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Cleaning validation of manufacturing
equipment involved in pharmaceutical production is an essential
factor in GMP. However, it requires complicated and laborious processes
such as sampling from the equipment, sample pretreatment, analysis
of the compound concerned, and evaluation of the residue amount.
Setting the threshold values, which have to be determined taking
into consideration various factors such as the effective amount
and dosage of the medicine, the size of the production batch, and
the size of the equipment, is also a difficult procedure. The Co-Sense
CV is an HPLC application system addressing this demand. The unique
system configuration and special software dramatically enhance
the efficiency of cleaning validation by automatically conducting
all processes from sample concentration to analysis and data processing.
A column-switching technique is used to concentrate the target
component within the sample onto the concentration column, then
send it to the analysis column for separation and detection. Complex
sample pretreatment is therefore unnecessary, as the target component
is concentrated from a large amount of sample, even a trace amount
of component can be detected with high sensitivity.
The target component is concentrated while diluting the sample
by any desired rate, assuring creation of a clear peak, as well
as a high recovery rate regardless of the type of the sample solvent
used for extraction (patent pending).
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for NMR & CoSense for MS |
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While LC-NMR and LC-MS are useful analytical
methods, for the structural analysis of compounds, the conditions
most often used for HPLC are not optimum for NMR or MS. For that
reason, analysis of samples in a complex matrix require cumbersome
procedures involving initial separation-purification using HPLC,
followed by desalting and other processes before NMR/MS analysis
can be performed.
Co-Sense LC-NMR / LC-MS is an automated sample pretreatment system
designed to facilitate the processing of complex samples and augment
the efficiency of NMR and MS measurements. HPLC column-switching
technology is used to separate, purify and concentrate target compounds,
and perform desalting and solvent replacement. This eliminates
the bother and expense of performing such operations manually.
Further, the separation of target compounds using HPLC is not limited
by NMR and MS restrictions, allowing HPLC parameter selection as
desired.
System is designed for LC-NMR and LC-MS sample preparation. After
a semi-preparative or analytical separation the peaks can be collected
and pre-concentrated on a trap column to reach the necessary concentration
for an NMR analysis. The expansive D²-solvents will be used
only in the last step, when the samples are re-eluted after trapping.
Full automation allow online or offline measurements and can reduce
the time for manual preparation.
For LCMS use the separation can be done with typical high concentrated
buffers, the solvents will be exchanged direct before the LCMS
inlet. Especially if LCMS is not the standard method and is asked
to confirm the results of other techniques this could be an alternative,
because validated methods are not need to change.
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Co-Sense for BA features the dilution
bypass added in the sample introduction flow channel leading to
the MAYI pretreatment columns. Different type of MAYI columns enable
to use this approach for various type of components. This dilution
bypass eliminates the need for preliminary dilution of the sample
by automatically diluting it on-line. Use of a buffer solution
as the sample introduction mobile phase or adding a small amount
of organic solvent to it ensures effective trapping and concentration
of even drugs with a high rate of protein binding, leading to highly
efficient deproteinisation and a high recovery rate. Thus, direct
injection of unprocessed blood plasma or blood serum has become
possible.
HPLC is widely employed in the analysis of drugs within bio-samples.
Conditions of the sample pretreatment, as well as chromatographic
conditions, are important factors that significantly affect the
accuracy and sensitivity of the analysis. Co-Sense for BA, with
its unique configuration comprised of the newly developed MAYI-ODS
on-line SPE column and the on-line dilution flow channel, automatically
and seamlessly conducts all processes from sample pretreatment
to analysis. On-line pretreatment of bio-samples such as blood
serum or plasma will remarkably enhance the efficiency, as well
as reduce the labor, of the analysis.
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Functioning as a module of LCsolution software, LCMSsolution provides
complete access to the analytical power of the mass spectrometer,
without compromising its ease of use as an LC detector. Truly integrated
chromatogram and spectral processing, with a powerful quantification
package and unsurpassed flexibility in reporting; operating in
a true 32 bit environment.
Excellent wizards guide the unaccustomed user through all aspects
of instrument and sample set up. Alternatively the experienced
user can rapidly access all necessary parameters directly. Innovative ‘browser'
software gives rapid and effective access to multiple data files
in either qualitative or quantitative screening applications.
For the multi-user environment there is full and effective control
of user rights via password protection, simple data export and
comprehensive audit trailing (with the optional Class Agent software
package).
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Sample Clean Up
