Track and Trace (T&T) Systems Keeping Turkish Pharma Operations on Track
On January 1, 2012 Turkey became the first country in the world to implement comprehensive legislation on traceability for 100 percent of the medicines sold in its territory. Italian specialist Antares Vision has played a leading role in this transition, equipping more than 40 percent of Turkey’s pharma production lines.
The Turkish projects have included complete T&T equipment for more than 110 production lines, of which 80 were supplied in the second half of 2011. Antares Vision produced more than 300 standalone modules and installed over 1,000 inline cameras with the help of more than 50 field technicians.
This article describes how T&T systems were installed in the country’s largest manufacturing plant and the biggest distribution center. Both are owned by a major multinational pharma company which chose Antares Vision as a strategic partner for traceability.
The two projects were carried out in parallel and coordinated with each other. Their size and timing, as well as the results achieved, made them real benchmarks in the T&T market.
Complex Facilities Create Challenge
The production plant includes 24 lines for products in both solid and liquid form. Many of the lines have a high degree of automation, with bundlers, shrink wrappers, houses packers and even robotic palletizers. Alongside these, however, are lines that rely on manual handling to insert products into boxes and make up pallets.
Production typically takes place over two shifts, six days a week, yielding over 150 million sales units per year. The distribution center delivers over 200 million sales units per year. The average workload is 600 packing orders per day, but at peak periods the system must be able to manage up to 2,000 orders per day.
The introduction of the T&T regulation dramatically changed the packing procedures. Since all the items are different, the operators must now scan every product before placing it into a shipping case. Any latency in the response from the database would delay the packing and shipping operations and reduce the throughput of the entire plant.
As the various plants have grown up over time they have come to use a range of different software architectures. All these had to be interfaced so that the new T&T systems could acquire data on work orders and return serial numbers to be forwarded to the Ministry of Health.
Beside the dimension and complexity of the projects, another critical point was the very tight deadline. See next page …
Planning Makes Short Deadlines Achievable
Beside the dimension and complexity of the projects, another critical point was the very tight deadline. “As the order for the new T&T systems was placed only seven months before the 1 January deadline, the Antares projects managers had to take a number of key decisions to guarantee deployment in time,” said Emidio Zorzella, CEO of Antares Vision.
The first decision was as far as possible to use modules that were “ready to plug” into the production and packaging lines. With four different serialization models, five different packing stations and several modular Print & Apply systems, the Antares offering is the widest on the market. In such diverse projects this flexibility is important. In the case of labeling, for example, the different line layouts require the codes to be read either on the side or on top, while the required output could be on the left, on the right or straight ahead.
The use of modules — instead of integrating cameras, printers, labelers, and reject stations directly into the lines — also helped to minimize the impact on production. The modules can be fully tested after assembly, and then installed in a matter of hours, instead of the days required to install and test individual equipment items.
Also important was the way the Antares Vision engineers were able to build flexibility into their schedules, allowing them to adapt quickly to unforeseen changes in production.
Cooperation, Team Building and Training
As well as the technical and organizational aspects, cooperation among the working teams was also key to success.
The multidisciplinary working group included, on the customer’s side, representatives of all the process owners involved, including information systems, maintenance, production and engineering. The Antares Vision team included people from the company’s local partner, Kura. “Antares and Kura have been partners for many years and have deployed a huge number of systems together,” said Ozgur Tansoy, head of Kura’s service department.
“Kura technicians spend many days in Italy each year, managing customers’ factory acceptance tests (FATs) and receiving training. They have full information on product development and give us important feedback,” said Massimo Bonardi, Technical Director at Antares Vision. “With Turkish as their mother tongue, they were the ideal link between Antares and the customer’s technicians on this project, as well as in delivering operator training. Early communication between the various groups was crucial to anticipating problems and meeting the deadline,” Bonardi added.
As T&T involves new operating procedures and new equipment, operator training was a crucial aspect of the project. Maintenance engineers must get acquainted with programming of formats for cameras, printers, and labelers, while for the line operators learning to manage exceptions is the critical point. For instance, reconciling product after a line jam requires different procedures once products are serialized. Antares and Kura engineers carried out a large number of training sessions to familiarize customer staff with the new systems.
Once the new systems were running, Antares and Kura engineers tuned them to improve performance. Please continue reading …
Fine Tuning Improves OEE
Once the new systems were running, Antares and Kura engineers tuned them to improve performance. Despite careful planning and training it was impossible to prevent a drop in OEE during the early stages of the project, and the incentive to improve was clear: “Production managers estimate that every 1 percent of reject causes a 2 percent loss of OEE, due to rework,” Ozgur Tansoy says.
Perfectly operating lines experience only minimum OEE drop with the introduction of serialization, but older lines with frequent stops are more difficult to manage.
For the first two months of operation, while supporting the operators, the team analyzed the performances of machines and devices in each of the 24 production lines, recording the causes and frequencies of “no read” events and rejects.
The resulting list of suggestions to improve performance included ways to reduce machine jams as well as better tuning of the labeling systems and better programming of label formats to maximize reading performance under plastic wrap.
Turkish Success Informs Future Projects
Between them the two projects successfully deployed T&T across 24 production lines and the largest pharma distribution center in Turkey.
Careful planning and cooperation between Antares, Kura and the customer allowed the projects to meet a very tight deadline. Extensive training, followed by generous on-site support and monitoring by Antares and Kura engineers, overcame the operators’ lack of experience and maximized OEE.
Taking a wider view, Antares Vision has played a key role in implementing the new Turkish T&T regulations, commissioning systems on more than 40 percent of Turkey’s pharma lines in less than eight months.
The Antares production facilities have proven their reliability and increased their production capability, being required to deliver massive quantities of modules in very short times.
The experience has broadened the skills of the Antares engineering team in integrating machines of many different types, including bundlers, case packers, and robots, from many different suppliers. Antares’ own production facilities have proved their reliability, while the company’s T&T project teams have demonstrated that they can manage multiple large projects together.