Aesica, the global pharmaceutical contract development and manufacturing organisation (CDMO), has today announced it has successfully introduced serialisation services and initiated commercial production of two anti-allergy product lines for the Chinese market at its Pianezza site, Italy. The packaging lines and associated serialisation services are for the dedicated supply for one of Aesica’s strategic partners. The implementation took under six months to complete, with the first production of serialisation batches just commenced.
The joint collaboration enabled the skills and unique knowledge of Aesica personnel at Pianezza to deliver serialisation packaging methods and processes that fully comply with stringent State Food and Drug Administration regulations set by the Ministry of Health of China and dovetailed with the partners coding requirements. As a consequence of the partnership, Pianezza is one of the first CDMOs in Italy to have successfully implemented serialisation for a pharmaceutical product.
The serialisation technology uses special digital techniques to check the linear barcode 128 and 20 digit serialised numbers. The code check is in full compliance with international ISO 15416 standards. The check system provides a reliable instrument for checking products and batches all the way through the packaging and distribution process.
The platform has capability for both thermal transfer and thermal ink jet printers for printing stickers with e-codes and variable data with 2D bar codes respectively. High quality variable programming, inks suitable for a multiplicity of applications and ribbons that comply with the latest legislative and environmental standards have all been part of the installation.
Paolo Pizzorni, Senior Director at Aesica Pianezza commented; “We are delighted that our strategic partnership model has seen the successful development of two robust serialisation packaging lines. For our customer this means improved patient safety with a reduced risk of competition from counterfeit products and the ability to detect expired drugs automatically. The end-users are now able to verify the integrity and authenticity of the products dispensed to patients using a simple scan.”
He continued: “China is a key geographic market that Western pharma companies seek to export to. At Aesica we are delighted to be providing serialisation services to enable one of our customers to meet the technical and complex serialisation regulations in this market.”