How Flexible Is Your Serialization Solution?

It is constantly evolving and never stands still. Just think about the rapidly-changing regulations which are being stipulated by governments across the globe – a completely understandable response to increasing amounts of forged medicines across the world.

Add to this the changing demands of the public, who are increasingly expecting pharma firms to ramp up their ESG efforts and to wear their green credentials with pride. This means pharma firms need to deploy forensic levels of production data to ensure no wastage is produced – something that serialization solutions can manage perfectly.

And let’s not forget the bigger picture – the Covid pandemic, for example, demanded a virtually brand-new entire cold supply chain to be set up within just a few months to ensure the all-important vaccines could be produced, stored, and shipped at temperatures as low as minus 80 degrees.

Therefore, for those who specialise in the design and implementation of pharmaceutical serialization solutions, the key word here is flexibility. What might have been a suitable serialization solution beforehand for a particular firm may well need to be changed – maybe at very short notice.

While many companies in the industry offer serialization solutions, are they truly flexible? Can they cope with a vastly increased demand, or a reduced workload if the need dictates? And are they able to manage low volume serialization? Or could they prove to be a hindrance to a company rather than helping it?

Why is there a need for serialization in pharma to be flexible?

More and more pharmaceutical firms are investing in serialization – largely because such solutions present the perfect way to adhere to complex governmental regulations and improve manufacturing efficiency.

However, if a pharmaceutical firm chooses the wrong serialization solution, it could prove to be a costly mistake.

Some pharma serialization solutions can be complex, inflexible, and unable to efficiently meet constantly evolving global and regional serialization requirements. As an example, and something that advanco has long argued against, many providers will install specific software which can only be used with their hardware. When this happens, the pharmaceutical company risks losing flexibility and the ability to either expand or adapt its manufacturing capabilities because of vendor lock-in.

Furthermore, it results in ever-increasing costs due to both the by-design inflexibility of the all-in-one vendor systems as well as the ongoing upgrade costs.

Advanco strongly asserts that the serialization sector should be far more open and transparent. If there were to be another pandemic, the pharmaceutical sector would likely face a host of brand-new challenges. This would demand a need to adapt quickly in order to identify and deploy the most appropriate action. In such a scenario, the ability for serialization and traceability solutions across the board to work together in unison would be a massive advantage. It would enable packaging serialization solutions to coordinate in warehouses and shop floors right across the globe. Indeed, it could potentially save millions of lives if the need for the vaccine was super-urgent.

The need for flexibility in Level 3 item level serialization

Turning specifically to level 3 serialization, the need for flexibility here is especially important.

One of the primary goals of Level 3 applications is to integrate and enable all of the vital processes when it comes to the isolation of automation and production devices from enterprise applications at Level 4. This separation provides governance, network traffic management and security, system access management and control and data domain establishment at the site level. Flexibility is therefore critical, especially the ability to work alongside machines from other providers.

Advanco’s ARC MES/Cockpit serves as a packaging management platform for serialization and aggregation in pharma operations, based around an open and secure interface technology. Flexibility is at the very heart of ARC MES/Cockpit. Not only does it connect with other ERP Level 4 and Level 5 systems, but it can also control and manage several serialization and aggregation machine vendors on one shop floor.

Indeed, ARC MES/Cockpit completely removes machine vendor lock-in, which advanco believes is critical for the overall future of serialization and track and trace solutions for the pharmaceutical sector as it continues to evolve towards cloud-based pharma serialization solutions. These are becoming the expected new normal as we increasingly march towards the realisation of Industry 4.0

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