warranty and technical support other technikrom … · user requirement specification (urs) design...
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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
HPLC Systems
For pharmaceutical, biopharmaceutical, and natural product purification
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 Pharma, TIDES, and BIO Industries::: Dynamic Axial Compression HPLC Columns
:: TechniPur™ chromatography packing materials
:: Large-scale Simulated Moving Bed systems
:: Process development, scale-up and tech transfer support
:: Knauer Preparative HPLC and SMB Systems
:: IBDTM in-line buffer dilution skids with Adaptive PATTM
:: Equipment Validation (IQ/OQ and GAMP-5)
:: Service Contracts
:: Engineered solutions to provide lowest total cost of ownership
:: Truly controlled mobile phase delivery
:: Industrial systems designed for minimized downtime
“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 ˚ TKHPLCSystemsBroch5-08
HPLC Systems:: Quality by Design - High Performance Isocratic and Gradient
Formation with Adaptive PAT™ provides highest return oninvestment
:: Run-to-run reproducibility to improve recovery and yield
:: Regulatory benefit of PAT implementation
:: Industrial platform to provide highest uptime
:: Both solvent and buffer based blending available
:: Seamless scale-up from pilot to commercial scale
:: Innovative zero static fraction valve manifolds for trulyminimized carryover
:: Low hold up volume design for optimized chromatographicperformance
:: Sanitary options available for high pressure bioprocessing
:: 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 alsoavailable.
:: Temperature control options available
:: Automated sample test injection loops available
:: Monitoring with NIR, conductivity, pH, temperature, pressure and flow measurement
:: Multiple and variable wavelength UV monitoring
:: All wetted parts are fully traceable and serialized
:: Hazardous area ratings in compliance with UL and ATEX available
:: Engineered HPLC systems at a wide range of flow rates up to 50L/min or higher and pressures of 100 bar or higher
:: Custom designs to fit into walk-in fume hoods or other tight spaces
:: Worldwide install base throughout US, Europe, and Asia
800-865-4100 ˚ International phone 847-556-9700Technikrom Inc. ˚ 1855 Elmdale Ave. ˚ Glenview, IL 60026 ˚ www.technikrom.com ˚ [email protected]
Validated Automation Package:: Available with Allen-Bradley PLC control and iFIX HMI with
integrated operator interface terminal or remote PC
:: 21CFR Part 11 capable and GAMP-5 compliantChromatography Process Control software
:: Full audit trail and electronic signature
:: Chromatography methods set up in minutes usingintuitive method editor software
:: Method steps can be imported, exported and copiedto simplify programming
:: Real time data logging of NIR, conductivity, pH,pressure, flow, temperature, UV
:: Built-in data analysis calculations forcolumn plate count, asymmetry, andarea under curve
:: Multi-level alarming
:: Batch reports canbe customized byuser
:: Complete IQ/OQexecution anddocumentationavailable forturnkey 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 fine chemical industries
Optional hazardous-area ratedDisplay and Keyboard
Easy-to-follow Process Control screen
3D CAD modeling forHPLC skids
Model # Flow Specification Pressure Rating Typical Column Pairing#HPLC-1L-1000psig 0.1 to 1 L/min 1000psig/70 barg 5cm to 15cm ID#HPLC-2L-1000psig 0.2 to 2 L/min 1000psig/70 barg 7.5cm to 20cm ID#HPLC-3L-1000psig 0.3 to 3 L/min 1000psig/70 barg 10cm to 25cm ID#HPLC-4L-1000psig 0.4 to 4 L/min 1000psig/70 barg 10cm to 30cm ID#HPLC-6L-1000psig 0.6 to 6 L/min 1000psig/70 barg 15cm to 35cm ID#HPLC-10L-1000psig 1.0 to 10 L/min 1000psig/70 barg 20cm to 45cm ID#HPLC-16L-1000psig 1.6 to 16 L/min 1000psig/70 barg 30cm to 60cm ID#HPLC-24L-1000psig 2.4 to 24 L/min 1000psig/70 barg 30cm to 80cm ID#HPLC-40L-1000psig 4.0 to 40 L/min 1000psig/70 barg 40cm to 100cm ID
Standard HPLC Systems
:: 100 bar or higherpressure ratings alsoavailable
:: Custom flow capacities,pressure ratings, andsystem configurationsare available
HPLC Systems:: Quality by Design - High Performance Isocratic and Gradient
Formation with Adaptive PAT™ provides highest return oninvestment
:: Run-to-run reproducibility to improve recovery and yield
:: Regulatory benefit of PAT implementation
:: Industrial platform to provide highest uptime
:: Both solvent and buffer based blending available
:: Seamless scale-up from pilot to commercial scale
:: Innovative zero static fraction valve manifolds for trulyminimized carryover
:: Low hold up volume design for optimized chromatographicperformance
:: Sanitary options available for high pressure bioprocessing
:: 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 alsoavailable.
:: Temperature control options available
:: Automated sample test injection loops available
:: Monitoring with NIR, conductivity, pH, temperature, pressure and flow measurement
:: Multiple and variable wavelength UV monitoring
:: All wetted parts are fully traceable and serialized
:: Hazardous area ratings in compliance with UL and ATEX available
:: Engineered HPLC systems at a wide range of flow rates up to 50L/min or higher and pressures of 100 bar or higher
:: Custom designs to fit into walk-in fume hoods or other tight spaces
:: Worldwide install base throughout US, Europe, and Asia
800-865-4100 ˚ International phone 847-556-9700Technikrom Inc. ˚ 1855 Elmdale Ave. ˚ Glenview, IL 60026 ˚ www.technikrom.com ˚ [email protected]
Validated Automation Package:: Available with Allen-Bradley PLC control and iFIX HMI with
integrated operator interface terminal or remote PC
:: 21CFR Part 11 capable and GAMP-5 compliantChromatography Process Control software
:: Full audit trail and electronic signature
:: Chromatography methods set up in minutes usingintuitive method editor software
:: Method steps can be imported, exported and copiedto simplify programming
:: Real time data logging of NIR, conductivity, pH,pressure, flow, temperature, UV
:: Built-in data analysis calculations forcolumn plate count, asymmetry, andarea under curve
:: Multi-level alarming
:: Batch reports canbe customized byuser
:: Complete IQ/OQexecution anddocumentationavailable forturnkey 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 fine chemical industries
Optional hazardous-area ratedDisplay and Keyboard
Easy-to-follow Process Control screen
3D CAD modeling forHPLC skids
Model # Flow Specification Pressure Rating Typical Column Pairing#HPLC-1L-1000psig 0.1 to 1 L/min 1000psig/70 barg 5cm to 15cm ID#HPLC-2L-1000psig 0.2 to 2 L/min 1000psig/70 barg 7.5cm to 20cm ID#HPLC-3L-1000psig 0.3 to 3 L/min 1000psig/70 barg 10cm to 25cm ID#HPLC-4L-1000psig 0.4 to 4 L/min 1000psig/70 barg 10cm to 30cm ID#HPLC-6L-1000psig 0.6 to 6 L/min 1000psig/70 barg 15cm to 35cm ID#HPLC-10L-1000psig 1.0 to 10 L/min 1000psig/70 barg 20cm to 45cm ID#HPLC-16L-1000psig 1.6 to 16 L/min 1000psig/70 barg 30cm to 60cm ID#HPLC-24L-1000psig 2.4 to 24 L/min 1000psig/70 barg 30cm to 80cm ID#HPLC-40L-1000psig 4.0 to 40 L/min 1000psig/70 barg 40cm to 100cm ID
Standard HPLC Systems
:: 100 bar or higherpressure ratings alsoavailable
:: Custom flow capacities,pressure ratings, andsystem configurationsare available
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
HPLC Systems
For pharmaceutical, biopharmaceutical, and natural product purification
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 Pharma, TIDES, and BIO Industries::: Dynamic Axial Compression HPLC Columns
:: TechniPur™ chromatography packing materials
:: Large-scale Simulated Moving Bed systems
:: Process development, scale-up and tech transfer support
:: Knauer Preparative HPLC and SMB Systems
:: IBDTM in-line buffer dilution skids with Adaptive PATTM
:: Equipment Validation (IQ/OQ and GAMP-5)
:: Service Contracts
:: Engineered solutions to provide lowest total cost of ownership
:: Truly controlled mobile phase delivery
:: Industrial systems designed for minimized downtime
“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 ˚ TKHPLCSystemsBroch5-08