For Lyophilization Process Optimization

Quantitative and precise
Detects contaminants
Real-time actionable results

OVERVIEW

Optimize Lyophilization

Photo of Atonarp Lyosentinel

The ASTON LyoSentinel uses a non-invasive, multi-channel technique to provide in-situ measurements during a lyophilization process including:

  • Measures residual water vapor for accurate endpoint detection to optimize cake and secondary drying formation in the lyophilization process
  • Detects trace heat transfer KT5/silicone oil contamination to minimize yield loss
  • Detects in-line vacuum leaks to reduce time to “production-ready” for the next batch.
Photo of a scientist at a lab

Lyophilization (freeze-drying) is the process by which water is removed from a frozen solution by sublimation. The result is a cake-like material that can be rehydrated easily. The process is used routinely in pharmaceutical and life science manufacturing. Water vapor is removed during primary drying (bulk sublimation) and secondary drying (surface desorption) cycles.  Temperatures must be controlled tightly during each cycle and the equipment must be monitored for mechanical stresses and leaks to avoid irreversible product damage.

The ASTON LyoSentinel is ideal for in-situ process control. Detecting contaminants or leaks in real-time enables the operator to correct or abort freeze-drying cycles when problems occur.  

  • Monitor for trace amounts refrigerants such as silicone/KT5 oil that can leak into the chamber and compromise product sterility
  • Detect air leaks or heat transfer oil contamination in real-time to reduce scrap rates 
  • Minimize drying cycle time to increase throughput

ASTON LyoSentinel for in-situ process monitoring 

  • Endorsed by major pharma process analytical technology professionals
  • 21 CFR part 11 compliant
  • Designed specifically for lyophilization process monitoring
  • Unique miniature high-pressure mass spectrometer design
  • Detect & Protect: Silicone and KT5 oil detection and system protection
  • Designed for standalone or integrated operation.
  • On-board use cases:
  • Primary and secondary drying endpoint
  • Fast silicone/KT5 oil detection
  • Baseline chamber health – leak and contaminates checking
  • Process transfer
  • User customizable
  • Edge device / cloud-ready integration for lyophilization system machine learning
  • Field serviceable
Photo of Atonarp Lyosentinel

Resources

Mass Spectrometry

Mass spectrometers (MS) are available in various sizes, capabilities and price range and have utility in vastly different applications. MS measures the mass of a molecule after converting the molecule to a gas-phase ion. The instrument imparts an electrical charge to molecules and converts the resultant flux of electrically charged ions into a proportional electrical current that a data system then reads. The data system converts the current to digital information, displaying it as a mass spectrum.

Mass Spectrometry Applications
Atonarp initially has deployed the ASTON Platform as an in-situ metrology product in semiconductor fabrication plants to monitor gases associated with the most advanced manufacturing processes. However, a wide variety of applications for our platform beyond semiconductors creates a large potential market for ASTON for the foreseeable future. Researchers from various disciplines within chemistry, biochemistry, and physics regularly depend on mass spectrometric analysis.

  • Oil and Gas industry: Fuels are derived from the distillation of crude oil and the properties are modified by adding chemicals to arrive at the final fuel. Natural fuels are extremely complex mixtures whose composition depends on the source of the crude oil and the processing of material. Determining composition is a complex and costly prospect that has driven the development of some of the earliest mass spectrometers and continues to drive advances in the technology.
  • Pharmaceutical scientists involved in drug discovery and development rely on the specificity, dynamic range, and sensitivity of MS to differentiate closely related metabolites in a complex matrix and thus identify and quantify metabolites. Particularly in drug discovery, where compound identification and purity from synthesis and early pharmacokinetics are determined, MS has proved indispensable.
  • Biochemists expand the use of MS to protein, peptide, and oligonucleotide analysis. Using mass spectrometers, they monitor enzyme reactions, confirm amino acid sequences, and identify large proteins from databases that include samples derived from proteolytic fragments. They also monitor protein folding and important protein-ligand complex formation under physiological conditions.
  • Clinical chemists use MS for drug testing and neonatal screening.
  • Food safety and environmental researchers use MS in water quality studies and to measure pesticide residues in foods.

ASTON Differentiation

HyperQuad Technology

  • Hyperbolic quadrupole magnets provide superior performance vs. traditional circular rods
  • High sensitivity (10 parts per billion), broad dynamic range, accuracy and repeatability

Plasma Ionization Method

  • Uniquely, ASTON takes advantage of using the process cleaning gases to clean itself during the normal chamber clean process

Advanced Vacuum Controller (AVC)

  • AVC integrates with the process chambers for fast changes in process gases
  • Measures dwell times as low as 1 msec, or 1000 data points per second

Key Benefits for Real-Time Process Control

  • ASTON is a robust, single instrument that replaces multiple legacy metrology tools
  • Advanced data analytics enables autonomous process control
  • Small and ready for full integration into high-volume production tools
  • Provides real-time, specific chemical data
  • Actionable information drives decisions to maximize throughput and yield