There is a growing urgency for track and trace serialisation solutions in the pharmaceutical industry. As a matter of fact this has become crucial against the global fight with counterfeit products. Pharmaceutical companies will be required to meet all regulatory compliances as gazetted by the South African Government and international authorities especially if they wish to operate successfully locally and abroad.
The South African Department of Health has phased in programmes such as implementation of the GTIN-14 Datamatrix Barcodes. This basically include GTIN, batch/lot and expiry dates. Additionally by the year 2022 serialisation of secondary (multi/single pack) and tertiary packaging (Pallet/Case) will be implemented effectively. This unquestionably will aid in the fight against counterfeit medication/products and to this end offer full traceability from production at manufacturing level to the final consumer.
Strato International has partnered with leading international track & trace technologies to manufacture the STRATO SPCC. This includes track and trace level 1 and level 2 hardware and software that ensures cartons are commissioned according to GS1 international coding standards.
Track and Trace Serialisation System
The STRATO SPCC Station is a state-of-the-art track and trace serialisation system. This system additionally uses the integrated technologies of a Wolke m610 touch printer and a Sea Vision OCV solution to produce a serialised print. This print is in accordance with global standards and regulations hence ensuring conformance of pharmaceutical user requirements specifications (URS) such as for example, 21 CFR part 11, full traceability, audit trail and and validation support documentation. The SPCC station can be easily integrated and synchronised after a cartoning machine, or as a stand-alone system with an option to be manually fed.
Serialisation Print Check Commission Track & Trace Systems
Track & Trace Serialisation system and complete aggregation solution integration
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