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Printer friendly HPLC systems brochure
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TechniKrom provides automated medium and high pressure liquid
chromatography systems, with modular designs for cGMP purifications.
They use on-line adaptive monitoring and feedback to reduce
costs and time to market.
TechniKrom's solvent blending utilizes
real time analysis of 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.
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 316L electro-polished piping, and
FDA approved materials for product contact are standard.
TechniKrom's
LC equipment meets the highest levels of cGMP Pharmaceutical
processing requirements. This includes +/- 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.
This overview is meant to illustrate the operating range and
the engineering capabilities of TechniKrom.
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High Pressure LC System Specifications: |
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MAX. FLOW:
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specified by user (up to 50L/min)
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MAX. PRESSURE:
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1000 PSI (optional 1500 PSI or 2000
PSI)
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BUFFER/SOLVENT INLETS:
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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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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
larger flow rates)
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POWER REQUIRED:
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3-phase 480V (also available 208V)
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POWER CONSUMPTION:
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2.0 kW (up to 20 kW for largest systems)
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COMPRESSED AIR SUPPLY:
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Minimum 70 PSI
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A preparative benchtop
HPLC system is also available.
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TechniKrom®'s adaptive process
analytical technology 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.
An automated bypass prevents incorrect mobile phase from reaching
the 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.
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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