FETTE Isolator

High Containment for the

Complete Tableting Process
Extremely Low OEL Figures

Leitz Metalworking Technology Group

 High containment through
the integration of all
production components
The innovative advantages Your benefits

■ Extremely low OEL* levels ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ■ Best and safest operator protection

■ No escaping dust ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ■ Does not need to be housed in special rooms

■ Air management with FETTE ABSOLUT filter

system ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ➜ ■ Monitored, closed safety system

■ Defined cleanliness after washing ➜➜➜➜➜➜ ■ No special safety precautions are required

■ Cost-oriented standard solution ➜ ➜ ➜ ➜ ➜ ➜ ➜ ■ Economical and easy to use

■ All necessary peripheral devices are integrated ➜ ■ Pragmatic solution for many applications

■ Special design protected to IP 65 ➜➜➜➜➜➜ ■ Peripheral devices fully cleaned at the same time

■ Very short change over intervals ➜ ➜ ➜ ➜ ➜ ➜ ➜ ■ Maximum availability of the total system

*Occupational Exposure Limit

Dust escaping when handling highly active
products on tablet presses can result in heavy
contamination of the workplace. Operator
safety plays a very important role, and OEL
figures must be kept low. Economic aspects
then become very important, as safe
implementations can be expensive.
At FETTE we have used our
skills, as the technological
leader in tablet presses, to
tackle the problem, and have
developed an approach that
offers an ideal solution to Care about health is complex. Tableting technology
is our contribution. FETTE COMPACTING.

both sides of the equation.

A standard system is now available in the form of
FETTE isolators, working in combination with
FETTE WiP containment presses. Expensive indi-
vidual systems – in particular those involving the
structure of the building – become unnecessary.
The closed system, with its own cleaning and
filtering equipment, is implemented as a total solu- 3

tion, combining maximum economy through fast

product change over with maximum safety
achieved through extremely low OEL.
 Economic application for
maximum safety

Complete containment from one source

■ The isolator as an important element in the

FETTE containment solution
– precisely tailored properties
■ A guaranteed OEL of 0.1 µg/m3 averaged over
8 hours of production
– a lower OEL can be achieved with certain
products
■ The WiP Center supplies all the washing equip-
ment in the press, in the isolators and the peri-
4
pheral units they contain
– no manipulations from outside are needed for
washing
■ Air management for all the air flowing in the
unit, which operates under partial vacuum
– high safety provided by filtering the exhaust
air through a FETTE ABSOLUT filter unit
All necessary peripheral
devices are integrated

Standard solution – individually adapted

■ 3 peripheral devices can be used, covering the

majority of standard requirements
– VERTICAL DEDUSTER for dust removal and
de-burring tablets
– METALCHECK to monitor the manufactured
tablets for metal contamination
– CHECKMASTER to monitor the weight,
thickness, hardness and diameter
■ Mountings for other laboratory devices such as
– friability tester
– scales
– FETTE WEIGHTMASTER
■ Quality and performance of the highest stan-
dard
– for processing the highest possible produc-
5
tion quantities
■ Other FETTE peripherals or devices wanted by
the customer meeting protection class IP 65
can be used as an alternative
– maximum flexibility
– manual suction hose and spray gun option-
ally available
 Secure connections to other
components

Contamination-free, easily released

connections

■ The press is connected to the isolator through a

Rapid Transfer Port (RTP) integrated into the
window flap of the tablet press
– total safety through closed airlock principle
– tablet outlet encapsulated in association with
the isolator
– additional safety, as there is no contact with
the product
■ The connection from the isolator to the tablet
container can optionally be made through a
contamination-free isolation valve system
– complete sealing of the entire system

Adapted transport system

■ Connection of multiple isolators implemented

through a venturi system
– venturi system transports tablet by air flow
– contamination-free transport of the tablets for
examination to the next isolator
– venturi system is only active when the corre-
sponding gate operates
■ Secure tablet discharge through the fully enclo-
sed transfer of the tablets between the isolator
and the container
– efficient docking system for contamination-
free container filling

6
Safe operation of all
equipment

Manual intervention through optional glove ports

■ Glove ports integrated into both window flaps

– contamination-free work at the isolator
– access to the entire interior space of the
isolator
– safe access, close to the working area
■ Ergonomic design, multiple ports
– the whole interior can be reached
■ Double seals on the gloves
– contamination-free glove exchange is facili-
tated
■ Functionality of the glove ports
– the glove is integrated between an inner and
outer cover in the window flap
– the outer cover is opened by means of a hinge
– the glove is located between the covers; the
inner cover is removed and placed inside the
isolator
– when leaving, the inner cover is closed with the
glove from outside

Optional Rapid Transfer Port for tools and

sample collection

■ Material lock implemented as RTP

– tools are passed in and out through the airlock
without contamination
■ Samples taken through material lock
– taking samples without contamination is
facilitated
■ Easily handled material lock
– safe operation through positive-lock mecha-
nism
7
■ RTP as double-flap transfer system, with
mechanical locking in the flap handle
– protection from unintentional opening
– opening not possible without flange-fitted
BETA-part
 Functional design down
to the smallest detail

Carefully thought-out construction

■ Design tailored for the tablet presses

– high-quality, long-lasting materials and fittings
■ Parts that contact the product made of stainless
steel
– no corrosion, with smooth surfaces
(Ra < 0.3 µm)
■ Constructed according to ergonomic principles
– optimum operation

Design details for perfect function

■ Mounted on roller bearings

– easy transport
■ Large window flaps
– the whole of the interior is easily seen and
reached
■ Monitored window flap locking
– function monitored by the controller
■ Glove ports on both sides
– direct access to the whole interior is possible
■ Edges and corners with large radii
– easier cleaning, no accumulation of soiling in
the corners
■ Operation and monitoring at the press terminal
– no need to find space for another operating
terminal
– simple, clear overview
– operation consistent with the tablet press
– specific diagnostic messages for the isolators
■ All pipe connections are orbitally welded
– no slots or cracks in which product can accu-
mulate
8
– easily clean, smooth surfaces without welding
occlusions
■ Washing water provided by the WiP Center via a
multi-way diaphragm valve and two single valves
Important details for reliable washability

■ Horizontal surfaces avoided through run-off

slopes
– no standing water
■ Complete emptying of the pipe system
– no hidden residues
■ Easy release of all connections
– secure handling with no risk of damaging the
gloves
■ Double seals on the window flaps
– static and dynamic, for ideal sealing against
water and dust
■ Seals close only against fixed surfaces
– secure closure guaranteed
■ Washing procedure integrated into the automatic
controller
– washing programs can be stored for different
products
■ 6 separate, controllable washing circuits
– 4 individual washing circuits for the isolator
interior
– an optional washing circuit for the spray gun
– an optional washing circuit for the isolation
valve system
– optimum, product-specific spraying and rinsing
through a large number of rotary and fan nozz-
les inside the isolator

Rotary and fan nozzles for complete washability

■ Specially developed washing nozzles

– all corners and surfaces thoroughly and
effectively reached
■ Nozzle form and direction adapted to positioning
9
– flushing the entire interior
 WiP Containment Presses
and WiP Center

Available equipment

■ FETTE 3090 WiP Containment double rotary press

– high-productivity machine for medium to large
batches
– double-layer pressing
■ FETTE 2090 WiP Containment single rotary press
– high-productivity machine for medium batches
– single-layer pressing
■ FETTE WiP Center
– adapted cleaning unit for supplying the press
and isolators with water and cleaning agents

Various isolator versions available

■ Isolator 1 contains vertical deduster with metal-

checking unit
■ Isolator 2 contains only the in-process control
■ Isolator 3 contains vertical deduster with metal-
checking unit and in-process control

Technical data Isolator 1 Isolator 2 Isolator 3

Dimensions W x H x D mm 1710 x 2100 x 1140 1710 x 2100 x 1140 1710 x 2100 x 1140
Working area W x H x D mm 1600 x 1500 x 990 1600 x 1500 x 990 1600 x 1500 x 990
Weight of isolator (empty) kg 900 900 900
Weight of vertical deduster +
metal check unit kg 350 - 350
Weight IP 65 CM kg - 35 35
Operating voltage AC/V 115-230 115-230 115-230
Power consumption (approx.) kW 0.5 0.5 0.5
Pressure connection for 9 mmØ pipe bar 6 6 6
Maximum bar 9 9 9
Flow rate (minimum) dm3/s 5 5 5
Water supply (hot/cold/purified)
to WiP Center R 3/4” (20 mmØ) bar 2-4 2-4 2-4
Water pressure dm3/s 1-1.76 1-1.76 1-1.76
Water outset connection (minimum) Ø mm/” 50/2 50/2 50/2
Cold water temperature (max.) °C/°F 40/104 40/104 40/104
10
Hot water temperature (recommended) °C/°F 60/140 60/140 60/140
Maximum °C/°F 80/176 80/176 80/176
Purified water temperature (recommended) °C/°F 60/140 60/140 60/140
Maximum °C/°F 80/176 80/176 80/176
Ambient conditions
Relative air humidity % 5-95 5-95 5-95
Temperature °C/°F 35/41-95 35/41-95 35/41-95

Because of the technical progress we reserve the right of alteration.

Floor plan - 2090 as example

11
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Leitz Metalworking Technology Group