Continuous Manufacturing is nowadays one of the main drivers of innovation in the pharmaceutical industry. Strongly encouraged by the regulatory authorities for drug production, Continuous Manufacturing can ensure flexible and efficient production, while improving the pharmaceutical products in terms of potency, effectiveness and safety.
Adopting a continuous process is a philosophical choice, the practicalities of which can play out in a number of ways. Some companies focus on total innovation; others rethink consolidated processes, aiming for reduced production time and lower costs. IMA has taken steps towards Continuous Manufacturing by adopting both ways: firstly through its collaboration with CONTINUUS Pharmaceuticals, secondly through the IMA Active Research and Development team.
CONTINUUS Pharmaceuticals is a spin-out of Boston MIT that operates in the development and implementation of continuous processes using new technologies. The aim at CONTINUUS is to produce a final dosage form with optimal therapeutic properties since its early production phases, and even including API synthesis. This approach is highly innovative: achieving results will be a long-term investment and will require the development of a modular technological platform for application to any product.
In the meanwhile, IMA Active is working on the continuous process by rethinking current technologies, embracing a concept of Continuous Manufacturing more closely related to conventional solid forms. This initiative aims primarily at taking to the market continuous equipment that can be integrated with conventional technologies, in order to improve the manufacturing performance of new or existing drugs.
When it comes to technologies for solid oral form production, IMA Active has chosen to start with the tablet coating process because it comes between two intrinsically continuous processes already managed by IMA machines: tablet pressing and packaging. CROMA, the new continuous tablet coating equipment, is sized to work downstream of a medium-speed tablet press.
Truly continuous. CROMA is designed to work in a truly continuous mode. The product flows continuously throughout the modules, with no steps. The breakthrough of CROMA lies in the product movement: both the design of the drum and the position of the mixing baffles provide motion to the minimum unit of product, thus keeping its flowing under control. Start and stop procedures are optimised to maximise Overall Equipment Effectiveness.
Modular by design. Modularity is the hallmark of the project. CROMA can be fitted with up to four coating modules, that can be connected either in series for higher weight gain or in parallel for higher throughput. Each module can be adjusted to work with different process parameters and can perform different processes, if required. The result is maximum flexibility in terms of machine configurations and process performance.
Compact by design. CROMA is designed to maximise accessibility. The perforated drum of each module is fully accessible once the side panels are removed, thus allowing easy inspection and cleaning. Its compact design takes inspiration from Rationalism, whose essential principle was the search for functionality by means of new construction techniques and new materials.
Towards Pharma 4.0. CROMA is developed addressing the Industry 4.0 topic. Fitted with highly innovative technologies for process monitoring and control, CROMA delivers coated tablets with specific, consistent properties. Real-time monitoring employs a combination of process parameter trends, measurements by PAT tools and sources of process analytical data that can facilitate decision-making and follow-up action.