Find a huge selection of Industrial Model Lyophilizer from China at LYOMAC TECHNOLOGY LTD. Provide professional after-sales service and the right price, looking forward to cooperation. The LYOMAC Industrial Model Lyophilizer , with its powerful ice condenser capacity ranging from 200kg to 1000kg, is specifically designed to meet the large-scale production needs of the pharmaceutical, biotechnology, vaccine, and diagnostic reagent industries. As a pharmaceutical-grade aseptic dedicated freeze-drying production equipment, it strictly adheres to cGMP and FDA regulations, perfectly integrating the high throughput, high stability, and stringent compliance required for industrial manufacturing. This series aims to provide ultimate production reliability, ensuring high batch-to-batch consistency, maximizing production efficiency, and effectively mitigating operational risks to accelerate product commercialization.
Find a huge selection of Industrial Model Lyophilizer from China at LYOMAC TECHNOLOGY LTD. Provide professional after-sales service and the right price, looking forward to cooperation. The LYOMAC Industrial Model Lyophilizer , with its powerful ice condenser capacity ranging from 200kg to 1000kg, is specifically designed to meet the large-scale production needs of the pharmaceutical, biotechnology, vaccine, and diagnostic reagent industries. As a pharmaceutical-grade aseptic dedicated freeze-drying production equipment, it strictly adheres to cGMP and FDA regulations, perfectly integrating the high throughput, high stability, and stringent compliance required for industrial manufacturing. This series aims to provide ultimate production reliability, ensuring high batch-to-batch consistency, maximizing production efficiency, and effectively mitigating operational risks to accelerate product commercialization.
1. Industrial-Grade Aseptic Dedicated Freeze-Drying System
Processing Capacity: LYOMAC Industrial Model Lyophilizer offers ice condenser capacities from 200kg to 1000kg, fully meeting the demands of large-scale industrial batch production.
Large-Area Freeze-Drying Shelves & Materials: Features multi-layered, large-area freeze-drying shelves, ensuring ample product freeze-drying surface area and high throughput. All internal components that directly or indirectly contact the product are made of medical-grade 316L stainless steel, ensuring compliance with GMP requirements.
Ultra-Large, High-Efficiency Cold Trap: The cold trap capacity is precisely calculated and optimally designed to ensure that the maximum required ice capacity can be effectively collected throughout the entire large-batch drying cycle, guaranteeing efficient and stable system operation.
Fully Automated Continuous Process: Configured with a SCADA control system, ensuring that all process steps—freeze-drying, defrosting, cleaning, and sterilization—are completed automatically and continuously in an industrial production environment.
2. High-Precision Shelf Temperature Control
Dual-Circulation Pump Silicone Oil System: LYOMAC Industrial Model Lyophilizer utilizes an industrial-grade dual-circulation pump silicone oil system for shelf cooling and heating, ensuring high heat transfer efficiency and minimal temperature fluctuations across large shelf areas.
Temperature Uniformity: Shelf flatness is less than 1mm, and shelf temperature difference is strictly controlled to ≤±1℃, ensuring the quality uniformity of all products within a batch.
Precise Temperature Control: The equipment uses PID precision controllers from internationally renowned brands like Siemens or Omron, enabling high-precision control of temperature during pre-freezing and sublimation drying, ensuring process stability in large-scale production.
3. Fully Automatic Clean-in-Place (CIP), Sterilize-in-Place (SIP) & Defrosting System
Clean-in-Place (CIP): As a standard feature, it includes a pure water or WFI (Water For Injection) CIP system, with multiple optimally positioned spray balls for comprehensive, dead-angle-free cleaning of the large chamber and all associated piping.
Sterilize-in-Place (SIP): The vacuum chamber is rigorously designed to pressure vessel standards, supporting 121℃ pure steam SIP, including the freeze-drying chamber and all relevant piping, ensuring an aseptic production environment and full compliance with FDA and other regulations.
High-Efficiency Defrosting: The equipment features high-efficiency defrosting, capable of rapid defrosting of the ultra-large cold trap using high-temperature steam or hot water, reducing non-production time.
4. High-Efficiency Refrigeration & Precise Vacuum Control
Single/Dual-Stage Refrigeration System: Utilizes a high-performance single-stage or dual-stage refrigeration system, ensuring cold trap temperatures can reach -75℃.
Precise Vacuum Control: Vacuum control employs a closed-loop method. This can be achieved by introducing inert gas (e.g., nitrogen) or clean air via a doping valve (servo proportional valve or on/off valve), or by controlling the start/stop ratio of the vacuum pump, ensuring a stable and controllable vacuum environment for large-scale production.
5. Fully Automated Negative Pressure Stoppering System
High-Precision Stoppering: LYOMAC Industrial Model Lyophilizer equipped with a highly reliable industrial-grade hydraulic stoppering system for fully automatic negative pressure stoppering. It can precisely stopper large quantities of vials under vacuum or inert gas protection, with adjustable pressure, ensuring product aseptic sealing and batch consistency.
6. Automated Material Handling Interface
Diverse Interfacing:LYOMAC Industrial Model Lyophilizer can be equipped with diverse industrial-grade material handling interfaces for efficient, seamless integration with large-scale automated loading/unloading systems such as isolators, RABS, and high-speed conveyor belts, supporting comprehensive production line automation.
7. PLC & SCADA Control System
Industrial-Grade Control: Employs international mainstream brand PLCs as the core controller, equipped with a professional SCADA monitoring system for remote monitoring and operation.
Regulatory Compliance: The system fully complies with GAMP5, FDA 21 CFR Part 11, and EU Annex 11 regulatory requirements, providing comprehensive Audit Trail functionality.
HMI and Remote Services: Equipped with both local HMI (Human-Machine Interface) and remote control HMI, allowing LYOMAC to provide remote services and software upgrade functionality, ensuring long-term stable equipment operation.
8. Integrated Equipment Installation & Flexible Layout
Convenient Installation: All connections utilize flanges or quick-connect fittings, effectively saving space and significantly reducing on-site installation difficulty.
Flexible Customization: Supports both integral and split-type layout designs, allowing for flexible customization according to customer factory layout and process flow, optimizing production space.
9. Comprehensive Validation Support
Documentation & Assistance: Provides comprehensive IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validation documentation and on-site assistance, ensuring the equipment meets pharmaceutical industry validation requirements and strongly supports regulatory submissions.
1. Freeze-Drying End-Point Determination System
Pressure Rise Test: Provides a Pressure Rise Test function, which helps customers determine the drying end-point, optimize process parameters, increase production efficiency, and reduce energy consumption.
2. Solvent Recovery Unit
Efficient Recovery: A solvent recovery unit installed below the cold trap can efficiently recover desired solvents and provide additional protection for the vacuum pump, extending its lifespan.
3. Multiple Vacuum Pump Configurations
Customized Selection: Customers can choose between oil-sealed rotary vane pumps or screw-type dry oil-free vacuum pumps based on specific needs and material characteristics.
4. Refrigeration System Upgrade
High-End Options: The refrigeration system can be upgraded to include single-stage/dual-stage piston compressors or single-stage/dual-stage screw compressors.
5. Eutectic Point Tester
Process Optimization: An optional eutectic point tester assists users in precisely determining the material's eutectic point, providing a scientific basis for process development and optimization.
