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GMP Certified Stainless Steel Fermenter for The Production of Recombinant Collagen Protein Reactor1
Pharmaceutical Equipment Machinery, Bioreactor, Fermenter
Nanjing BioWill Biological Engineering Co., Ltd.
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Product Description Detailed PhotosApplicationsI. Biopharmaceutical field1. Recombinant protein production: pilot and industrial production of biologics such as monoclonal antibodies and insulin2. Vaccine preparation: pilot scale-up and production of vaccines such as MCV4, Poliomyelitis, HPV, FMD, AIV, etc3. Cell and gene therapy: CAR-T cell expansion, viral vector (AAV/LV) production, meeting the compliance requirements for clinical-grade therapeutic productsII. Food and Fermentation Industry1. High value-added fermentation products: enzyme preparations (amylase, protease), probiotic production2. Brewing of alcoholic beverages and condiments: temperature-controlled fermentation of beer and wine, continuous fermentation process of soy sauce and vinegarIII. Bioenergy and Environmental Protection:1. Biofuel synthesis2. Organic waste treatment Product characteristics1.Technical highlights:Efficient mass and oxygen transfer: optimizing stirring and aeration design to increase product yield by 10% -30%;2.Ultra low bacterial risk: Fully enclosed pipeline and SIP/CIP function, bacterial infection rate<0.1%;3.Intelligent automation: One click process formula calling, reducing human operation errors;4.Global compliance: Provide IQ/OQ/PQ validation file packages to meet FDA/EMA certification requirements.5.User value: By simplifying operational processes and enhancing production stability, the risk of batch failure is significantly reduced, making it particularly suitable for large-scale production of high-value biological products such as antibodies and vaccines. Product ParametersStainless steel bioreactors fermenter for pilot and commercial production:Specially designed for pilot to commercial production, with high reliability and compliance as core advantages. The system adopts ASME BPE standard hardware architecture, combined with GAMP5 software specification, to ensure the cleanliness and data integrity of the entire process from cell culture to microbial fermentation. Volume5-5000L customizableMaterial316LHeight to diameter ratio1.5~3 customizableMixing driveSingle mechanical seal, double mechanical seal, magnetic drive optionalTemperature control15-45 oC, accuracy ± 0.1 oC, steam (electric) heating&cold water coolingPressure control0-2bar, tail gas PID regulating valve cascade pressure sensorPH control2-12; accuracy ± 0.02; Cascade acid-base peristaltic pump, CO2 flowmeter; Can set dead zoneDO control0-100%; accuracy ± 3%; Cascade stirring, air MFC, oxygen MFC; 7 ventilation strategies to meet different process needsAir intake device0.22 μ m PTFE filter, independent SIP, equipped with pneumatic diaphragm valve and one-way valve to effectively prevent backflowExhaust pipeline condenser+sterilization filter (electric heating), effectively preventing filter blockage Feeding deviceoptional needles, push valves, and four valve groupsSIP online sterilizationone click operation automatic control, F0 value calculation, automatic generation of temperature-time curveCIP online cleaningcan achieve pre cleaning, circulating alkali cleaning, and final cleaning, with drainage conductivity detectionSensorsIntelligent pH/Optical DO Sensor (Hamilton), Weighing Module (Mettler Toledo)Audit TrackingStandard configuration, real-time recording that cannot be modified or deletedReportAssociated batch number, can set data interval time, can output batch report or batch single variable reportRemote operationsupports IOS/Android/Windows multi platform remote monitoring and operation Product ApplicationCompany ProfileNanjing Biowell Biotechnology Co., Ltd. is a one-stop solution provider specializing in the fields of biopharmaceuticals and bioengineering. The company's core business covers the research and development of equipment such as bioreactors, fermentation tanks, and liquid preparation systems, as well as customized culture media and process development services. Relying on its full process technical capabilities (from strain optimization, small-scale development to commercial production), the company serves biopharmaceutical companies such as antibodies, vaccines, recombinant proteins, and covers industrial customers such as enzyme preparations and biofuels. It is committed to promoting the upgrading of the biotechnology industry through efficient and compliant solutions. We take innovative technology and full process services as our core, helping customers seamlessly transition from laboratory research and development to commercial production. Through customized solutions and continuous collaboration, we accompany customers to overcome technical bottlenecks, achieve large-scale implementation, and witness the growth and success of biomanufacturing together.CertificationsPackaging & ShippingFAQQ:Are you factory or trading company?A:We are a factory.Q:What's the MQQ?A:1 unit.Q:Do you offer overseas service?A:Yes,We are dispatch engineer to overseas.Q:Can we visiting your factory?A:Yes,warmly welcome.Our factory location is Nanjing, China. Q:How about your delivery time?A: 1 week to 3 months.Depend on the model and quantity.Q: Does the equipment comply with international standards?A: The hardware follows ASME BPE (Biological Processing Equipment Standard), the software complies with GAMP5 specification, and a complete IQ/OQ/PQ verification file package is provided to meet FDA/EMA certification requirements.Q: Does it support multi country voltage?A: Standard wide voltage input (100-380V, 50/60Hz), customizable for specific country voltages (such as 230V in Europe and 120V in the United States).Q: How to obtain technical support overseas?A: Provide remote diagnostic services (with customer authorization) and respond within 48 hours.Q: How long is the spare parts supply cycle?A: Standard spare parts are urgently shipped within 72 hours worldwide, while customized components (such as special mixing blades) need to be pre ordered 4 weeks in advance.Q: Do you provide process training?A: Optional online training or on-site guidance (including Chinese/English manuals), covering equipment operation, maintenance, and troubleshooting.
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