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In terms of quality control, you can’t get
more state-of-the-art than a fibre-optics-based
spectrometer to analyse solids and liquids. ABB
has some illuminating facts about its
range of process analysers.
Process Analytical Technology (PAT) monitoring
and
control (PAT) is one of the key enabling elements
of the
concept of quality by design (QBD), introduced
by the
FDA to improve quality insurance and control in
pharmaceuticals
manufacture. Within that framework, Fourier transform
nearinfrared
(FT-NIR) analysers such as the FTPA2000-260PH
have
rapidly found their place as essential components
of the PAT
toolkit, mainly due to their flexibility and reliability.
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ABB’s
FTPA analyser: a fibre-optics-based spectrometer |
This type of analyser is a fibre-optics-based
process spectrometer that can be interfaced to
a wide range of sampling accessories, including
flow-through cells or insertion probes for analysis
of solids and liquids.
From its early R&D stages, this analyser
allows the user to
screen a large number of chemical or physical
properties of
a formulation. This enables you to identify the
critical process
attributes (CQAs) and to understand their relationship
to critical
process parameters (CPPs). Applications developed
at
laboratory or pilot scale can then be scaled up
to manufacture,
thanks to ABB’s stringent manufacturing standards
and
reproducibility specifications, which make all
these types of
analyser virtual clones of each other.
Multi-purpose spectrometer
This analyser is ideally suited to performing
real-time monitoring
of pharmaceutical and biopharmaceutical processes.
It is also
ideal for unit operations, such fermentation,
downstream
purification, crystallisation, lyophilisation,
distillation, drying,
granulation, extrusion, blending or milling. Thanks
to the
accuracy, speed and superior repeatability of
the FT-NIR
technology, users can substitute this process
analyser for their
traditional methods based on final-stage quarantine
and laboratory
testing. It also eliminates safety risks associated
with operators’
exposure to potent compounds during manual sample
extraction.
A remarkable feature of the analyser is that
it can be connected to up to eight sampling points
to parallel-monitor multiple operations. Engineering
requirements for process implementation are minimised,
as the spectrometer can be located in a general
purpose area isolated from the process and hazardous
areas.
Also, the outstanding
signal-to-noise
performance of the
analyser allows it to
transfer optical
signals through fibre
optics over distances
of up to 80 metres –
even more for liquid
applications.
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Real-time
monitoring of CQA during a drying process |
The most current sampling interfaces are insertion
probes which can easily be adapted to the manufacturing
process vessel. Optional features, including integrated
temperature sensor, automated retraction and self-cleaning
capability or optical window purge, can be implemented
if required for unattended operations. The FT-NIR
measurement technique is intrinsically safe and
totally nondestructive.
The integration of spectral records over multiple
scans in a dynamic process ensures that the CQA
values
(updated typically every 30 seconds) are measured
over
representative samples and therefore extremely
reliable.
The main benefit of this spectrometer as a PAT
tool is that it
performs real-time detection of the process end
point and
therefore contributes to reducing cycle time for
batch operations.
It also enables development of innovative pharmaceutical
manufacturing strategies based on continuous processes.
Control strategies
Additionally, users benefit from the sensitivity
of the FT-NIR
technology with respect to chemical and physical
variations in
the sample matrix. This allows process engineers
to develop
control strategies based on objective diagnostics
that can flag
in real-time abnormal process conditions and help
identify their
root causes. Connection of the analyser to plant
IT and control
systems is straightforward, as it supports industry-standard
communication protocols (OPC, Modbus, CANopen).
In summary, ABB’s process analyser enables
reduction and
potential elimination of out-of-specification
products, reduction
of costs and production cycle times (sometimes
exceeding
30%), identification of relevant process and product
performance attributes, elimination of potential
product
degradation, avoidance of recalls and improvement
in product
quality homogeneity. It also provides a closer
insight into batch
or continuous processes to pharmaceutical manufacturers.
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