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
4
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
5
PREXIMA 300
6
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
7
IN-LINE CONFIGURATIONS
8
1. WITHOUT BUFFER, IN SAME ROOM RT = 0
9
2. WITH SINGLE BUFFER, IN SAME ROOM RT = x minutes
10
3. WITH MULTIPLE BUFFER, IN SAME ROOM RT = x minutes / hours
11
4. WITHOUT BUFFER, IN DIFFERENT ROOMS RT = x hours
12
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
13
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.
14
CONCLUSIONS
Manufacturing optimization depends on: • process parameters, • equipment configuration, • tablet and coating formulations.
15
Thank you for your attention
16