A pressure on innovation and costs shifts Continuous Manufacturing into the focus of the pharmaceutical industry: where possible, all production steps are to be linked.
Continuous Manufacturing refers to the production of drug products in a continuous production chain with machines which are directly connected to each other. As an alternative to conventional batch processes, it offers technical and economical processing advantages. As the Continuous Manufacturing systems are smaller than batch equipment, the user saves on cost-intensive clean room space and does not require any storage space for interim products thanks to the continuous flow of materials.
Furthermore, with continuous production, the size of the batches can be customized to the available running time of the machines. Another advantage is the fast market launch of new products, because the same machine is used for development and production. Time-to-Market is, for pharmaceutical manufacturers, often the most important determining factor for the success of a product.
There are also advantages in terms of product quality and safety: “Feeding the powder from the mixer directly into the tablet press dispenses with qualityreducing factors such as vibrations during transport which can lead to segregation,” explains Dr. Marten Klukkert, Manager Technology Center at Fette Compacting.
Demands on machine construction
Many regulatory authorities also support this comprehensive and safe approach to production. To combine financial and regulatory incentives, manufacturers produce oral solid dosages (OSD) more and more frequently by Continuous Manufacturing.
Developing new solutions for Continuous Manufacturing is always based on two initial questions: How can the various production steps be linked seamlessly? And how can consistently high product quality be guaranteed and monitored in this process? “Ultimately, it comes down to collaboration across the various areas of competence,” replies Klukkert. “
First step: direct compression
This is the approach pursued by Fette Compacting along with its Excellence United Partner Glatt. Together, these two companies offer manufacturing lines for the continuous production of tablets. On these lines, powder is dispensed, mixed, granulated where necessary and finally added to the tablet press.
Customers mostly prefer the “direct compression” configuration. In this set-up, powder is directly led from the blender into the tablet press without any granulation. Efficiency and quality of the final product are paramount to deciding how the tablet press is integrated into the process.
Fette Compacting and Glatt partnered their process experts during development, e.g. for establishing comprehensive control concepts. What’s more, many employees in both companies also cooperate in the areas of Sales and Research & Development, as well as, provide advice on formulation, PAT concepts or cleaning cycles within the line. And last but not least, joint tests are conducted in the Technology Centers at Fette Compacting and Glatt. Klukkert explains:
“This is where our cooperation with Glatt comes in: we offer our customers pooled expertise and have turnkey solutions for continuous production which have already been tried and tested in practice – in the high quality they expect from us.”