Case Study

Serialization/Anti-Counterfeiting for
Several Leading Pharmaceutical Manufacturers

Project Snapshot

Counterfeit drugs are a real risk 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.

For several pharmaceutical companies, Sterling provided capital program management for the overall project and created a team including mechanical, controls, vision, validation and packaging engineers. Our team supported projects worldwide to meet US, 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.

Set up global teams of integration engineers to address a significant number of line upgrades to be completed in a very limited amount of time.
Packaging lines modified 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.

Project Challenges

A majority of the pharmaceutical global packaging lines had to be retrofitted at the same time 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.
Due to the new technology and the tight deadline constraints, hardware and software was being developed throughout the integration phase.

Results

Sterling was able to provide the technical program management and the expertise to complete the projects before the project deadline, making it of 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 the 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 has become 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 your needs.

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