Recipharm and Syntegon upgrade GKF 2500 from one to three tablet stations.
The market for tablets filled into capsules has been growing for years. This dosage form is proving particularly advantageous due to its controlled dissolution behavior. Moreover, the capsules are easier for patients to take. The long-standing business partners Recipharm and Syntegon are breaking new ground for this type of product by upgrading a GKF 2500 capsule filling machine from one to three tablet stations – and are celebrating a successful premiere.
Tablets filled into capsules are enjoying increasing popularity in the pharmaceutical market. One of the reasons is that encapsulated tablets are much easier for patients to take. Some tablets could not be administered at all without the protective capsule because of their aggressive effect on the mucous membranes of the mouth and stomach. Pharmaceutical manufacturers avoid this problem by filling the coated tablets into a capsule that dissolves in a controlled manner after overcoming gastric juice resistance.
"The customer project was and still is a novelty in many respects."
Supervisor Mechanic at Recipharm
However, this trend confronts pharmaceutical producers as well as contract manufacturers with new challenges regarding their equipment. Recipharm was no exception when a customer approached the contract manufacturer with a very special request. He wanted Recipharm to fill three differently colored tablets of the same size into one capsule. "The customer project was and still is a novelty in many respects," explains André Trommer, Supervisor Mechanic at Recipharm. "We have never before filled several tablets into one capsule. We did not yet have the necessary machine in our production facility. So we had to come up with a solution that was technically feasible and has a small footprint."
Long-standing partnership breaking new ground
Recipharm (formerly Consort Medical) and Syntegon (formerly Bosch Packaging Technology) are old acquaintances and look back on a long business relationship. At its German locations in Zwickau, Monheim and Wasserburg, the contract manufacturer produces pharmaceutical products for customers all over the world. Syntegon's GKF machines have been in use here for over 30 years. The last one was put into operation at the beginning of 2017. It is a GKF 2500 ASB 100% capsule filling machine in the high-performance segment. The machine is equipped with an automatic trouble-shooting system (ASB) and a capsule weighing machine (KKE).
Recipharm has so far used the GKF 2500 mainly for pellets and powder products.
With an output of up to 150,000 capsules per hour, the capsule filling machine is suitable for powders, micro-dosing, pellets and liquids. The exact filling quantity is pressed into a capsule via a dosing disk before the integrated checkweigher examines each individual capsule and sorts out any that are incorrectly filled. Thanks to the modular design of the machine, products with changing parameters can be quickly processed and precisely dosed. Recipharm has so far used the GKF 2500 primarily for pellets and powder products. Moreover, Recipharm fills pellets in combination with a tablet using the existing tablet station and the retrofitted pellet station. The GKF 2500 is also suitable for filling tablets and micro-tablets into capsules – but up to now only with one tablet station.
All good things come in threes
When the new customer contacted Recipharm, Engineering Specialist Jens Muhsold soon realized that he wanted to give the existing GKF 2500 a try. "I have been working with the GKF platform for over a quarter of a century and still have great confidence in the quality and reliability of the machine and its manufacturer." Recipharm decided to realize the demanding project together with Syntegon and to upgrade the capsule filling machine for the new customer project.
"We needed a creative solution which, in addition to the filling itself, also took into account the limited space available on the machine," says Muhsold. "This project depends on the successful upgrade. Hence, the pressure on both us and our colleagues at Syntegon was very high. Flexibility was a priority throughout the entire project. And the Syntegon team truly demonstrated its flexibility."
DUAL CONTROL FOR QUALITY ASSURANCE
Although the three tablets contain different active ingredients, they are identical in size and weight. The only difference is their different colored coatings. It is therefore all the more important to ensure that only one of each tablet ends up in each capsule. The existing tablet station had already proven its worth in practice thanks to its reliable dosing process. Mechanical filling via a dosing disk makes sure that only the desired number of tablets reach the capsule base. In the unlikely event of a tablet getting stuck in the chute, the integrated gravimetric weighing cell automatically issues an alert.
To be entirely on the safe side, the identical weight of the tablets requires a further control stage. Since the space inside the capsule filling machine was already used up by the three tablet stations, the second step had to be transferred. The color inspection of the tablets is therefore not carried out on the GKF, but on the downstream blister machine (by the way, an older TLT 3060 from Bosch) by means of color recognition. "We also looked for the best possible solution for this step together – and found it by efficiently using an existing technology," says André Trommer.
Teamwork for flexible problem solving
In the meantime, extensive tests have confirmed the reliable and high quality of the dispensed capsules. In the future, Recipharm will be able to process capsule sizes 0 and 00 with different tablet sizes on each of the three tablet stations of the GKF 2500 capsule filling machine. What sounds simple in retrospect required a lot of courage and commitment from both sides within a short time. "The task was tricky because there were no parameters for comparison with previous projects. However, the tests proceeded without any problems. I am very satisfied with the technical implementation and the commitment of the entire service team," says Jens Muhsold.
The upgrade of the GKF 2500 from one to three tablet stations was a first for both Recipharm and Syntegon. Nevertheless, the project partners completed the conversion in around three weeks, during which time three Syntegon service technicians were on duty at the Zwickau plant. In this way, a specific customer inquiry turned into a challenging project with great future potential. Recipharm can now fill various tablets into capsules, and Syntegon can offer the right equipment for a growing market trend.