Antares Vision explains how Brazil, the first large country to adopt Track and Trace Regulation, is tackling the challenge of pharmaceutical drug serialisation
The pharmaceutical industries working in Brazil must comply with the upcoming Track & Trace Regulation. The objective is to increase patient safety thanks to reliable traceability and anti-counterfeiting. With a local branch, Antares Vision is close to its customers who are in the process of implementing serialisation and aggregation systems. Here we present three cases, with very diverse needs, where it has been applied.
Brazil will be the first large country to adopt the Track and Trace Regulation for the pharmaceutical sector. Following the regulation's coming into effect in Turkey in 2011, the South American country represents the first true testing bench, on a large scale, of the implementation of tracking systems intended to radically change the drug supply chain. The objective is to constantly increase patient safety, thanks to the complete traceability of each individual medicine packet and protection against tampering and counterfeiting, throughout every phase of packaging and distribution.
The pharmaceutical industries that work in Brazil have in a short time to comply with the new regulation and will provide the international market with a very interesting test, considering the great volumes involved, in view of the coming into effect of the second milestone of the US Drug Supply Chain Security Act (DSCSA).
Antares Vision, who for number of installations and technological level, is the international standard setter for drug tracking systems, has been active in Brazil for some years through its local branch, built around a designated group coordinated by Rafael Latorre, an expert manager in primary and secondary drug packaging safety.
The branch has already acquired numerous projects for the implementation of serialisation and aggregation systems. Below are three cases, which exemplify different challenges that can arise in this phase of great evolution: a large multinational, an important producer concentrated on the domestic market and an industry that may have smaller dimensions but a greater percentage of foreign sales.
Local regulation to worldwide management
The first case looks at a large multinational with the largest of its 40 facilities, spread out worldwide, right in Brazil.
With the pilot system already running, Antares Vision has started to install its systems on the first half of the more than 40 packaging lines involved, with the aim of completing this first phase by the end of 2015. The entire project will be completed by the end of 2016.
One of the main challenges of this installation concerns the management of all of the events relative to Track & Trace. With a two-fold requirement: in fact, the multinational needs to manage facility data locally, sending it to Brazilian authorities, and at the same time, the data needs to go into the global repository, which collects the information coming from all the systems around the world, and keeps it for at least 10 years.
"This large group chose Antares Vision as its global supplier for serialisation in all its facilities", said Rafael Latorre, country manager for Antares Vision do Brasil.
“Thanks to the experience that we have gained with the implementation of over 600 serialisation lines and the use of plug-in modules, we are able to offer quick installation and reduce line downtime to a minimum", continued Latorre. Adopting such modules is beneficial and helps minimise the impact on the customer’s production lines.”
"We are used to working alongside factory managers, jointly planning intervention times in synch with the production requirements", added Latorre. "Accordingly, as with other projects, we have put together a multi-disciplinary team that brings together ours and the customer's technical managers, for periodic updates on progress.”
The number of lines to be deployed in the two plants is impressive and by 2016 over 35 lines will have to be equipped. In view of this size, the project has been split into two phase – by the end of 2015, the target is to have a total of 15 lines operational. By September 2016, the remaining lines will be completed. All the lines include full aggregation. From the automation point of view we have here the complete range of situations: most of them are fully automated. The includes machines from leading manufacturers such IMA, with their renewed CP28 and CP18, Pester, Marchesini with a fully robotised line, and the Brazilian manufacturer, Tecnor.
“100% reading success is fundamental in maintaining a high OEE. Putting a camera inside a case packer and reading sometimes over 100 codes for each layer can be very challenging”, said Simone Orsi, technical manager at Antares Vision do Brazil.
“A case can contain 400 cartons in 4 layers, and the packaging can have different layouts and colours according to the drug we pack. T light reflectivity and contrast can, therefore, interfere with the reading performance of the camera.”
Missing even one of the 400 readings, will reject the whole case and rework all the cartons, with a dramatic loss of OEE. For this reason, the mechanical position of the camera and lighting must be perfectly designed to ensure all the codes are perfectly lit and focused.
When the geometry of the case packer doesn’t allow for a full image of the layer to be taken, the Antares Vision engineers have designed an intermediate solution, consisting ofreading all the cartons as they enter the case packer (last code reader).
Support for a national big player
The second application example, for which a pilot system has been built, also concerns a large facility, with considerable production volumes and a variety of lines. This case, however, is dedicated to domestic consumption. There is an evident difference in approach to tracking. In the previous example, the pharmaceutical multinational was already familiar with the new production concept in countries where it is in force, such as Turkey. The Brazilian experience was triggered based on those competencies. In this case, however, the local producer faced the Track & Trace issue almost from scratch.
"Basically three factors led them to choose Antares Vision: for the availability of modules with integrated functions, for the experience that Antares Vision was able to concretely demonstrate, by organising a visit to a system installed in Turkey, which is becoming an international standard-setting model for pharmaceutical serialisation, but most of all for the incredible pre-sales service provided by our branch", explained Adriano Fusco, global marketing director for Antares Vision.
Also, this plant has some very interesting aspects: some lines for example, don’t have enough space to fit the new serialisation modules, so the customer decided to introduce the P&C-CW. This solution, which is only 1.7 m long allows the old checkweigher to be removed and integrates both functions virtually in the same space.
The checkweigher control is completely integrated in the T&T software, so the unit configuration is done automatically and remotely, minimising set-up times for a new lot.
Even in this case, due to the size of the project, the deployment was split into two phases, with 23 lines to be deployed by the end of 2015, with 3 pilot lines already fully operational.
Machine manufacturers present here include, in addition to IMA and Marchesini, German manufacturers such as Uhlmann, Skinetta, Romaco, besides the Brazilian Tecnor. From the automation point of view, the lines can be viewed as: fully automatic, semi-automatic, completely manual.
The greater the human intervention, the higher the risk of mistakes in the aggregation process. To avoid these potential problems, the Antares Vision solution has a number of redundant controls that alert the operator in the case of error and prohibits certain operations that can jeopardise the integrity of the process.
As serialization involves completely new operating procedures and an additional number of devices on the lines, operator training is a crucial aspect of this project.
Flexible systems for a small industry
Another different, third case of application. This concerns a smaller producer, mainly involved in exports, as much as 80% of production. "The first production line was installed over a year ago to comply with Korean regulations, while we are now complying with Chinese regulations, and then completing the entire system for Brazilian serialised production.
"The great variety of drugs that are produced and the markets that are served require smaller batches, therefore manual lines are still the most efficient", explained Latorre.
"The know-how and the flexibility of the software that we offer make it possible to comply completely and effectively with the various regulations in the different countries they export to. When new regulations are introduced, re-validating the entire software is not necessary. Only the new modules, know as domains, need to be tested and validated. The individual packets, once they are serialised, are placed inside the box by hand. As the operation is completely manual, the machines must not have any downtime, to avoid slowing productivity. The hardware defined for this task is the new ‘Packing station top view’.
This is a second generation machine, developed and improved after the Turkish experience.
The decoding system is even more powerful and can decode hundreds of datamatrix codes in just fractions of a second, immediately providing the operator with confirmation of the reading, so that he/she can then proceed to fill the next layer without losing time. When the box is full, the system automatically prints out the label to apply to it.
"This is one of our best sellers", explained Adriano Fusco. "This station has just been announced and we have already installed almost 100 of them”.