Keeping on track for traceability

Paolo Landriani, technical department director at SEA Vision, discusses the importance of the right equipment and software in this approach and how it can save space, improve quality and ultimately save manufacturers time and money.

Across the globe, more than 40 countries are working on or have already enacted track and trace laws aimed at securing the pharmaceutical products supply chain and providing a higher level of quality control. While these regulations may vary in their scope and requirements, each demands a considered approach to ensure compliance.

Simultaneously, there is growing demand for small, easy-to-implement solutions from manufacturers, packers and wholesalers that have limited space in their operational environment and a continuous pressure to keep costs low.

Space saving

The drive to achieve regulatory compliance and meet the demands of global markets requires an audit of all systems and processes and will likely mean that investment in new equipment and technologies are required. For many manufacturers, space is at a premium and the addition of a new line and a range of new machinery may simply not be feasible.

Wherever possible, pharma companies must seek out equipment that can meet compliance requirements while performing multiple tasks. Ergonomically designed machines that have the capability to print, scan and check serialization data and perform other tasks such as aggregation and pack inspection are a must, especially for businesses where investment in multiple pieces of hardware is either impractical or impossible.

Additional value and futureproofing

While investment in serialisation is being driven by compliance — businesses should look to add value to their operations by implementing hardware and software solutions that offer multiple processes.

Aggregation may not be mandated for in by the Falsified Medicines Directive (FMD) but most global regulations require it, and many pharmaceutical businesses require it of their partners. Adding aggregation capabilities to a packing line after, instead of in conjunction with a serialization solution will be costly.

There are several supply chain scenarios where aggregation is beneficial. Whenever a batch needs to be reworked or recalled, which happens to 2–3% of all drug products in the market, or

when two wholesalers exchange products, aggregation allows for products to be found without the need to open all the cases and reprocess cartons individually.

It is also written into the FMD regulations that when a product is stolen during transport, it should be decommissioned within the database. Without aggregation, it will be difficult to know which cartons have been stolen without scanning products manually.

Overall equipment effectiveness can be negatively affected by adding additional equipment and processes to packaging lines. However, this can be negated with the use of all-in-one solutions designed to manage multiple process.

Reducing maintenance overheads: all-in-one solutions

The right equipment and software can also rate time and cost savings — pressures which the pharma industry is very familiar with.

Machines controlled by a single piece of software which manage the machine working cycle for serialized cartons checks, vision systems, multilevel aggregation as well as the performance of the equipment itself can introduce efficiencies in several areas.

These all-in-one solutions are often more easily integrated with current systems and simpler to validate. As a result, they are often easier to connect to enterprise software, meaning the data exchange for regulatory compliance is more readily achieved. Ultimately, this makes the install and validation processes more streamlined, prevents manufacturing line downtime and reduces capex costs.

Post-deployment, all-in-one solutions also create considerable long-term savings. With better designed and optimally installed equipment, all the hardware’s functions are managed by a single piece of software. This has a dramatic impact on reducing servicing requirements as all maintenance can be carried out by one engineer — minimising the number of companies providing aftersales support, reducing downtime and simplifying maintenance schedules.

Ever-changing regulations

The global regulatory environment continues to evolve and it’s important for manufacturers to have the best equipment and software in place to meet these requirements while maintaining the flexibility to adapt. Advances in technology mean that the pharmaceutical industry is in a better position than ever before to create a safer, higher-quality supply chain and now is the time to ensure your facilities are on track.

All-in-one serialisation equipment that can be delivered, deployed and validated in a short timeframe is an optimal solution for markets where there are short regulatory deadlines such as the EU, USA and more recently, Russia. Beyond compliance, they save-space, keep costs low and reduce operational downtime thanks to their simplicity.