GMP tempering skid 1.4435 Brinox LEP 2.3 KK6752 Paket 7

Brinox · LEP 2.3 KK6752 Paket 7

Caractéristiques techniques

Description

Condition: new, Year of construction: 2020, functionality: fully functional, Equipment: documentation/manual, Manufacturer: BRINOX Process Systems Type: LEP 2.3 System Type: Temperature Control Unit for Washing and Elution Solutions Year of Manufacture: 2020 Serial Number: 1003563 Device Number: KK6752 Design: Stainless Steel Skid, Pharmaceutical Construction LEP 2.3 KK6752 Package 7 Technical Data Design: Compact, pre-assembled temperature control unit on a welded stainless steel frame (skid system) Materials: Product-contact: Stainless Steel 1.4435 / 1.4404 Non-product contact: Stainless Steel 1.4301 Piping System: Orbital welding (pharmaceutical grade) Fully welded construction As-built isometric drawing available Pressure Data: Leak test using compressed air Test pressure: 3.37 bar Holding time: 1 hour Result: Leak-free Measurement and Control Technology: Pressure measurement (PIR, PI, PIRC) Temperature measurement (TI, TIRC) Level measurement (limit) Flow monitoring Position feedback Motor control On/Off pneumatic valves Pressure sensor measuring range: 0–10 bar Electrical Connection: Control air: 6 bar Automation-capable (PLT nodes fully documented) Main Components: 2 process pumps Plate heat exchanger Finned tube heat exchanger Expansion vessel Multiple hygienic control and shut-off valves Integrated instrumentation units Cooling Medium: Csupd Sjyl Ipce T Ushb Chilled brine (supply/return interfaces available) ───── Dimensions / Weight Construction: Compact skid unit Industrial design for cleanroom/technical areas (Transport and installation dimensions as per layout drawing) Application Area Temperature control of: Washing solutions Elution solutions Process media in biopharmaceutical environments Fields of Application: Biotechnology Plasma fractionation GMP production facilities Build / Construction Welded stainless steel frame Low-vibration pump mounting Hygienic piping Full implementation according to P&ID Clear separation between product and non-product areas Service and maintenance access tested Mechanical SAT-IQ test performed Metrological SAT-IQ test performed P&ID diagram check completed Layout drawing check completed Condition Manufactured in 2020 Industrial and pharmaceutical version New, original packaging Pressure tested Sensors calibrated FAT performed FAT / Documentation Available: FAT plan and report Deviation management Layout check P&ID check Leak test Sensor calibration Service and accessibility inspection EN10204 factory certificate Material lists (LBM) As-built isometry Component lists (equipment & PLT nodes) Special Features Pharma-GMP compliant design Complete validation documentation Full traceability Certified pressure testing Calibration certificates from accredited laboratories High-quality plant construction by BRINOX High-end biopharma standard

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