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CREATE OR ADJUST EXTREMELY ACCURATE BUFFER FEEDS FOR LC, UF/DF,
FERMENTATION AND FORMULATION
PROTEIN IN-LINE PH ADJUSTMENT (E.G., POST VIRAL INACTIVATION
STEPS)
TechniKrom®
provides lab/pilot to full commercial scale automated buffer
dilution units utilizing the same sanitary cGMP platform and
technology base as our Bioprocess LC and UF/DF system skids.
They can accommodate both manual and
fully automated operation. They are designed, built and tested
in accordance with ISPE GAMP-4, ASME-BPE, UL, and ATEX (EU)
guidelines.
Each buffer dilution unit is custom
designed with multiple sanitary inlet and outlet ports. This
permits easy connection with multiple feeds, whether from
portable vessels or installed tanks.
Our portable systems prepare, adjust
and deliver very precise and reproducible buffer feed streams
with an accuracy of +/-0.1% of full scale monitoring. This
reduces variability by a factor of 20-50X over traditional
means.
Used as stand alone units to adaptively
dilute buffer concentrates on demand, they eliminate the need
for large tanks of multiple dilute buffer feeds. The units
can also be used in conjunction with existing large tank systems
and protocols to provide point of use adjustment and precise
control of dilute buffer feeds.
Units can be customized for rapid
pH adjustment of product streams, for example in the case
of post viral inactivation steps. This will minimize protein
degradation and permit operation using a more controlled cGMP
production scale approach.
Built on a 316L stainless steel platform,
they are manufactured with the highest level of validated
sanitary design. They include individually PIN stamped components,
boroscoped piping welds, customer-specified process control
systems (Delta V, ABB, Allen Bradley). Footprints are minimized
and flow rates range from 250ml/min to 250L/min.
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