With pharmaceutical counterfeiting an increasing problem, there is a growing requirement for packaging to be part of the defence system. In the near future, many new regulatory markets are set to require the serialization of packages – meaning individual identification for each packaged item to enable the verification of its authenticity. Orion has been at the forefront of pharmaceutical manufacturers when it comes to meeting the new regulatory demands for serialization.
At the company’s tablet packaging and logistics center in Salo, Finland, most packaging lines have been equipped with serialization capacity. In 2017, Orion already delivered plenty of batches of serialized packages for global markets. This year, the program continues with the few remaining lines being updated to include serialization.
“Our aim is to provide serialized packaging for all global markets well in time for the regulatory deadlines,” says Salo Plant Manager Juho Hellman. “We already deliver to the Chinese, Korean and Saudi Arabian markets, and are well ahead of schedule for the upcoming US and European requirements.”
Meeting serialization demands in advance has been a strategic choice by Orion and the Salo plant.
“Moving ahead of schedule gives us time to practice and create smooth and efficient processes before the actual deadlines for serialization are put into place,” Hellman says.
Full range of services for serialization
On top of the serialization of individual packages, Orion can provide aggregation of serialized packages as well as offer tamper-evident solutions – a regulatory demand set to be taken into use at least in the European market. Serialization data management is handled via a cloud based application which can be connected with the customer´s system in a smooth and flexible way.
Clients who work with Orion as a CMO can have their entire packaging serialization needs met through one provider.
“We offer the full range of supporting services, including data transfer and connectivity between different data repositories, as well as a smooth art work process, support for registration and logistics, and – if needed – re-analysis and release for products entering the EU market,” says Esa Nauska, the Head of Orion Contract Manufacturing.
“We tailor the solution and services based on the client’s needs.”
Setting up strong serialization know-how at Salo
Since the start, the serialization project has advanced at Orion with in-house specialists in charge.
”We’ve wanted to ensure that we have the know-how for serialization within the company so that we can continue to develop and serve our customers’ needs with flexibility,” says Hellman.
At the Salo plant, setting up serialization capacity for a packaging line follows a well-thought-out procedure that takes from two weeks to a month or two.
“Besides installing the new technology, automation and data systems, we train the operators for the new procedures and of course do careful validation. It’s a bit of a mindset shift for the operators: as each package item must always be tracked and accounted for, serialization involves a new level of data management,” says Production Engineer Sami Tuominen.
At Orion’s plants, the serialization program has advanced according to plan.
“We see this as a crucial capacity that will ensure our ability to deliver our own and our clients’ products for all global markets for years to come,” says Hellman.
Read more about Orion CM.