Trusting the Italian One-Stop-Shop-Strategy - From 0 to 336,000 blister-per-hour capacity
A complex project for a complete new site in Nantong, with a Packaging Department for standard and hormonal products was started in 2014. A true greenfield project with a complete new engineering and production team supported heavily by the German headquarters and their consulting capabilities. Merck designed a facility with Standard Blisterlines and Hormon-Blisterlines handling product feeding right up until the cases are placed on pallets. Every line consists of a C80HSA96 High-Speed-Blister machine with an integrated continuous cartoning machine with a maximum output of 700 blisters/min. Furthermore, there is a check-weigher, an MS 250 bundling machine and a CP18 case packer.
Before IMA was selected as the sole supplier of packaging lines for Merck Healthcare China, a realistic environment to test the feeding of technically difficult products was built in Bologna in the R&D department to establish part sizes. A challenging objective had been achieved and these results were repeated during the rest of the test phase until final performance validation. Without this validation and testing, reaching such high feeding speed and efficiency, the decision could have been more challenging.
Close teamwork among different stakeholders achieved an outstanding result. When the users from Merck Healthcare China arrived in Bologna to test what they had purchased, they performed 8 complete Line-FATs, with all 5 machines of the line connected and synchronized. The team always managed to successfully pass the performance test with higher efficiency than defined. The installation sequence was scheduled and adapted according to the progress of the building.
At the same time a training programme, which had already started in Bologna, was completed and subsequently the entire new Merck packaging team ran 8 complete Line -SATs from the feeding of the tablets up to the finished shipping cases. All lines also achieved results above expectations thanks to the fantastic teamwork during the whole process.
The qualification and validation of the lines later on was a positive consequence of the detailed preparation done beforehand in the design and planning phase.
The whole process, from assembly of the lines in Italy to the qualification and training of operators, was supported by the local Chinese team from IMA China. IMA Pharma operates from 3 sites in China and the Service Hub in Tianjin (only 1000 km away from the Merck site in Nantong) supplied manpower from the FAT in Italy up to the training sessions and production guidance during the first batches.
Making it easier to troubleshoot, the IMA C80HSA86 Blister and Cartoning machines were equipped with a software support programme called “Photographic diagnostic”. A machine alarm activates a sequence of pictures, where the operator is guided from the main machine area where the problem occurs down to the single sensor, for example, which has indicated a problem. Furthermore, the HMI also provides trouble-shooting suggestions for solving issues. Nowadays, this would be called an “Industry 4.0” feature, but at that time it was just meant to reduce downtime.
Being today’s only supplier for packaging lines at Merck Nantong, IMA SAFE understood the significant responsibility concerning After-Sales services. A regular contact has been established in order to keep the efficiency level of the lines at this exceptionally high level as a team effort together with the maintenance staff at Merck. A new facility like this is generating high expectations regarding the output and the reliability of the modern equipment and Merck Nantong even appreciated this challenge. The positive result was recognised by the Global Merck organisation in Darmstadt. Mr. Oliver Moik mentioned: “After the first tests in Bologna, our expectations were high. Together we achieved these goals and now I can confirm that we made the right choice.”
One of the key contact persons during the whole project was Marcus Claassen, who coordinated all activities and also took responsibility for the relationship between the different parties. Let’s ask him some questions to get his point of view.
Mr. Claassen: How were the design and planning activities handled between Germany, China and Italy?
The collaboration was driven by excellent communication between all involved parties: IMA Italy, IMA China, Merck Germany and Merck China. The target was always to start up the site as smoothly as possible with the quality standard ensured. Therefore, a substantial training program was rolled out for our new production colleagues that comprised several steps from overseas hands-on training in-house via technical insights during FATs up to extensive on-site support from IMA China. All this led to the successful start-up and delivery of essential medicines to our Chinese patients as of October 2017.
Mr. Claassen: Do you continue to measure the efficiency of the lines and how do you achieve your targets?
We measure efficiency during operation and continuously analyse the manufacturing data to increase our efficiency. There are many programmes and data sources in place to help us achieve the goals. The production department works closely together with our operational excellence department to observe operations from different angles.
Mr. Claassen: Did you face any communication or cultural problems?
No. It was always a pleasure and fun to experience the difference in the cultures. I enjoyed working in an international environment with many different styles of communication and culture.