Sunday, 2 May 2010

CIP-13. Serialisation and Integrators

In previous a blog we have discussed the French CIP-13 legislation that will require a datamatrix barcode to be added to pharmaceutical packs from 1st January 2011. If you missed the posting, there was a link to a data sheet produced by CIP that you might find interesting.

The legislation is often refered to as "track and trace" where the French legislation covers the "trace" part - i.e. the product is traceable throught its production process by virtue of the variable information printed on the pack, notably the lot number.

A further refinement of the legislation is the "track" part which adds a unique serial number to the datamatrix code, allowing the authenticity and route to market to be verified. Whereas the traceability data can be entered at the start of the batch and remains unchanged, a different tracking number has to be generated and printed on every pack. Furthermore, to ensure that the barcode containing the number has been printed successfully, it needs to be scaned to verify that the number is readable and therefore "live" in the distribution channel.

While Rotech, with the Apsolute thermal inkjet printer, can print the information on both porous and non-porous surfaces, you will need the services of a third party integrator if you need to handle the serialisation data and interface with a camera system to scan the code. If you'd like more information, we'd be happy to talk it through further - just contact us via this link

2 comments:

  1. cip 13 code if a fixed code for each product or it is variable for each container ?

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  2. Hi Prasad,
    Many thanks for the comment. The code will be fixed if it only contains information specific to the batch i.e. the GTIN (Product Code), the Lot number and the Expiry date. This is the "Trace" part of "Track and Trace".
    To "Track" the product, each specific container (or, more usually, the primary carton into which it is packed) will carry a unique tracking number which is also encoded into the datamatrix bar code. Tracking needs the services of an integrator as they need to generate the tracking numbers, confirm that they have been successfully printed onto the product and then produce a database of "live" tracking numbers.
    I hope this is helpful to you.

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