Serialisation? Of course!
With the entry into force of EU Regulation 2016/61 and the Anti-Counterfeiting Directive 2011/62/EU the requirements placed on manufacturers of prescription-only medicines have increased. We will support you with the serialisation of your products. We receive the individual serial numbers via our validated IT solution or issue them ourselves.
Our serialisation station prints each individual package with the two-dimensional barcode and attaches the tamper-proof seal. If you want to aggregate products, we can aggregate them for you. Our serialisation services in detail:
- Printing and tamper-proof sealing
UNITAX has its own serialisation line that reliably prints two-dimensional barcodes and seals with Tamper Evident labels in a single operation.
- Serial-number transmission
UNITAX is connected to the Health Care Cloud of TraceLink. Via the cloud, clients from the pharmaceutical industry can send us serial numbers directly to the line manager in our manufacturing area. Immediately after printing with the Data Matrix code, we record the numbers of the finished packaged products by means of a final control scan. At the end of the serialisation process, the numbers are transmitted to our customers via the cloud. The licence holders can – also via the cloud – pass on the serialisation data to the central data storage and retrieval system (the EU hub).
- Serial-number issuing, product aggregation
Since we have our own software licence for TraceLink, it is possible for us to generate serial numbers independently. This also applies to aggregation: On request, we can aggregate your products, i.e. bundle serialised individual packs and provide the new packaging unit with its own serial number. This will contain all the serial numbers of the products that have been combined in a master carton or on a pallet. The advantage of this is that the outer packaging then doesn't need to be opened for control purposes.
- Validated IT: the Health Care Cloud from TraceLink
Our IT connection is validated according to GAMP 5. Individual serial numbers can be securely generated and transmitted via the Health Care Cloud. All the relevant serialisation data is documented and archived here in accordance with the applicable specifications.