Biopharma processanlage GMP plasma

Brinox

Kondisi: sangat baik (bekas), Tahun pembuatan: 2018, Brinox SVMHI-550 Tang Penyimpanan Steril Kapasitas: 550L Baja Tahan Karat 316L Tahun: 2018 Nkedsymymvepfx Ahweu Tekanan Uji: 7,2 Bar Sangat jarang digunakan. Tangki dalam kondisi sangat baik.

Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Paket 15 PP6715 – CS6715 Brinox LEP 11 – Pharma Chromatography and CIP System New – Original Packaging – Factory New Manufacturer: Brinox Model: LEP 11 Version: PP6715 with CIP System CS6715 Condition: New, unused, in original packaging Description Nodsyl Rqpspfx Ahweku For sale is a high-quality pharmaceutical chromatography system Brinox LEP 11, consisting of the PP6715 control panel and the corresponding CIP unit CS6715. The system is completely new, unused, and in the manufacturer’s original condition. It was designed for industrial C1-INH chromatography and meets the highest GMP standards. Scope of Functions Slurry transfer Washing and elution processes Transfer to pre-precipitation tanks Gel disposal Independent CIP circuit Technical Specifications Product-contacting parts made from stainless steel 1.4435 Electropolished to Ra ≤ 0.8 μm FDA-compliant sealing systems CIP/SIP-capable Operating pressure up to 6 bar Temperature range up to 95 °C Drainable piping CIP skid CS6715 Stainless steel frame Centrifugal pump Tube bundle heat exchanger Temperature control of cleaning medium Adjustable inlet pressure The system is in like-new factory condition and has zero operating hours.

Tahun pembuatan: 2020, Kondisi: baru, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Package 14 PP6713 – CS6713 Brinox LEP 11 – GMP Chromatography System with CIP Skid New – unused – in original packaging Manufacturer: Brinox Model: LEP 11 Configuration: PP6713 with CIP System CS6713 Condition: New – in original packaging – never installed Description Offered is a pharmaceutical chromatography system LEP 11, consisting of the chromatography panel PP6713 and the corresponding CIP skid CS6713. The system is completely new, unused, and in original manufacturer condition. The unit was designed for GMP-compliant protein purification within the scope of C1-INH chromatography. System Features Cleanroom panel for wall integration Transfer lines to sieve-bottom tanks Precipitation vessel connection Gel waste line Complete media piping Technical Specification Design pressure: –0.9 to +6 bar Design temperature: +2 to +95 °C Electropolished surfaces Ra ≤ 0.8 µm Nkodeyl Rnnjpfx Ahwou Material: 1.4435 Completely drainable Manufactured according to GMP standards CIP System CS6713 Stainless steel frame construction Centrifugal pump Shell-and-tube heat exchanger Conductivity, pressure, and temperature monitoring Adjustable CIP feed The system is brand new and has never been in operation.

Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Brinox LEP 11 – Pharmaceutical Chromatography System with CIP Unit New, unused, original packaging Manufacturer: Brinox Model: LEP 11 Version: PP6711 with associated CIP unit CS6711 Condition: New – unused – factory packed (Factory New Condition) Description For sale is a Brinox LEP 11 pharmaceutical chromatography system, comprising the chromatography panel PP6711 and the associated CIP unit CS6711. The system is completely new, unused, and in the original packaging. It was designed, manufactured, and delivered, but never installed or commissioned. The unit is designed for C1-INH chromatography and is used for controlled protein purification using sieve-bottom vessels in a GMP environment. Process Functions - Transfer of loaded QAE resin (slurry) - Washing and elution processes - Transfer of eluate into precipitation vessels - Gel disposal via container station Nodpjyl Ndnofx Ahwjku - Fully automated CIP and SIP cleaning Technical Data - Fully CIP and SIP capable - Design pressure: –0.9 to +6 bar - Design temperature: +2 °C to +95 °C - Flow rates up to 10 m³/h - Adjustable slurry feed: 0.2 – 3 m³/h Construction - Product-contact parts: Stainless steel 1.4435 - Electropolished, Ra ≤ 0.8 µm - FDA and EU compliant seals - Draining design - Cleanroom panel with Tri-Clamp connections - Magnetically monitored connection bends - 0.2 µm vent filter CIP Unit CS6711 - Compact stainless steel skid - Centrifugal pump - Shell-and-tube heat exchanger - Adjustable operating pressure - GMP-compliant construction The system is in factory-new condition and has never been used in production.

Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, BRINOX LEP13.2 – AS Storage Tempering Unit – GMP – Year of Manufacture 2020 – As New Manufacturer: BRINOX Process Systems LEP13.2 KK6772 Package 12 System type: LEP13.2 – AS Storage Tempering Unit Project: Ammonium Sulfate System Year of manufacture: 2020 Serial number: 1003624 Tag number: MR-ASF-ASF61-KK6772 Location: Germany DESCRIPTION For sale is an as-new tempering unit LEP13.2 in GMP pharmaceutical design, manufactured by BRINOX Process Systems. The system is built as a compact, pre-assembled skid unit and was designed for use in an ammonium sulfate storage system. Complete project and FAT documentation available. TECHNICAL DATA Nodpfjyl Na Njx Ahwoku Type: LEP13.2 – AS Storage Tempering Unit Medium: Ammonium sulfate Design: Pharma / GMP Materials: Stainless steel 1.4435 / 1.4301 Control air pressure: 6 bar Pressure and leak tests performed FAT successfully completed MAIN COMPONENTS 2x KSB Movitec centrifugal pumps Alfa Laval plate heat exchanger Electric flow heater Reflex expansion vessel Samson control valve GEMÜ ball valves (manual & pneumatic) Labom pressure gauges Comprehensive sensors & measuring devices Insulated piping Stainless steel skid frame construction APPLICATIONS Temperature control of process media Use in GMP-regulated production areas Pharmaceutical and biotechnology plants Media circuits with temperature control CONSTRUCTION Compact, enclosed skid unit Fully piped Professionally insulated piping High-quality industrial components Service-friendly design Fully dismountable and transportable CONDITION Condition: New, original packaging Year: 2020 Project system Barely used (very low hours) Excellent optical and technical condition DOCUMENTATION FAT documents Pressure test protocols P&ID diagrams Layout drawings Factory certificates according to EN10204 Material lists EU Declarations of Conformity HIGHLIGHTS Complete GMP documentation High-quality branded components Ideal for pharma and biotech applications Immediately available Significantly below new price

Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Manufacturer: BRINOX Process Systems LEP13.2 KK6771 Package 11 System Type: Temperature Control Unit – LEP13.2 AS Storage Project: Ammonium Sulfate Supply and Disposal System: KK6771 Year of manufacture: 2020 Serial number: 1003622 Equipment number: 20022749 LEP13.2 – AS Storage Temperature Control Unit TECHNICAL DATA Product: LEP13.2 – AS Storage Temperature Control Unit Medium: Ammonium sulfate Design: Pharmaceutical / GMP-compliant Product-contact materials: 1.4435 / 1.4301 (stainless steel) Dimensions (L x W x H): approx. 1900 x 1545 x 1580 mm Control air pressure: 6 bar (AIP) Tested pressure range: up to approx. 3–4 bar (leak test documented) MAIN COMPONENTS 2x Centrifugal pumps Shell-and-tube heat exchanger (horizontal) Electric instantaneous water heater Expansion vessel Pressure and temperature measurement points Pneumatic control valves Manual ball valves (GEMÜ) Stainless steel control cabinet / junction box Fully insulated piping APPLICATION The temperature control unit is used for precise temperature management in the ammonium sulfate storage system of a pharmaceutical production facility. Suitable for: Pharmaceutical production environments GMP-regulated facilities Media temperature control systems Turnover package integration DESIGN / CONSTRUCTION Complete, pre-assembled skid unit Stainless steel frame construction Compact design with free maintenance access Fully piped and insulated Clear labeling of all measurement points and fittings Pharma design per customer specification CSL Behring P&ID checked Layout checked Multiple documented leak tests Calibrated measurement devices with certificates The system is fully assembled and prepared for integration into existing pharmaceutical systems. CONDITION As new / project system Year of manufacture: 2020 FAT performed Pressure test passed Complete documentation available DOCUMENTATION (COMPREHENSIVE) Includes, among others: Factory certificates according to EN 10204 Material lists EU Declarations of Conformity Test reports Documentation of installed equipment Instrumentation documentation As-built isometrics User manual Nkjdpfsyl I S Djx Ahwou Calibration certificates SPECIAL FEATURES Project-specific pharma design GMP-compliant manufacturing Complete skid construction Compact footprint (approx. 1.9 x 1.5 m) Maintenance-friendly setup High-quality pipe insulation Ideal for near-cleanroom technical areas

Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Manufacturer: BRINOX Product: LEP13.1 – AS Feed Solution Temperature Control Unit System Type: Temperature control unit for ammonium sulfate feed solution system Year of Manufacture: 2020 Serial Number: 1003620 Tag Number: MR-ASF-ASF61-KK6770 Equipment Number: 20022748 Media Connections / Process Data WCOV – Chilled water supply: 6°C WCOR – Chilled water return: 12°C WSV – Process/City Water AIP10 – Control compressed air 6 bar Design as a closed temperature control skid with integrated pump and heat exchanger technology. Dimensions Overall dimensions as per layout: approx. 1920 x 1435 x 1573 mm (L x W x H) Compact, skid-mounted unit with welded stainless steel frame. Construction Frame structure in stainless steel Fully insulated piping (industrial insulation) Stainless steel shell-and-tube heat exchanger Electric instantaneous water heater WT1011 Pump PU1021 Pump PU9203 Heat exchanger WT1001 Expansion vessel BH9701 Fittings: GEMÜ shut-off valves Pneumatically actuated valves Manual ball valves Pressure gauges Sensors and measuring points as per P&ID Pipework and component labeling fully provided. Condition Brand new and original packaging. Never commissioned in a production environment. Factory New Condition. Nksdpfx Ahsyl Izxoweu Supplied directly from manufacturer Brinox. FAT / Test Status FAT completed. Leak Test: Test medium: Compressed air Test pressure: approx. 3 bar Holding time: 1 hour Result: Passed Calibration: Pressure gauge calibrated Measuring range: 0–10 bar Calibration certificate available Traceable to national standards Documentation Turn-Over Package complete Included Documents: FAT plan FAT report Deviation form Layout drawing check Maintenance and calibration accessibility check P&ID check Leak test protocol Calibration certificates Documentation check Certificate of Compliance 2.1 as per EN 10204 LBM material list including EU declarations List of installed components – Equipment List of installed components – I&C points Material BOM for as-built isometrics Special Features GMP-compliant design Pharma/Biotech project quality Full traceability Compact plug-and-play skid construction Completely piped, insulated, and ready for connection Available immediately

Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Manufacturer 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 Nkjdpfx Ahoyl Iwtewou 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

Kondisi: baru, Tahun pembuatan: 2020, Fungsionalitas: berfungsi sepenuhnya, Perlengkapan: dokumentasi / manual, Manufacturer: BRINOX Type: LEP2.3 – Wash Solution Temperature Control Unit Year of manufacture: 2020 Serial number: 1003507 LEP2.3 KK6761 Package 8 Tag no.: MR-INH-VPR61-KK6761 Equipment no.: 20023781 Technical Specifications System type: Temperature control unit / Heating and cooling module for wash solution (CIP or process cleaning system) Design: Compact, fully pre-assembled skid unit in a heavy-duty stainless steel frame construction, craneable via integrated lifting lugs. Frame and structure: Welded stainless steel construction in industrial design, free-standing, multi-layer pipework layout for optimal space utilization. Maintenance-friendly accessibility from several sides. Integrated cable trays. Piping: Stainless steel process pipes with hygienic finish, welded and partially flanged. Multi-layer thermal insulation for main lines and equipment. Integrated drain and vent valves. Valve technology: Nodpfx Ahsyl It Iowjku Several manual ball valves (GEMÜ) in main and secondary circuits. Pneumatically actuated control and shut-off valves for automatic temperature regulation. Diaphragm and control valves integrated into the heating and cooling loop. Measurement and control technology: Temperature sensors in flow and return lines. Pressure sensors in the process section. Integrated flow measurement. Electrical connection box with safety labelling. Automatic temperature control via pneumatic control valve. Heat exchanger: Cylindrical stainless steel heat exchanger, insulated and integrated into the piping system. Designed for controlled heating and/or cooling of the wash solution in a closed loop. Pump technology: Two electrically driven centrifugal pumps with red-lacquered motors for process circulation within the temperature control unit. Electrics: Electrical connection box with warning labelling. Wired sensors and actuators. Prepared for integration into an overall control or process control system. Application The unit serves for precise temperature control of a wash solution within a pharmaceutical or biotechnological process system. Typical areas of application are CIP systems, wash stations for production plants, and temperature-controlled cleaning processes in the pharmaceutical and biotech industries. The wash solution is circulated in a closed loop by pumps, temperature-controlled via the integrated heat exchanger and continually monitored by sensors. Temperature regulation is automatic via pneumatic control valves to precisely maintain defined setpoints. Construction Compact modular skid construction with fully insulated main pipework. Stainless steel surfaces in a hygienic industrial design. Clear media routing and structured pipe arrangement. Crane-transportable via integrated lifting lugs. Condition Year of manufacture 2020. Very good visual and technical condition. Professionally executed pharmaceutical plant engineering. FAT / Documentation Typically supplied with CE conformity, factory acceptance test (FAT) as well as technical documentation including P&ID diagrams and material certificates for product-contact parts. Special Features Fully insulated temperature control module in a compact design with high power density. High-quality valve technology (GEMÜ). Multiple integrated measurement and control points. Suitable for validated pharmaceutical processes. Industrial, pre-assembled skid solution with clearly structured media routing.

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: Nkedeyl Ipcspfx Ahwou 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 Calibration certificates from accredited laboratories Premium system construction by BRINOX High-end biopharma standard