In low bulk densities, inadequate flowing properties and the risk of segregation of the mixture tabletting machines have difficulties to press high-quality tablets required in the pharmaceutical industry. To press these mixtures, dry granulation technology is needed to adjust the material behaviour to a natural flow, higher bulk density and reduce the tendency of segregation.
The drive of the pharmaceutical industry goes to continuous manufacturing. Gerteis has been the prime supplier for dry granulation for more than three decades, giving the company distinct process expertise and the knowledge that no other competitor has. GlobalData sat down with Hartmut vom Bey and Christoph Schnitzer of Gerteis to discuss the company’s contribution to dry granulation systems for the pharmaceutical industry.
VS: What are your company’s latest innovations in dry granulation technology?
HvB: We are currently implementing a new process analytical technology called “PAT software” into our roller compactor, which enables us to measure and determine the hardness of the ribbon online. That is one of the key features we have, and we overhauled the whole machine to provide the latest hardware platform in terms of computers, drives and software. We also integrated a new control system in terms of the process itself. For example, it is helpful to minimise the product you are going to use for small-scale trials.
VS: What gives Gerteis the advantage over other companies in dry granulation systems? What do you have that no other company can offer?
HvB: I think it’s the overall combination of many things. We have a unique device solely produced for dry granulation. Our machine is much more accurate than any other, and we have very extensive process know-how. We go beyond the role of a machine supplier by providing assistance in pharmaceutical development, including supporting fundamental process and hardware problems in production.
CS: Our machine is adjusted to the needs of dry granulation in the pharmaceutical industry. It is very sensitive towards the powder’s characteristics. The advantage we have compared to other companies is that we directly develop our machines in dedication to this and cooperation with the industry.
HvB: An example: A newly developed product in oncology costs up to thousands of dollars in raw materials only. Imagine a batch would fail simply because of a poor machine design! That’s not an option! If you damage a product like this, you destroy a value higher than your whole machine is worth and patients might suffer from medication shortage. Having said that it is obvious to us that the appliance must be sensitive and very well controlled.
VS: Why does dry granulation get more and more important in the pharmaceutical space?
HvB: Dry granulation is a very economical process. Traditionally there was wet granulation, a reasonably time-consuming process, especially towards needed resources. Beside the huge footprint many fluids are needed. Also, the cost of ownership is high compared to dry granulation or roller compaction. In roller compaction also fewer process parameters need to be considered. Roller compaction is a continuous process. As long as the machine is fed with powder granules are produced. And that with a compact machine layout, a small number of needed utilities and a future-proofed machine design.
VS: Can you tell me more about the pharmaceutical dry granulation process?
HvB: Our customers often have the problem that particle flowability of their powders is not good. Consequently, the tablet presses or capsule fillers cannot be fed in a constant way. Besides they have segregation tendencies. With our machine, you feed this flow product into our roller compactor. We densify it, and after densification, it will be milled. This means you a get better product flow, one that is not segregating, out of a product with poor flow properties. After compacting the produced granules flow better and can be fed into the next processes – the tablet press. There they ensure a more economical tablet with fewer rejects and fewer tasks, more throughput, and fewer variations in the quality.
VS: Do you have any new dry granulation products in the pipeline? What’s next for Gerteis in regard to dry granulation technology?
HvB: We are continuously improving the whole roller compaction technology, creating a platform model offering more flexibility in the future. Because the demands of our customers vary more and more. This means they have fluctuating demand of capacities, are driven for containment, or request very quick changeovers. We understand their needs and are developing our portfolio accordingly.
