At the Meditraq: Centre of Excellence
one of the Tjoapack lines has been
dedicated to the development of a
completely new level of coding
and marking to offer,
what we believe, is the
first complete solution
that can identify, and
therefore authenticate
product not just at
carton, case and pallet
but at blister strip
and pouch level.

   
 
     
 
line control
   

True Aggregation
– a whole new level of complexity:

The requirement to link (aggregate) each level of packaging - blister pouch to blister strip; blister strip to item (patient pack/carton); item to bundle; bundle to case and case to pallet etc. i.e. mass serialisation and aggregation is now a
pre-requisite of most modern Track and Trace mandates.
The understanding of the complete process and the experience of building, operating and running such a complex and complete system is only currently vested in very few companies or organisations – and not just in pharmaceutical. Tjoapack is one of the few to both understand the requirements and to have developed technical solutions to have implemented a complete production line that can be used in a commercial and more importantly a compliant and regulated system such as the pharmaceutical industry requires.

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 has developed the MeditraQ: Centre of Excellence that now has 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. 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 prove the comprehensive nature of the MeditraQ: Centre of Excellence production line the process uses complex data allocation, code application and verification at blister pouch, blister strip, item, bundle, case and pallets levels. But this has not simply being achieved using 2-D codes such as Data Matrix at a number of levels, the system also prints human readable (alpha-numeric) codes, and at case and pallet level it also prints linear bar codes (EAN 128) and can write data to an RFID tags that can be encapsulated into the labels that are used. Again this allows for the maximum flexibility and interoperability right along the production line. At this point all codes that are printed or written to RFID tags are the same but there is no reason (for additional security purposes) why different code carriers such as RFID tags, linear and 2-D bar codes do not contain unique and different data that is also linked and aggregated by the system. 		 

Not just on brand new lines but also capable of being retrofitted onto existing lines:

If this is not enough, the whole system has been retrofitted onto an existing production line that runs daily batches of product for Tjoapack’s existing customers. 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.

Generic URS and a Complete Set of Validated Documentation
This documentation and description of the complete process also allows Tjoapack to offer pharmaceutical customers a number of benefits – not least a completely validated and detailed description within a generic URS. It also ensures that customers who wish to use Tjoapack’s contract packing services can do so with the complete peace of mind that complex Track and Trace systems, coding and marking at all packaging levels and secure storage, aggregation and authentication of data can now be achieved to all known mandates and regulations worldwide. By building such a complete end-to-end solution the requirements for France (CIP), Turkey, IFAH, EFPIA, California (as far as we know) and all other Track and Trace systems can be met by Tjoapack on a single line and also allow ultimate flexibility to change from coding and marking from pack to pack as well as batch to batch as required.

Don’t forget we still also do
Contract Packing

Because of their unique position and working knowledge in this market Tjoapack through the MeditraQ Division is able to offer contract packing, its traditional area of skill as well as a number of other services and facilities.

Do you need to See the MeditraQ: Centre of Excellence at Boskoop?

Manufacturing line skills and knowledge, as earlier described, 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.

 

 

~ Home Page ~ MeditraQ ~ Facilities ~ Services~ Tjoapack ~ Line Overview ~ Partners ~ Knowledge ~ Video - Contact ~