GALVEX, spol. s r.o.
Location: Banská Bystrica, Slovensko
Production:
Medicines
Medical supplements
Food supplements
Preparations for pharmacies
Ingredients
Implemented products: Pharma Track&Trace
Background:
Prior to 2019, the risk of medicine falsifications increased worldwide. As a result, the European Union has set out in Directive 2011/62 / EU a set of measures to to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled.
The European Organization for the Validation of Medicines (EMVO) has taken responsibility for progress in setting up the European Medicines Validation System (EMVS). The company Galvex spol., s.r.o., decided to replace the original drug serialization system with a new one in 2022. In May 2022, a contract was signed for the implementation of the drug serialization system.
Requirements:
Labeling of drug packages with a data matrix code containing a unique serial number - serialization
Ensuring anti-tampering packaging by gluing
The system is intended to ensure that the 2nd, 3rd and 4th level of the data matrix marked with a code for the purpose of "track and trace"
Checking the correctness and legibility of the marking and checking the gluing
Evidence of all packaging of manufactured drugs
Evidence of disposal, inclusion of packaging and transfer of packaging to the laboratory
Report of produced and discarded packages
Approval of the list of packages produced for dispatch
Sending data to the central European database
Possibility of packaging for external customers and import of serial numbers of external customers
Export of used serial numbers for external customers
Our tailored solution:
Serialization system components:
Central application
Automated production line
Industrial code printers
Industrial and handheld scanners
Control PLC with HMI console
Operator PC
Communication interfaces
Key features:
Generating numbers for drug packages according to EU standards
Verification of numbers on packages
Possibility of automatic and manual marking of packaging
Evidence of produced packages
Export to external customer applications
Communication line No.1.:
delivery of generated codes level 1 for the printer
obtaining information if the marked product has been validated as bad or good
Communication line No.2.:
obtaining information of the entering of the package level 1 into the group package
delivery of generated codes level 2 for the printer
obtaining information about the output of the package level 2 from the group package
Communication line No.3.:
obtaining information about the entering of the package levels 1 and 2 into a cartboard package
delivery of generated codes level 3 for the printer
obtaining information of the output of the 3rd level package from the cardboard package
Communication line No.4.:
obtaining information of the entering of packaging level 3 into the pallet packaging
delivery of generated codes level 4 for the printer
obtaining information on the output of packaging level 4 from the pallet packaging
Handheld scanner with touch screen:
for administrative tasks (for example sampling in the lab)
Results:
Thanks to the deployment of our drug serialization system, Galvex is now able to label and register EU manufactured drugs.
Currently, 130 packages per minute can be marked and checked.
After the successful implementation of the Track & Trace system - Serialization of drugs, we plan to expand the functionality by Connection to other external customers' systems.
