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The Liquid Preparation System Machine for Lvp Drug Production CIP/SIP, Dispersion1
Pharmaceutical Equipment Machinery, Dispersion, Pharmaceutical Machine, Stainless Steel Tank
Nanjing BioWill Biological Engineering Co., Ltd.
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Product Description Detailed PhotosApplications1. Production of biological bulk liquids such as antibodies, proteins, and vaccines (harvesting, ultrafiltration, centrifugation, clarification, inactivation, chromatography)2. Emulsification and vaccine preparation of inactivated vaccine/attenuated live vaccine3. Small volume injections (lyophilized, aqueous injection)4. Large infusion5. Eye drops6. Emulsion7. Gel agent8. Oral liquid preparations9. Fat emulsion10. Liposome injection11. Enzyme preparation production12. Probiotic production Product Characteristics1.Full process automation: closed-loop control from weighing to filling, reducing the risk of human intervention;2. Sanitary design: Complies with GMP A-level cleanliness requirements, integrates SIP/CIP functions, and ensures sterile assurance;3.Process consistency: high-precision sensors and dynamic hybrid technology, CV value<5%;4.Compliance: Provide complete DQ/IQ/OQ/PQ validation documents to meet FDA/EMA audit requirements.5.Technical highlights:Customized mixing system suitable for high viscosity, suspension, emulsion drugs;Aseptic transfer interface to avoid cross contamination;The recipe library supports one click calling of historical processesProduct Parameters Liquid preparation system for biological Drug Substance&Product The intelligent solution designed specifically for the production of biological product raw materials and formulation of drugs has been successfully applied to many leading pharmaceutical companies in China. The system adopts a modular architecture and ISA-88 BATCH standard control platform, supporting rapid switching of multi product co production and significantly improving production line flexibility. Volume5-5000L customizableMaterial316LHeight to diameter ratio1-3 customizableDesign pressure-1~4 barMixing driveSingle end mechanical seal, double end mechanical seal, magnetic drive optionalMixing forms paddle type, propulsion type, anchor type, homogeneous emulsification, coaxial mixing and other forms can be selectedTemperature control methodsvarious forms such as electric heating, steam heating, and cold water cooling can be selectedDischarge methodsgas pressure discharge, centrifugal pump discharge, rotary pump discharge, diaphragm pump discharge, etcLevel measurementLoad cell or liquid level gauge, achieving automatic constant volume measurementLiquid level filtrationTitanium rod filtration, 0.45 μ m pre filtration, 0.22 μ m sterilization filtration, all of which can achieve SIP and online integrity testing. The sterilization filter can achieve PUPSIT (certified by the European Union)CIP/SIPSupport, one click operationVerification documentsDQ/IQ/OQ/PQ/FS/HDS/SDS, etc. comply with EU and FDA certification requirements, including CSV services 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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