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Solingen
11.259 km
Tangki Cuci/Elusi GMP 9000L 316L
BRINOX 9.000 L WaschlösungsbehälterBH6752-BH1001 Paket 32
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, kapasitas tangki: 9.000 l, Perlengkapan: dokumentasi / manual, BRINOX 9000 L GMP Washing and Elution Solution Tank
Horizontal Stainless Steel Pressure Vessel – Year of Manufacture 2020 – Complete FAT & GMP Documentation
BH6752-BH1001 Package 32
Manufacturer: BRINOX Process Systems
Serial Number: 1003558
Year of Manufacture: 2020
Nominal Volume: 9,000 liters
Design: GMP-compliant stainless steel pressure vessel
Application
The vessel was used in a pharmaceutical production facility.
Suitable for the preparation, storage, and provision of process solutions in GMP environments.
Construction and Features
Cylindrical stainless steel vessel in horizontal configuration
Process connections on end faces
Large manway with pressure-tight cover
Integrated CIP system with spray ball
Highly polished internal surfaces
Hygienic product-contacting fittings
Multiple measurement and instrumentation nozzles
Documented weld seams with full traceability
Separate stainless steel feet included in delivery
Condition
Visual and technical condition: Very good.
Internal surfaces mirror-polished and clean.
No visible damage to the jacket or connections.
Accessories and attached components as per photo documentation included.
FAT and Documentation Status
According to the FAT documentation “IT-11.1 Welding Documentation Inspection”, the welding documentation was reviewed during the Factory Acceptance Test (FAT 01, 23.10.2020).
The following were confirmed, among others:
Identification of welders and weld seam inspectors
Welder qualifications according to EN ISO 9606-1
WPS and WPQR documentation
Evidence of shielding gas suitability
Documented test welds
Random visual inspection without complaints
Traceability according to 3.1 material certificates
The complete welding documentation is part of the Turn-Over Package.
Documentation – fully available
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FAT plan and FAT report
Layout and construction drawings
P&ID diagrams
Calibration protocols
Surface and roughness measurements
Leak test
Welding plan
WPQR
WPS
Welder qualifications
Borescope inspection report
Goods receipt inspection reports
Sensor calibrations
The complete technical documentation is available in digital format.
Special Features
Fully documented GMP version with verified welding documentation and comprehensive quality package.
Very well suited for reinstallation in pharmaceutical production plants or applications requiring validation.
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Solingen
11.259 km
1500L 1.4435 GMP tang pengendap
BRINOXBH6724-BH1001 Paket 22
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, kapasitas tangki: 1.500 l, Perlengkapan: dokumentasi / manual, BRINOX 1,500 L Primary Precipitation Vessel – 316L – Double Jacket – PED Module G – FAT 2020 – Mint Condition
Manufacturer: BRINOX d.o.o.
Type: SVMBI-1500
Tag No.: BH6724-BH1001 Package 22
Serial No.: 1003457
Year of Manufacture: 2020
Condition: As new / Unused
CE Certification: CE 0036
TECHNICAL DATA
Product type: Primary precipitation vessel / process vessel
Nominal volume: 1,500 liters
Total volume: 1,785 liters
Empty weight: approx. 866 kg
Product contact material: 1.4435 (AISI 316L pharmaceutical grade)
Jacket material: Stainless steel
Operating pressure vessel: –1 / +3 bar
Test pressure vessel: 5.4 bar
Operating pressure jacket: as per design
Temperature range: –10 °C to +150 °C
Pressure vessel according to PED 2014/68/EU
Module G – Individual acceptance
Inspection by Notified Body 0036
FAT – Factory Acceptance Test (08/2020)
The vessel was fully tested at the BRINOX factory as part of a documented FAT.
Tests performed include:
• Delta ferrite testing of weld seams (compliant, no deviations)
• Surface roughness testing (internal Ra ≤ 0.8 µm, compliant)
• Visual inspection of all product-contact surfaces
• Pressure test according to specification
• Documentation review
• GMP deviation management (non-critical items, fully closed)
• Measuring equipment with valid calibration certificate
DESIGN FEATURES
• Double jacket for heating/cooling
• Horizontal design
• High-quality pharmaceutical construction
• Complete 316L stainless steel in product contact areas
• Mirror polished internal surface
• GMP-compliant, documented welds
• Large manway with swing lid
• Multiple clamp and flange connections
• Spray ball / CIP connections
• Instrumentation prepared (pressure, temperature, sensors)
• Insulated jacket with fittings
• Solid flange bottom
• Lifting lugs and transportation setup
• Project-built for CSL Behring (SPHINX project)
CONDITION
• Never used in production
• Direct from project surplus
• Internally absolutely as new
• No corrosion
• No signs of use
• Factory new industrial condition
• Immediately available
DOCUMENTATION
Comprehensive, project-specific quality and manufacturing documentation available, including:
• EU Declaration of Conformity
• TÜV test documents
• PED Module-G documentation
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• Material certificates 3.1
• Welding documentation (WPS/WPQR)
• Delta ferrite test protocols
• Surface roughness protocols
• Calibration certificates for measuring devices
• GMP deviation protocols
• FAT protocols fully signed
• Operating and maintenance manuals
Documentation is complete and systematically organized.
• Pharmaceutical API processes
• Precipitation and reaction processes
• Buffer and solution preparation
• Sterile liquid handling
• Biotechnology
• GMP-compliant production facilities
• High-purity media
SPECIAL FEATURE
This is a high-end BRINOX process vessel in genuine pharmaceutical project quality, manufactured for CSL Behring, with full PED Module-G individual certification, documented 2020 FAT, and complete GMP documentation. Not a standard tank – certified project quality for sterile applications. Immediately available.
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Solingen
11.259 km
3500L 1.4435 tang pencampur farmasi
BRINOX 3.500 L AnsatzbehälterBH6770-BH1001 Paket 28
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, kapasitas tangki: 3.500 l, Perlengkapan: dokumentasi / manual, BRINOX 3,500 L Batch Tank – 1.4435 – Double Jacket – PED Module G – TÜV SÜD – FAT – 2020 – As New
Manufacturer: BRINOX d.o.o.
Type: SVMBHI-3500
Tag No.: BH6770-BH1001
Serial No.: 1003460
Year of Manufacture: 2020
Condition: As New / Unused
BH6770-BH1001 Package 28
TECHNICAL DATA
Product type: Batch Tank / Pressure Vessel
Working volume: 3,500 liters
Total volume: 4,304 liters
Jacket volume: 202 liters
Empty weight: 1,958 kg
Product-contact material: 1.4435 (AISI 316L)
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Jacket: 1.4404 (AISI 316L)
CE marking: CE 0036
Permissible pressure vessel PS: -1 / +3 bar
Test pressure vessel PT: 5.6 bar
Permissible pressure jacket PS: -1 / +6 bar
Test pressure jacket PT: 10.8 bar
Permissible temperature TS: -10 °C to +150 °C
Fluid Group: 2
Design in accordance with AD 2000 regulations
Pressure vessel according to PED 2014/68/EU
Category III
Module G – Individual Inspection
Notified Body: TÜV SÜD Industrie Service GmbH (Notified Body No. 0036)
TÜV approval including final inspection and pressure test fully documented.
FAT – Factory Acceptance Test
The vessel underwent complete FAT testing and release at the manufacturer’s site.
Tests performed include:
• Pressure test according to PED
• Visual inspection of all weld seams
• Non-destructive tests (RT, PT as per test plan)
• Dimensional and drawing verification (as-built)
• Internal surface roughness measurement (Ra ≤ 0.8 µm)
• Calibration check of pressure gauges
• Verification of markings
• Complete documentation review
FAT protocols are fully available.
EXECUTION
• Cylindrical, horizontal vessel
• Double jacket with half-pipe coil system
• Internal surface electropolished and passivated
• High-gloss polished product-contact surfaces
• Pharmaceutical-grade weld seams
• Manway DN 500
• Powder/inlet socket DN 300
• CIP connections
• Safety valve
• Pressure and temperature connections
• Agitator connection
• Heavy-duty trunnion mounting
• Lifting lugs
DOCUMENTATION – complete and well-structured
Comprehensive project-specific quality and manufacturing documentation available, including:
• EU Declaration of Conformity and warranty certificates
• TÜV certificate with acceptance report (Module G)
• TÜV design review and certification
• 3.1 material certificates
• Welder lists and welding procedure qualifications (WPQR/WPS)
• Non-destructive test reports (RT, PT etc.)
• Analysis certificates for filler and shielding gases
• Company qualification certificate
• Roughness protocol
• Surface treatment report
• Dimensional accuracy report
• Internal pressure test report
• Calibration certificates
• Reports and EU conformity statements of installed components
• Complete parts list
• Part drawings
• Operating and maintenance manuals
Complete digital documentation dossier included.
CONDITION
• Never used in production
• Stock item
• Internal surfaces in absolutely as-new condition
• No corrosion
• No signs of use
• Factory-new industrial condition
• Immediately available
SUITABLE FOR
• Pharmaceutical solutions
• WFI / PW systems
• Buffer and media preparation
• Sterile liquid processes
• GMP-compliant production facilities
• Biotechnological applications
SPECIAL FEATURE
High-end BRINOX pharmaceutical-grade manufacturing with complete PED Module G individual inspection by TÜV SÜD, CE 0036 marking, and full FAT documentation.
Not a standard tank – but a tested, project-quality vessel with comprehensive GMP-compliant documentation.

Informasi sekarang
+44 20 806 810 84
+44 20 806 810 84
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*per iklan/bulan
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Solingen
11.259 km
9000L 316L pharma cuci tangki
BRINOXBH6751-BH1001 Paket 31
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, kapasitas tangki: 9.000 l, Perlengkapan: dokumentasi / manual, BRINOX 9,000 L Washing Solution Tank – 316L – Double Jacket – TÜV / PED – As New
Manufacturer: BRINOX d.o.o.
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Tag-No.: BH6751-BH1001 Package 31
Year of manufacture: 2020
Condition: As new / unused
Technical Data
Product type: Washing solution tank
Nominal volume: approx. 9,000 litres
Product-contact material: 1.4404 (AISI 316L)
Design: Horizontal orientation
CE marking: available
Pressure vessel according to PED 2014/68/EU
TÜV-inspected with test report
Double jacket for heating/cooling available
Designed for pharmaceutical applications
Internal surface:
• Mirror-polished
• Pharmaceutical-grade weld seams
• Documented surface quality
Configuration / Features
• Heavy-duty custom fabrication in stainless steel 316L
• Large-dimension manway with pressure closure
• Integrated CIP spray lances / cleaning pipes
• Multiple clamp and flange connections
• Instrumentation ports (pressure, temperature, sensors)
• Sturdy lifting and carrying lugs
• Robust, heavy industrial construction
• External pipework and process connections pre-installed
• Excellent accessibility for maintenance and inspection
The photos clearly show the high-quality workmanship, clean welds and the mirror-polished, product-contact internal surface.
Condition
• Never used in operation
• Stock item from project surplus
• Internally absolutely clean
• No corrosion
• No signs of use
• As-new industrial condition
• Immediately available
Suitable for
• Washing solutions in pharmaceutical processes
• WFI / PW applications
• CIP media
• Buffer and process solutions
• Biotechnology
• GMP production plants
• Sterile liquid processes
Documentation – fully and systematically available
Comprehensive, project-specific quality and manufacturing documentation available for the tank, including:
• EU Declaration of Conformity and warranty certificates
• Reports and EU component verifications
• Assembly documentation
• Part drawings
• TÜV certificate with acceptance test report
• Nameplate documentation
• TÜV design review and certification
• Welder lists, welding procedure qualifications, sample welds
• Analysis certificates for welding filler material
• Analysis certificates for shielding gas
• Manufacturer’s qualification certificate
• Non-destructive testing (NDT) reports
• Material certificates (3.1)
• Calibration certificates
• Internal pressure test report
• Dimensional accuracy check
• Surface roughness protocol
• Surface treatment report
• Operation and maintenance manuals (unit)
• Operation and maintenance manuals (components)
• FAT documentation (Factory Acceptance Test)
Complete documentation file available digitally.
Special feature
This is not a standard tank, but a high-grade custom-manufactured vessel in genuine pharmaceutical quality, with certified pressure rating, documented fabrication, and full PED compliance including TÜV inspection.
Heavy-duty build, large-dimensioned connections and integrated CIP make this tank ideal for demanding GMP applications.
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Solingen
11.259 km
Tangki penyimpanan GMP 3500L 1.4404
BRINOXBH6771-BH1001 Paket 29
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, kapasitas tangki: 3.500 l, Perlengkapan: dokumentasi / manual, BRINOX 3,500 L Storage Tank – 1.4404 – PED Module G – TÜV – FAT – 2020 – As New
Manufacturer: BRINOX d.o.o., Slovenia
Type: SVBBH-3500
Tag No.:
Serial No.: 1003461
Year of manufacture: 2020
Condition: As new / unused
BH6771-BH1001 Package 29
TECHNICAL DATA
Product type: Storage tank / process vessel
Nominal volume: 3,500 liters
Total volume: approx. 4,082 liters
Empty weight: approx. 1,750 kg
Product contact material: 1.4404 (AISI 316L)
Internal surface: electropolished
Surface roughness: tested according to roughness protocol (Ra ≤ 0.8 µm)
Permissible pressure PS vessel: -1 / +3 bar
Test pressure PT vessel: 5.6 bar
Permissible pressure PS jacket: -1 / +6 bar
Test pressure PT jacket: 10.8 bar
Permissible temperature TS: -10 °C to +150 °C
Fluid group: 2
Design in accordance with AD 2000
Pressure vessel according to PED 2014/68/EU
Category III
Module G – Single unit inspection
CE marking
FAT – Factory Acceptance Test
Complete FAT conducted on 26.08.2020
Documentation review: completed and released
Welding documentation checked and compliant
Delta ferrite test carried out, no deviations
Surface roughness checked and passed
All inspections rated "OK"
FEATURES
• Horizontal cylindrical pressure vessel
• Dished ends (Klöpperböden)
• Multiple frontal CIP connections
• CIP spray ball system
• Manhole with round pressure closure
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• Pressure and temperature connections
• Bottom outlet
• Stainless steel support legs
• Pharmaceutical-grade weld seams
DOCUMENTATION – completely available
• EU Declaration of Conformity
• TÜV certificate
• Module G single unit inspection
• FAT protocols
• Welding documentation
• WPQR / WPS
• Material certificates 3.1
• Non-destructive test reports
• Delta ferrite test report
• Roughness protocol
• Dimensional accuracy inspection
• Calibration certificates
• Technical drawings
• Parts list
• Operating and maintenance manual
Complete digital documentation folder available.
CONDITION
• Never used in production
• Stock item
• Interior surface absolutely as new
• No corrosion
• No signs of use
• Factory-new condition
• Immediately available
SUITABLE FOR
• Pharmaceutical solutions
• WFI / PW systems
• Buffer and media preparation
• Sterile liquid processes
• GMP production plants
• Biotechnological applications
SPECIAL FEATURES
Project-specific BRINOX pharmaceutical vessel with complete FAT acceptance, verified welding documentation, delta ferrite certificate, documented surface roughness, and comprehensive PED Module G single unit inspection.
Not a standard tank – but pharmaceutical-grade, validation-ready quality with complete technical documentation.
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Solingen
11.259 km
Skid CIP Farmasi 1.4435 GMP
BrinoxLEP 11 CS6710 Paket 1
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Manufacturer: BRINOX
Type: LEP 11 – CIP-Skid
Year of manufacture: 2020
Design: Pharmaceutical / GMP
Condition: New, unused, original packaging
LEP 11 CS6710 Package 1
Machine type
Pharmaceutical CIP System (Cleaning in Place) as a compact package unit on a stainless steel frame.
Application
For automated cleaning of process systems, chromatography systems, vessels, and piping systems in the pharmaceutical, biotech, and chemical industries.
Suitable for NaOH, acetic acid, WFI, PW, and other cleaning media.
Technical Data
Heating capacity CIP medium:
from +5 °C to +80 °C in max. 10 minutes
Pump capacity:
1 – 4 m³/h (adjustable)
Operating pressure at CIP supply:
1 – 3 bar (adjustable)
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Measuring ranges:
Flow: 0 – 10 m³/h
Temperature: 0 – +150 °C
Pressure: 0 – 6 bar
Design pressure:
-0.9 to +6 bar
Design temperature:
+2 to +95 °C
Construction
• Compact package unit on stainless steel frame
• CIP supply pump as centrifugal pump
• Shell-and-tube heat exchanger with leak-proof design
• Height-adjustable dished feet
• Fully drainable execution
• Maintenance-friendly design
• Industrial heavy-duty construction
Material & GMP design
• Product-contact and cleaning media-contact parts made of stainless steel 1.4435
• Electropolished surfaces Ra ≤ 0.8 µm
• FDA-compliant seals (EPDM / PTFE / silicone)
• Designed for NaOH 0.3 mol/L at +80 °C
• Resistant to acetic acid, WFIH, WFIC, PUW
Documentation & Quality
• Complete GMP documentation
• CE conformity
• 3.1 material certificates
• Complete welding protocols
• Weld seam documentation incl. photo documentation
• Pressure and tightness tests documented
• FAT documents available
• Drainability and final rinse certificates available
Condition
• New
• Unused
• Original packaging
• No operating hours
• Immediately available
Special features
• Very high thermal cleaning power
• Fully adjustable process operation
• Top pharmaceutical GMP execution
• High-quality European components
• Investment-secure system with full documentation
Location: Germany
Inspection possible by appointment
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Solingen
11.259 km
GMP CIP plant 1.4435 skid
BrinoxLEP 12 CS6721 Paket 3
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, manufacturer-brinox-model-lep-12-cip-system-precipitation-pre-le p-12-cs6721-package-3-year-of-manufacture-2020-condition-new-in-o riginal-packaging-unused-the-system-has-only-undergone-fat-testin g-at-the-factory-no-commissioning-no-production-no-media-contact- in-operation-description-modular-cip-process-system-for-pharmaceu tical-applications-in-hygienic-stainless-steel-design-compact-ski d-unit-with-fully-integrated-instrumentation-pumping-and-valve-te chnology-dimensions-approx-1520-x-970-x-1994-mm-materials-product -contact-parts-stainless-steel-1-4435-frame-structure-1-4301-weld s-in-accordance-with-en-iso-13920-features-shell-and-tube-heat-ex changer-hygienic-centrifugal-pump-magnetic-inductive-flow-meter-c onductivity-measurement-pressure-transmitters-temperature-measure ment-points-pneumatic-seat-and-diaphragm-valves-stainless-steel-f rame-construction-cip-supply-return-media-connections-for-naoh-ac etic-acid-steam-condensate-wastewater-testing-complete-fat-testin g-conducted-including-layout-inspection-pid-diagram-verification- accessibility-for-maintenance-and-calibration-documentation-check -surface-roughness-inspection-instrument-calibration-weld-documen tation-verification-leak-test-with-compressed-air-passed-calibrat ion-certificates-available-material-certificates-3-1-available-co mplete-weld-documentation-wps-wpqr-welder-certificates-ndt-eviden ce-ce-compliant-design-scope-of-supply-complete-pre-assembled-pro cess-module-including-documentation-fat-records-welding-protocols -material-certificates-and-calibration-certificates-fully-include d
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Solingen
11.259 km
Gmp-temperierskid-14435
BrinoxLEP 2.3 KK6752 Paket 7
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Manufacturer: BRINOX Process Systems
Model: LEP 2.3
System type: Temperature control unit for washing and elution solutions
Year of manufacture: 2020
Serial number: 1003563
Equipment no.: KK6752
Design: Stainless steel skid, pharmaceutical construction
LEP 2.3 KK6752 Package 7
Technical Data
Design:
Compact, pre-assembled temperature control unit mounted 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 (pharma grade)
Fully welded design
As-built isometrics available
Pressure data:
Leak test with compressed air
Test pressure: 3.37 bar
Holding time: 1 hour
Result: leak-free
Measuring 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 range: 0–10 bar
Electrical connection:
Control air: 6 bar
Automation-capable (all I&C points 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:
Chilled brine (flow/return interfaces available)
─────
Dimensions / Weight
Design: Compact skid unit
Industrial version for cleanroom/technical area
(Transport and installation dimensions according to layout drawing)
Application Area
Temperature control of:
Washing solutions
Elution solutions
Process media in biopharmaceutical environments
Areas of use:
Biotechnology
Plasma fractionation
GMP production plants
Construction
Welded stainless steel frame
Low-vibration pump mounting
Hygienic piping
Full compliance with P&ID
Clear separation of product / non-product zones
Service and maintenance access verified
Mechanical SAT-IQ test performed
Measurement SAT-IQ test performed
P&ID diagram check completed
Layout drawing check completed
Condition
Year of manufacture: 2020
Industrial and pharmaceutical version
Brand new, original packaging
Pressure tested
Sensor system calibrated
FAT performed
FAT / Documentation
Available:
FAT plan and report
Deviation management
Layout check
P&ID check
Leak test
Sensor calibration
Maintenance and accessibility check
EN10204 factory certificate
Material lists (LBM)
As-built isometrics
Component lists (equipment & I&C points)
Special features
Pharma-GMP compliant design
Complete validation documentation
Full traceability
Certified pressure testing
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Calibration certificates from accredited laboratories
Premium system construction by BRINOX
High-end biopharma standard
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Solingen
11.259 km
GMP pencuci larutan pemanas skid
BRINOXLEP 2.3 KK6762 Paket 9
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Manufacturer
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BRINOX d.o.o.
Project Number
B-0001113-LEP2.3
LEP 2.3 KK6762 Package 9
Module
M024
Product Description
LEP2.3 – Washing Solution Temperature Control Unit
Serial Number
1003572
Equipment Number
20022782
Tag Number
MR-INH-VPR61-KK6762
Year of Construction
2020
Technical Data
System Type
Pharma temperature control skid for the precise temperature control of washing and elution solutions.
Constructed as a compact, multi-tiered stainless steel frame design with fully integrated pump, heat exchanger, and valve technology.
Dimensions
Length 1920 mm
Width 1365 mm
Height 1840 mm
Version
Completely pre-assembled, insulated temperature control skid
Pharmaceutical-grade design in accordance with GMP requirements
Industrial stainless steel frame construction
Materials
Product-contacting parts: Stainless steel 1.4435 / 1.4571
Frame construction: Stainless steel 1.4301
Welding in accordance with EN ISO 13920 D
Insulation
Completely insulated pipelines and apparatus
Closed-cell high-performance insulation with black protective casing
Main Components
PU1021 Process pump
PU9203 Cooling medium pump
WT1001 Plate heat exchanger
WT1011 Finned tube heat exchanger
BH9701 Expansion vessel
Pneumatically actuated control valves
GEMÜ stainless steel ball valves
Pressure transmitters
Temperature measuring points
Pressure gauges
Electrical connection box with warning label
Stainless steel cable trays
Media
Cooling brine supply/return
Washing solution (process medium)
Control compressed air 6 bar
All media connections sealed at the factory and packaged for transport.
Leakage Tests
Performed as pressure tests with compressed air.
DP-01
Medium: Compressed air
Test pressure: 3.15 bar
Pressure drop: 0.13 bar
Date: 27.07.2020
Result: Passed
DP-02
Medium: Compressed air
Test pressure: 3.28 bar
Pressure drop: 0.07 bar
Date: 26.07.2020
Result: Passed
Pressure holding time: 1 hour each
No leaks detected
Calibration Certificates
Calibration laboratory: LOTRIČ Metrology
Certificates in accordance with EN ISO/IEC 17025
Measuring ranges: –1 to 20 bar and 0 to 10 bar
Calibration performed
Scope of Documentation
FAT plan and report
Deviation form
Layout drawing inspection
Maintenance inspection
P&ID diagram
Pressure test
Calibration certificates
Manufacturer's certificate 2.1 EN10204
Material list
As-built isometry
Complete turn-over package
Inspection Status
FAT performed
Pressure test passed
Calibrations available
PED-compliant design
Pharmaceutical documentation complete
Application
Temperature control of washing and elution solutions in biopharmaceutical production facilities
Suitable for GMP environments
Condition
New unit
Original packaging
Unused
Year of construction 2020
Factory condition
Fully documented
Immediately available
Iklan kecil
Solingen
11.259 km
Biopharma processanlage GMP plasma
Brinox
Hubungi
Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, For sale is a fully procured, modular GMP process system for the production of C1-esterase inhibitor (C1-INH) from human plasma.
The plant was engineered, procured, and subjected to complete FAT (Factory Acceptance Testing), but it was never installed or put into operation. It is explicitly not a used line, but a brand-new project and module package.
Year of manufacture: 2020
Condition: brand new, original packaging
Operating hours: 0
Storage: temperature-controlled warehouse
SYSTEM SCOPE (EXCERPT WITH QUANTITIES)
Adsorption / Chromatography (Bay 2 & 3):
- 2 adsorption lines (DEAE / QAE)
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- 2 intermediate tanks
- 2 pigging systems
- 2 cooled transfer lines (pipe-in-pipe)
- 4 filter press racks
- 4 cooling cascades
- 4 CIP loops
Precipitation PRE:
- 3 pre-precipitation tanks (incl. 1,000 L)
- 3 main precipitation tanks
- 3 CIP stations
- 3 multilayer filters
- 1 vacuum station
Buffer preparation (Bay 2 & 3):
- 6 buffer tanks (NaCl, DEAE, QAE buffer)
- 6 tempering skids
- 4 media/WFI/CIP manifolds
LEP 2.3 – Wash & elution solutions:
- 2 wash solution tanks (up to 9,000 L)
- 2 elution solution tanks
- 4 temperature control units
LEP 13 – Ammonium sulfate system:
- 1 preparation tank (3,500 L)
- 2 storage/distribution tanks
- Solids crusher
- Dosing and neutralization system
- Heat-traced pipelines
Media distribution:
- 1 pharmaceutical NaOH 1M system
- 1 technical NaOH 32% system
- 1 acetic acid 60% system
- Pump and dosing stations
Additional process tanks:
- >15 stainless steel tanks 316L (1,000–9,000 L)
- Various skids, distribution and instrumentation units
GMP & DOCUMENTATION
- URS / User Requirements Specification per LEP
- P&ID diagrams
- Layout and section drawings
- EMSR & instrumentation documentation
- FAT documentation
- Complete weld seam documentation (digital)
- Comprehensive photo documentation
Project documentation is available in full, structured both digitally and physically (316 folders).
PCS connection with prepared MES interface provided. Cleanroom integration according to specification.
SALE
Preferably as a complete system. Sale by module possible if no overall sale is realized.
Suitable for plasma fractionators, biopharmaceutical manufacturers, CDMOs, or site development projects.
Availability: short notice
Inspection by appointment
Price: on request
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