1. EU Bridge Pharma Traceability Pilot.
One of the Work Packages (WP6) of the
EU funded BRIDGE project. The Pharma Traceability Pilot aimed to demonstrate the implementation of a full supply chain traceability system of pharmaceutical products in a live, operating environment. The system deployed mass serialisation techniques to uniquely identify all levels of packaging (pack, case and pallet), encoding product on the manufacturing line using the 4 string data structure (product code, serial number, batch/lot number, expiry date) symbolised by a hybrid mix of 2-D Data Matrix and RFID EPC tags.
Information visibility was managed by multiple instances of EPCIS (EPCglobal standards) to enable tracking information to be collected along all 'hops' in what was an international supply chain - from the manufacturers, through the distribution chain, on to the wholesaler and finally to the hospital Goods In. Comprehensive use of GS1 Standards was made throughout.
The pilot successfully demonstrated how a track and trace system
can bring significant benefits to the user community -
for counterfeit combatance, product recall, inventory management,
financial reconciliation and, not least, for automatic medication identification,
all contributing to a safer, more secure, healthcare environment.
2. The World’s first truly integrated pharmaceutical line with 6 levels of packaging identification down to blister pouch.
Working with Control Software (now part of Domino Printing Sciences) and Domino Printing Sciences, Tjoapack in 2008 has further developed the Meditraq: Centre of Excellence to have the capability to acquire (generate, take from ERP or other source) and manage, input, output and store data at high speed and to a high level of complexity (see video). Not only can the system print a unique Data Matrix on each blister pouch, it can also print human readable text (up to four lines has been tested) that include Expiry Date and Lot Number and could include GTIN, National Pharmaceutical Product Code and unique serial number if required on the pouch.
The individual Data Matrix codes on the blister are then read, checked for content and the information is recorded to a database once it has been verified as correct. Multiple reads are taken analysed, checked and either passed or rejected at line speed on individual blister pouches. This information can then be aggregated to item level pack, whether a single blister or multiple blisters are being inserted. Any unread, misread or unknown codes will be rejected and the event recorded to meet the most stringent pharmaceutical regulations such as 21 CFR Part11. To ensure that the work meets all current quality and compliance requirements as contracted by customers, the implementation, which took just 6 weeks to complete and 2 weeks to validate has a complete set of validation documentation including URS, FDS, SDS and Risk Analysis that have been completed to GAMP4 and ISO standards.
One of the Work Packages (WP6) of the
EU funded BRIDGE project. The Pharma Traceability Pilot aimed to demonstrate the implementation of a full supply chain traceability system of pharmaceutical products in a live, operating environment. The system deployed mass serialisation techniques to uniquely identify all levels of packaging (pack, case and pallet), encoding product on the manufacturing line using the 4 string data structure (product code, serial number, batch/lot number, expiry date) symbolised by a hybrid mix of 2-D Data Matrix and RFID EPC tags.
Information visibility was managed by multiple instances of EPCIS (EPCglobal standards) to enable tracking information to be collected along all 'hops' in what was an international supply chain - from the manufacturers, through the distribution chain, on to the wholesaler and finally to the hospital Goods In. Comprehensive use of GS1 Standards was made throughout.
The pilot successfully demonstrated how a track and trace system
can bring significant benefits to the user community -
for counterfeit combatance, product recall, inventory management,
financial reconciliation and, not least, for automatic medication identification,
all contributing to a safer, more secure, healthcare environment.
2. The World’s first truly integrated pharmaceutical line with 6 levels of packaging identification down to blister pouch.
Working with Control Software (now part of Domino Printing Sciences) and Domino Printing Sciences, Tjoapack in 2008 has further developed the Meditraq: Centre of Excellence to have the capability to acquire (generate, take from ERP or other source) and manage, input, output and store data at high speed and to a high level of complexity (see video). Not only can the system print a unique Data Matrix on each blister pouch, it can also print human readable text (up to four lines has been tested) that include Expiry Date and Lot Number and could include GTIN, National Pharmaceutical Product Code and unique serial number if required on the pouch.
The individual Data Matrix codes on the blister are then read, checked for content and the information is recorded to a database once it has been verified as correct. Multiple reads are taken analysed, checked and either passed or rejected at line speed on individual blister pouches. This information can then be aggregated to item level pack, whether a single blister or multiple blisters are being inserted. Any unread, misread or unknown codes will be rejected and the event recorded to meet the most stringent pharmaceutical regulations such as 21 CFR Part11. To ensure that the work meets all current quality and compliance requirements as contracted by customers, the implementation, which took just 6 weeks to complete and 2 weeks to validate has a complete set of validation documentation including URS, FDS, SDS and Risk Analysis that have been completed to GAMP4 and ISO standards.
Do you need to See the Meditraq:
Centre of Excellence at Boskoop
The Meditraq: Centre of Excellence is a world’s first for pharmaceutical track & trace and is based at one of the Tjoapack pharmaceutical packing facilities in Holland. Meditraq currently has a fully working and fully operational manufacturing line that actually meets and exceeds all global coding and packaging track and trace requirements known today. Meditraq can demonstrate and provide coding & traceability from the first point of manufacture to pallet level within a validated pharmaceutical environment.
Manufacturing line skills and knowledge are difficult to find and even more difficult to implement. Understanding the complexities of the new track and trace systems that effect coding, marking and data is one thing, being able to design, implement, install, train, maintain, upgrade and develop systems is even more difficult and important.
If you would like to witness the systems and facilities at Meditraq for your self please do not hesitate to
contact us.
Centre of Excellence at Boskoop
The Meditraq: Centre of Excellence is a world’s first for pharmaceutical track & trace and is based at one of the Tjoapack pharmaceutical packing facilities in Holland. Meditraq currently has a fully working and fully operational manufacturing line that actually meets and exceeds all global coding and packaging track and trace requirements known today. Meditraq can demonstrate and provide coding & traceability from the first point of manufacture to pallet level within a validated pharmaceutical environment.
Manufacturing line skills and knowledge are difficult to find and even more difficult to implement. Understanding the complexities of the new track and trace systems that effect coding, marking and data is one thing, being able to design, implement, install, train, maintain, upgrade and develop systems is even more difficult and important.
If you would like to witness the systems and facilities at Meditraq for your self please do not hesitate to
contact us.
