Biopharma procesná jednotka GMP Plazma

Brinox

Stav: veľmi dobrý (použitý), Rok výroby: 2018, Brinox SVMHI-550 Sterilný zásobník 550 l Nerezová oceľ 316L Nodpfx Asymymvjg Aowc Rok výroby: 2018 Skúšobný tlak: 7,2 bar Veľmi málo používané. Nádrže sú vo vynikajúcom stave.

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, Brinox LEP 11 – Pharma Chromatography and CIP System New – in original packaging – Factory New Manufacturer: Brinox Model: LEP 11 Version: PP6715 with CIP system CS6715 Condition: New, unused, in original packaging Description For sale is a high-quality pharmaceutical chromatography system Brinox LEP 11, consisting of the PP6715 control panel and the associated CIP unit CS6715. The system is brand new, unused, and in the manufacturer’s original condition. It was designed for industrial C1-INH chromatography and complies with the highest GMP standards. Scope of Functions - Slurry transfer - Washing and elution processes - Transfer to pre-precipitation tanks - Gel waste disposal - Standalone CIP loop Technical Features - Product-contacting parts made of 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 - Drainable piping CIP skid CS6715 - Stainless steel frame - Centrifugal pump - Shell-and-tube heat exchanger - Temperature control for cleaning medium - Adjustable feed pressure The system is in mint, factory-new condition without any operating hours. Nwodpfx Agoyl Rqpj Aec

Rok výroby: 2020, Stav: nový, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, Package 14 PP6713 – CS6713 Brinox LEP 11 – GMP Chromatography System with CIP Skid New – unused – original packaging Manufacturer: Brinox Model: LEP 11 Configuration: PP6713 with CIP system CS6713 Condition: New – in original packaging – never installed Description Offered 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. The unit was designed for GMP-compliant protein purification as part of C1-INH chromatography. System Features Cleanroom panel for integration into wall Transfer lines to false-bottom containers Njdpfjyl Rnnsx Ag Aewc Connection for precipitation vessel Gel disposal line Complete process 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 construction CIP System CS6713 Stainless steel frame construction Centrifugal pump Shell and tube heat exchanger Conductivity, pressure, and temperature monitoring Adjustable CIP forward flow The system is brand new and has never been in operation.

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, Brinox LEP 11 – Pharmaceutical Chromatography System with CIP Unit New, unused, in original packaging Manufacturer: Brinox Model: LEP 11 Version: PP6711 with dedicated CIP system 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 corresponding CIP unit CS6711. The system is completely new, unused, and in its original packaging. It was designed, manufactured, and delivered, but was never installed or put into operation. This unit is designed for C1-INH chromatography and is intended for controlled protein purification using sieve bottom tanks in a GMP environment. Process Functions - Transfer of loaded QAE gel (slurry) - Washing and elution processes - Transfer of eluate to 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 rates up to 10 m³/h Nedpfx Aoyl Ndnjg Aowc - Adjustable slurry transport: 0.2 – 3 m³/h Construction - Product-contact parts made of stainless steel 1.4435 - Electropolished finish Ra ≤ 0.8 µm - FDA and EU-compliant seals - Completely drainable design - Cleanroom panel with Tri-Clamp connections - Magnetically monitored connection loops - 0.2 µm ventilation 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.

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, BRINOX LEP13.2 – AS Storage Tank Temperature Control Unit – GMP – Year of Manufacture 2020 – Like New Manufacturer: BRINOX Process Systems LEP13.2 KK6772 Package 12 System Type: LEP13.2 – AS Storage Tank Temperature Control Unit Project: Ammonium Sulfate System Year of Manufacture: 2020 Serial Number: 1003624 Tag Number: MR-ASF-ASF61-KK6772 Location: Germany DESCRIPTION For sale is a nearly new LEP13.2 temperature control unit in pharmaceutical GMP design, manufactured by BRINOX Process Systems. This unit is configured as a compact, pre-assembled skid system and was designed for use in an ammonium sulfate storage system. Complete project and FAT documentation available. TECHNICAL DATA Nwodpfx Ageyl Na Nj Asc Type: LEP13.2 – AS Storage Tank Temperature Control Unit Medium: Ammonium Sulfate Design: Pharma / GMP Materials: Stainless Steel 1.4435 / 1.4301 Control Air: 6 bar Pressure and leak testing performed FAT successfully completed MAIN COMPONENTS 2x KSB Movitec centrifugal pumps Alfa Laval plate heat exchanger Electric instantaneous water heater Reflex expansion vessel Samson control valve GEMÜ ball valves (manual & pneumatic) Labom pressure gauges Comprehensive sensor and instrumentation suite Insulated piping Stainless steel skid frame construction APPLICATION Temperature control of process media Use in GMP-regulated production environments Pharmaceutical and biotechnology facilities Temperature-controlled media circuits CONSTRUCTION Compact, closed skid system Fully piped Professionally insulated piping High-quality industrial components Service-friendly design Completely dismountable and transportable CONDITION Condition: New in original packaging Year: 2020 Project installation Minimal operating hours Excellent visual and technical condition DOCUMENTATION FAT documentation Pressure test protocols P&ID diagrams 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 Priced significantly below new

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, 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 No.: 20022749 LEP13.2 – AS Storage Temperature Control Unit TECHNICAL SPECIFICATIONS 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 flow heater - Expansion vessel - Pressure and temperature measuring points - Pneumatic control valves - Manual ball valves (GEMÜ) - Stainless steel switch cabinet / terminal box - Fully insulated piping APPLICATION The temperature control unit provides 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 - Turn-over package integration DESIGN / CONSTRUCTION - Complete, pre-assembled skid unit - Stainless steel frame construction - Compact design with clear maintenance access - Fully piped and insulated - Clearly labeled all measuring points and valves - Pharmaceutical version per customer specification CSL Behring - P&ID checked - Layout verified - Multiple documented leak tests - Calibrated measuring instruments with certificates The system is fully assembled, ready for installation, and prepared for integration into existing pharmaceutical systems. CONDITION Like new / Project equipment 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 - Test reports - Documentation of installed equipment - I&C point documentation - As-built isometrics - User manual - Calibration certificates SPECIAL FEATURES - Project-specific pharmaceutical version - GMP-compliant manufacturing - Complete skid construction - Compact footprint (approx. 1.9 x 1.5 m) - Maintenance-friendly design - High-quality piping insulation - Ideal for areas adjacent to cleanrooms Nwjdpfjyl I S Djx Ag Asc

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, Manufacturer: BRINOX Product: LEP13.1 – AS-Mix Tempering Unit System Type: Tempering Unit for Ammonium Sulfate Preparation 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 – Utility/City Water AIP10 – Instrument Air 6 bar Design as a closed-loop tempering 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 construction in stainless steel Fully insulated pipework (industrial insulation) Stainless steel shell-and-tube heat exchanger Electric instantaneous water heater WT1011 Pump PU1021 Pump PU9203 Njdpfx Ageyl Izxe Aowc 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 Complete pipeline and component identification available. Condition Brand new and in original packaging. No commissioning in production use. Factory new condition. Directly supplied by manufacturer Brinox. FAT / Test Status FAT conducted. Leak Test: Test Medium: Compressed air Test Pressure: approx. 3 bar Hold Time: 1 hour Result: Passed Calibration: Pressure gauge calibrated Measurement 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 Service and calibration accessibility check P&ID verification 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 – equipment List of installed components – I&C points Material parts list according to as-built isometry Special Features GMP-compliant design Pharmaceutical/Biotech project quality Full traceability Compact plug-and-play skid construction Fully piped, insulated, and ready-to-connect Immediately available

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, 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 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 parts: Stainless steel 1.4435 / 1.4571 Frame construction: Stainless steel 1.4301 Welds according to EN ISO 13920 D Insulation Completely insulated pipework and equipment Closed-cell high-performance insulation with black protective jacket Main Components PU1021 process pump PU9203 cooling medium pump WT1001 plate heat exchanger WT1011 finned tube heat exchanger BH9701 expansion vessel Pneumatically operated 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 Chilled brine supply / return Washing solution process medium Control compressed air 6 bar All media connections factory-sealed and securely packaged for transport. Nwsdoyl Iwtopfx Ag Asc Leak Tests Conducted 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 check Service inspection P&ID diagram Leak test report Calibration certificates Factory certificate 2.1 EN10204 Material list As-built isometry Turn-over package complete Inspection Status FAT completed Pressure test passed Calibration certificates 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

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, 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 solution (CIP or process cleaning system) Configuration: Compact, fully pre-assembled skid unit with a robust stainless steel frame construction, can be craned via integrated lifting points. Frame and Construction: Welded stainless steel construction in industrial design, free-standing, with multi-layered piping layout for optimal space efficiency. Maintenance-friendly access from multiple sides. Integrated cable trays. Piping: Stainless steel process piping in sanitary design, welded and partially flanged. Multi-layer thermal insulation of main lines and devices. Integrated drain and vent valves. Valve Technology: 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 in the heating and cooling circuits. Instrumentation and Control Technology: Temperature monitoring points in supply and return lines. Pressure sensors in the process section. Integrated flow measurement. Electrical terminal box with protective 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. Pumping Technology: Two electrically driven centrifugal pumps with red-lacquered motors for process circulation within the temperature control unit. Electrics: Electrical terminal box with warning markings. Wired sensors and actuators. Prepared for integration into a higher-level control or process management system. Application The system is used for precise temperature control of a wash solution in a pharmaceutical or biotechnological process system. Typical applications include CIP systems, wash stations for production lines, and temperature-controlled cleaning processes in the pharmaceutical and biotechnology industries. The wash solution is circulated in a closed loop using pumps, temperature-adjusted via the integrated heat exchanger, and continuously monitored by sensors. Temperature regulation takes place automatically via pneumatic control valves for precise adherence to specified setpoints. Construction Compact, modular skid design with fully insulated main lines. Stainless steel surfaces in sanitary industrial finish. Clear media routing and structured piping arrangement. Suitable for crane transport via integrated lifting points. Condition Year of manufacture 2020. Very good visual and technical condition. Professionally executed for pharmaceutical plant engineering. FAT / Documentation Njdsyl It Ispfx Ag Aewc 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 thermal module in a compact design with high power density. Premium valve technology (GEMÜ). Multiple integrated measuring and control points. Suitable for validated pharmaceutical processes. Industrial pre-assembled skid solution with clearly structured process media routing.

Stav: nový, Rok výroby: 2020, Funkcionalita: plne funkčný, Výbava: dokumentácia / manuál, 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 Construction: Compact, pre-assembled temperature control unit on a welded stainless steel frame (skid system) Materials: Product-contacting: Stainless steel 1.4435 / 1.4404 Non-product-contacting: 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 On/off valves, pneumatic Pressure sensor range: 0–10 bar Electrical connection: Control air: 6 bar Automation-ready (all control points fully documented) Main components: 2 process pumps Plate heat exchanger Finned tube heat exchanger Expansion vessel Several 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 area 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 Fully compliant with P&ID Clear separation of product / non-product areas Service and maintenance accessibility tested Mechanical SAT-IQ test performed Metrological SAT-IQ test performed P&ID diagram review completed Layout drawing review completed Condition Nwedjyl Ipcjpfx Ag Ajc Year built: 2020 Industrial and pharmaceutical-grade construction New – original packaging Pressure tested Sensors calibrated FAT performed FAT / Documentation Available: FAT plan and report Deviation management Layout review P&ID review Leak test Sensor calibration Maintenance and accessibility check EN10204 mill certificate Material lists (LBM) As-built isometry Component lists (equipment & automation points) Special features Pharma GMP-compliant design Complete validation documentation Seamless traceability Certified pressure testing Calibration certificates from accredited laboratories High-quality plant construction by BRINOX High-end biopharma standard