identification sequence code to enter the European Union, including the US market. “Undoubtedly, we must implement the serialization logo required by the regulations. This CYCJET T6040 industrial inkjet printer allows us to complete the task,” concluded the production supervisor.