Wiewelhove GmbH has been a contract manufacturer of solid oral dosage forms for more than 15 years, processing plant-based and synthetic active ingredients. Established in 1976, the family business has developed into an international contract manufacturer of pharmaceuticals, homeopathic products, and dietary and vitamin supplements. With two production sites and a laboratory in Ibbenbüren, Germany, the company has a range of machines suited for all common manufacturing processes for solids and uses the Syntegon Technology GKF series including the GKF 400, GKF 700, and GKF 2000 capsule filling machines. When Wiewelhove decided to expand its production capacity to accommodate large batches with a high unit count, it decided to add another GKF machine. Rainer Wibbelmann, technical director at Wiewelhove, said, "We can look back on good experience with the company and their machines, which have been running reliably for many years at our sites. After some market research, we quickly realized that we again wanted a GFK.”
Training, a successful strategy
Both the number of machines and employees is increasing at Wiewelhove. In addition to its long-standing workforce, Wiewelhove relies on young talent who must be trained before operating the machines - making training and education a top priority. "When we order new machines, training sessions held by our supplier are part of our requirements specification," Wibbelmann said. "Our operators need to become experts so that they can use all the machines’ advantages for our production – and ultimately for our customers. In turn, we must give them the opportunity to ask questions before new machines are put into operation. Only then will they feel comfortable with the technology and look forward to using it."
Employees were trained in two three-day training sessions on the new GKF 2600 capsule filling machine at the equipment provider’s site in Waiblingen. Production staff learned how to start-up and prepare the machine for production runs and how to perform format changeovers. Calibration, troubleshooting, and maintenance were also part of the in-depth training, and, since the training sessions took place two weeks before the Factory Acceptance Test (FAT), there was time to submit requests for changes. "During the FAT, we took over a machine that met our requirements down to the smallest detail," Wibbelmann said.
It’s the little things that count
The most important change affected the scanning station of the GKF 2600. With the machine knowledge already acquired before the FAT, Wiewelhove opted for a single-capsule scanning system. In combination with the "no cap, no fill" feature and an automatic error clearance, Wiewelhove now has increased operational reliability that saves both product and empty capsules. Wiewelhove also suggested replacing the metal slide used to adjust the suction with a plastic one, which is easier to clean and makes for gentler handling.
"Any potential for optimization that we address at the supplier’s site is much easier to implement," Wibbelmann said. The training sessions and the discussions also provided interesting insights for Syntegon Technology. For example, some of the suggestions from Wiewelhove could be incorporated into the standard version of the GKF 2600. "In the end, it’s the small things that make the difference between good and great," Wibbelmann said. "We really enjoyed and benefitted from working on constructive solutions together."
Flexible and reliable
Since production started in August 2018, the company has been able to take full advantage of the new capsule filling machine. Its high filling flexibility makes it possible to fill different capsule sizes from 1 to 00 elongated, such as longer capsules of the same diameter, which can be processed on the GKF 2600 without separate format parts. The patented slidegate technology reduces scatter loss, which is important for critical products that should not get into the machine interior. In addition to the standard features, Wiewelhove has the option of adding a KKE capsule checkweigher for 100% in-process control. The GKF 2600 can also be upgraded for micro-tablets.
The compact capsule filling platform GKF 2600 was developed for the high-performance range. It is cGMP-compliant and fulfills the various requirements of the pharmaceutical industry. Wiewelhove achieves an output of more than 110,000 capsules per hour with capsule size 00. The flexible capsule filling machine can be adapted to different products in a short time with its accessibility and the extended machine platform. Rapid format changes and easy changeovers with a plug-in system minimize standby times and machine downtime.
Well-positioned for the future
Technological highlights and cooperation during the project were both key for Wiewelhove. "The entire process, from initial discussions and on-site appointments to training and adjustments, through to installation and implementation was very target-oriented and well structured," said Lars Peters, head of the capsule filling department at Wiewelhove. For the contract manufacturer, the new machine is "the logical extension of the GKF 2000 range." It facilitates product transfer and can also be used as a back-up for the slightly older GKF 2000.
The most important innovation of the new capsule filling machine is that powders and pellets can be filled on a single dosing station. "We observe a trend in pellet filling that we couldn’t have responded to so far,” said Peters. With the new machine, we are well prepared for future requirements…We want to expand our capacities and ability to fill pellets into capsules to compensate for bottlenecks and quickly respond to new customer inquiries.”