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www.technikrom.com
TechniKrom, Inc.1855 Elmdale Ave.
Glenview, IL 60026 U.S.A.800-865-4100
800-293-5059 (fax)+1 847-556-9700 (int’l)
+1 847-556-9701 (int’l fax)www.technikrom.com
Bioprocess LC Systems
For Purification of Biological Compounds
Warranty and Technical Support:: One year extendable warranty, service contracts and 24
hour response time means peace of mind and fast supportwhen you need it
:: Partner companies throughout Europe and Asia assist withoverseas tech support
Other TechniKrom Products andServices for the Bio, TIDES, and Pharma Industries::: Dynamic Axial Compression Bioprocess LC Columns
:: IBD™ In-line buffer dilution skids with Adaptive PAT™
:: TechniPur™ chromatography packing materials
:: Process development, scale-up and techtransfer support
:: Equipment Validation services (IQ/OQ and GAMP-5)
:: Service Contracts
:: Engineered solutions to provide lowest total cost of ownership
:: Integrated IBD™ in-line buffer dilution
:: Sanitary and drainable design
“Designed by Chromatographers” ™
About TechniKromTechniKrom is a privately held, diversified engineering and qualification firmthat provides technologically advanced blending, synthesis, filtration andpurification equipment, products and services to the Biopharmaceutical,Pharmaceutical, and Nutraceutical Industries worldwide that permit thelowest cost of production and highest innate product quality, especially incGMP regulated environments. TechniKrom promotes the implementation of Manufacturing Science in biopharmaceutical manufacturing facilities. For additional information, please visit www.technikrom.com.
© Copyright TechniKrom Inc. ˚ www.technikrom.com ˚ 800-865-4100 ˚ TKBioProcLCSysBroch9-08
Bioprocess LC Systems:: Quality by Design - High Performance In-line Buffer Dilution and Gradient
Formation with patented Adaptive PAT™ provides highest return oninvestment
:: Decouple accuracy of diluted buffer from concentrate make-up accuracy
:: Run-to-run reproducibility to improve recovery and yield
:: Regulatory benefit of PAT implementation
:: Binary gradient blending control with optional ternary blending
:: Industrial platform to provide highest uptime
:: Seamless scale-up from pilot to commercial scale
:: Innovative zero static fraction valve manifolds for truly minimized carryover
:: Low hold up volume design for optimized chromatographic performance
:: Sanitary and ASME-BPE compliant; drainable options available
:: Built-in CIP software module to automate skid cleaning
:: Electropolished 316L SS and PTFE parts are compatible with typical mobile phases.Other materials of construction such as Hastelloy and AL6XN also available.
:: Temperature control options available
:: Automated sample test injection loops available
:: Monitoring with conductivity, pH, temperature, pressure and flow measurement
:: Tempurature-compensated conductivity and pH measurement
:: Multiple and variable wavelength UV monitoring
:: Built-in CIP software module to automate skid cleaning
:: All wetted parts are fully traceable and serialized
:: 100% boroscopic inspection available
:: Hazardous area ratings in compliance with UL and ATEX are available
:: Engineered bioprocess LC systems at a wide range of flow rates up to 250 L/min orhigher and pressures of 7 bar or higher
:: Custom designs to fit through doorways or into tight purification suites
:: Worldwide install base throughout US, Europe, and Asia
:: CE Pressure Equipment Directive compliance available
:: USP Class VI and non-animal-derived gasket options available
Validated Automation Package:: Available with Allen-Bradley PLC control and iFIX HMI or
integrate into your plant-wide control system (DeltaV, Allen-Bradley, ABB)
:: 21CFR Part 11 capable and GAMP-5 compliantChromatography Process Control software
:: Full audit trail and electronic signature
:: Chromatography methods set up in minutes using intuitivemethod editor software
:: Method steps can be imported, exported and copied tosimplify programming
:: Regulate your process by flow rate set point orpressure set point
:: Real time data logging of conductivity, pH,pressure, flow, temperature, UV
:: Built-in data analysis calculations for HETP,asymmetry, and area under curve
:: Multi-level alarming
:: Batch reports can be customized by user
:: Complete IQ/OQ execution and documentationavailable for turnkey operation
Intuitive method creation
Accurate mobile phase blending enables run to runreproducibility and optimized product recovery
User RequirementSpecification
(URS)
Design Specifications(HDS/SDS)
InstallationQualification
(IQ)
OperationalQualification
(OQ)
System Build
FunctionalRequirementSpecifications
(FRS)
ProcessQualification
(PQ)Verifies
Verifies
Verifies
GAMP-5 Lifecycle Validation
World class processing equipment and services for biopharm, pharma and nutraceutical industries
Fully sanitary design
Easy-to-follow Process Control screen
3D CAD modeling forBioprocess LC Skids
Model # Flow Specification Pressure Rating Operation Mode
#LPLC-5.7L-150psi 0.2 to 5.7 L/min 150psig/10 bargOptimized for gradient; limited IBD™ (in-line buffer dilution)
#LPLC-IBD-5.7L-150psi 0.2 to 5.7 L/min 150psig/10 barg Optimized for IBD™; limited gradient
#LPLC-10L-150psi 0.3 to 10 L/min 150psig/10 barg Optimized for gradient; limited IBD™
#LPLC-IBD-10L-150psi 0.3 to 10 L/min 150psig/10 barg Optimized for IBD™; limited gradient
#LPLC-19L-110psi 0.5 to 19 L/min 110psig/7.5 barg Optimized for gradient; limited IBD™
#LPLC-IBD-19L-110psi 0.5 to 19 L/min 110psig/7.5 barg Optimized for IBD™; limited gradient
#LPLC-30L-110psi 0.8 to 32 L/min 110psig/7.5 barg Optimized for gradient; limited IBD™
#LPLC-IBD-30L-110psi 0.8 to 32 L/min 110psig/7.5 barg Optimized for IBD™; limited gradient
Standard Bioprocess LC Systems
:: Engineered systemswith flow rates up to250 L/min areavailable
:: Custom flowcapacities, pressureratings, and systemconfigurations areavailable
800-865-4100 ˚ International phone 847-556-9700Technikrom Inc. ˚ 1855 Elmdale Ave. ˚ Glenview, IL 60026 ˚ www.technikrom.com ˚ [email protected]
Bioprocess LC Systems:: Quality by Design - High Performance In-line Buffer Dilution and Gradient
Formation with patented Adaptive PAT™ provides highest return oninvestment
:: Decouple accuracy of diluted buffer from concentrate make-up accuracy
:: Run-to-run reproducibility to improve recovery and yield
:: Regulatory benefit of PAT implementation
:: Binary gradient blending control with optional ternary blending
:: Industrial platform to provide highest uptime
:: Seamless scale-up from pilot to commercial scale
:: Innovative zero static fraction valve manifolds for truly minimized carryover
:: Low hold up volume design for optimized chromatographic performance
:: Sanitary and ASME-BPE compliant; drainable options available
:: Built-in CIP software module to automate skid cleaning
:: Electropolished 316L SS and PTFE parts are compatible with typical mobile phases.Other materials of construction such as Hastelloy and AL6XN also available.
:: Temperature control options available
:: Automated sample test injection loops available
:: Monitoring with conductivity, pH, temperature, pressure and flow measurement
:: Tempurature-compensated conductivity and pH measurement
:: Multiple and variable wavelength UV monitoring
:: Built-in CIP software module to automate skid cleaning
:: All wetted parts are fully traceable and serialized
:: 100% boroscopic inspection available
:: Hazardous area ratings in compliance with UL and ATEX are available
:: Engineered bioprocess LC systems at a wide range of flow rates up to 250 L/min orhigher and pressures of 7 bar or higher
:: Custom designs to fit through doorways or into tight purification suites
:: Worldwide install base throughout US, Europe, and Asia
:: CE Pressure Equipment Directive compliance available
:: USP Class VI and non-animal-derived gasket options available
Validated Automation Package:: Available with Allen-Bradley PLC control and iFIX HMI or
integrate into your plant-wide control system (DeltaV, Allen-Bradley, ABB)
:: 21CFR Part 11 capable and GAMP-5 compliantChromatography Process Control software
:: Full audit trail and electronic signature
:: Chromatography methods set up in minutes using intuitivemethod editor software
:: Method steps can be imported, exported and copied tosimplify programming
:: Regulate your process by flow rate set point orpressure set point
:: Real time data logging of conductivity, pH,pressure, flow, temperature, UV
:: Built-in data analysis calculations for HETP,asymmetry, and area under curve
:: Multi-level alarming
:: Batch reports can be customized by user
:: Complete IQ/OQ execution and documentationavailable for turnkey operation
Intuitive method creation
Accurate mobile phase blending enables run to runreproducibility and optimized product recovery
User RequirementSpecification
(URS)
Design Specifications(HDS/SDS)
InstallationQualification
(IQ)
OperationalQualification
(OQ)
System Build
FunctionalRequirementSpecifications
(FRS)
ProcessQualification
(PQ)Verifies
Verifies
Verifies
GAMP-5 Lifecycle Validation
World class processing equipment and services for biopharm, pharma and nutraceutical industries
Fully sanitary design
Easy-to-follow Process Control screen
3D CAD modeling forBioprocess LC Skids
Model # Flow Specification Pressure Rating Operation Mode
#LPLC-5.7L-150psi 0.2 to 5.7 L/min 150psig/10 bargOptimized for gradient; limited IBD™ (in-line buffer dilution)
#LPLC-IBD-5.7L-150psi 0.2 to 5.7 L/min 150psig/10 barg Optimized for IBD™; limited gradient
#LPLC-10L-150psi 0.3 to 10 L/min 150psig/10 barg Optimized for gradient; limited IBD™
#LPLC-IBD-10L-150psi 0.3 to 10 L/min 150psig/10 barg Optimized for IBD™; limited gradient
#LPLC-19L-110psi 0.5 to 19 L/min 110psig/7.5 barg Optimized for gradient; limited IBD™
#LPLC-IBD-19L-110psi 0.5 to 19 L/min 110psig/7.5 barg Optimized for IBD™; limited gradient
#LPLC-30L-110psi 0.8 to 32 L/min 110psig/7.5 barg Optimized for gradient; limited IBD™
#LPLC-IBD-30L-110psi 0.8 to 32 L/min 110psig/7.5 barg Optimized for IBD™; limited gradient
Standard Bioprocess LC Systems
:: Engineered systemswith flow rates up to250 L/min areavailable
:: Custom flowcapacities, pressureratings, and systemconfigurations areavailable
800-865-4100 ˚ International phone 847-556-9700Technikrom Inc. ˚ 1855 Elmdale Ave. ˚ Glenview, IL 60026 ˚ www.technikrom.com ˚ [email protected]
www.technikrom.com
TechniKrom, Inc.1855 Elmdale Ave.
Glenview, IL 60026 U.S.A.800-865-4100
800-293-5059 (fax)+1 847-556-9700 (int’l)
+1 847-556-9701 (int’l fax)www.technikrom.com
Bioprocess LC Systems
For Purification of Biological Compounds
Warranty and Technical Support:: One year extendable warranty, service contracts and 24
hour response time means peace of mind and fast supportwhen you need it
:: Partner companies throughout Europe and Asia assist withoverseas tech support
Other TechniKrom Products andServices for the Bio, TIDES, and Pharma Industries::: Dynamic Axial Compression Bioprocess LC Columns
:: IBD™ In-line buffer dilution skids with Adaptive PAT™
:: TechniPur™ chromatography packing materials
:: Process development, scale-up and techtransfer support
:: Equipment Validation services (IQ/OQ and GAMP-5)
:: Service Contracts
:: Engineered solutions to provide lowest total cost of ownership
:: Integrated IBD™ in-line buffer dilution
:: Sanitary and drainable design
“Designed by Chromatographers” ™
About TechniKromTechniKrom is a privately held, diversified engineering and qualification firmthat provides technologically advanced blending, synthesis, filtration andpurification equipment, products and services to the Biopharmaceutical,Pharmaceutical, and Nutraceutical Industries worldwide that permit thelowest cost of production and highest innate product quality, especially incGMP regulated environments. TechniKrom promotes the implementation of Manufacturing Science in biopharmaceutical manufacturing facilities. For additional information, please visit www.technikrom.com.
© Copyright TechniKrom Inc. ˚ www.technikrom.com ˚ 800-865-4100 ˚ TKBioProcLCSysBroch9-08
