ICF N° 4 Settembre/Ottobre 2020 Supplemento

Machines
contaminated liquid is conveyed;
• ergonomic design for easy access to
all internal surfaces and to the work
areas in relation to the process performed
in them (possibility of performing
ergonomic tests on simulacrum
- mock up test);
• use of glove ports, of variable shape
and size, made of different materials,
suitable for easy replacement of the
gloves maintaining the integrity of
the system;
• use of gloves of different sizes and
materials in relation to operational
needs, the characteristics of the
washing solvents used and the product
to be handled;
• use of high efficiency filters of different
types (screwed, push-through,
push-push, bag in bag out), which
can be replaced in safe conditions for
the operator;
• prearrangement for the installation/integration
of product transfer
systems, process tools and discharge
of waste material (continuous liner,
RTP, split valve, etc.);
• appropriate instrumentation and
alarm signaling according to operational
and safety requirements;
• variously implementable control
systems; from the basic configurations
for controlling the internal negative
pressure regime and any interlocks,
up to the more sophisticated
solutions with PLC and GAMP 5 - CFR
21 compliant software;
• safety tests: leak test as per ISO
10648-2, helium test.
Nuova Guseo’s containment systems
are capable of combining the special
attention paid to the needs of
protection, with the high ergonomic
level for the operator, concepts
that characterize our configurations
in the various areas of application,
such as: loading and unloading of reactors
and filters dryers, centrifugal
discharge, laboratory analytical ac-
tivities, weighing and dispensing and
much more.
In this context the consolidated knowhow,
both in the milling and containment
sectors, has enabled Nuova Guseo
to fully understand the critical
process safety aspects and problems
related to the need to avoid environmental
contamination by managing a
milling process in a contained way,
offering to the market perfectly integrated
process solutions.
We pay now particular attention to
some examples of realized configurations
that combine this integrated
know-how in strict compliance with
current Good Manufacturing Practices,
and operating by important pharmaceutical
companies around the world.
Example of particular interest is represented
by a multi-chamber isolator,
for calibration and micronization activities,
configured for a containment
level in band 5 (OEB5).
The system consists of a material inlet
pre-chamber, a central chamber
where the jetmill (our model M200),
is housed connected with a screw
feeder in a wall mounted configuration
(motorization group outside the
working chamber), increasing in thus
the operating space within the same.
The central chamber is connected to
a double stage gas-solid separation
chamber, with a bag filter “octopus”
type in the upper section - equipped
with pneumatic shaking for an effective
product recovery action - and a
lower section, with a double continuous
liner system for the bagging and
outlet of the processed product, ensuring
the high containment performance
required.
The chambers work with different
negative pressure setting, and the
operating logic is highly automated
and managed by PLC, the isolator is
also inertized by nitrogen, with constant
monitoring of the oxygen content
present in the work chambers,
in compliance with the project's AT-
EX requirements.
An aspect of particular interest is represented
by the integration, in the
central chamber, of a second milling
device, a conical mill (our model
Conical Mill CM
100 and Jetmill
M200 in isolator
Multistage
isolator with
possibility
to install
a Jetmill M200
and M300
September/October 2020
RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 31