Adixen guarantees secure freeze-drying.

<b>Adixen guarantees secure freeze-drying.</b>
Annecy, France, September 2007.

Alcatel Vacuum Technology France, the global expert in the manufacturing of vacuum pumps and leak detectors, has just finalized a new process for humidity detection. This sensor, called Lyotrack, is the first diagnostic tool to offer real-time monitoring of the water vapour concentration inside freeze-drying chambers. It ensures instantaneous monitoring throughout the process.

The freeze-drying process of sensitive biotechnological products (such as vaccines, enzymes, antibodies and hormones) relies on dehydration by sublimation of components. This method is based on two key phases - primary and secondary drying, phases when the products concerned are first frozen then reheated. Today, monitoring of this process requires an accurate measurement of the differences in temperature or pressure, in order to determine the end of the primary drying phase, characterised by a very low level of water vapour. Lyotrack offers a new and radically different method of direct measurement.

Lyotrack uses ICP-OES technology (inductively coupled plasma – optical emission spectroscopy). It includes a plasma generator by induction and an optics spectrometer of emission, monitored by embedded systems.

Lyotrack’s monitoring is doubly efficient. The created electromagnetic field ionizes the gases, breaking the molecules down into simple elements, at the freeze-dryer exhaust. Gas atoms are thus identified, as they oscillate between excited and stable states, emitting characteristic photons several thousand times a second. The light emitted is then analyzed by spectroscopy in order to isolate wavelengths related to water, and Lyotrack instantly detects the quantity of remaining water vapour. It therefore doesn’t need to rely on less accurate measurements of temperature and pressure which, though complementary, remain indirect methods.

This new humidity sensor can monitor the parameters of the different freeze-drying phases using sublimation of compounds, as well as primary and secondary drying-phases of up to 5 µbar, for all batches and not only for the vials equipped with thermal probes.
Lyotrack also withstands sterilization cycles, enabling it to be integrated as an intrinsic component of the freeze-dryer.

A fast, cost-effective solution

Installed in just a few minutes between the chamber and the condenser, using a 1.5 inch tri-clamp connection, Lyotrack doesn’t require major intrusive modifications to freeze-dryers. It is directly connected via Ethernet to a computer equipped with the analysis software, which displays and stores the data and history of the process. Lyotrack also has an analogical output which can export the humidity signal value for recording purposes by devices complying to the CFR21/part11 standard. It can be integrated on new freeze-dryers but can also be adapted to less recent installations as a retrofit improvement, at a very competitive market price.

Lyotrack represents a relevant and economical solution to the Food and Drug Administration recommendations, including the Process Analytical Technologies (PAT) guideline which recommends modern process analysis tools and real-time process monitoring for the whole cycle.

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