Sterile lyophilization for oncology pharmaceuticals

Optimize the sterility and stability of high-potency drugs with advanced lyophilization, ensuring precise moisture removal while handling toxic and flammable solvents.

Performs Sterile Freeze-Drying for Biopharmaceuticals

The Lyogistics Zero, offered by Azbil Telstar, stands out as a vital asset for pharmaceutical manufacturers and biotech companies seeking precision in sterile lyophilization. This system integrates seamlessly into your existing production lines, using a vertical two-storey configuration to maximize space efficiency while maintaining high capacity with four lyophilizers and a 30 m² ice condenser capable of handling 600 kg. This versatile solution is designed for a range of biopharmaceutical processes including monoclonal antibody purification and high potency API treatments. Engineered for robust containment, it includes mushroom-type isolation valves and full compatibility with toxic and flammable solvents. Efficiency is further enhanced by the inclusion of dry vacuum pumps and an advanced CIP/SIP protocol for contamination-free operations. It meets stringent GMP and FDA guidelines, ensuring compliance and product integrity. Customize the system to fit your operational needs, with options for automatic loading and unloading via the Lyogistics Zero pass-through system, which enhances productivity and maintains a cleanroom environment.

Benefits

  • Ensures product sterility and quality with GMP-compliant lyophilization processes.
  • Increases operational efficiency through a vertical design optimized for space and capacity.
  • Reduces contamination risk with advanced CIP/SIP protocols and isolated operational zones.
  • Enhances safety for handling toxic and flammable solvents with specialized containment features.
  • Supports seamless integration and automated operation, reducing manual labor and error rates.

General


Applications
High potent drugs,Innovative drugs,Biopharmaceuticals,Live attenuated bacteria vaccine,Anticancer drugs
End products
Measles vaccine,Monoclonal antibodies,Chemotherapy drugs,High potency api capsule,Novel cancer treatments,High potency api tablet,Bcg vaccine
Steps before
Solution Preparation,Compounding,Filtration
Steps after
Aseptic Filling,Packing,Quality Control Testing
Input ingredients
vials,toxic solvents,flammable solvents,hygroscopic products,live attenuated bacteria,high potent drugs
Output ingredients
lyophilized products,sterilized vials,low moisture products,anticancer drugs,innovative drugs
Market info
Telstar is known for specializing in the design, engineering, and manufacturing of advanced vacuum and aerospace solutions, gaining a strong reputation for their innovative and customized equipment in pharmaceutical, medical, and scientific research sectors.

Technical Specifications


Capacity
600 kg ice condenser capacity
Configuration
Vertical (two-storey)
Size
4 lyophilizers of 30 m²
Handling
Ready for toxic and flammable solvents
Vacuum systems
Dry vacuum pumps
Automation
Automatic loading/unloading system
Cleaning method
CIP/SIP (Cleaning in Place/Sterilization in Place)
Isolation Valve Type
Mushroom-type isolation valve
Integration
Integration with an isolator
Unloading system
Lyogistics Zero pass-through system

Operating Characteristics


Batch vs. continuous operation
Batch
Automation level
Automatic loading/unloading system
CIP/SIP
CIP/SIP (Cleaning in Place/Sterilization in Place)
Integration with isolator
Integrated with an isolator
Handling of solvents
Ready for toxic and flammable solvents

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Product type Characteristics


Solvent handling capability
Toxic and flammable

Physical Characteristics


Machine footprint
Not specified
Condenser configuration
Vertical (two-storey)
Isolation valve type
Mushroom-type
Discharge method
Automatic loading/unloading system
CIP/SIP feature
Available
System integration
Integration with an isolator

Custom Options


Integration possibilities
Integration with isolator,automatic loading/unloading system
Vertical configuration
Two-storey
Isolation valve type
Mushroom-type
Configuration for solvents
Ready for toxic and flammable solvents