Supplies and Services
- Laboratory freeze dryers (LYO-0.5 ㎡)
- Pilot freeze dryers (LYO-1~5 ㎡)
- Production freeze dryers (LYO-7.5~20 ㎡)
- Mass-production freeze dryers (LYO-25~50 ㎡)
Strengths and Advantages
- Whole-life dedication to lyophilization technology.
- Experience over 5000 freeze dryers manufactured since 1993.
- The largest and most modem freeze dryer manufacturing facility in the world.
- Reliable, flexible and affordable technology.
- Quicker response, faster delivery and longer service guarantee.
- Locally-based sales and service.
- Cost effective manufacturing and documentation.
Technology and Qualifications
- Screw compressor
- VFD for Screw Compressor
- Backup or Redundancy Design
- Dual Heat Exchanger
- Dry pump
- Filter Integrity Test (WIT)
- CIP external system (tank and pump)
- Slot door
- Cooing Heat Exchanger after SIP
- Silicone oil jacket for cooling & heating
- Low temperature trap
- LN2 refrigeration system
- Vacuum brazing shelves
- Condenser as CIP Buffer Tank
Chamber/Condenser/Shelves
- GB-150/PED/ASME Code Pressure Vessel.
- cGMP guidelines and US-FDA recommendation.
- All chamber edges and corners are rounded to facilitate cleaning.
- Chamber dead legs are limited to a length to diameter ratio L/D≤3 and are sloped to ensure free draining. Where the length to diameter ratio can not be achieved, cleaning action is provided with spray-nozzle.
- Chamber cooling jackets for rapid cool down after sterilization with steam.
- Condenser coils are made from polished and AISI-316L stainless steel tubing.
- Condenser coils design offers a high level of ice trapping.
- For production freeze dryers, there is optional shelf double spacing mechanism to meet requirements of different size vials.
- Optional customized shelves design for auto loading systems.
- Chamber - condenser isolation valve: mushroom valve - hydraulically driven or butterfly valve - pneumatically driven.
Refrigeration System
- Modular design to achieve reliable and high efficiency production.
- Advanced pipeline process technology prohibits leaks.
- World-class refrigeration units ensure reliability with long service life.
- Each compressor has an independent circuit to cool shelves or condenser.
- Safety protection for compressors in high pressure, low pressure, motor overheat, differential oil pressure, unstable current, short circuit, lacking phase and cooling water flow, etc.
- Environment friendly HFC refrigerant: free of CFC and HCFC.
- Vibration absorbers to reduce vibration and noise.
- The flow rate of refrigerant is controlled by an expansion valve to achieve the precise temperature.
- Compressor: Bitzer® or Kobelco®, Mycom®.
Liquid Nitrogen Refrigeration System
- Increases lyophilizer flexibility: 1. Achieves lower temperatures 2. Precise temperature control(high reproducibility) 3. Provides faster cooling and/or freezing
- Improves reliability and requires minimum maintenance vs mechanical refrigeration
- Cost competitive with mechanics
- Smaller footprint than mechanics
- Environmentally friendly and quiet operation
- Nitrogen gas may be available for other uses
- US Praxair NCOOL TM Heat Exchanger
- Samson® (Germany) LN2 control valve
- Hermetic® (Germany) low temperature pump
- Rosemount® (America) liquid level indicator and pressure sensor
- Shelf Final Temperature:-70°C(≤-100°C depends on silicon oil)
- Shelf Cooling Rate: 20 to -40°C≤30min(Empty Loaded)
- Condenser Cooling Rate:20 to -40°C≤30min(Empty Loaded)
- Noise:60-65dB
Vacuum System
- Vacuum pump plus mechanical booster pump (for large scale freeze dryers) used to achieve better vacuum, (i.e. less than 0.01 mbar vacuum).
- Vacuum anti-suck valve closes automatically in case of power outage so as to preserve vacuum environment.
- Vacuum pump: Edwards®
- Optional Edwards® dry pump to avoid product contamination from back-streaming vacuum oil.
- Vacuum gauge: MKS® capacitance manometer or Edwards® APG-MP vacuum gauge
- Vacuum control: Needle valve or MKS® PID control valve
CIP/SIP
- Rotary sprayer and fixed wide-angle nozzles ensure maximum cleaning coverage.
- Pure steam sterilization minimizes contamination risks for sterile drugs.
- Ports, gaskets and viewing glasses are suitable for high temperature.
- The steam supply clean pipeline is made from polished stainless steel and is orbitally welded, tested and documented by boroscope inspection.
- Temperature control and monitoring are done at the coldest point of the system.
- CIP/SIP runs automatically.
- Interlocking mechanism ensures safety during sterilization process.
- External CIP system (tank and pump) as option.
- Control System
- 21 CFR Part 11 and cGAMP compliance.
- Access control according to authority levels.
- Audit trail recording user actions and changes to process parameter.
- Query the curve and data table record.
- Query alarm record.
- Database management and maintenance.
- Manual or automatic control available.
- Recipe management.
- PLC/Touch Screen: Omron®/Siemens®/AB®
- Breaker / Contactor / Relay: ABB®
Layout
Laboratory freeze dryer (0.5㎡) Pilot freeze dryer(5㎡)
Production freeze dryer
Mass-Production freeze dryer
Utility Requirement
- 380V, 50Hz / 440V,60Hz,3-phase,5 wires
- Cooling water for compressor (1.5≤P≤2bar,T≤25°C)
- Steam for sterilizing or defrosting (2≤P≤3bar)
- WFI for cleaning (P≥4bar,T=80 °C)
- Compressed air for pneumatic system (5≤P≤8bar)
- Inert gas for vacuum release (0.5≤P≤1bar)
Technical Data
- Shelf temperature range: -55°C to + 80°C
- Shelf cooling rate: 20°C to -40°C≤60min
- Shelf heating rate: Approx. 1°C /min
- Condenser final temperature: ≤75 °C
- Condenser cooling rate: 20°C to -40 °C ≤30min
- Final vacuum: ≤ 0.01 mbar
- Evacuation Rate: 1000mbarto 0,1mbar≤30min
- Leakage Rate: ≤ 0.03mbar▪L/sec
Manual Loading and Unloading
Automatic Loading and Unloading