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19 Jun 2018

Telstar Lyosensing, a versatile process analyzer developed to monitor the freeze drying cycle & detect and prevent real and virtual leakages in pharma freeze-dryers

To safeguard the integrity of the lyophilized product

  • Lyosensing addresses one of the main fears associated with lyophilization processes, the presence of silicone oil leaks from thermal fluid through the shelves circuit that could generate the loss of an important amount of contaminated product
  • As a real time in-situ tracking system, Telstar Lyosensing also detects the presence of water vapors in the chamber being capable to monitor the primary and secondary drying, as well as identifying residual gases or external agents in the aseptic environment

Lyosensing is an in-line process analyser based on the application of a quadrupole mass spectrometer system, a non-invasive technique capable of performing quantitative real-time measurements during freeze-drying processes.  Embedded into a lyophilizer, the use of the analyser in Telstar freeze dryers enables detecting and monitoring the presence, as well as the behaviour, of several agents (humidity, gases, silicon oil,…) that could be present during maintenance operations, performance test or, in the most critical case, during the freeze-drying cycle. As a process analytical tool (PAT), Lyosensing has been designed by Telstar to monitor potential silicon oil contamination, primary and secondary drying endpoints, and perform in-line vacuum leak detection in the field of lyophilization processes.

While the majority of gas found within the freeze-dryer comes from the sublimation water, other gases are also present from the controlled leak (argon, GN2, or even clean air from the clean room...), real or virtual leakages, as well as backstreaming from the vacuum pumps. Used as a contaminant detection tool, Lyosensing allows a safe detection of traces of silicone from thermal fluid through the shelves circuit. It is, in fact, probably one of the principal concerns for freeze dryer users. Trace levels of contaminants present in large systems are often left undetected, which requires a safe preventive control system to avoid loss of large amount of potentially contaminated product, preserving the integrity of the product, in addition to guaranteeing quality assurance.

The versatility of the equipment allows the user to choose the placement on the freeze-dryer, either on the condenser, on the chamber, or between both locations, depending on the type of process being managed. The in-line process analyzer integrated by Telstar in its freeze-dryers allows freeze-drying process cycle monitoring by providing accurate data of the water concentration during primary and secondary drying.

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