Imas New Concept for Continuous Manufacturing

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IMA S.p.A. - IMA ACTIVE division

IMA INDUSTRIES S.R.L Unipersonale

Truly Continuous

Croma is designed to work in a truly continuous mode. The product flows continuously throughout the modules, with no steps. The breakthrough 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 optimized to maximize 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.

Additional Information

In demand at Ima Product Manager Guia Bertuzzi

Direct Compression will prevail?

? Why does Ima rely on direct compression as a technological basis for its continuous manufacturing?

Guia Bertuzzi: We see as a crucial goal in the implementation of a continuous manufacturing process not necessarily a high output volume, but a lean and consistent production, which guarantees a continuous quality control of the product instead of testing them only at the end of the process. We are talking about flexible technology that meets the needs of the market. Depending on the portfolio, pharmaceutical companies produce around the clock in three shifts with correspondingly high levels of automation, or they need high flexibility and short set-up times for frequently changing small batches. The second scenario will be enabled by direct compression. Therefore, the main objective of our initiative is the rapid market introduction of a complete direct compression process line for manufacturing solid dosage forms in a continuous way.

? At the moment, however, the lion's share of all OSDs is produced by wet granulation.

Bertuzzi: It is certainly true that at the moment, 60 percent of all solid oral forms require a wet granulation process—typically a batch process, while only ten percent are produced by direct compression. We are focusing on a future, where direct compression represents 70 percent of all processes, with 20 percent wet granulation and ten percent dry granulation.

Compact by Design

Croma is designed to maximize 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.

Croma is developed addressing the Industry 4.0 topic. Fitted with highly innovative technologies for process monitoring and control, the machine 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.

An integrated control system is required to make the whole process work according to a Quality by Design approach. To foster this approach, Ima Active creates innovation by packaging together all the needed competences: Process Engineering, Equipment Design, Process Control and Process Analytical Technology.

To be closer to the end-users, understand and match their needs, Ima Active R&D team gathers people having different backgrounds: Engineers, Designers, Software Specialists, but also Pharmacists, Chemists, Physicists, experts in Statistics and Chemometrics. Only a multidisciplinary approach can generate effective technologies for the future of pharmaceutical manufacturing.

* * The author is Product Manager at Ima, Ozzano dell'Emilia/Italia. Contact: Phone +39-051-651-4927

(ID:45215084)

Continuous manufacturing

Imas New Concept for Continuous Manufacturing

Truly Continuous

Modular by Design

Compact by Design