TechniKrom provides technologically advanced Processing Equipment, Products and Services to the Biopharmaceutical, Pharmaceutical, Veterinary, and Nutraceutical Industries that permit the lowest cost of production and highest innate product quality, especially in cGMP regulated environments. We help our clients implement true Manufacturing Science in their facilities to enable their achievement of these goals.

TechniKrom designs and manufactures a full line of Process Equipment that includes Liquid Chromatography Columns and Systems, SMB columns and systems, UF/DF systems, BioSynthesizers (dna, ma, peptide), Flow-Through Reactor Columns, and Bioreactors (fermentors). We apply Failure Mode Effect Analysis (FMEA) in agreement with the FDA directive for risk-based management in order to identify and eliminate equipment and process related sources of product variability that reduce quality and raise costs. TechniKromŽ Bioprocess equipment is built in the U.S.A. in accordance with ISPE GAMP-4, ASME, ASME-BPE, NEC, UL and FDA guidelines requirements, as well as European (ATEX) codes.

TechniKromŽ equipment is designed for cGMP operation with a combination of industrial hardware, EXP ratings, CIP sanitary designs, and robust, operator-friendly 21 CFR part 11 fully capable software. Our design philosophy is to address cGMP process scale requirements and then "down-scale" to the pilot and laboratory scale, rather than the opposite. The portability and modularity of the equipment permits flexible facility layouts that minimize the required floor space and make expansion and relocation easy. TechniKrom's experienced engineers and scientists provide on-site start-up, training, validation and troubleshooting. As part of its full service capability, TechniKrom's process scientists also develop and optimize process methods, and perform contract purifications in cGMP or GLP environments.

TechniKrom follows manufacturing procedures and policies (S.O.P.P.'s) to ensure the highest level of quality assurance. This also allows us to complete and document the industry's most comprehensive pre-delivery equipment IQ/OQ validation package.

Technikrom Process Systems
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TechniKrom provides automated Process Chromatography (HPLC, MPLC, LPLC) systems, with modular, low dead volume designs for cGMP purifications. They use our patent pending on-line adaptive monitoring and feedback to reduce costs and time to market.

TechniKrom's reagent 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). This technology is referred to as Technikrom's Adaptive PAT Process Control.

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 sanitary 316L electro-polished piping, and FDA approved materials for product contact are standard.

Technikrom Process HPLC, MPLC, LPLC Columns and
Flow-Through Reaction Vessels
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TechniKrom designs and manufactures 316L stainless steel (and Hastelloy) LC columns ranging from 10cm to 2 meter internal diameter and up to 2 meter length, that have additional utility as solid phase reaction vessels for synthetic processes. We design, build and test in accordance with ASME code calculations and FDA requirements and provide IQ/OQ validation documentation. Our proprietary permanent interior passivations make column/vessel tubes inert to acids, bases and salts throughout their lifetime.

TechniKrom offers both axial and fully adaptive dynamic axial compression designs with customized pressure ratings such as: LPLC (150 PSI), MPLC (300 PSI) and HPLC (up to 5,000 PSI). They share the same high performance flow distributor and overall sanitary low dead volume design with the most sanitary of any design available. While axial compression columns provide an initial cost savings, dynamic axial compression provides unique benefits for both chromatography steps and synthesis steps. The elimination of void and channel formation in media/resin beds vessels, combined with our specially designed "active" flow distributor, permits extremely uniform product or reactant mass transfer independent of media/resin type or bed pressure. For LC this maintains the most focused product bands throughout all purification runs providing a tremendous economic advantage with higher purity, throughput and recovery of purified product. It also greatly increases the number of runs that can be made on a bed. For solid phase synthesis, reactants are quickly and uniformly distributed in a controlled manner across the resin giving the highest product yield. Media/resin charging takes minutes using a side-mounted slurry loading port. Precise piston pressure regulation prevents media/resin crushing including during caustic wash or solvent changes. During both elution and synthesis, backpressure buildup is reduced, permitting constant flow rates during critical steps, without forced flow rate drop-offs.

Our dynamic axial compression columns include our patent pending "hoist-free" operation and maintenance compatible with use in modem controlled manufacturing environments.

Frits are constructed from a specially made woven mesh 316L stainless steel or Hastelloy with very narrow pore size distribution and minimum hold-up volume. This minimizes frit blockage by media particles as well as introduced contaminants and simple back flushing is sufficient for most cleaning requirements. The frits are available in any desired porosity and are changed in minutes.

These columns are also ideal for multi-column applications, especially Simulated Moving Bed (SMB) due to their portability, minimum footprint and height, easy packing, unpacking and maintenance procedures with exceptional and reproducible performance.

Technikrom Process Reagent Preparation/Dilution Equipment
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TechniKrom designs and manufactures buffer/solvent preparation systems for fully automated operation with a sanitary cGMP design and fully capable 21 CFR part 11 control software. The systems prepare and deliver reagents at exact concentrations using software control and feedback to support multiple LC process steps simultaneously. Reagent buffers are stored as concentrates to eliminate the need for large storage tanks. Skid-mounted modular designs allow for floor space flexibility. Sanitary 316L stainless steel design with cleaning in place (CIP) capability permits easy validation. Our proprietary permanent passivation is available for tanks and piping and is more durable, resistant and cost effective than materials like Hastelloy®, or Teflon® coatings. Comprehensive IQ/OQ documentation is generated throughout the equipment fabrication and provided on delivery.

Technikrom Contract Services
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Our staff of engineers and scientists includes hands-on chromatographers dedicated to assisting our clients using a direct and effective approach. TechniKrom's R&D facility maintains automated analytical and preparative LC systems, dynamic axial compression columns, and a wide range of silica and polymer based chromatography resins.

Contract services include, but are not limited to, full analytical and process LC method development, process LC scale-up, and purifications (up to kilogram quantities) in a GLP or GMP environment. For existing LC processes our process chemists provide optimization and method re-development support to significantly reduce overall purification costs while maintaining purity and throughput requirements.

Technikrom Chromatography Bulk Media and Packed Columns
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TechniKrom provides a full line of highest quality and performance bulk LC medias to support laboratory scale to commercial scale applications. Our process chemists can perform objective evaluations of any commercially available medias along with our proprietary medias to help select the most cost effective media for your separations.

Technikrom Synthesizers for Peptides and Oligonucleotides
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TechniKrom provides large-scale synthesis systems for fully automated operation with a sanitary cGMP design and 21 CFR part 11 control software. These systems, which include all solvent storage tanks and amino acid tanks, are mounted on 316L stainless steel frames and enclosures. Units meet EX requirements and include a control panel with necessary controls. Each system is controlled by PLC that is connected to a remote PC. The PC can be placed outside of the production area and contains all operation and batch documentation software. Comprehensive IQ/OQ documentation is generated throughout the equipment fabrication and provided at the time of delivery.

Technikrom UF/DF Equipment
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TechniKromŽ provides pilot to production scale automated membrane filtration units using the same sanitary cGMP platform and technology base our LC system skids utilize. Units are designed to accommodate manual to fully automated operation depending upon need. Units accommodate the variety of customer specified membrane technologies which are available today. Flexibility is provided for use of the most appropriate filters and/or membranes for the specific application offering options beyond any one product line or manufacturer.