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Continuous Manufacturing to believe in.
Continuous Manufacturing underpins the improvement of pharmaceutical products in terms of potency, effectiveness and safety by means of accurate process control.
IMA’s way to Continuous Manufacturing
IMA Active is now ready for the paradigm shift in pharmaceutical manufacturing and taking the lead in the future of pharmaceutical technologies for OSD forms.
IMA Active’s belief in and knowledge of Continuous Manufacturing have grown stronger thanks to intensive R&D work carried out on two fronts.
CONTINUOUS FLOW OF BENEFITS
Quality
- QbD approach bringing reduced time for quality control and test release.
- Reduced risk of human errors due to a high level of automation.
Flexibility
- Batch size and production volumes are defined by runtime. No more constraints due to equipment size.
- Flexibility in process flow thanks to modularity of the Continuous Pharmaceutical Manufacturing operations.
- CM unit operations are compact, designed with standard connections and minimum utilities, conceived for easy and quick installation to replicate in any manufacturing site worldwide with a short startup time.
Sustainability
- Reduced plant footprint which means smaller equipment, no more need of work-in-process inventory, less personnel, with consequent space and energy savings.
- Lower environmental impact through reduced utility consumption.
- Reduced process surface to clean: less water consumption.
- Less risk of drug shortage thanks to reduced time to market.
Costs
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Important contribution for reducing costs includes smaller equipment and fewer manufacturing steps, with consequent saving for installation, validation and maintenance. In addition, rapid development, improved yields, less personnel achieve overall estimated cost reduction range from 30% to 50%, with impact on drugs affordability as well.
Safety
- Patient safety is ensured by adoption of QbD and PAT (Process Analytical Technologies). Minimum risk to fall OOS (Out of Specifications).
- Operator safety provided by lower risk of exposure means reduction of PPE.
- Operators are better protected since product handling, process space and air displacement are significantly reduced.
Efficiency
- Shorter time to market due to quicker product and process development, minimization of process scale-up.
- Significant increase in productivity and improvement of OEE generated by:
– Faster production time, also by minimizing product handling.
– Reduction of waste and losses.
– Quicker changeover due to minimum downtime.
THE CONTINUOUS SCENARIO
Based on more than 50 years’ process experience, IMA Active would like to involve you and rapidly illustrate the benefits of continuous processing. IMA Active contributes to making Continuous Manufacturing available for all and not just for a small elite of pharmaceutical manufacturers.
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Continuous direct compression
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CDC with continuous coating
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CONTINUOUS DIRECT ENCAPSULATION
CDC is a very lean, efficient and flexible tableting technology that, in combination with PAT, allows easy adoption of a QbD approach. CDC provides excellent operation performance; the system is designed to achieve a state of control very quickly and avoid any waste during startup and shutdown phases.
A CDC line has a lean configuration which promotes smooth product flow, consisting of unit operations to configure a set of feeders (up to 6 units), horizontal mixer, press for continuous tableting and integrated control system. All the parts of a CDC line are dimensioned according to a required production throughput. Average throughput recommended for pharmaceutical manufacturing is in the range 20-100 kg/h.
Continuous coating is a further manufacturing step that can be considered either straight inline or as a separate and subsequent step with regard to CDC.
CROMA coater has been specifically designed to provide a truly continuous coating technology. It can work downstream from a tablet press or a capsule filler. ACCELA CTC continuous coaters by Thomas Processing complete the IMA Active range of continuous coating equipment, particularly suited to very high throughputs or large batches.
IMA Active capsule fillers with all their hallmarks in dosing and weight controls are particularly suitable for being prime unit operations of a processing manufacturing line. All the benefits of Continuous Manufacturing are gained by reducing the overall complexity of the product lifecycle and by decreasing the number of process variables.
Hardshell capsules are the preferred choice for packing a simple blend of powders with no other intermediate steps.
Academy
IMA Active has been cultivating its own knowledge and is ready to welcome the demand for innovation, working together with companies and stakeholders to design the future of pharmaceutical manufacturing.