Brazil will be the first large country to adopt the track and trace regulation for the pharmaceutical sector. Following the regulations 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 until the end of 2016 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, in November 2017, 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. In this article we will examine 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.
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 and 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 ten years.
"This large group chose Antares Vision as its global supplier for serialisation in all its facilities. Standard solutions and a common architecture at every site make it possible to manage the lines more easily and to respond to requests more rapidly", said Rafael Latorre, country manager for Antares Vision do Brasil.
Another plus of the Italian company is that it guarantees quick installation and the least possible interference with production: a key aspect in the pharmaceutical sector, where every line needs to be validated anew after any change is made. "Thanks to the experience that we have gained with the implementation of over 500 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 (instead of integrating cameras, printers, labellers, reject stations on the lines) is beneficial and helps minimise the impact on the customer’s production lines: the modules can be fully tested outside the production lines, than can be installed in hours, instead of blocking the production lines for days.
"We are used to working alongside factory managers, jointly planning intervention times in synch with the production requirements: the goal is to interfere as little as possible, concentrating on the lines that are momentarily loaded the least", added Latorre. "Offering this type of flexibility requires expertise, as well as good coordination with the production management. 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 multidisciplinary work group is composed of – from the customer – all the process owners involved (from IS to maintenance, to production, quality and engineering), while the Antares Vision team was formed by engineers from the corporate offices and the local subsidiary.
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 phases: by the end of 2015, the target is to have a total of 15 lines operational (including the 2 pilot lines already working). 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.
Antares Vision has been cooperating extensively with all these manufacturers in several projects across Europe and the US. Although the machines may differ due to the different formats they are required to produce, the working principles and the main geometric dimensions are similar. Therefore the integration of cameras and lighting systems inside the case packer is a process very well known to the Antares Vision engineers.
"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 four 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 (i.e. the ones in the far angles) 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 of reading all the cartons as they enter the case packer (last code reader). The consistency of the process is assured even if the machine stops or is blocked, as a camera fitted inside the case packer will read one or more codes in a predefined position (i.e. the last code in the sequence). Associating the position information with the list of inbound codes guarantees the exact content of the case, even when it is impossible to take a complete image.
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 and trace issue almost from scratch. The choice went to the Italian company precisely because of its ability to offer global service on serialisation and aggregation applications, starting with training and assistance for technicians, to developing the most efficient solution, based on the broad range of available modules.
"Basically three factors led them to choose Antares Vision: for the availability of modules with integrated functions that can save precious space on lines and maximise OEE, 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, who designed the solution in detail, in collaboration with the customer, well before receiving the formal job order", explained Adriano Fusco, global marketing director for Antares Vision.
"The human element is essential in the vendor’s choice for an investment as strategic as tracking. Beyond the technical solutions that a company can implement, it is essential that the customer have absolute trust in the team it will be collaborating with for months, if not years. The Brazilian team is proving to have absolutely outstanding competence and dedication to the customer, and the results in terms of sales are there for everyone to see".
Also, this plant has some very interesting aspects: some lines for example, don’t have enough space to fit the new serialization modules, so the customer decided to introduce the P&C-CW, featuring a high precision checkweigher module.
This solution, which is only 1.7m 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, and – again – optimising OEE.
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 where the entire process, from printing and verification of the serial number to palletizing, is done without any human intervention; semi-automatic, where the case is constructed automatically but is then filled manually by the operator; completely manual, where the operator takes care of every operation after serialization, filling and closing the case, labelling it and building the pallet.
The greater the human intervention, the higher the chance of errors, and therefore 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. Maintenance engineers have to get acquainted with programming formats for cameras, printers, and labellers.
As for packaging line operators, they have to learn how to manage machinery "exceptions" that might arise. After all, product reconciliation following a machine jam is one thing when unique serial numbers are not in the picture, but it is an entirely different story when they are. Consequently, a great many training sessions are planned in advance, even before the new machine modules are deployed. When serialization becomes a part of everyday production, Antares Vision engineers are beside the operators, ready to help them in the most efficient way. While supporting the operators, Antares Vision engineers are able to fully assess the operation of the devices on the lines and detect possible points of improvement that might increase overall performance. This leads to a detailed report being produced with a list of suggested improvements, clearly defined for each line, aimed at optimising OEE. The report includes, not only fine-tuning devices such as print-and-apply labellers, but also solutions to reduce machine jams.
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 new station was designed ergonomically: the supporting surface for filling is streamlined and its angle can be adjusted for maximum operator efficiency and comfort. The image acquisition and lighting systems have been designed to remain outside of the operator’s area of movement.
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. The North American market is particularly receptive to this type of unit, where ergonomics and efficiency are essential features".