Biopharma procesna naprava GMP za plazmo

Brinox

Stanje: zelo dobro (rabljeno), Leto izdelave: 2018, Brinox SVMHI-550 Sterilna posoda za shranjevanje 550L Nerjavno jeklo 316L Leto izdelave: 2018 Preizkusni tlak: 7,2 bara Zelo malo uporabljena. Rezervoarji so v odličnem stanju. Bjdpfeymymvsx Ag Tscw

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, Package 15 PP6715 – CS6715 Brinox LEP 11 – Pharma Chromatography and CIP System New – Factory Sealed – Factory New Manufacturer: Brinox Model: LEP 11 Configuration: PP6715 with CIP System CS6715 Condition: New, unused, factory-sealed Description For sale is a high-quality pharmaceutical chromatography system Brinox LEP 11, consisting of the PP6715 panel and the dedicated CIP unit CS6715. The system is completely new, unused, and in the original manufacturer's condition. It was designed for industrial C1-INH chromatography and meets the highest GMP standards. Scope of Functions - Slurry transfer - Washing and elution processes Bodjyl Rqpjpfx Ag Tocw - Transfer to pre-precipitation vessels - Gel disposal - Standalone CIP loop Technical Features - Product-contact surfaces in stainless steel 1.4435 - Electropolished, Ra ≤ 0.8 µm - FDA-compliant sealing systems - CIP/SIP capable - Operating pressure up to 6 bar - Temperature range up to 95 °C - Pipework can be completely drained CIP Skid CS6715 - Stainless steel frame - Centrifugal pump - Shell-and-tube heat exchanger - Temperature control of cleaning medium - Adjustable inlet pressure The system is in mint, factory-new condition with zero operating hours.

Leto izdelave: 2020, Stanje: novo, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, Package 14 PP6713 – CS6713 Brinox LEP 11 – GMP Chromatography System with CIP Skid Bcedpfx Aeyl Rnnjg Tew New – unused – original packaging Manufacturer: Brinox Model: LEP 11 Version: PP6713 with CIP unit CS6713 Condition: New – in original packaging – never installed Description For sale is a pharmaceutical chromatography system LEP 11 consisting of the chromatography panel PP6713 and the associated CIP skid CS6713. The system is completely new, unused, and in the manufacturer’s original condition. This unit was designed for GMP-compliant protein purification as part of C1-INH chromatography. System Technology - Cleanroom panel for wall integration - Transfer lines to sieve-bottom tanks - Precipitation vessel connection - Gel disposal 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 - Material: 1.4435 - Fully drainable - GMP-compliant design CIP Unit CS6713 - Stainless steel frame construction - Centrifugal pump - Shell-and-tube heat exchanger - Conductivity, pressure, and temperature monitoring - Adjustable CIP forward flow The system is factory-new and has never been in operation.

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, Brinox LEP 11 – Pharmaceutical Chromatography System with CIP Unit New, unused, in original packaging Manufacturer: Brinox Model: LEP 11 Configuration: PP6711 with associated CIP unit CS6711 Condition: New – unused – in original packaging (Factory New Condition) Description For sale is a Brinox LEP 11 pharmaceutical chromatography system, consisting of the chromatography panel PP6711 and the associated CIP unit CS6711. The system is completely new, unused, and in its original packaging. It was designed, built, and delivered, but never installed or put into operation. Bodjyl Ndnspfx Ag Tjcw This unit is designed for C1-INH chromatography and is used for controlled protein purification with sieve bottom tanks in a GMP environment. Process Functions - Transfer of loaded QAE gel (slurry) - Washing and elution processes - Transfer of eluate to the pre-precipitation vessel - Gel disposal via container station - 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 ranges up to 10 m³/h - Adjustable slurry transfer 0.2 – 3 m³/h Configuration - Product-contact parts made of stainless steel 1.4435 - Electropolished, Ra ≤ 0.8 µm - FDA- and EU-compliant seals - Residue-drainable construction - Cleanroom panel with Tri-Clamp connection points - Magnetically monitored connecting 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 design The system is in factory-new condition and has never been used in production.

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, BRINOX LEP13.2 – AS Storage Temperature Control Unit – GMP – Year 2020 – As New Manufacturer: BRINOX Process Systems LEP13.2 KK6772 Package 12 System Type: LEP13.2 – AS Storage Temperature Control Unit Project: Ammonium Sulphate System Year of Manufacture: 2020 Serial Number: 1003624 Tag Number: MR-ASF-ASF61-KK6772 Location: Germany DESCRIPTION For sale is an as-new temperature control unit LEP13.2 in pharmaceutical GMP configuration, manufactured by BRINOX Process Systems. The system is designed as a compact, pre-assembled skid unit and was developed for use in an ammonium sulphate storage system. Complete project and FAT documentation available. TECHNICAL DATA Type: LEP13.2 – AS Storage Temperature Control Unit Medium: Ammonium Sulphate Version: 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 Extensive sensors & measuring devices Insulated piping Stainless steel skid frame construction APPLICATION 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 of manufacture: 2020 Project unit Very few operating hours Excellent optical and technical condition DOCUMENTATION FAT records Pressure test protocols P&ID diagrams Bjdpfjyl Na Njx Ag Tscw Layout drawings Factory certificates according to EN10204 Material lists EU Declarations of Conformity SPECIAL FEATURES Complete GMP documentation High-quality branded components Ideal for pharmaceutical and biotech applications Immediately available Significantly below new price

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, Manufacturer: BRINOX Process Systems LEP13.2 KK6771 Package 11 System Type: Temperature Control Unit – LEP13.2 AS Storage Project: Ammonium Sulphate 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 sulphate Design: Pharma / GMP Product-contacting materials: 1.4435 / 1.4301 stainless steel Dimensions (L x W x H): approx. 1900 x 1545 x 1580 mm Control compressed air: 6 bar (AIP) Tested pressure range: up to approx. 3–4 bar (leak test documented) MAIN COMPONENTS 2x centrifugal pumps Horizontal shell-and-tube heat exchanger Electric flow heater Expansion vessel Pressure and temperature measuring points Pneumatic control valves Manual ball valves (GEMÜ) Stainless steel control cabinet / terminal box Fully insulated pipework APPLICATION This temperature control unit is used for precise temperature management in the ammonium sulphate storage system of a pharmaceutical production facility. Suitable for: - Pharmaceutical production environments - GMP-regulated plants - Media temperature control systems - Turn-Over Package integration DESIGN / CONSTRUCTION Complete, pre-assembled skid unit Stainless steel frame construction Compact design with open maintenance access Fully piped and insulated Clear identification of all measuring points and fittings Pharmaceutical design according to customer specifications (CSL Behring) P&ID tested Layout verified Multiple documented leak tests Calibrated measuring instruments with certificates The system is fully pre-assembled, ready for installation, and prepared for integration into existing pharmaceutical systems. CONDITION As new / project system Year of manufacture: 2020 Factory Acceptance Test (FAT) performed Pressure test passed Comprehensive documentation available DOCUMENTATION (COMPREHENSIVE) Includes, among others: - Factory certificates according to EN 10204 - Material lists - EU declarations - Test reports - Documentation of installed equipment - I&C point documentation - As-built isometrics - User manual Bcedsyl I S Depfx Ag Tew - Calibration certificates FEATURES - Project-specific pharmaceutical design - GMP-compliant manufacturing - Complete skid construction - Compact footprint (approx. 1.9 x 1.5 m) - Maintenance-friendly design - High-quality pipe insulation - Ideal for cleanroom-adjacent technical areas

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, Manufacturer: BRINOX Product: LEP13.1 – AS Batch Tempering Unit System Type: Tempering unit for ammonium sulfate batch 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 / Municipal Water AIP10 – Control Compressed Air 6 bar Design as a closed tempering module with integrated pump and heat exchanger technology. Dimensions Overall dimensions according to layout: approx. 1920 x 1435 x 1573 mm (L x W x H) Compact, skid-mounted unit with welded stainless steel frame. Construction Frame construction in stainless steel Fully insulated pipework (industrial insulation) Stainless steel shell-and-tube heat exchanger Electric flow heater WT1011 Pump PU1021 Pump PU9203 Heat Exchanger WT1001 Expansion Vessel BH9701 Fittings: GEMÜ shut-off valves Pneumatically actuated valves Bcjdpfx Asyl Izxog Tjw Manual ball valves Pressure gauges Sensors and measuring points as per P&ID Complete pipe marking and component identification present. Condition New and in original packaging. Never commissioned in production. Factory new condition. Supplied directly from manufacturer Brinox. FAT / Test Status FAT performed. 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 Complete Turn-Over-Package Included documents: FAT plan FAT report Non-conformance form Layout drawing check Maintenance and calibration accessibility check P&ID diagram check Leak test report Calibration certificates Documentation check Factory certificate 2.1 according to EN 10204 LBM material list incl. EU declarations List of installed components – Equipment List of installed components – Instrument points (PLT) Material parts list to as-built isometry Special Features GMP-compliant design Pharmaceutical/biotech project quality Full traceability Compact plug-and-play skid design Completely piped, insulated, and ready for connection Immediately available

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, Manufacturer BRINOX d.o.o. Project Number B-0001113-LEP2.3 LEP 2.3 KK6762 Package 9 Module M024 Product Description LEP2.3 – Wash Solution Tempering Unit Serial Number 1003572 Equipment Number 20022782 Tag Number MR-INH-VPR61-KK6762 Year of Manufacture 2020 Technical Data System Type Pharmaceutical tempering skid for precise temperature control of washing and elution solutions. Constructed as a compact, multi-level stainless steel frame structure with fully integrated pump, heat exchanger, and valve technology. Dimensions Length: 1920 mm Width: 1365 mm Height: 1840 mm Design Fully pre-assembled, insulated tempering skid Pharmaceutical design in accordance with GMP requirements Industrial stainless steel frame construction Materials Product-contact parts: Stainless steel 1.4435 / 1.4571 Frame structure: Stainless steel 1.4301 Welds according to EN ISO 13920 D Insulation Completely insulated piping and equipment Closed-cell high-performance insulation with black protective covering Main Components PU1021 Process Pump PU9203 Cooling Medium Pump WT1001 Plate Heat Exchanger WT1011 Finned Tube Heat Exchanger BH9701 Expansion Vessel Pneumatic Control Valves GEMÜ Stainless Steel Ball Valves Pressure Transmitters Temperature Measurement Points Pressure Gauges Electrical Junction Box with Warning Labels Stainless Steel Cable Trays Media Cooling brine supply/return Wash solution process medium Control compressed air 6 bar All media connections factory-sealed and securely packed for transport. Leak Testing Conducted as a pressure test 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 Documentation Scope FAT plan and report Deviation form Layout drawing check Maintenance inspection Bcsdpfxoyl Iwto Ag Tew P&ID diagram Leak test Calibration certificates Factory certificate 2.1 EN10204 Material list As-built isometrics Complete turn-over package Test Status FAT performed Pressure test passed Calibrations available PED-compliant execution Complete pharmaceutical documentation Application Temperature control of washing and elution solutions in biopharmaceutical production plants Suitable for GMP environments Condition New system Originally packed Unused Year of manufacture: 2020 Factory condition Fully documented Immediately available

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, 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 Data System type: Temperature control unit / heating and cooling module for wash solutions (CIP or process cleaning systems) Design: Compact, fully pre-assembled skid unit in heavy-duty stainless steel frame construction, craneable via integrated lifting points. Frame and Structure: Welded stainless steel construction in industrial design, free-standing, multi-level piping arrangement for optimal space utilization. Maintenance-friendly access from multiple sides. Integrated cable trays. Piping: Stainless steel process piping in hygienic design, welded and partly flanged. Main pipelines and components with multilayer thermal insulation. Integrated drain and vent valves. Valve Technology: Several manual ball valves (GEMÜ) in main and bypass circuits. Pneumatically actuated control and shut-off valves for automatic temperature regulation. Membrane and control valves integrated into heating and cooling circuits. Instrumentation & Control: Temperature measurement points in supply and return lines. Pressure sensors in process lines. Integrated flow measurement. Electrical connection box with safety marking. 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 circuit. Pump Technology: Two electrically driven centrifugal pumps with red-coated motors for process circulation within the temperature control unit. Electrical: Electrical connection box with warning labeling. Wired sensors and actuators. Prepared for integration into a higher-level control or process control system. Application The system is used for the precise temperature control of a wash solution within a pharmaceutical or biotechnological process system. Typical applications include CIP systems, washing stations for production equipment, and temperature-controlled cleaning processes in the pharmaceutical and biotechnology industries. The wash solution is circulated in a closed loop by pumps, temperature adjusted via the integrated heat exchanger, and continuously monitored by sensors. Temperature is automatically regulated via pneumatic control valves to precisely maintain defined setpoints. Construction Compact modular skid design with fully insulated main pipelines. Stainless steel surfaces in hygienic industrial finish. Clear media routing and structured piping arrangement. Transportable by crane using integrated lifting points. Condition Year of manufacture: 2020. Very good visual and technical condition. Professional execution for pharmaceutical plant engineering. Bcsdeyl It Iepfx Ag Tew FAT / Documentation Typically supplied with CE conformity, factory acceptance test (FAT), and technical documentation including P&ID diagrams and material certificates for product-contact components. Special Features Fully insulated temperature control module in compact design with high power density. High-quality valve technology (GEMÜ). Multiple integrated measuring and control points. Suitable for validated pharmaceutical processes. Industrial, pre-assembled skid solution with clearly structured media routing.

Stanje: novo, Leto izdelave: 2020, Funkcionalnost: popolnoma funkcionalen, Oprema: dokumentacija / priročnik, 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 Equipment Number: KK6752 Design: Stainless steel skid, pharmaceutical-grade 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 design As-built isometry available Pressure Data: Leak test with 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 Open/Close valves pneumatic Pressure sensor measuring range: 0–10 bar Electrical Connection: Control air: 6 bar Automation-ready (instrumentation 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: Cooling brine (supply/return interfaces available) ───── Dimensions / Weight Design: Compact skid unit Industrial version for cleanroom/technical area (Transport and installation dimensions as per layout drawing) Application Area Temperature control of: Washing solutions Elution solutions Process media in biopharmaceutical environments Field of Application: Biotechnology Plasma fractionation GMP production facilities Build / Construction Welded stainless steel frame Vibration-damped pump mounting Hygienic piping layout Fully P&ID-compliant implementation Clear separation of product/non-product areas Service and maintenance accessibility tested 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-grade version New, original packaging Pressure tested Sensors calibrated FAT (Factory Acceptance Test) performed FAT / Documentation Available: FAT plan and report Deviation management Layout check P&ID check Leak test Sensor calibration Service and accessibility check EN10204 factory certificate Material lists (LBM) As-built isometry Component lists (equipment & instrumentation points) Special Features Bcodeyl Ipcspfx Ag Tsw Pharma GMP compliant design Complete validation documentation Full traceability Certified pressure testing Calibration certificates from accredited laboratories High-quality system construction by BRINOX High-end biopharmaceutical standard