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Printer Friendly Version of Bioprocess Systems Brochure
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TechniKrom
provides automated Bioprocess chromatography systems, with
modular, sanitary designs for cGMP purifications, synthesis
and fermentation. They use on-line adaptive monitoring and
feedback to reduce costs and time to market.
TechniKrom's buffer blending utilizes
real time analysis of buffer and solvent blends to create
the most accurate and reproducible feed delivery possible
in the world today (within 0.1% accuracy of full scale measurement).
The equipment is configured for multi-product
use with automated CIP and flexible software, although it
is easily dedicated for single product use. A rugged industrial
platform minimizes downtime and maintenance, and fully integrates
all functions into a single system.
All analog signals, e.g. pressure,
UV, NIR, conductivity, pH, temperature and flow rate, are
monitored and automatically compiled into customizable batch
reports.
In depth IQ/OQ procedures are performed
and fully documented by TechniKrom prior to delivery enabling
rapid start-up and final IQ/OQ/PQ.
The 21 CFR part 11 compliant control
software operates at the highest level of compliance with
complete audit trail and security features.
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Designed and built by TechniKrom in Chicago, these
systems meet U.S. codes including NEC, UL, ASME, ASME-BPE
and FDA and are designed, built and tested using the latest
industry standards such as ISPE GAMP-4 guidelines for automated
systems. Explosion Proof equipment for use in Class 1, Division
1 or Division 2 EX areas is provided. ASME compliant fabrication
for vessels, columns and piping, boroscopically inspected
orbital welded sanitary 316L electro-polished piping, and
FDA approved materials for product contact are standard.
TechniKrom's BioProcess
LC equipment meets the highest levels of cGMP Biopharmaceutical
processing requirements. This includes a sanitary design,
+/- 0.1% full scale accurate/reproducible buffer and/or solvent
blending (isocratic and gradient), strict 21CFR11 capability,
pre-delivery IQ/OQ, UL approval, Gamp-4 validated software,
and EXP options.
All TechniKrom's systems
are custom built exactly in accordance to the specifications
that your engineers and end-users in collaboration with our
engineers. The overview below is meant to illustrate the operating
range and the engineering capabilities of TechniKrom. Contact
us to discuss specific requirements or custom options that
you may require.
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| Typical
BioProcess LC System Specifications: |
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MAX. FLOW:
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specified by user (200 mL/min up to
250L/min)
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MAX. PRESSURE:
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up to 300 PSI
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BUFFER INLETS:
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typically 4 (additional as needed)
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GRADIENT:
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from 2 buffers/solvents (additional
as needed)
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OUTLETS:
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typically 5 (additional as needed)
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SPACE REQUIRED (H x W x L)
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~6.5'H x ~3'W x ~6'L (larger skids for
higher flow rates)
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POWER REQUIRED:
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3-phase 480V (also available 208V and
120V)
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POWER CONSUMPTION:
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2.0 kW (up to 5 kW for largest systems)
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COMPRESSED AIR SUPPLY:
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Minimum 70 PSI
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Two benchtop Bioprocess Pilot scale
systems are also available; one with a maximum flow rate of
500 ml/min and one with a maximum flow rate of 1 L/min.
TechniKrom's adaptive process analytical
technology sanitary controlled blending module permits the
most accurate (to within 0.1% of full scale) and reproducible
(to within 0.1% variation) in-line dilution of concentrated
buffers for isocratic, step gradient and linear gradient applications.
Incoming buffers/solvents must be supplied at consistent pressure
and flow rate. An automated bypass prevents incorrect mobile
phase from reaching the LC column. Pre-column conductivity
or NIR sensor provides real-time analysis of blended mobile
phase with feedback for maximum reproducibility and accuracy.
This feature alone can reduce process costs by several thousands
of dollars per batch.
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All software is designed, developed
and tested in accordance with GAMP4 guidelines to ensure the
highest system quality.
This industry leading comprehensive
system IQ/OQ package (6 binders) documents the detailed quality
assurance procedures performed by TechniKrom during the fabrication
and in-depth testing performed on your system.
We pride ourselves on the fastest delivery
times in the industry.
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One year extendable warranty, service contracts and 24 hour
response time in the United States means peace of mind and
quick support when you need it.
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TechniKrom® Adaptive P.A.T.TM
Buffer Mixing Module