Lyophilization process optimization sensors

Achieve precise real-time monitoring of water vapor during freeze-drying, streamlining lyophilization cycles to enhance product quality and maintain sterility without process interruptions.

Monitors and Analyzes Lyophilization Processes

The LyoFlux 200 TDLAS Sensors, from Physical Sciences Inc., revolutionize lyophilization by providing non-invasive, real-time monitoring of water vapor mass flow. These sensors enhance the freeze-drying process for biologics and pharmaceuticals, such as vaccines and protein therapeutics, by enabling continuous measurement of product temperature and resistance. Utilizing Tunable Diode Laser Absorption Spectroscopy, the LyoFlux 200 allows for seamless scale-up from laboratory to production environments, maintaining aseptic conditions. Ideal for pharmaceutical manufacturers and biologics developers, it helps determine heat transfer coefficients without manual intervention. Designed to integrate smoothly into your processes, the LyoFlux 200 supports compliance with industry standards, ensuring high product quality through Quality by Design principles.

Benefits

  • Enhances product quality by providing precise, real-time monitoring of lyophilization parameters.
  • Reduces manual intervention and labor costs by streamlining data analysis through automated measurement.
  • Maintains product sterility in aseptic production environments with non-invasive sensor technology.
  • Simplifies scale-up from development to full-scale production, ensuring consistent batch quality.
  • Supports regulatory compliance through accurate, continuous assessment of critical process parameters.

General


Applications
Biologics,Freeze-drying applications,Drug development,Life sciences,Pharmaceutical manufacturing,Pharmaceuticals
End products
Vaccines,Peptide drugs,Personalized medicine formulations,Monoclonal antibodies,Plasma derivatives,Enzyme preparations,Live attenuated microorganisms,Liposomal formulations,Protein therapeutics,Probiotics
Steps before
Formulation,Preparation,Solution mixing
Steps after
Sterilization,Packaging,Quality control
Input ingredients
water vapor,biologics,vials
Output ingredients
real-time monitoring data,product temperature,resistance to vapor flow,heat transfer coefficients (Kv)
Market info
SP Scientific is known for manufacturing high-quality freeze dryers, laboratory thermal control systems, and aseptic processing equipment, catering primarily to the pharmaceutical, biotech, and life sciences sectors with reputation for precision engineering and reliable performance.

Technical Specifications


Sensor Type
TDLAS (Tunable Diode Laser Absorption Spectroscopy)
Measurement Range
Water vapor mass flow
Installation
Compact
Fits various sizes of freeze dryers
Non-invasive Measurement
Yes
Application Scale
Laboratory,Pilot,Production Scale
Process Monitoring
Real-time,Continuous Monitoring
Heat Transfer Coefficient Measurement
Yes
Product Attribute Monitoring
Temperature,Resistance

Operating Characteristics


Monitoring type
Non-invasive
Installation
Simple and Compact
Real-time monitoring
Yes
Automation level
Continuous monitoring
Application flexibility
Laboratory to Production Scale
Operation environment
Aseptic

Material Compatibility


Biological compatibility
Aseptic / Sterile
Corrosive resistance (e.g. acids)
Yes
Cleanability
Non-invasive measurement
Density/particle size
Compatible with pharmaceutical forms

Product type Characteristics


Aseptic Environment
Maintained
Scale-Up Capability
From laboratory to production scale

Physical Characteristics


Compact footprint
Yes
Discharge method
Non-invasive
Control panel type
Compatible with various scales

Custom Options


Installation flexibility
Various freeze dryer sizes
Integration capabilities
PAT tool,near-infrared (NIR)
Non-invasive measurement
Yes
Control panel type
Not specified
Compact footprint
Yes