As the professional manufacturer, we would like to provide you high quality Lab Model Lyophilizer. The LYOMAC 4L-12L Series Experimental Freeze Dryer is specifically designed to bridge the gap between laboratory benchtop units and pilot-scale production systems. This series boasts a powerful ice condenser capacity ranging from 4kg to 12kg, combining a stringent cGMP-compliant design philosophy with advanced shelf temperature control technology. It perfectly balances experimental flexibility with the simulation of production conditions. It is an ideal choice for high-value drug development, biologic formulation, and the exploration of complex lyophilization processes, ensuring seamless scalability of experimental data to industrial production.
As the professional manufacturer, we would like to provide you high quality Lab Model Lyophilizer. The LYOMAC 4L-12L Series Experimental Freeze Dryer is specifically designed to bridge the gap between laboratory benchtop units and pilot-scale production systems. This series boasts a powerful ice condenser capacity ranging from 4kg to 12kg, combining a stringent cGMP-compliant design philosophy with advanced shelf temperature control technology. It perfectly balances experimental flexibility with the simulation of production conditions. It is an ideal choice for high-value drug development, biologic formulation, and the exploration of complex lyophilization processes, ensuring seamless scalability of experimental data to industrial production.
1. In-Situ Design for Optimal Processing
Processing Capacity: LYOMAC Lab Model Lyophilizer Offers various ice condenser capacities such as 4kg, 8kg, and 12kg, capable of handling micro-scale research of precious samples as well as small-batch preparation of hundreds of vials.
In-Situ Structure: Features a medical-grade 316L stainless steel square chamber, where pre-freezing and drying are completed with a single process, eliminating contamination and melting risks associated with manual sample transfer.
2. Industrial-Grade Silicone Oil Fluid Temperature Control
Low-viscosity silicone oil is circulated within the shelves for precise cooling/heating, eliminating the instability inherent in electrical heating methods.
Temperature Uniformity: Shelf temperature difference is strictly controlled to ≤±1℃, ensuring consistent drying quality from the first vial to the last.
Ramp Rate Control: LYOMAC Lab Model Lyophilizer equipped with precise programmable ramp rate control for heating and cooling, capable of simulating industrial-scale crystallization and drying kinetics.
3. High-Efficiency Cold Trap & Intelligent Vacuum Regulation
Powerful Ice Condensation: Cold trap temperatures can reach -80℃ (lower optional), combined with a 4kg-12kg ice capacity, effectively preventing vacuum pump oil backflow and vapor escape.
Vacuum Fine-Tuning: Features high-precision sensors and a micro gas-doping valve, supporting precise vacuum set-point control to optimize heat transfer efficiency and shorten drying cycles.
4. Standard Eutectic Point Test System
Built-in resistance-based eutectic point detection function, providing real-time monitoring of material resistivity changes during the freezing process. This assists users in accurately determining collapse and eutectic temperatures, transforming "empirical experimentation" into "data-driven process development."
5. Flexible Hydraulic Stoppering System
LYOMAC Lab Model Lyophilizer equipped with a highly reliable hydraulic drive, supporting fully automatic stoppering under vacuum or inert gas protection. Adjustable pressure accommodates various vial sizes, ensuring an aseptic seal.
6. Pharmaceutical-Grade PLC Control & Data Logging with SCADA
Large industrial touchscreen operation, complemented by a SCADA monitoring system, providing real-time display and logging of cold trap, shelf, sample temperatures, and vacuum curves. Data includes power-off memory, supports USB export, meeting experimental traceability requirements.
1. Clean-in-Place (CIP) & Sterilize-in-Place (SIP) Modules
CIP: Optimized spray ball layout ensures thorough, dead-angle-free cleaning across all internal chamber surfaces.
SIP: Vacuum chamber upgraded to pressure vessel standard, supporting 121℃ pure steam sterilization (or VHP interface), meeting high-standard requirements for aseptic formulation development and High Potency Active Pharmaceutical Ingredient (HPAPI) handling.
2. Non-Stop Online Sample Thief – R&D Enabler
Utilizing a specialized vacuum interlock device, it allows for the retrieval of sample vials for moisture or crystal form analysis at any time during the drying cycle, without compromising the main chamber's vacuum integrity. This significantly reduces time costs and conserves expensive API (Active Pharmaceutical Ingredient) raw materials.
3. FDA 21 CFR Part 11 Compliant Software
LYOMAC Lab Model Lyophilizer is designed for regulated pharmaceutical companies. The software upgrade includes three-tier user access management, electronic signatures, and immutable Audit Trail functionality, ensuring Data Integrity and facilitating compliant regulatory submissions.
4. Drying End-Point Determination System
LYOMAC Lab Model Lyophilizer Offers a Pressure Rise Test function. An algorithm automatically analyzes the pressure recovery rate within the drying chamber, scientifically determining the completion of primary drying and preventing unnecessary extension of drying time.
5. Organic Solvent Trapping Package
For formulations containing organic solvents, this package provides corrosion-resistant piping upgrades, a capacitive diaphragm gauge, and lower cold trap temperature configurations, protecting the equipment and enabling precise process control.
