Extruder4M8-TriX

F o r m a t r i x

approved

scalability

w w w.pro cept.b eP a r t i c l e P r o c e s s i n g E q u i p m e n t

HOT MELT EXTRUSIONHot melt extrusion is a commonly applied continuous technology to fabricate amorphous solid dispersions of poorly soluble drugs to enhance the dissolution and the bioavailability. The API and the polymer melt together due to the high shear forces and elevated temperature in the barrel followed by complete homogenisation of the components through mixing and conveying stages. When the extrudate exits the die, it solidi�es suddenly providing no chance for the API to crystallize. The die can be a round hole (to create a stand) or thin �at line (to create a �lm). Further downstream processing (such a milling) is needed.

WET EXTRUSIONIn wet extrusion the API and powder excipients are mixed together with a liquid binder. The mas is extruded and discharged through a die with various holes to create stands, which are further processed to spheres in a spheroniser.

CONTINUOUS WET GRANULATIONIn continuous wet granulation powders and granulating liquid can be fed at di�erent parts. The powder and the liquid are sheared, homogenized and granulated due to high shear forces applied, especially at the kneading zones. With various processing and screw setups, the properties of the obtained granules can be modi�ed according to your needs.

CONTINUOUS MELT GRANULATIONMelt granulation is a solvent-free process that can be carried out on a twin-screw equipment in a continuous manner. In course of this process, the granulating agent is molten due to the elevated temperature and the shear forces. It �ows around the other particles and it forms aggregates when it solidi�es.

Introduction & Features

Process set-upThe Twin-Screw system

has 2 co-rotating screws driven by a high torque geared

servo motor. The screws have a nominal diameter of 16mm, with a ratio of 25 L/D.

The body has 5 ports for powder feeding / liquid feeding / degassing/venting and 4 individualy controlable heating zones

(with optional water cooling).

Process Batch capacity

Extrusion

Granulation

0.1 - 2.8 kg/h

0.3 - 3.0 kg/h

Min. batch

15 gram

20 gram

The ProCepT Twin-Screw Extruder module, developed in partnership with Q-Development, is designed to be used as an extruder or continuous granulator for small scale feasibility studies to small GMP production runs.

It is the ideal equipment for R&D and features:✓ Monitoring and control of all critical parameters✓ Easy cleanability and strip-down of components in minutes✓ Modular screw elements to customise screw con�gurations

ProCepT has more than 20 years of experience in designing small scale processing equipment and has acquired a large amount of processing knowledge. We o�er services such as contracting, medium term equipment rental, drying and formulation feasibility trials, as well as consulting and guidance in scale-up.

Di�erent screw elements allow to modify the screw set-up for di�erent applications

Extrusion die head with additional controlable heating zone and integrated product pressure and temperature sensor.

Set-up with granulation head

Chilled hopper for powder feeding

4M8-TriXF o r m a t r i x

Excel Control System

✓ 20” Touch panel PC✓ Monitor and control all critical

process parameters in a synopitc or table view

✓ Input of end-points: the process stops automatically if the time or parameter value exceeds the end-point

✓ Real-time trends on screen of all measurements

✓ Insert comments and notes to save with the batch report

Integrated datalogger generates a batch report that is saved onto the hard disk or directly to a network location.The batch report consists of 3 sheets:✓ Identi�cation sheet: data & time, operator,

batch description and comments✓ Data sheet: on this sheet, the raw data of

all parameters are registered every second and shown in columns

✓ Graph sheet: on this sheet, all parameters are visualised in a graph

QbD PROCESS CONTROL

EXCEL BATCH REPORTING

Modular Set-up

The Excel Control system with fanbox can be combined with other ProCepT process modules (such as Spray Dryer, Fluid Bed, Pan Coater) to save on lab space and total invest-ment costs. Extra processes can easily

be added at a later point in time for a phased investment.

ProCepT’s modular design allows us to provide full �exibility towards integrating the equipment in your laboratory.

The unit is available as a bench-top set-up, with a separate electrical cabinet and control module, or can be integrated in a trolley to wheel it in and out the lab and save space when not in use. ProCepT is also �exible towards customised designs if needed.

Move/place the individual modules according to your space. The Extruder module could be placed in a fume hood, while keeping the controls accessible for the operator.

Screw Speed

Screw Torque

Barrel Temperature Zone1

Barrel Temperature Zone2

Barrel Temperature Zone3

Barrel Temperature Zone4

Extrusion Die Temperature

Material Temperature

Material Pressure

Pump Speed

Balance (Dosed Liquid Weight)

Liquid Flow (30s average)

Feeder Speed

Cooling Circuit Temperature

Process Time

rpm

Nm

°C

°C

°C

°C

°C

°C

bar

rpm

g

g/min

rpm

°C

h:m:s

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Process Parameters(depending on options) Un

its

Setp

oint

Endp

oint

Disp

laye

d

HMI:Intuitive control via full colour graphical touch panel with various tab-pages

By simply copying the Excel �le to your PC, we o�er you maximum �exibility to process your data.

Choose for a dedicated electrical cabinet on wheels with integrated PC to wheel in/out the lab. Alternately the electrical cabinet can be positioned under your lab bench with a separate PC to control the Extruder.

Quality by Design

QbD

Optional CFR 21 PART 11 compliance with full traceability and reporting for clinical productions.

High Shear Granulator /Vacuum Dryer Module

Fluid BedModule

Pan CoaterModule

Central Module:Excel ControlAir Handling

Liquid Dosing

Spray DryerModule

ExtruderModule

Filter DryerModule

Industriepark Rosteyne 4, B-9060 Zelzate, BelgiumTel. +32 9 342 23 23 E-mail: sales@procept.be

Required Supply

Power Rating

Voltage

Cooling liquid (optional)

3000 Watt / 16 Amp

230 V, 50~60 Hz

water @ min. 1 bar

Technical Data

Dimensions

Speci�cations

Nominal Screw Diameter and Ratio

Capacity

Drive Load

Screw Speed

Torque

Heating Capacity

Control System

Interface

16 mm – 25 L/D

0.1 - 2.8 kg/h (HME) ; 0.3 - 3.0 kg/h (TSG)

740W servo geared drive

5 - 900 rpm

2x35 Nm

4 x 400 Watt + 200 Watt (at die) – up to 250 °C

20” Touch Flat Panel PC with Windows 10

USB & LAN connections

w w w.pro cept.b e

513 mm

227 m

m

405 m

m

405 m

m

330 m

m

829 mm176 mm

Table top version (without electrical cabinet)