Embed Size (px)
Citation preview
www.technikrom.com
Asahi Gold Particle Test SystemIntegrity Tester for the Planova™ Virus Removal Filter
:: An automated and validated system for conducting the Asahi Gold Particle Test(AGPT), a post-use colloidal particle integrity test to confirm membrane poredistribution of the Planova™ filters
:: Available for 0.3m2, 1m2, and 4m2 filters
Asahi Gold Particle Test SystemTechniKrom offers this equipment as part of our alliance with AsahiKasei Medical to better support the Planova™ users with automatedequipment including viral filtration skids and automated gold particleintegrity test systems.
:: Portable, skid-mounted unit on casters with all valves and instruments fullyaccessible for maintenance
:: Polished stainless steel frame with all welds ground and polished:: Lined pressure vessel for storage of dilute AGP solution with pressure relief
device:: Air filter and pressure regulators for controlled clean air pressure delivery to
feed tank:: All valving and tubing for process water feed :: Smooth bore beadless weld PFA tubing flowpath:: Liquid detection sensors for AGP and water solutions:: Pressure sensors for measurement of pressure inside and outside hollow fibers:: Variable wavelength spectrophotometer with fiber optic flow cell for
automatic pass/fail result of filter:: Flowmeter for totalized flow measurement of AGP and water solutions:: Filter mounting stand with sanitary Triclamp connections to connect the
Planova™ filter :: Bar code reader for the Planova™ filter (no need to manually enter filter
information):: Option: mount the Planova™ Leak Tester (PLT) to the system, so that both the
PLT and AGPTS post-use integrity tests can be performed at a single skid:: Option: add pre-GPT wash capability to the system:: Option: auto spectrophotometer rinsing to permit direct flow cell
rinsing/flushing:: Dimensions: approximately 52" W x 38" D x 74" H
:: Utilities:- 120V single phase- 80psig clean air- 80psig instrument air
Benefits of the AGPTS::: Simple to use for operators
:: Ensures rapid, automated testing to reduce operational costsassociated with manual integrity tests
:: Eliminates operator error in your filter integrity testing
:: Mitigates risk through automatic alarming for high pressure events, low level events, etc.
:: Save time: execute the AGPT in less than 20 minutes
:: Units can be customized to accommodate different filter sizes or pore sizes (15N, 20N, or 35N)
World class processing equipment and services for biopharm, pharma and nutraceutical industries
3D CAD modeling
Close-up of filtration system
Technikrom Inc. ˚ 1855 Elmdale Ave. ˚ Glenview, IL 60026 ˚ www.technikrom.com ˚ [email protected]
Receive a pass/fail for thePlanova™ filter in less than 20 minutes.
Fully validated throughTechniKrom’s IQ/QO protocols
800-865-4100 ˚ International phone 847-556-9700
Pre-programmed methods forintegrity tests included
Validated Automation Package:: Designed with Allen-Bradley PLC
control
:: Integral 17" touchscreen HMIwith optional NEMA 4X keyboardand trackball
:: 21CFR Part 11 capable ProcessControl software
:: Full audit trail and electronicsignature
:: Pre-programmed test method isset up in minutes
:: Real time data logging ofpressure, flow, and absorbance
:: Multi-level alarming
:: Batch report printout withpass/fail result included
:: Complete IQ/OQ execution anddocumentation available forturnkey operation
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
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::: Tangential Flow and Viral Filtration systems
:: IBD™ inline buffer dilution skids
:: Dynamic Axial Compression Bioprocess LC Columns
:: Bioprocess LC Systems
:: TechniPur™ chromatography packing materials
:: Process development, scale-up and tech transfer support
:: Equipment Validation services (IQ/OQ and GAMP-5)
:: Service Contracts
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 ˚ TKAGPTSBroch9-08
