The collaboration combines Aesica’s capabilities and personnel at the Pianezza site for serialization packaging methods and processes that comply with SFDA regulations set by the Ministry of Health of China, with the partners coding requirements. As a result of the partnership, Pianezza is one of the first CDMOs in Italy to implement serialization for a pharmaceutical product.
The serialization technology uses digital techniques to check the linear barcode 128 and 20 digit serialized numbers, and is in compliance with ISO 15416 standards. The system provides checks products and batches through the packaging and distribution process. The platform has capability for thermal transfer and thermal ink jet printers for printing stickers with e-codes and variable data with 2D bar codes, respectively.
Paolo Pizzorni, senior director at Aesica Pianezza said, “We are delighted that our strategic partnership model has seen the successful development of two robust serialization 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 added, “China is a key geographic market that Western pharma companies seek to export to. At Aesica we are delighted to be providing serialization services to enable one of our customers to meet the technical and complex serialization regulations in this market.”