Supplies and Services
- Laboratory freeze dryers (LYO-0.5 m)
- Pilot freeze dryers (LYO-1~5 m)
- Production freeze dryers (LYO-7.5-20 m)
- Mass-production freeze dryers (LYO-25~50 m)
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 SlF。
- Silicone oil jacket for cooling & heating
- Low temperature trap
- LN2 refrigeration system
- Vacuum brazing shelves
- Condenser as ClP Buffer Tank
Features:
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 LDs3 and are sloped to ensure free draining. here 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 AlSl-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. 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® PlD 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 ClP 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®
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)
- WFl 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: 20C 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 0,1mbars30min
- Leakage Rate: 0.03mbar-L/sec
