Biyofarma proses tesisi GMP Plazma için

Brinox

Durumu: mükemmel (kullanılmış), Üretim yılı: 2018, Brinox SVMHI-550 Steril Tutma Tankı 550L Ncedpfxeymymve Aa Ijn 316L Paslanmaz Çelik 2018 Model Test Basıncı: 7,2 Bar Çok az kullanılmıştır. Tanklar mükemmel durumda.

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, Package 15 PP6715 – CS6715 Brinox LEP 11 – Pharma Chromatography and CIP System New – factory-sealed – Factory New Manufacturer: Brinox Model: LEP 11 Version: PP6715 with CIP System CS6715 Ncedpfjyl Rqpox Aa Ion Condition: New, unused, factory-sealed Description For sale is a high-quality pharmaceutical chromatography unit Brinox LEP 11 consisting of the PP6715 panel and the accompanying CIP unit CS6715. The system is completely new, unused, and is in the manufacturer's original condition. It was designed for industrial C1-INH chromatography and meets the highest GMP requirements. Scope of Functions - Slurry transfer - Washing and elution processes - Transfer to precipitation vessels - Gel disposal - Stand-alone CIP loop Technical Specifications - Product-contacting parts made of stainless steel 1.4435 - Electropolished Ra ≤ 0.8 µm - FDA-compliant sealing systems - Suitable for CIP/SIP - Operating pressure up to 6 bar - Temperature range up to 95 °C - Piping can be fully drained CIP Skid CS6715 - Stainless steel frame - Centrifugal pump - Shell and tube heat exchanger - Temperature control of cleaning media - Adjustable feed pressure The system is in mint, factory-new condition with zero operating hours.

Üretim yılı: 2020, Durumu: yeni, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, 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 Unit CS6713 Condition: New – in original packaging – never installed Description Offered here is a pharmaceutical chromatography system LEP 11, consisting of a chromatography panel PP6713 and the associated CIP skid CS6713. The system is completely new, unused, and in its original manufacturer's condition. Ncjdpfjyl Rnnsx Aa Isn This unit was designed for GMP-compliant protein purification as part of C1-INH chromatography. Plant Technology Cleanroom panel for wall integration Transfer piping to sieve bottom vessels Precipitation vessel connection Gel disposal line Complete process piping Technical Specifications Design pressure: –0.9 to +6 bar Design temperature: +2 to +95 °C Electropolished surfaces Ra ≤ 0.8 µm Material: 1.4435 stainless steel Drainable without residue GMP-compliant design CIP Unit CS6713 Stainless steel frame construction Centrifugal pump Shell-and-tube heat exchanger Conductivity, pressure, and temperature monitoring Adjustable CIP flow The system is brand new and has never been in operation.

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, Brinox LEP 11 – Pharmaceutical Chromatography System with CIP Unit New, unused, in original packaging Ncjdpfxeyl Ndnj Aa Ien Manufacturer: Brinox Model: LEP 11 Version: PP6711 with corresponding 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 accompanying CIP unit CS6711. The system is completely new, unused, and remains in its original packaging. It was designed, manufactured, and delivered but never installed or put into operation. This unit is intended for C1-INH chromatography and enables controlled protein purification using sieve-bottom vessels in a GMP-compliant environment. Process Functions - Transfer of loaded QAE gel (slurry) - Washing and elution processes - Transfer of eluate to precipitation vessel - Gel disposal via container station - Fully automatic CIP (clean-in-place) and SIP (sterilize-in-place) cleaning Technical Specifications - 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 Execution - Product contact parts made of stainless steel 1.4435 - Electropolished, Ra ≤ 0.8 µm - Seals conforming to FDA and EU standards - Fully drainable construction - Cleanroom panel with tri-clamp couplings - Magnetically monitored connection arcs - 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.

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, 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 Sulphate System Year of manufacture: 2020 Serial number: 1003624 Tag number: MR-ASF-ASF61-KK6772 Location: Germany DESCRIPTION For sale is an as-new LEP13.2 tempering unit in pharmaceutical GMP-compliant design, manufactured by BRINOX Process Systems. The unit is configured as a compact, pre-assembled skid and was engineered for use in an ammonium sulphate storage system. Complete project and FAT documentation is available. TECHNICAL DATA Type: LEP13.2 – AS Storage Tempering Unit Medium: Ammonium sulphate Design: Pharmaceutical / 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 inline heater Reflex expansion vessel Samson control valve GEMÜ ball valves (manual & pneumatic) Labom pressure gauges Extensive sensor technology & measurement devices Insulated piping Stainless steel skid frame construction APPLICATIONS Tempering of process media Use in GMP-regulated production environments Pharmaceutical and biotechnology plants Media circuits with temperature control CONSTRUCTION Compact, closed skid unit Fully pre-piped Professionally insulated piping High-quality industrial components Maintenance-friendly design Fully dismountable and transportable CONDITION Nedpfx Asyl Na Noa Iscn Condition: New, original packaging Year of manufacture: 2020 Project equipment Very low operating hours Visually and technically in excellent condition DOCUMENTATION FAT documentation Pressure test certificates P&ID diagrams Layout drawings Factory certificates according to EN10204 Material lists EU declarations of conformity FEATURES Complete GMP documentation High-quality branded components Ideal for pharmaceutical and biotech applications Immediately available Significantly below new price

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, 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: Pharma / GMP compliant Product-contacting 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 (pressure test documented) MAIN COMPONENTS 2x Centrifugal pumps Shell-and-tube heat exchanger (horizontal) Electric instantaneous water heater Expansion vessel Pressure and temperature measuring points Pneumatic control valves Manual ball valves (GEMÜ) Stainless steel control cabinet / terminal box Fully insulated piping APPLICATION The temperature control unit ensures controlled temperature management in the ammonium sulfate storage system of a pharmaceutical production site. Suitable for: Pharmaceutical production environments GMP-regulated facilities Media temperature control systems Ncodpoyl I S Dofx Aa Ijn Turn-over package integration DESIGN / CONSTRUCTION Complete, pre-assembled skid unit Stainless steel frame construction Compact design with accessible maintenance Fully piped and insulated Clearly labeled measuring points and fittings Pharmaceutical design as per client specification CSL Behring P&ID verified Layout verified Multiple documented leakage tests Calibrated measuring instruments with certificates The unit is fully assembled, ready for installation, and prepared for integration into existing pharmaceutical systems. CONDITION As new / Project unit Year of manufacture: 2020 FAT completed Pressure test passed Full documentation available DOCUMENTATION (COMPREHENSIVE) Includes, among others: Factory certificates to EN 10204 Material lists EU declarations Test reports Documentation of installed equipment Instrumentation (PLT) documentation As-built isometrics User manual Calibration certificates SPECIAL FEATURES Project-specific pharmaceutical design GMP-compliant manufacturing Complete skid construction Compact footprint (approx. 1.9 x 1.5 m) Maintenance-friendly configuration Premium-grade pipe insulation Ideal for areas adjacent to cleanrooms

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, Manufacturer: BRINOX Product: LEP13.1 – AS Batch Temperature Control Unit System Type: Temperature control unit for ammonium sulfate batch system Year of construction: 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 – Utility/municipal water AIP10 – Control air pressure: 6 bar Designed as a closed temperature control module 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 constructed from stainless steel Fully insulated piping (industrial-grade 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 All piping and component identification present. Condition Brand new and original packaging. No commissioning in production operation. Factory new condition. Direct delivery from manufacturer Brinox. FAT / Inspection Status FAT performed. Leakage test: Test medium: compressed air Test pressure: approx. 3 bar Holding time: 1 hour Result: passed Nsdpfxsyl Izxs Aa Iscn 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 Deviation form Layout drawing check Maintenance and calibration accessibility check P&ID diagram check Leak test protocol Calibration certificates Documentation review Factory certificate 2.1 according to EN 10204 LBM material list incl. EU declarations List of installed components – devices List of installed components – E&I points Material parts list as-built isometry Special Features GMP-compliant design Pharma/biotech project quality Full traceability Compact plug-and-play skid design Fully piped, insulated, and ready for connection Immediately available

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, Manufacturer BRINOX d.o.o. Project Number B-0001113-LEP2.3 LEP 2.3 KK6762 Package 9 Module M024 Product Designation LEP2.3 – Washing Solution Temperature Control Unit Serial Number 1003572 Equipment Number 20022782 Tag Number MR-INH-VPR61-KK6762 Year of Manufacture 2020 Technical Data System Type Pharmaceutical temperature control skid for precise temperature regulation of washing and elution solutions. Constructed as a compact, multi-level stainless steel frame with fully integrated pump, heat exchanger, and valve technology. Dimensions Length: 1920 mm Width: 1365 mm Height: 1840 mm Design Fully pre-assembled, insulated temperature control skid Pharmaceutical design according to GMP requirements Industrial stainless steel frame construction Materials Product-contact surfaces: Stainless steel 1.4435 / 1.4571 Frame construction: Stainless steel 1.4301 Weld execution according to EN ISO 13920 D Insulation All piping and equipment completely insulated Closed-cell high-performance insulation with black protective sheathing 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 Manometers Electrical terminal box with warning labeling Stainless steel cable trays Media Chilled brine supply / return Washing solution process medium Control compressed air 6 bar All media connections sealed at factory and packed secure for transport. Leak Tests Ncedsyl Iwtepfx Aa Isn Performed as pressure testing 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 hold time: 1 hour each No leaks detected Calibration Certificates Calibration Laboratory: LOTRIČ Metrology Certificates as per 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 check P&ID diagram Leak test Calibration certificates Manufacturer’s certificate 2.1 EN10204 Material list As-built isometry Complete turnover package Testing Status FAT completed Pressure testing passed Calibrations available PED-compliant design Complete pharmaceutical documentation Application Temperature control of washing and elution solutions in biopharmaceutical production plants Suitable for GMP environments Condition New system Original packaging Unused Year of manufacture: 2020 Factory condition Fully documented Immediately available

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, Manufacturer: BRINOX Type: LEP2.3 – Washing 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 washing solution (CIP or process wash system) Design: Compact, fully pre-assembled skid unit with heavy-duty stainless steel frame construction, suitable for crane handling via integrated lifting points. Ncedpfx Aasyl It Ie Isn Frame and Assembly: Welded stainless steel industrial frame, free-standing with multi-level piping for optimal space utilization. Maintenance-friendly access from several sides. Integrated cable trays. Piping Construction: Stainless steel process piping in hygienic design, welded and partially flanged. Multi-layer thermal insulation of main pipes and components. Integrated drain and vent valves. Valve Technology: Multiple manual ball valves (GEMÜ) in main and bypass lines. Pneumatically actuated control and shut-off valves for automatic temperature control. Diaphragm and control valves integrated in the heating and cooling circuits. Measurement and Control Technology: Temperature sensors in supply and return lines. Pressure sensors in the process line. Integrated flow measurement. Electrical junction 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 washing solution in a closed circuit. Pump Technology: Two electrically driven centrifugal pumps with red-lacquered motors for process circulation within the temperature control unit. Electrical: Electrical control cabinet with warning labeling. Wired sensors and actuators. Prepared for integration into an overall control or process automation system. Application The unit is designed for precise temperature control of a washing solution within a pharmaceutical or biotechnological process system. Typical applications include CIP systems, washing stations for production equipment, and temperature-controlled cleaning processes in pharmaceutical and biotech industries. The washing solution circulates in a closed loop via pumps, is temperature controlled by the integrated heat exchanger, and continuously monitored via sensors. Temperature is regulated automatically using pneumatic control valves to ensure precise adherence to setpoints. Construction Compact, modular skid construction with fully insulated main lines. Hygienic-grade stainless steel surfaces. Clear media routing and organized piping layout. Transportable by crane via integrated lifting points. Condition Year of manufacture: 2020. Very good optical and technical condition. Professional execution for pharmaceutical plant engineering. FAT / Documentation Typically delivered with CE conformity, Factory Acceptance Test (FAT), and technical documentation including P&ID diagrams and material certificates for product-contacting parts. Special Features Fully insulated temperature control module with compact footprint and high power density. High-grade valve technology (GEMÜ). Several integrated measuring and control points. Suitable for validated pharmaceutical processes. Industrial pre-assembled skid unit with clearly structured media routing.

Durumu: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, 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 Nedpfx Aoyl Ipcsa Iecn Technical Specifications 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 isometrics available Pressure Data: Leak test with compressed air Test pressure: 3.37 bar Holding time: 1 hour Result: Leak-free Measurement & Control Technology: Pressure measurement (PIR, PI, PIRC) Temperature measurement (TI, TIRC) Level measurement (limit value) Flow monitoring Position feedback Motor control Pneumatic on/off valves Pressure Sensor Measuring Range: 0–10 bar Electrical Connection: Control air: 6 bar Automation-capable (all instrumentation/control 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 (supply/return interfaces available) ───── Dimensions / Weight Design: Compact skid unit Industrial design for cleanroom/technical areas (Transport and installation dimensions as per layout drawing) Application Temperature control of: Washing solutions Elution solutions Process media in biopharmaceutical environments Areas of Use: Biotechnology Plasma fractionation GMP production facilities Construction / Design Welded stainless steel frame Low-vibration pump mounting Hygienic piping layout Fully compliant with P&ID implementation Clear separation of product/non-product area Service and maintenance accessibility verified Mechanical SAT-IQ test performed Metrological SAT-IQ test performed P&ID diagram inspection completed Layout drawing inspection completed Condition Year of manufacture: 2020 Industrial and pharmaceutical configuration Brand new, original packaging Pressure tested Sensors calibrated FAT completed FAT / Documentation Available: FAT plan and report Deviation management Layout inspection P&ID inspection 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 execution Complete validation documentation Full traceability Certified pressure tests Calibration certificates from accredited laboratories High-quality plant construction by BRINOX High-end biopharma standard