US brand protection specialist Authentix has worked with the pharma company for several years to perfect a way of safeguarding patients and supply chain integrity by applying special unit-level tamper-evident security seals (TESS) and a unique carton number (UCN) to each carton. Astra Zeneca will shortly implement the first phase of its so-called Serialised Authentication Programme on blister pack cartons of Nexium supplied to all sales territories excluding the US and Japan. Ten manufacturing sites will initially participate, beginning with Macclesfield in the UK and Gärtuna, Sweden.
Jim Rittenburg, Authentix vice-president, Healthcare and Life Sciences, explains: “The TESS is in essence a sophisticated transparent label, incorporating serialised data, designed for application over the carton's end flaps. The combination of the TESS and UCN will eventually enable verification of product authenticity from manufacturing to the point of dispensing.”
Rittenburg says the combination of authentication features selected is up to the user, but will typically include a unique serial number, hologram, and covert features only readable with a special viewer. Once each carton has been fitted with its TESS on the packaging line its serial number, and a human-readable UCN applied elsewhere on the pack, will be activated, validated and entered into a database. Thereafter, any authorised personnel can cross-check the pack data against all serialised codes on the database.
Responsible for applying the UCN codes, embedded in a two-dimensional Data Matrix Code, will be the UK's Domino Integrated Solutions Group, whose director, Simon King, says: “Our flexible traceability solutions are tailored to meet the recommendations of global regulatory bodies and are in line with EFPIA's (European Federation of Pharmaceutical Industries and Associations) recent recommendations on secure serialised code structures embedded in two-dimensional Data Matrix code carriers.”
Last November EFPIA endorsed serialisation as “the most promising solution to fight counterfeiting and illegal diversion threats in Europe and globally”. Authentix says EFPIA recognises too that serialisation will, in future, work well with RFID.
Astra Zeneca, is currently undertaking a risk assessment to determine which of its drugs will be next to feature the new security features.
Domino's Simon King: “Our flexible traceability solutions are tailored to meet the recommendations of global regulatory bodies.” SimonKing The UCN codes will be embedded in 2-D Data Matrix code carriers Data_Matrix Contact details
Authentix
T: +44 (0)1904 486800
www.authentix.com
Domino Integrated Solutions Group
T: +44 (0)1954 782551
www.domino-printing.com/uk
