How can serialization be implemented effectively?

20.10.2015
Serialization

The thoughts of each prescription medicine manufacturer are currently focused on the same, pressing question: how can serialization be implemented effectively? The deadline set by the EU is in three years, by which all of the 15 000 production lines of prescription medicines in Europe should be renewed with serialization automation. The pressure to invest is huge, and all advice seems to be highly valued by decision-makers in the industry. In this update, I will provide answers to a few questions that have been presented to me concerning serialization – I hope they are helpful!

When should the project be launched?

There is a need to launch serialization projects quickly because the deadline is approaching fast. The assessment of product lines and serialization planning should begin as soon as possible because the delivery capacity of equipment manufacturers and automation mechanics is limited and delivery times are already being extended. As the deadline draws near, it will already be too late, because all of the professionals will have their hands full by that time.

Alone or with a partner?

The first priority is to decide whether the company wants to manage the entire automation planning, construction, and maintenance process alone. This is a feasible option mainly for major pharmaceutical factories. A small or medium-sized pharmaceutical company is more likely to outsource serialization planning, implementation, and maintenance – or at least the latter two processes.

A pharmaceutical manufacturer does not necessarily have in-house automation planning personnel. In such cases, a good serialization partner can assess the product lines of the manufacturer and prepare a plan on their behalf. An experienced automation supplier schedules planning, equipment orders, and implementation so that the project is completed on time.

When planning and implementation are handled by the same party, timeframes will be efficient and cost-effective. Responsibilities are also clear when operating with a single supplier. If the pharmaceutical factory decides to order the equipment, software, and work separately and manage the project on its own, it also takes responsibility for the knock-on effects of possible delays in delivery.

A good serialization partner is also well-aware of the development of EU legislation and can advise the pharmaceutical manufacturer as well as take the development of the sector into account at work. At the same time, the development of the serialization legislation in other relevant market areas will also have to be monitored: the same medicine is usually delivered to multiple market areas. The development of solutions in the USA, China, Brazil, and other countries must be observed constantly. The serialization model of China, in particular, differs considerably from other countries.

How should the project be launched?

A manufacturer should go through its production lines and products. An important point of consideration is: which products are sold as prescription medicines and into which countries? Prescription medicines in the EU must be serialized, but over-the-counter medicines may not be serialized. This means that the same product must be serialized for one market and left unserialized for another. Serialisation is a major investment in the product line, so serialized products should be focused on their product lines and unserialized on their own. The situation is difficult in terms of small lines producing prescription medicines because the costs of serialization automation are hardly in scale with the size of the line.

Adding serialization printers and print quality inspection units into an existing production line requires line-specific planning. The remaining life of the equipment along the line, such as a palletizer, should be clarified at the same time, because it may be worthwhile to take advantage of the break in production to replace the equipment. Depending on the aggregation level of serialization (primary package – secondary package – bundle – case – pallet), the line will need one or more serialization units.

Since the serialization of a production line involves a lot of line- and equipment-specific planning and customization, a highly experienced automation supplier who has an understanding of the different types of equipment along the line is essential when implementing serialization. A significant share of the costs is incurred during the installation stage when the production line is at a standstill (costs of production downtime). If the installation is not completed by the set deadline, it will become a major expense for the pharmaceutical manufacturer and may eliminate the benefits of potentially cheaper work.

Serialisation equipment with software is also important. The software must function reliably 24/7, and the number of errors must be minimized. A tested, functional, and ready-made serialization solution is the ideal choice. Serialisation solutions that are part of an Enterprise Resource Planning system are also available on the market, but they still require equipment integration: serialization software alone is not enough, but equipment is needed.

Servicepoint Ltd in Finland provides serialization and other types of automation to the pharmaceutical industry as well as other industries in North-Eastern Europe.

 

Iiro Jantunen
CTO, Chief Technology Officer
Servicepoint Kuopio Oy
iiro.jantunen@servicepoint.fi
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