LYOMAC TECHNOLOGY LTD. is a professional leader in China in Pilot Model Lyophilizer manufacturing with high quality and reasonable prices. Welcome to contact us. The LYOMAC Pilot Model Lyophilizer, with its powerful ice condenser capacity ranging from 20kg to 150kg, is specifically designed for the pharmaceutical, biotechnology, vaccine, and diagnostic reagent industries. It serves as an ideal platform for transitioning from laboratory formulations to industrial production, and is also a suitable equipment model for clinical testing. As a pharmaceutical-grade aseptic dedicated freeze-drying equipment, it strictly adheres to cGMP and FDA regulations, perfectly balancing research flexibility, process scalability, and production compliance.
LYOMAC TECHNOLOGY LTD. is a professional leader in China in Pilot Model Lyophilizer manufacturing with high quality and reasonable prices. Welcome to contact us. The LYOMAC Pilot Model Lyophilizer, with its powerful ice condenser capacity ranging from 20kg to 150kg, is specifically designed for the pharmaceutical, biotechnology, vaccine, and diagnostic reagent industries. It serves as an ideal platform for transitioning from laboratory formulations to industrial production, and is also a suitable equipment model for clinical testing. As a pharmaceutical-grade aseptic dedicated freeze-drying equipment, it strictly adheres to cGMP and FDA regulations, perfectly balancing research flexibility, process scalability, and production compliance.
1. Industrial-Grade Aseptic Dedicated Freeze-Drying System
Processing Capacity: LYOMAC Pilot Model Lyophilizer Offers various ice condenser capacities from 20kg to 150kg, meeting the demands of different-scale pilot batches.
Large-Area Freeze-Drying Shelves & Materials: Equipped with multi-layered, large-area freeze-drying shelves to ensure ample product freeze-drying surface area and increase batch processing volume. All internal components that directly or indirectly contact the product are made of medical-grade 316L stainless steel, ensuring compliance with GMP requirements.
High-Efficiency Cold Trap: The cold trap capacity is precisely calculated to ensure that the maximum required ice capacity can be effectively collected throughout the entire drying cycle.
Fully Automatic Process: Configured with a SCADA control system, ensuring that all process steps—freeze-drying, defrosting, cleaning, and sterilization—are completed automatically in a continuous cycle.
2. High-Precision Shelf Temperature Control
Dual-Circulation Pump Silicone Oil System: LYOMAC Pilot 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. A three-pump configuration further ensures production safety.
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, ensuring precise control of temperature ramps during pre-freezing and sublimation drying.
3. Fully Automatic Cleaning, Sterilization & Defrosting System
Clean-in-Place (CIP): As a standard feature, LYOMAC Pilot Model Lyophilizer includes a pure water or WFI (Water For Injection) CIP system, with multi-stage spray balls for comprehensive cleaning of all corners of the chamber and 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 relevant piping, complying with FDA and other regulations.
High-Efficiency Defrosting: The equipment features high-efficiency defrosting, capable of rapid defrosting of the cold trap using high-temperature steam or hot water.
4. High-Efficiency Refrigeration & Precise Vacuum Control
Single/Dual-Stage Refrigeration System: Utilizes a single-stage or dual-stage refrigeration system, ensuring cold trap temperatures can reach -75℃.
Precise Vacuum Control: Vacuum control can employ 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.
5. Fully Automatic Negative Pressure Stoppering System
High-Precision Stoppering: LYOMAC Pilot Model Lyophilizer equipped with a highly reliable hydraulic stoppering system for fully automatic negative pressure stoppering. It can precisely stopper vials under vacuum or inert gas protection, with adjustable pressure, ensuring product aseptic sealing.
6. Automated Loading/Unloading Small Door Design
Diverse Small Door Design: LYOMAC Pilot Model Lyophilizer can be equipped with an independent small door that moves up/down or left/right, or uses a hinged opening. This fully meets user requirements for seamless interfacing with various loading/unloading systems such as isolators, RABS, and conveyor belts.
7. PLC & SCADA Control System
Industrial-Grade Control: Employs international mainstream brand PLCs as the core controller, equipped with a professional SCADA monitoring system.
Regulatory Compliance: The system fully complies with GAMP5, FDA 21 CFR Part 11, and EU Annex 11 regulatory requirements.
HMI and Remote Services: LYOMAC Pilot Model Lyophilizer equipped with both local HMI (Human-Machine Interface) and remote control HMI, allowing LYOMAC to provide remote services and software upgrade functionality.
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 site space and process requirements.
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.
1. Freeze-Drying End-Point Determination System
Pressure Rise Test: LYOMAC Pilot Model Lyophilizer provides a Pressure Rise Test function, which helps customers determine the drying end-point, optimize process parameters, and reduce energy consumption.
2. Solvent Recovery Unit
Efficient Recovery: A solvent recovery unit installed below the cold trap can largely recover desired solvents and protect the vacuum pump.
3. Automated Loading/Unloading System (ALUS)
Integrated Solutions: LYOMAC Pilot Model Lyophilizer can be equipped with an automated loading/unloading system, and also configured with SLAED (Sealed Liquid Aseptic Filling Line) or Isolator systems, with personalized designs for raw materials or vials.
4. Eutectic Point Tester
Process Optimization: An optional eutectic point tester assists users in precisely determining the material's eutectic point, providing scientific basis for process development.
5. 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.
6. 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.
