Case Study


Serialization/Anti-Counterfeiting for
Several Leading Pharmaceutical Manufacturers

Project Snapshot

Counterfeit drugs are a real danger to customers’ health. As falsified medicines become more sophisticated, the risk of them reaching patients increases. For that reason, government agencies around the world have implemented regulations with which pharmaceutical industry players have to comply.

Serialization and aggregation contribute to building end-to-end traceability in order to secure the global supply chain.

Sterling provided capital program management solutions for several pharmaceutical companies. We created teams including mechanical, controls, vision, validation, and packaging engineers. Our team supported projects worldwide to meet U.S., Asia, and EU serialization requirements. Lines were integrated with serialization hardware and software in Germany, Italy, Puerto Rico, and several locations in the United States.

Project Challenges

A majority of the pharmaceutical global packaging lines had to be retrofitted simultaneously to meet the deadline.

Each pharmaceutical company had a large-scale project to meet these requirements, impacting the availability of limited resources with the required expertise.

Hardware and software were being developed throughout the integration phrase, due to new technology and tight deadline constraints.

Sterling’s Solution

Established global teams of integration engineers to address a significant number of line upgrades in a very limited timeframe.

Modified packaging lines with vision cameras, printers, and line and site level software.

Coordinated with IT areas to implement data exchange between ERP systems with to line and site level software.

Sterling’s Results

Sterling provided the technical program management and  expertise to complete the projects ahead of schedule, allowing these to be among the few global projects to meet regulatory requirements on time. The various projects covered 90 packaging lines with a budget of $120 million.

Sterling provided leadership to develop multi-year budgets and schedules to meet governmental requirements. With Sterling Engineering’s strategic alliances, a customized turnkey serialization solution was provided.

Dedicated to providing selection, integration, and validation of serialization and aggregation systems for the last 10 years, Sterling is a key recognized partner in Track & Trace technology projects.

The first building block of a secure and transparent digital supply chain is serialization – and the first challenge is to choose the right serialization partner to meet and exceed your needs.

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