Novo Nordisk is a global healthcare company based in Denmark, with more than 90 years of expertise in diabetes care, bleeding and growth hormone-related disorders, and obesity. It markets products in more than 180 countries, with U.S. headquarters in Plainsboro, NJ.
At its Novo Nordisk Pharmaceutical Industries, Inc. facility in Clayton, NC, the production process includes product formulation, followed by aseptic filling of vials and cartridges, inspection and packaging. Novo Nordisk also assembles and packages prefilled insulin devices for the U.S. market. The Clayton site uses three complete filling lines for liquid pharmaceuticals from Bosch Packaging Technology. Injectable products are packaged and sealed on two cartridge lines and one vial line.
To ensure that their machines keep running smoothly, manufacturing companies count on regular maintenance intervals. Special Preventive Maintenance Kits further help to have all required spare parts available at the right intervals. By combining the pharmaceutical manufacturer’s application-oriented viewpoint with the experience of Bosch Packaging Services, the companies developed a tailor-made solution with a positive effect on the workflow.
Taking maintenance strategy one step further
Novo Nordisk’s vial filling line is equipped with a Bosch RRN 3084 vial washing machine, a HQL 3480 sterilization tunnel, a FSM 2700 filling machine and a VRK 4010 capping machine.
“In order to increase the lifespan of our machines and to improve their cost effectiveness, we execute regular maintenance shutdowns twice a year,” explains Jim Buckley, Novo Nordisk Reliability Engineer. During one of these shutdowns, the company started developing its own PM Kits for three key machines—washing, filling and capping—to take the company’s preventive maintenance strategy one step further.
When the Novo Nordisk engineers first contacted Bosch Packaging Services for support, the timing worked well as Bosch engineers had recently defined new PM Kits exactly for these machines. By combining the respective PM Kits and new maintenance intervals, the two partners were able to develop a highly efficient solution to meet the specific requirements of Novo Nordisk’s production processes.
“We regularly consulted the Bosch service experts during earlier shutdowns,” Buckley says. “They were always a great help in adjusting and improving our strategy. So it was only logical to count on the same expertise when defining the right sets of spare parts that need replacing on a regular basis.”
The RRN, FSM and VRK are complex machines with several moving parts, making continuous servicing crucial. Also, the RRN and the VRK were newer additions to the vial line, and the operators had little experience in maintaining the equipment. Several different sections had to be taken into account for each machine. The Bosch engineers focused not only on the visible parts but also suggested to regularly replace additional key components in the respective assemblies.
The VRK 4010 capping machine, for instance, requires regular changes of blades, the crimping wheels but also parts of the spinning stations or the drive component section.
“We effectively combined our engineers’ application-oriented point of view with the long-term technical expertise from Bosch to come up with a customized solution,” says Carrie Walker, Product Transfer Engineer at Novo Nordisk. The Bosch service team and the line engineers from Novo Nordisk met on-site several times to discuss different strategies and to refine the time intervals until they matched Novo Nordisk’s specific needs.
Defining new maintenance intervals
The PM Kits from Bosch usually consist of minor and major kits. Minor PM Kits comprise wear parts, which need replacing after a production interval of approximately 2,000 hours. Major PM Kits are designed for replacements after 4,000 hours. In comparison, Novo Nordisk’s maintenance concept originally envisioned three intervals of six, 12 and 24 months. The new jointly developed concept combines Bosch’s hour-based model with Novo’s idea of three exchange intervals.
The hourly-based schedule allows for parts to only be exchanged when they have performed the expected amount of hours, rather than parts replacement at a fixed date regardless of how long and often a machine has been in operation.
The newly arranged PM Kits now include parts that are replaced either after 2,000 (category A), 3,000 (category B) or 4,000 hours (category C). Category A comprises components that are susceptible to wear, such as washer bearings, which are constantly exposed to water. Category B is designed for parts with an intermediate susceptibility to wear, such as belts. Category C parts have a relatively long life-span and wear slowly like guides.
Savings in time and costs
The development of the three PM Kits with categories A, B and C was completed within a couple of weeks. Novo Nordisk already reports advantages of the new PM Kits.
“Having all required parts right at hand allows us to execute our shutdowns much more smoothly than before. We also need less manpower since we are better prepared and organized,” says Walker. “However we not only save time. We are also able to reduce costs, since we have a much better overview of what is needed at any moment and avoid unnecessary stocking.”
Describing the collaboration with Bosch as a “truly joint effort,” the Novo Nordisk engineers in Clayton are considering developing further PM Kits with Bosch for several machines used for their cartridge lines.