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Prexima and Croma, integrated technologies for Continuous Manufacturing

October 2018


CROMA

Presented at Achema 2018, Croma is IMA Active’s first step towards a more comprehensive vision of Continuous Manufacturing.

TRULY CONTINUOUS • MODULAR • COMPACT • EASY INSPECTION • PROCESS CONTROL 2


CROMA Based on a traditional coating system: cores mixing through perforated drum rotation, coating distribution through spray guns, hot air drying system.

Throughput designed so that the machine can be integrated in-line with a tablet press, enabling a continuous production of coated tablets. 3


PREXIMA SERIES • Isolation of the processing area • Optimized lubrication • Quick turret removal • Excellent accessibility • Low noise level • Robust structure • XIMA HMI for enhanced usability

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PREXIMA SERIES

Min. throughput (tablets 50mg 5mm diameter)

Max. throughput (tablets 1,500mg 20mm diameter)

Prexima 80

2 kg/h

59 kg/h

Prexima 300

6 kg/h

195 kg/h

Prexima 800

20 kg/h

620 kg/h

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PREXIMA 300

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CORE RELAXATION TABLET CORE RELAXATION: dimensional and hardness changes after compression. RT: TIME TO REACH STABILITY 1. RT = 0 2. RT = x minutes 3. RT = x hours

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IN-LINE CONFIGURATIONS

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1. WITHOUT BUFFER, IN SAME ROOM RT = 0

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2. WITH SINGLE BUFFER, IN SAME ROOM RT = x minutes

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3. WITH MULTIPLE BUFFER, IN SAME ROOM RT = x minutes / hours

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4. WITHOUT BUFFER, IN DIFFERENT ROOMS RT = x hours

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CASE STUDY AIM OF THE STUDY Given a formulation which causes core relaxation, evaluate the time to reach stability (RT) considering the temperature variation between compression and coating. MATERIALS • Prexima 300 tablet press machine. • 550mg weight, 5.5 mm height, 17x7 oblong tablets.

FORMULATION Component

Load (%)

Pre-gelatinized Starch (Starch 1500, Colorcon)

49.9

Microcrystalline Cellulose PH102 (Vivapur, JRS)

49.5

Ferric oxyde (red colorant) Sodium Stearyl Fumarate (PRUV, JRS) Total

0.1 0.5 100

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CASE STUDY CONCLUSIONS The heat treatment depends on: • time • temperature • heat cycle (shock vs. gradual) The study shows the influence of these variables on tablet RT and dimensions.

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CONCLUSIONS

Manufacturing optimization depends on: • process parameters, • equipment configuration, • tablet and coating formulations.

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Thank you for your attention

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Nicola Gandolfi of IMA S.p.A Proxima and Croma, integrated technologies for Continuous Manufacturin  
Nicola Gandolfi of IMA S.p.A Proxima and Croma, integrated technologies for Continuous Manufacturin  
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