Merck's second largest pharmaceutical production site is currently taking shape on the east coast of China, just around a two-hour drive away from Shanghai. When the factory reaches full capacity in 2021, plans call for the production of ten billion tablets a year in Nantong. The tablet presses required to achieve this come from Fette Compacting.
From the outside, the logistics and production buildings look fully completed already. Inside are areas with equipment that meets the highest standards. They are strictly seperated from the clean rooms next door that are under construction. Here tablet presses still in their shipping crates await their big debut. The continuous development from construction site to completed factory has been daily routine for Marcus Claassen since 2014: "We laid the cornerstone just three years ago, attained full approval in accordance with GMP (Good Manufacturing Practice) in June 2017, and are now taking the final steps on the path to full production. So we are precisely on schedule," he says contentedly. Claassen is Director Technical Projects at Merck and responsible for outfitting the new factory with pharmaceutical manufacturing equipment.
Essential drugs for the Chinese market
Merck is the first and only internationally active pharmaceutical company that is establishing a location dedicated to the production of drugs for the so-called "Essential Drug List" (EDL). Pharmaceuticals that are included in the EDL are deemed to be indispensable medications and are paid for by the Chinese health insurance. However, they are subject to comparatively stringent price constraints.
Thus the key to success in the Chinese market for Merck is efficient local production in compliance with the highest international standards. The aim is to produce the drugs at the required level of quality and in the required quantity at a reasonable cost. In Nantong, Merck will produce medications that can be used to treat widespread chronic illnesses such as diabetes, thyroid disorders, and cardio-vascular diseases. To this end, the company is establishing an entirely new location in a so-called "green field project". This ambitious plan also entails special requirements. "Unlike with an existing production facility, we also had to plan the entire infrastructure. And we want to use all resources as efficiently as possible, which also means reducing waste and product losses to an absolute minimum," explains Claassen.
Production in compliance with international quality standards
Even before full production, the first tablets produced in Darmstadt are already being packaged and delivered. Merck is sourcing all of the production facilities and laboratory equipment from European manufacturers. The quality standards and the high reliability of supply of these global vendors were key in this regard. Claassen emphasizes, however, that a new construction project of this type makes higher demands of all who are involved: " Our suppliers must interact optimally. Above all during the project planning phase, this requires strict adherence to the schedule and professional management of sub-contractors by our partners."
Fette Compacting is the exclusive partner for tablet presses and the associated equipment at the Nantong facility. Merck already uses the special purpose machine builder's technology in Darmstadt; in the future, it is intended to ensure efficient production in Nantong. "Our customersupplier relationship with Fette Compacting is one of the longest such connections in our company's history," says Oliver Moik, Associate Director Group Procurement EMEA / Capital Investments Merck Group. " We are delighted that Fette Compacting submitted the winning bid for our new plant and we can continue our cooperation."
"The initial indications that Merck intended to establish a factory in China surfaced in the trade press in July 2014," recalls Dr. Steffen Wehlte, Sales Director Global Accounts & EMEA at Fette Compacting. The actual call for bids followed in September. "We systematically followed our Efficiency Guide in preparing our bid. Because it is a green field project, we knew that quick and trouble-free commissioning would be an important criteria. For this reason, in addition to the technical user requirement specifications, we also developed an extensive service and training concept as an integral part of our bid," says Wehlte. Among other things, this concept encompassed service by our subsidiary Fette Compacting China and a training concept for the operators including training at Fette Compacting's Competence Centers.
"In a detailed training plan, we extended a proposal to Merck regarding the number of employees who will require training and how the individual training periods should be synchronized." The proposal was convincing and Fette Compacting was awarded the contract in December 2014. Wehlte feels validated: In addition to machines, services are becoming increasingly relevant for customers.
Successful process and know-how transfer
Marcus Claassen emphasizes the fact that the training component is an important factor: "To expand in China as powerfully as we have planned, we need employees who are trained at an internationally competitive level. Anyone who operates a machine in Nantong should also be able to do so without any problems in Darmstadt, and vice versa." Thus employees from the Nantong factory were trained on site and at the competence center of Fette Compacting's Chinese subsidiary in Nanjing. Moreover, experienced operators from Germany are sharing their knowledge with their Chinese colleagues.
"This ensures that every operator receives high-quality, comprehensive training," emphasizes Jian Gong. In his capacity as a pharmaceutical engineer, he is responsible for the production process at Merck in Nantong. "Our aim is for all employees to know the critical process parameters and attain mastery of the machines," he explains. In this way, the company ensures that the pharmaceuticals from Nantong fulfill the highest standards of quality.
Reliable technology, simple operation
Another reason why Merck chose Fette Compacting was that the machines exhibit an extremely high level of performance and are easy to operate, Jian Gong explains, and demonstrates the humanmachine interface of a tablet press. "We can transfer all process parameters of the production in Darmstadt relatively easily. That makes many things easier for us." This also applies to the machines themselves, which offer numerous technical advantages: "Fette Compacting's segment technology simplifies mounting of the tools and enables us to clean them faster. Subsequently, this reduces product changeover time."
Fette Compacting will continue to support its customer even after commissioning.
"After the machine has been handed over, we rely on comprehensive after-sales service and quick onsite support," emphasizes Marcus Claassen. Fette Compacting's subsidiary in Nanjing - just 250 kilometers west of Nantong - was a convincing argument. The Schwarzenbek-based global market leader employs twelve specially qualified service technicians there and is available to Merck on very short notice.
This service capacity will be crucial when the entire facility goes into operation in 2018. Plans call for the factory to attain full capacity no later than 2021. Then ten billion tablets a year will be produced using the Fette Compacting presses and delivered to patients throughout China.