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China, Chinese Marya Shanghai Pharma Isolator System in Sterile Production Line Factory1 Industrial Products Supplier Manufacturer Details, price list catalog:
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Air Clean EquipmentOther Air Clean EquipmentsSterile Production Line FactoryPharma Isolator
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
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Product Description Marya Shanghai Pharma Isolator System in Sterile Production Line FactoryIntroductionMarya's Shanghai Pharma Isolator System is a game-changer in sterile production lines. Installed with precision on filling machines and equipment, it creates a secure barrier, segregating operators from products. This isolator system significantly cuts the risk of drug contamination, enhancing drug quality. Ideal for sterile production, it's a reliable choice for pharmaceutical manufacturing, ensuring compliance and safety in every step. Features1.Comprehensive product portfolio: isolation systems for water injection, powder injection, prefilled syringe and sterile powder production lines.2.Stable and reliable environment: reliable and stable class A environment, which meets cGMP, FDA, ISO, ISPE, and pharmacopoeia requirements.3.New VHPS technology: the latest H2O2 sterilization system, which can achieve rapid sterilization, control the concentration and saturation of H2O2, with good sterilization reproducibility.4.Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H2O2 solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements.5.Independent temperature and humidity control mode: with the integrated independent air conditioning system, it can realize that the internal temperature and humidity in the chamber is not affected by the external environment.6.MOCK-UP: complete wood model verification service, ergonomic operation qualification and 3D model display service in the middle of the project.7.Sterilization process development support: qualification and validation services for sterilization cycle development of the whole process can be provided.8.Customization: support customized isolation system design, and provide systematic closed isolation solutions and CE certification services.9.Integrated monitoring system: integrated monitoring systems of temperature and humidity, differential pressure, air speed, H2O2 concentration, optical grating, particles and airborne viable bacteria, etc.10.Multiple sterile transfer solutions: multiple and combined sterile transfer solutions are available to meet customers' diversified production needs.11.Complete life cycle support: covering consulting, project design, installation scheme design and verification design, etc.12.Wireless glove leakage detector: multi-head wired glove leakage detector or wireless glove leakage detector is optional.13.CDCV service: sterilization cycle development, validation studies and services.Product Parameters NameParametersMaterial316LPolishing grade 0.4μm~0.6μmProtection levelOEB 5 (OEL<1ug/m3)Internal arc angleR≥20Cleanliness levelClass APower supply380V 50Hz(Note: Other voltages require a transformer)
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