Hands off!
The pressure is on to do more with less. Whether
this applies to increased workload
with lower headcount or more analytical tests
with fewer milligrams of sample, how can
today’s pharmaceutical and biopharma companies
make ends meet? Joanne Ratcliff of
Mettler Toledo has the answers.
The way to free up your business and improve
its efficiency
is by automating the tedious, repetitive laboratory
processes to allow chemists and analysts more
precious
time to concentrate on higher-value tasks.
Weighing out powders or liquids to prepare samples
and
standards for analytical methods such as HPLC
can be a timeconsuming
task with a high risk of error. The trend of recent
years has shown that automated analysis systems
are getting
faster, safer and more precise. With the advent
of quicker analytical
methods, such as Ultra High Performance Liquid
Chromatography
(UHPLC), and rapid advances in software developments
providing
faster data processing, attention is once again
focused on
sample preparation as the bottleneck in the process.
Manual
sample and standard preparations are still influencing
the daily
routine in the laboratories.
In a recent survey, groups including method development,
stability testing, formulation and quality control
all identified the
manual preparation of samples and standards as
the most timeconsuming
and error-prone part of their procedure.
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Old-school
prep; in contrast, automation speeds some
tasks by 25%. |
The preparation of a solution is a demanding
process that takes some time. Imprecise sample
preparations lead to Out-of- Specification (OoS)
results and can cause time and cost-intensive
analyses of the variation. Challenges or errors
can stem from inaccurate weighing, loss of substance
in transfer from weighing paper to flask, and
documentation, tracking and labelling of samples.
Due to the minimum weight range of balances typically
not allowing the required concentration to be
made up directly, serial dilutions with volumetric
flasks potentially compound any errors. Variability
and OoS results in analytical testing of active
pharmaceutical ingredients (APIs) are still at
the top of the list of critical issues registered
by the regulatory inspectorates.
Implementing automated powder and liquid dosing
into the
sample preparation workflow can bring massive
gains in speed,
safety and savings. The amount of time and money
spent on OoS
investigations and inconclusive results can be
reduced by
eliminating errors in weighing and sample preparation.
Multi-component standards
A good example is the preparation of multi-component
standards.
Using manual weighing, the risk of overshoot of
each individual
component weighing and potential loss of valuable
material if a
mistake is made on the final component is too
high. So substances
tend to be weighed into a weighing paper and transferred
into the
volumetric flask one at a time rather than all
weighed directly into
the target vessel. This gives an additional area
of doubt: is the
amount of the weighed substance correct or did
we lose some
material while transferring it to the vessel?
A simple example of the preparation of a multi-component
standard demonstrates the advantages of using
the Quantos QB1-L automated powder-dosing system
equipped with a liquiddosing head. A five-component
mixture was prepared in a single vial per concentration
level. The five compounds were all weighed into
the same vial at different target weights.
Linearity tests were performed by UHPLC measurement
at five
different concentrations. The correlation coefficient
is greater than
0.999 for all analytes and the intercept is close
to zero. A fivecomponent
standard plus the diluent can be prepared by this
automated method in 10 minutes.
An analyst at Dionex Corporation, a specialist
organisation in
chromatography, compared the time taken for the
manual
preparation of these five multi-component standards
of three to
four hours with the automated preparation of these
samples, which
was less than one hour including filling the five
dosing heads used.
This simple example nicely illustrates the time
savings that can
be made by automation: multi-component standards
prepared in
25% of the time, while delivering high-quality
data and, more
importantly, reducing the error risk involved
in sample preparation.
The future
Improved performance in analytical processes is
only possible by
improvements in the critical steps – sampling,
sample preparation,
weighing, sample clean-up and dilution.
Repetitive tasks such as weighing and preparing
samples for
method development and method validation can be
performed
four times faster with automation than with traditional
manual
techniques. Automating the sample preparation
steps significantly
improves the precision of the process.
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