reinvented

reinvented
Continuous
Manufacturing
reinvented

For more than a decade, Continuous Manufacturing has been trying

to make its entrance in the industry of Oral Solid Dosage production.
Acceptance and adoption of this new way of manufacturing tablets
and capsules is progressing very slowly. This is due to several
significant entrance hurdles, inherently related to the specific
technical solutions offered so far by other OEMs and system integra-
tors: highly customized and large installations requiring high invest-
ment cost for both equipment and infrastructure, high com­p lexity
requiring extensive scientific know-how and expensive skilled
personnel, and last but not least lack of flexibility for multi-product
manufacturing operations.

As the world’s leading supplier of tablet compression technology,

Fette Compacting is now offering a revolutionary new simple and
compact solution for Continuous Direct Compression, which wipes
away these hurdles, making Continuous Manufacturing accessible
and economically justifiable for any size company in the pharma­
ceutical and nutraceutical industry.

Starting from a Quality-by-Design (QbD) approach, Fette Compacting

has re-invented Continuous Manufacturing by re-thinking and
re-designing every unit operation, as well as their integration into
a compact standardized machine design. This has resulted in several
revolutionary design improvements:
– linear arrangement of Loss-in-weight (LIW) feeders instead
of typical circular set-up
– full separation between the process area and the technical area
of the machine
– n ovel blender design featuring two in-line independent mixing
zones and multiple inlet ports
– fully embedded Process Analytical Technology (ePAT), including
Near-infrared spectroscopy (NIRS)
– c ompact design allowing one-floor arrangement

The FE CPS – Continuous Processing System – is the industry’s new

state-of-the-art solution for continuous dosing and blending of raw
materials, including conveying and delivering the high-quality blend
to any downstream powder processing equipment. When combined
with a Fette Compacting tablet press, the result is a Continuous
Direct Compression line with unique advantages in terms of invest-
ment requirements, product quality, production efficiency and
operator safety.

FE CPS 2|3
Reinvented again
in seven areas Blend conveying

ePAT, Process analysis

(embedded Process Analytical Technology)

Modular Compact Generic Containment

Offering maximal flexibility – Allowing one-floor set-up in Suitable for a wide range of Inherently closed double-barrier
both in set-up (installation) and existing production facilities formulations and operational machine design, offering
use (application) throughputs maximal operator safety
 Raw material

Automatic Refill Systems (ARS)

Loss-in-weight (LIW) feeder

Funnel Configuration

Blending

Fast changeover Embedded PAT (ePAT) TRI.EASY

Full product changeover and Machine, process and quality Easy to set-up, operate
cleaning in one shift control integrated in one and maintain, one terminal
single controller, including NIR for all processes
spectroscopy for blend
uniformity and 100 % tablet
assay analysis

FE CPS 4|5
Modular, offering maximal flexibility
in use and installation set-up

The modular design of the FE CPS makes it extremely versatile –

both in terms of its installation in a production facility, and its
application in a wide range of manufacturing processes.

The FE CPS continuous dosing and blending unit can be integrated

with any type of downstream powder processing equipment, such
as a tablet press, capsule filler or granulation equipment. It can also
be used in a stand-alone mode, producing a high-quality dry powder
blend, being fed into an Intermediate Bulk Container (IBC) or a
sachet-filling machine.

The FE CPS can be installed on the same level as the downstream

process equipment, resulting in a horizontal set-up of the line.
In such a single-floor set-up, a special conveying device performs
the blend transfer without any risk for segregation. The line can be
installed in one single room (1-floor/1-room set-up) or in two
adjacent rooms (1-floor/2-room set-up), offering maximal flexibility
for installation in an existing tablet manufacturing facility.

Alternatively, the FE CPS can be installed above the powder

processing machine, resulting in a vertical set-up of the line.
In such a two-level set-up the powder transfer is achieved solely
by gravity.

The integration of the FE CPS with a tablet press results in a

Continuous Direct Compression line. The FE55 by Fette Compacting
is the preferred tablet compression machine for this purpose
because of its process versatility, having three consecutive compres-
sion stations, and its high output.

Modular – flexible in installation:

vertical or horizontal set-up
 FE CPS used in stand alone configuration:
Producing a high-quality dry blend

Horizontal set-up
FE CPS connected with tablet press or capsule filling machine:
Continuous Direct Compression line

FE CPS 6|7
Compact, allowing one-floor
set-up in existing facilities

The FE CPS is an extremely compact unit that fits in a standard

pharmaceutical production room.

Its footprint is significantly smaller than any competitive system as

no operator platforms and stairs are required to access the unit for
routine operations and maintenance.

Furthermore, the height of the unit allows for the docking of various
raw material charging devices within the height of a standard tablet
compression room.

Even in horizontal connection with downstream equipment, the size

is so compact that it also can fit into a standard room.

Thanks to its compact dimensions and its extreme flexibility of

installation, the FE CPS can be installed in most existing tablet
production facilities. Additionally the installation of the machine
is extremely easy and fast as the unit only needs to be placed
in its room and utilities connected. Investment cost in facilities and
installation are therefore reduced to an absolute minimum.

Alternatively, in case of greenfield projects, the compact and

modular design allows to reduce the dimensions of the clean rooms
significantly, leading to major savings in both Capex and Opex.

Conventional set-up vs. FE CPS

 2650 mm

2290 mm
1450 mm
Compact dimension

FE CPS 8|9
Generic, maximal
processing flexibility

From the early development phases of the FE CPS onwards,

a Quality-by-Design (QbD) approach was used which enabled
Fette C­ ompacting to design a flexible dosing-blending-
conveying module that is robust towards handling a wide variety
of ingredients and formulations at versatile throughputs
(i.e. 10–200 kg/h).

A standardized, generic machine and process design for the

FE CPS was derived from the same philosophy as a tablet press.
By exchanging a minimal amount of format parts and recipe
parameters, the FE CPS is rapidly tailored to optimally process
any formulation:
– v arious sets of twin-screws for optimal LIW-feeding
performance over all throughput ranges
– m ultiple funnel configurations to connect each ingredient
infeed stream to its optimal blender inlet port
– p ossibility for combining both high-shear and low-shear
mixing within a single blender Different formulation, uniform powder flow –
through ultrasonic
The generic design of the FE CPS allows applications in both
production and R&D-environments. A fast changeover to
R&D-mode allows operation of the FE CPS for gaining product
and process understanding in the multiple stages of product
formulation development:
– s cientific testing of individual unit-operations & formulations
– e fficient execution of design-of-experiments (DOE) by
embedded features and functionalities

Multiple funnel configurations

Two-zone blender: possibility to blend with high shear
and low shear in defined zones

Process understanding

Process QbD Design

control Quality by Design

Scientific knowledge

Various sets of twin screws FE CPS development:

realized with a QbD approach

FE CPS 10 | 11
Containment
Operator Safety

The FE CPS is characterized by a revolutionary novel machine

design, offering unmatched advantages in terms of compactness,
accessibility and process flexibility, but also in terms of product
containment and operator safety.

In order to achieve this, a radically different approach was chosen

whereby the Loss-in-weight (LIW) feeders are installed in a line as
opposed to the conventional circular set-up. This linear set-up of the
feeders allows them to be installed through a stainless steel wall,
creating and separating a process area and a technical area within
the machine.

The LIW feeders have a quick-release design whereby the product

contact parts can easily and without tools be detached from the
technical part, containing the loadcell, drives and controller. The
product contact part is located in the process area, while the
technical part is located in the technical area.

The same concept is applied to the other unit operations, such as

the Automatic Refill Systems (ARS) and the continuous blender: all
product contact parts are located in the process area and are easily
removable from the unit. All support elements, drives, sensors and
controls are located in the technical area, in the back of the
machine.

The process area is located in the front of the machine and contains
all product contact parts. It is isolated from the technical area of the
machine by the separation wall and from the outside of the FE CPS
machine by two large sealed doors. The process area is kept under
a controlled negative pressure.

All unit operations (ARS, LIW feeder, blender) are dust-closed by

design and have dust-tight interconnections using bellows. This is
the first powder containment barrier. The isolated process area
forms the second barrier. This inherently closed double-barrier
machine design offers maximal operator safety during machine
operation.

The technical area of the FE CPS contains all actuators, motors,

sensors, valves, load cells, electrical and pneumatic components
and generally all parts which cannot be exposed to the product. The
technical area is easily accessible from the back of the machine and
allows for technical inspection or maintenance work. This can even
be done without opening the process area of the machine, allowing
technical personnel to do troubleshooting without breaking the
product containment.
 Process area Technical area

Separation between process area

and technical area

Isolated process area: containing all

product contact parts

FE CPS 12 | 13
Fast changeover,
full product changeover
and cleaning in one shift

The specific FE CPS design makes product changeover and cleaning

of the unit extremely easy and fast:
– T he product contact parts of all unit operations are designed
to be lightweight and quickly detached from their support in the
process area.
– T he total number of removable elements is limited and can easily
be transferred to a washing room for further disassembly and
off-line washing.
– T he remaining empty process area is widely accessible, compact
and has smooth walls, making cleaning extremely easy.

The components to be removed from the process area are:

– A utomatic Refill Systems (ARS)
– Q uick-release part of the LIW feeders
– F unnel configuration
– B lender
– B lend conveyor inlet hopper

Each of the components can be dismantled without tools and is

designed such that one person can remove and install the parts in
an ergonomic way.

The specific machine design and cleaning concept allows a full

cleaning and product changeover of the FE CPS by one person
in one shift. All removable components can be duplicated as
a fast changeover set. When using such FCO set, the off-line
component cleaning can be done while the FE CPS is operational
again, reducing the changeover time further still.

As the FE CPS is the only system on the market for continuous

dosing and blending with a truly fast and easy product changeover
capability, its integration in a production line finally makes efficient
multi-product continuous manufacturing of OSDs possible.
 All product contact parts are easily
removable from process area

Front doors rotating 270 degrees –

offering maximum accessability and minimal
footprint

FE CPS 14 | 15
Embedded Process
Analytical Technology,
ePAT

Whether the FE CPS is operated in stand-alone mode or as part Product tracking

of a Continuous Direct Compression line, one single control system – R eal-time Line Product Tracking (LPT) running on the embedded
performs all machine, process and quality control functions. The controller
control system architecture consists of one high-speed embedded – L PT used as basis for lot genealogy including cGMP compliant
controller and an industrial PC for HMI, including central recipe reporting
management and reporting. This simple hardware architecture, – R ejection of out-of-spec material using the tablet press slow gate
combined with 100% proprietary software from Fette Compacting, for bulk rejection and fast gate for single-tablet rejection
significantly reduces the system’s validation requirements and
results in a robust, reliable control system. Virtual PAT
The use of a high-speed embedded controller with integrated
Process Analytical Technology is fully embedded in the control spectroscopic sensors makes all sensor data and process control
system: parameters available in real time and synchronized in one central
CPU. Together with LPT, this allows the combination of any of these
NIR spectroscopy data to calculate various prediction models in real time, predicting
– In-line product quality monitoring using embedded spectroscopic various Critical Quality Attributes (CQA’s).
sensors, i.e. sensor spectrometers are directly connected to the
machine’s embedded controller Advanced Process Control
– N IR-Blend measurement using an active measurement head, Accurate line product tracking combined with virtual and embedded
available at various positions: blender outlet, tablet press infeed spectroscopic PAT allows the development and implementation of
or inside the feed frame (Fill-O-Matic, FOM) optimized formulation specific control strategies, keeping all CQA’s
– N IR tablet measurement (CU) during tablet ejection on the die within tight control limits, resulting in minimal product loss and
table enables 100% inspection of all tablets, including the rejection maximal patient safety.
of individual tablets that do not meet the specifications
– M VA/chemometrics classification/quantification prediction engine
running on the embedded controller; full access to all supported
models of this engine via the offline model builder
– PAT method management is integrated in the central product
recipe management
– C omplete system, including PAT method management, is cGMP
compliant
– Industrial robust execution
– M ES OPC interface for partial PAT method management and
retrieval of prediction values

The NIR technology helps reduce batch-release time

and costs.
 ePAT sensors available in multiple
measurement positions

NIR spectroscopic sensor for blend uniformity

and content uniformity measurement

FE CPS 16 | 17
TRI.EASY, easy set-up,
operation and maintainance

One important hurdle for the industry-wide adoption of Continuous

Manufacturing is the high complexity of the technical solutions
offered by equipment suppliers. This leads to time-consuming
validation processes and the need for highly skilled and specialized
personnel.

Fette Compacting set itself the goal to develop a simple standard-

ized solution, which can be easily set-up, operated and maintained
by experienced personnel, available in any tablet manufacturing
operation.

Process engineers can set up the FE CPS using a very similar

approach as for a tablet press: by selecting only a few format parts
and optimizing unit operation parameters, the FE CPS covers a wide
range of different formulations and throughputs.

Tablet press operators can start-up, run, stop, disassemble, clean

and changeover the FE CPS also in a fashion very similar to that
used for a tablet press, while technical personnel can easily perform
the necessary calibration and maintenance tasks by accessing the
FE CPS from the technical area in the back of the machine.
The new user interface offers a quick overview of the
The FE CPS represents the full embodiment of TRI.EASY: optimal parameters of the entire continuous process.
set-up, operation and maintenance.
Technical Data

145 Max: 2690

450

Min: 1740
Max: 2540

2353
2290
Min: 1040

1190 2650 1190

1425
1495

1200

Throughput capacity 10 ~ 200 kg/h (formulation and tablet dependent)

Number of dosing stations 2 to 6

Number of blender mixing zones 2

Feeder-blender funnel configuration Various configurations – formulation dependent

Ingredient characteristics Powder density: 0.2 ~ 0.8 kg/l *

Ingredient inlets DN150 tri-clamp connection

Main connection ratings Operating voltage 400–480 V, frequency 50/60 Hz ±5%

Voltage supply 3-phase + PE

Power 6 kW

Compressed air supply 6 bar / 300 l/min peak volume flow

Air extraction rate 200 m 3/h

Air extraction negative pressure – 0.2 hPa

Air extraction unit connection 70 mm

Dimension Machine height: 2,300 mm, Ingredient inlet: 2,355 mm

Total height including blend conveyor arm: 3,000 mm

Weight approx. 5,000 – 5,500 kg **

In the interest of further development, subject to technical alterations.

* Assumption of typical values, others on request
** Depending on exact configuration

FE CPS 18 | 19
© by Fette Compacting GmbH

220819 E
This publication may not be reprinted in whole or part without our express
permission. All right reserved. No rights may be derived from any errors in
content or from typographical or typesetting errors. Diagrams, features and
dimensions represent the current status on the date of issue of this leaflet.
We reserve the right to make technical changes. The visual appearance of
the products may not necessarily correspond to the actual appearance in all
cases or in every detail.

Fette Compacting GmbH Fette Compacting Machinery India Fette Compacting Belgium BVBA
Grabauer Strasse 24 Private Limited Schaliënhoevedreef 1b
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