Getting serious about serialization of pharmaceuticals

Pharma 2D is a complete solution for serialization of pharmaceutical products, enabling printing of high-quality 2D codes, alphanumeric markings, vision control and security labelling

Counterfeit medicine is a growing challenge for today's pharmaceutical industry. Patients in the European Union are protected by Falsified Medicines Directive 2011/62/EU, which places mandatory serialization and verification requirements on medicinal packaging. To comply, packaging lines need special equipment to print and verify 2D product codes, like the Pharma 2D from Intrex. Equipped with modular automation hardware and software from B&R, the new machines can be quickly adapted to on-site requirements.

For more than a quarter-century, Intrex has made a name for itself creating proprietary solutions for marking, labeling, printing and vision control, with customers in nearly every industry. Recognising the pharma market's demand for a new serialization and labeling machine, they designed the new Pharma 2D Light and Pharma 2D Pro.

Individual requirements vs. Restrictive standards

While solving the individual requirements of its pharma customers, Intrex would also have to ensure that the new machines meet the industry's restrictive standards and guidelines. A prime example is the FDA 21 CFR Part 11 regulation stipulating documentation and tamper-proofing requirements for all electronically stored data. For the operator interface, this means guaranteeing certain functions, such as alarm management, audit trail and user account management.