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Performance
Specifications
TechniKrom® Adaptive P.A.T.™ BufSolvent and Buffer Mixing Module
Control Software Description
Comprehensive LC Skid System IQ/OQ Validation Documentation
Delivery
Warranty and Technical Support
 
HPLC systems with exceptional process control and reproducibility
Adaptive PAT to monitor, correct and deliver incoming feed streams to within 0.1% accuracy
Accurate solvent blending for isocratic, step & linear gradients on any scale
Flow rates from 25 ml to 250 liter/min
 
 

Performance
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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.


Specifications
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Typical High Pressure LC System Specifications:
MAX. FLOW:
specified by user (up to 50L/min)
MAX. PRESSURE:
1000 PSI (optional 1500 PSI or 2000 PSI)
BUFFER/SOLVENT INLETS:
4 (additional as needed)
GRADIENT:
from 2 buffers/solvents (additional as needed)
OUTLETS:
5 (additional as needed)
SPACE REQUIRED
(H x W x L)
~6.5'H x ~3'W x ~6'L (larger skids for larger flow rates)
POWER REQUIRED:
3-phase 480V (also available 208V)
POWER CONSUMPTION:
2.0 kW (up to 20 kW for largest systems)
COMPRESSED AIR SUPPLY:
Minimum 70 PSI
A preparative benchtop HPLC system is also available.

TechniKrom® Adaptive P.A.T.™ Solvent and Buffer Mixing Module
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.

Control Software Description
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All software is designed, developed and tested in accordance with GAMP4 guidelines to ensure the highest system quality.

Comprehensive LC Skid System IQ/OQ Validation Documentation
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.

Delivery
We pride ourselves on the fastest delivery times in the industry.

Warranty and Technical Support
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.