Biyofarma proses tesisi GMP Plazma için

Brinox

Durum: iyi (kullanılmış), 5 ADET İYİ DURUMDA BİR CIP CİHAZINDA MONTE EDİLMİŞLERDİ Dwodeykk Edspfx Al Djc

Çalışma saatleri: 240 h, durum: yenilenmiş (kullanılmış), Fonksiyonellik: tamamen fonksiyonel, makine/araç numarası: MSB14, Machine completely disassembled and overhauled with new and original GEA-Westfalia spare parts. During the overhaul, among other interventions, the bevel gear set was replaced with new and original components, and the frame was oven-painted. Hydraulic capacity: Up to 8,000/9,000 l/h Actual throughput: between 500/1,000 l/h, capacity measured by tests with your treated product. The actual capacity may vary significantly depending on the percentage of solid residues present in the product to be processed. Technical specifications: - Electric motor: 7.5 kW, 380V/3-phase, 50Hz - Bowl volume: 6.9 l; sludge chamber: 3.9 l - Bowl speed: 7,500 rpm The machine is sold complete with the following accessories: - Set of special keys for disassembling the bowl - New electrical control panel with 11 kW inverter power section and discharge control section with PLC, all housed in a stainless-steel box. Djdexvrfnepfx Al Djwc The use of an inverter ensures smoother startups and significant reduction in power consumption and maintenance. - New control water unit with 20-litre stainless steel tank, complete with float and stainless steel pump for consistently steady pressure - Flow indicator - Machine mounted on a robust platform with four M20 anti-vibration feet, made from square profiles

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Machine Designation BRINOX Process System / CIP Skid Type CS6700 (CS6723) GMP CIP Process Skid 1.4435 Manufacturer BRINOX Process Systems Year of Manufacture 2020 Technical Specifications Constructed as a stainless steel process skid in hygienic design. Conductivity measurement 1–500 µS/cm, analogue signal (AI), hygienic connection DN 50. Flow measurement 0–18,000 kg/h, analogue signal (AI), connection DN 25, sterile flange DIN 11864-2A. Dodsyl H Svepfx Al Dowc Pressure measuring points −1 to 9 bar as well as −1 to 15 bar, analogue signal (AI), hygienic connections DN 50 and ½", including DIN EN ISO 228. Temperature measuring points −50 °C to +200 °C, analogue signal (AI), connection DN 32, welded according to DIN 11866/A. Limit level sensors, digital (DI), hygienic connection DN 50. Multiple position feedbacks with IO-Link / digital. Pneumatically actuated on/off valves (DO) in stainless steel hygienic design. Product-contact materials as per EN 1.4435 / 1.4404 (AISI 316L). Documented surface roughness of product-contact surfaces in the range of Ra approx. 0.3–0.4 µm. Application Hygienic CIP and process system for pharmaceutical and biotechnological applications. Suitable for cleaning process pipelines and vessels under GMP conditions. Construction Welded stainless steel skid with orbital welded piping. Hygienic clamp and sterile connections. Fully instrumented with flow, pressure, temperature and conductivity measurement. Pneumatic valve technology with digital feedback. Components from renowned manufacturers such as Endress+Hauser, Gemü, Samson, SICK, among others. Clean, GMP-compliant execution. Condition New. In original packaging. Unused. Never installed or commissioned. FAT / Documentation Status Fully documented Factory Acceptance Test carried out. Layout drawing inspection documented. Maintenance and calibration accessibility check documented. Surface roughness test documented. Leak test documented. Calibration of sensors documented. Welding documentation fully verified. Complete Documentation List FAT plan and FAT report. P&ID diagram. Layout drawings. Metal and polymer material lists. Material certificates 3.1. WPQR, WPS, welder qualifications. Welding protocols and isometrics. Calibration certificates for measuring devices. Surface roughness measurement protocols. Leak test protocols. EU declarations of conformity for installed components. Operating documentation. Special Features GMP-compliant, fully documented manufacturing. Premium instrumentation. Very low documented surface roughness values. Immediately available. Ideal for pharmaceutical, biotech or contract manufacturers with high documentation requirements.

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, Machine Description BRINOX LEP 12 – CIP System Precipitation PRE LEP 12 CS6725 Package 5 Dwodpfeyl H Taex Al Djc Manufacturer BRINOX Prozess- und Edelstahltechnik GmbH, Offenburg Year of Manufacture 2020 Serial Number 1003614 Technical Specifications Compact CIP skid unit with stainless steel frame construction. Product name: LEP 12 – CIP System Precipitation PRE. Dimensions approx. 1520 x 970 x 1994 mm. Product-contact parts material: stainless steel 1.4435. Frame and structural components: stainless steel 1.4301. Integrated shell-and-tube heat exchanger by NEUMO. Hygienic centrifugal pump. Piping fully welded, pharmaceutical-grade execution. Insulated media lines. Fittings include GEMÜ ball valves. Various integrated pressure gauges and measuring instruments. Calibrated pressure measuring system (Fluke pressure transducer, measurement range −1 to 20 bar, resolution 0.001 bar, accuracy 0.06% FS). Media connections: NaOH Acetic acid CIP supply CIP return Plant steam Plant steam condensate Neutralized wastewater Leak test performed with compressed air. Test pressure range approx. 3.19–3.24 bar. Maximum measured pressure drop < 0.015 bar during test duration. Result: passed. Application CIP cleaning system for pharmaceutical process plants, especially for precipitation vessels. Suitable for alkaline and acid cleaning as well as steam connection. Designed for hygienic applications in pharmaceutical production. Construction Welded, compact skid design with heavy-duty stainless steel frame. Hygienic piping layout with defined media paths. Integrated shell-and-tube heat exchanger for tempering CIP media. Integrated process pump, valve technology, and measuring instrumentation on one compact frame. General tolerances according to EN ISO 13920. Industrial design with crane lugs for transport. Condition New, unused, in original packaging. The unit has only undergone FAT and was never in production operation. FAT / Documentation Status Complete Factory Acceptance Tests performed. Leak tests successfully passed. Calibration certificates available. Test reports fully documented. Full Documentation List FAT documentation Leak test protocols Calibration certificates P&ID 3D drawings Material and welding documentation Nameplate and manufacturer documentation Special Features Pharmaceutical-grade material selection. Compact, ready-to-use skid unit. High-quality components from renowned manufacturers. Complete technical documentation available. Immediately available.

Durum: yenilenmiş (kullanılmış), Üretim yılı: 2023, Fonksiyonellik: tamamen fonksiyonel, toplam yükseklik: 1.850 mm, toplam genişlik: 1.400 mm, toplam uzunluk: 2.000 mm, film genişliği: 600 mm, Servo kontrollü, yüksek esneklikte paketleme makinesi (hacim 10 litreye kadar.H=1850mm) Dwedpfev Dwbbsx Al Doc Çok iyi durumdadır ve hemen çalıştırılabilir. Tüm kompozit filmler için ısıyla yapıştırma makinesi, talep üzerine PE filmler için kalıcı ısıtmalı, teflon kaplamalı yapıştırma aparatları da mevcuttur. Torba genişlikleri 260 mm'ye kadar (opsiyonel 320 mm) ve torba uzunlukları 500 mm'ye kadar. Makine çok iyi durumdadır. Reçete yönetimine sahip dokunmatik ekranlı işletim terminali üzerinden yeni kontrol. İstenirse devreye alma konusunda da sizlere yardımcı olmaktan mutluluk duyarız. Ayrıca yedek parçaların uzun vadeli tedariğini de sağlayabiliyoruz ve tüm çanta şekilleri için tedarik format setleri vb. (örneğin blok tabanlı çantalar için dönüşüm kolayca uygulanabilir) Paslanmaz çelik olarak da mevcuttur

Durum: 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 Djdpfx Aoyl Izxel Dowc 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 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

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, Donanım: dokümantasyon / kılavuz, Brinox LEP 11 – Pharmaceutical Chromatography System with CIP Unit New, unused, in original packaging 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 Dedeyl Ndnepfx Al Dowc - 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.

Üretim yılı: 2020, durum: yeni, Fonksiyonellik: tamamen fonksiyonel, Manufacturer: BRINOX Machine Description: CIP System CS6720 Model: LEP12 – CIP Module with Insulated Buffer Tank 200 L Year of Manufacture: 2020 Condition: New, unused, original packaging, never installed, never commissioned System Type: Modular CIP (Cleaning in Place) system mounted on a stainless steel frame, fully pre-assembled. Consisting of: insulated CIP buffer tank, centrifugal pump, heat exchanger, stainless steel piping module, valve technology, measuring and control technology, and media connections. Frame Dimensions: approx. 2330 x 1224 x 2127 mm Buffer Tank: - Working volume: 200 liters - Total volume: 278 liters - Cylindrical design with dished ends according to DIN 28011 - Operating pressure: -1 to +3 bar - Test pressure: 5.4 bar - Permissible temperature: -10 °C to +150 °C - Operating temperature: 0 °C to +85 °C Djdpfxoyl H Hts Al Djwc - Fluid group: 1 - Insulation: Glass wool with low chloride content (

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, depo kapasitesi: 30.000 l, Donanım: dokümantasyon / kılavuz, BRINOX 30,000 L WWAS / Solution Vessel – 316L – PED – FAT – complete GMP documentation – incl. saddle support – 2020 – as new Manufacturer: BRINOX d.o.o. Tag No.: LV6456-BH1001 Serial Number: 1003464 Year of Manufacture: 2020 Condition: As new / unused Location: Europe LV6456-BH1001 Package 66 TECHNICAL DATA Product type: WWAS / Solution Vessel / Pharmaceutical Process Vessel Working volume: 30,000 liters Total volume: 33,213 liters Product-contact material: Stainless steel 1.4404 (AISI 316L) Surface finish: Chemically pickled, passivated, and cleaned Surface roughness: Ra < 1.6 µm Standards and Guidelines: • PED 2014/68/EU compliant • CE marking present • GMP-compliant pharmaceutical design Pressure Data: Min.: –0.14 bar(g) Max.: +0.5 bar(g) Test pressure: 0.72 bar(g) Temperature range: –20 °C to +50 °C Hydrostatic pressure test performed. FAT – Factory Acceptance Test Fully documented FAT carried out, including: • Dimensional, visual, and identification check • Weld inspection and NDT • Pressure test in accordance with PED • Inspection of all connections • Documentation and quality check FAT fully passed. FAT report available. DESIGN / CONSTRUCTION • Horizontal pharmaceutical process vessel • Stainless steel 316L, pharmaceutical grade • Internal surfaces pickled and passivated • Hygienic, GMP-compliant construction Connections include: • Manway DN500 • Inlet DN100 • Outlet DN50 • Measuring, safety, and process connections Mechanical design: • Original BRINOX stainless steel saddle support included • Heavy-duty construction • Lifting points for crane handling available CONDITION • Absolutely like new • Never installed or used in production • Never filled with product • No corrosion or signs of use • Original industrial packaging available • Immediately available Saddle support also in as-new condition and part of the delivery scope. DOCUMENTATION – fully available (GMP-compliant) Extensive manufacturer and project documentation including: • EU declaration of conformity and CE documentation • PED documentation • Material certificates EN 10204 – 3.1 • Welding documentation (WPS / WPQR, welder lists) • NDT test reports • FAT protocol and pressure test report • Roughness and surface finish protocols • Calibration certificates • Partial drawings and parts lists • Operating and maintenance manuals Documentation fully available in digital form. TRANSPORT AND PACKAGING • Professional export packaging available • Original industrial packaging • Crane handling without difficulty • Worldwide shipping possible SUITABLE FOR • Pharmaceutical industry • Biotechnology • WWAS, WFI and PW systems Dodpfxoykngfo Al Dowc • Sterile process solutions • GMP production facilities SPECIAL FEATURE Project surplus from an international pharma greenfield project with complete FAT, PED compliance, and GMP documentation. Large-volume BRINOX 30,000 L pharmaceutical process vessel in new equipment quality incl. saddle support – immediately available

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, depo kapasitesi: 1.500 l, Donanım: dokümantasyon / kılavuz, BRINOX 1,500 L Process Vessel – 1.4435 – Double Jacket – PED Module G – TÜV – FAT – 2020 – Mint Condition Manufacturer: BRINOX d.o.o. Tag No.: BH6722-BH1001 Year of Manufacture: 2020 Condition: As new / unused CE Marking: CE 0036 TECHNICAL DATA Product Type: Main process vessel Dwjdpfx Alsykuc To Dsc Design: Cylindrical with dished heads Working Volume: 94 – 1,500 litres Empty Weight: 866 kg Product-contact material: 1.4435 Jacket material: 1.4307 Insulation: present Vessel operating pressure: -1 / +3 barg Permissible pressure (PS): -1 / +3 barg Test pressure (PT): 5.4 bar Permissible temperature (TS): -10 °C / +150 °C Pressure test date: 2020/04 Pressure Equipment Directive 2014/68/EU Category IV Assessment Procedure: Module G Notified Body: TÜV SÜD Industrie Service GmbH Design Code: AD 2000 SURFACES & WELDS Internal Surface: Electropolished and passivated Pharmaceutical grade External Surface: Industrial ground finish NDT / Testing: RT (Radiographic testing) PT (Dye penetrant testing) Pressure test 2020 documented EQUIPMENT • Double jacket for heating/cooling • Large frontal manway • Multiple process nozzles • CIP connections • Temperature and pressure connections • Safety fittings • Agitator mounting • FDA-compliant gaskets • Complete piping module CONDITION • Never used in production • Stock item • Internal surface in as-new condition • No corrosion • No signs of use • Immediately available DOCUMENTATION – complete • EU Declaration of Conformity • TÜV certificates and acceptance reports • PED Module G documentation • 3.1 material certificates (EN 10204) • Welding protocols • NDT reports (RT / PT) • Pressure test report 2020 • Surface certificates • Detail and assembly drawings • FAT documentation • Operating and maintenance manuals SPECIAL FEATURE BRINOX pharma process vessel in 1.4435 with electropolished internal surface, AD2000 design, PED Category IV Module G, complete TÜV acceptance 2020 and full technical documentation. Project quality for sterile applications – immediately available.

Durum: mükemmel (kullanılmış), Cam pişirme tavası 300 litre ve yan duvar sıyırmalı. Termik yağ kazanı ile. Her iki tarafa da yatar. Dwedpfxjumb His Al Dsc

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, depo kapasitesi: 1.500 l, Donanım: dokümantasyon / kılavuz, BRINOX 1,500 L Process Vessel – 1.4435 – Double Jacket – PED Module G – TÜV – FAT – 2020 – As New Manufacturer: BRINOX d.o.o. Dwsdpfx Ajykuhijl Djc Tag No.: BH6726-BH1001 Type: SVMBBI-1500 Year of Manufacture: 2020 Serial No.: 1003458 Equipment No.: 20051401 CE Marking: CE 0036 Condition: As new / unused Empty Weight: 866 kg TECHNICAL DATA Product Type: Main storage vessel / process vessel Design: Cylindrical with dished ends Working Volume: 1,500 litres Total Volume: 1,785 litres Product-contact material: 1.4435 Jacket material: Stainless steel (double jacket design) Max. allowable pressure (PS) vessel: -1 / +3 bar Test pressure (PT): 5.4 bar Max. allowable temperature (TS): -10 °C / +150 °C Pressure vessel according to PED 2014/68/EU Module: G Fluid group: 1 SURFACES & EXECUTION Internal surface: High-gloss polished, pharmaceutical grade Product-contact areas in 1.4435 Weld seams finely ground Pharma-CIP-capable version EQUIPMENT • Double jacket for heating/cooling • Large manway with clamp closures • Multiple instrumentation and process nozzles • Pressure sensor / temperature connections • Bottom outlet • CIP/spray ball connectors • Various blind flanges • Insulated service connections on jacket • FDA-compliant seals CONDITION • Never used in production • Stock item • Interior absolutely as new • No corrosion • No signs of use • Immediately available DOCUMENTATION – complete • EU Declaration of Conformity • TÜV inspection documents • PED Module G documentation • 3.1 Material certificates • Pressure test protocol (PT 5.4 bar) • Technical drawings • FAT documentation • Operating manual SPECIAL FEATURE High-volume BRINOX main process vessel 1,500 L in 1.4435, PED Category IV Module G, CE 0036, with complete documentation, pharmaceutical-grade surface finish and 5.4 bar pressure test. Project quality for sterile applications – immediately available.

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, depo kapasitesi: 3.500 l, Donanım: dokümantasyon / kılavuz, BRINOX 3,500 L Storage Tank – 1.4435 – Double Jacket – PED Module G – TÜV SÜD – FAT – 2020 – As New Manufacturer: BRINOX d.o.o. Type: SVBBHI-3500 Tag No.: BH6772-BH1001 Package 30 Serial Number: 1003462 Year of Manufacture: 2020 Condition: As new / unused TECHNICAL DATA Product type: Storage vessel / Process vessel Nominal capacity: 3,500 liters Total volume: 4,082 liters Jacket volume: 226 liters Empty weight: approx. 1,760 kg Product-contact material: 1.4435 (AISI 316L pharmaceutical grade) Jacket material: 1.4404 CE marking: CE 0036 Dsdpfx Aljylnwye Dswc Permissible pressure PS vessel: -1 / +3 bar Permissible pressure PS jacket: -1 / +6 bar Test pressure PT vessel: 5.6 bar Test pressure PT jacket: 10.8 bar Permissible temperature TS: -10°C to +150°C Fluid group: 2 Design according to AD 2000 regulations Pressure vessel in accordance with PED 2014/68/EU Category IV Module G – Individual test Notified Body: TÜV SÜD Industrie Service GmbH (identification no. 0036) TÜV approval including design review, final inspection, and pressure test fully documented. FAT – Factory Acceptance Test The vessel has been fully tested and released by the manufacturer. Tests performed include: • Pressure test in accordance with PED • Design review by TÜV SÜD • Visual inspection of all weld seams • Non-destructive testing (RT, PT) • Dimensional and drawing comparison (as-built) • Verification of material certificates • Calibration test of manometers • Marking verification • Documentation check as per inspection list Complete FAT and TÜV protocols available. CONSTRUCTION • Cylindrical, horizontal storage vessel • Double jacket for heating/cooling • High-quality pharmaceutical-grade design • Manhole with round pressure lock • CIP pipework • J-pipe / internal piping • Sight glass DN80 • Multiple spare and process connections • Biocontrol flanges • Heavy-duty supports / trunnion type • Lifting lugs • Nameplate with full PED marking DOCUMENTATION – fully available and well-structured • EU Declaration of Conformity • TÜV certificate with acceptance report (Module G) • TÜV design review & certification • 3.1 material certificates • Welder lists and work samples • Non-destructive test reports (RT, PT) • Dimensional inspection reports • Manometer calibration protocols • Surface and manufacturing reports • Parts list • Detailed drawings (shell, lid, CIP, J-pipe, etc.) • Operating and maintenance manuals Complete digital documentation folder available. CONDITION • Never used in production • Stock item • Interior surface as new • No corrosion • No signs of use • Industrial new condition • Immediately available SUITABLE FOR • Pharmaceutical solutions • WFI / PW systems • Buffer and media preparation • Chemical media • GMP production plants • Process and wastewater plants FEATURE High-end BRINOX pharmaceutical manufacturing with full PED Module G individual acceptance by TÜV SÜD, CE 0036 marking, and documented FAT testing. Not a standard tank – but certified project-quality equipment with comprehensive GMP-compliant documentation.

Üretim yılı: 1979, durum: ikinci el, Westfalia Separator, last used in a fruit juice processing facility. The separator's control system was modernized by GEA. The product is clarified within the centrifuge's discs and is discharged under pressure. Solids are collected in the solids chamber and periodically discharged automatically. During CIP (Cleaning-in-Place), the cleaning fluid is recirculated through the system. Machine type: Disc stack centrifuge Throughput capacity: 22,000 l/h; throughput for fruit juice approx. 4,000 l/h Bowl speed: 6,500 rpm Density of liquid phase: 1 kg/dm³ Density of solid phase: 1.4 kg/dm³ Power: 18.5 kW Current: 37 A Voltage: 380 V Frequency: 50 Hz Length: 1,485 mm Width: 850 mm Height: 1,470 mm Material: product-contacting surfaces made of stainless steel Location/position: mounted on a 685 x 585 mm base Djdpeyr Ic Nefx Al Djwc Equipment: bowl, drive unit, inlets for product and displacement liquid, control water inlet with solenoid valve, outlet, solids discharge, control water outlet, circulation controller, oil sight glass, brake, regulating valve, hood cleaning, pressure gauge Weight: 1,200 kg

Durum: yeni, Üretim yılı: 2020, Fonksiyonellik: tamamen fonksiyonel, makine/araç numarası: BH6721-BH1001, depo kapasitesi: 1.000 l, Donanım: dokümantasyon / kılavuz, BRINOX 1,000 L Prefill Tank – 1.4435 – Double Jacket – PED Module G – TÜV SÜD – FAT – 2020 – As New Manufacturer: BRINOX d.o.o. Type: SVMBBl-1000 Tag No.: BH6721-BH1001 Serial No.: 1003453 Year of Manufacture: 2020 Condition: As new / unused TECHNICAL DATA Product Type: Prefill/Process Tank Nominal Volume: 1,000 liters Total Volume: 1,400 liters Empty Weight: 762 kg Product-contact material: 1.4435 (AISI 316L pharmaceutical grade) CE Marking: CE 0036 Permissible Pressure PS: -1 / +3 bar Test Pressure PT: 5.4 bar Permissible Temperature TS: -10 °C to +150 °C Fluid Group: 1 Design according to AD 2000 code Pressure vessel in accordance with PED 2014/68/EU Category IV Module G – Individual inspection Notified body: TÜV SÜD Industrie Service GmbH (ID number 0036) TÜV approval including final inspection and pressure test fully documented. FAT – Factory Acceptance Test The vessel was fully FAT-tested and released at the manufacturer. Tests performed include: • Pressure test according to PED • Visual inspection of all weld seams • Non-destructive tests (RT, PT as per inspection plan) • Dimensional and drawing check (as-built) • Internal surface roughness measurement (Ra ≤ 0.8 µm) • Calibration check of pressure gauges • Marking verification • Comprehensive documentation review Complete FAT protocols available. Djdjykpqropfx Al Dowc EXECUTION/FEATURES • Cylindrical, horizontal tank • Double jacket for heating/cooling • Interior electropolished and passivated • High-gloss polished product-contact surface • Pharma-grade weld seams • Manway DN 500 • CIP connections • Safety valve • Pressure gauge • Bottom diaphragm valve • Agitator connection (DN 200) • Multiple reserve connections • Heavy-duty trunnion/pin bearing • Transport and lifting device DOCUMENTATION – complete and well-structured Extensive project-related quality and manufacturing documentation available, including: • EU declaration of conformity and warranties • TÜV certificate with acceptance report (Module G) • TÜV design review and certification • Material certificates 3.1 • Welder listings and welding procedure qualifications (WPQR/WPS) • Non-destructive inspection reports (RT, PT, etc.) • Analysis certificates for welding consumables and shielding gas • Company qualification certificate • Roughness protocol • Surface treatment report • Dimensional accuracy report • Internal pressure test report • Calibration certificates for pressure gauges • Reports and EU conformity details for all installed components • Compiled parts list • Partial drawings • Operating and maintenance manuals Complete digital documentation package available. CONDITION • Never used in production • Stored as inventory • Internal surfaces absolutely as new • No corrosion • No signs of wear • As-new industrial condition • Immediately available SUITABLE FOR • Pharmaceutical solutions • WFI / PW systems • Buffer and media preparation • Sterile liquid processes • GMP production systems • Biotechnological applications SPECIAL FEATURES Premium BRINOX pharmaceutical manufacturing with complete individual approval to PED Module G by TÜV SÜD, CE 0036 marking and fully documented FAT testing. Not a standard tank, but certified project quality with comprehensive GMP-compliant documentation. Immediately available.