SP Industries announces the release of Version 2 of its FTS SMART Freeze-Dryer™ Technology. This software release adds user functionality for developers of lyophilization cycles.
SMART Freeze-Dryer Technology is available exclusively on the FTS LyoStar II process development freeze-drying system.
According to Leslie Mather, Product Manager, R&D Lyophilizers, "Over the past few years, our pharmaceutical customers have enthusiastically embraced SMART Freeze-Dryer Technology. Through close cooperation with these users, we were able to improve key features and add new functionality that was requested. We are pleased to give the scientists even more innovative ways to use the SMART freeze-dryer system."
Adds Mather, "A select group of customers has been testing the new SMART release and their reaction has been overwhelming. This enhanced version of SMART provides a consistent, repeatable method for calculation of product temperature, cake resistance, ice thickness and heat flow on pre-existing recipes. We're now thrilled to release this to the broader marketplace."
Specific additions and enhancements included in the Version 2 release of the SMART system include:
1. Manometric Temperature Measurement (MTM) data are now available on standard (user defined) recipes. This functionality allows the user to collect MTM data (resistance measurements, product temperature calculations, heat flow calculations) in the elegant SMART Freeze-Dryer format on standard automatic recipes.
In this mode of operation, the operator stays in control of the cycle. While SMART data is generated, the LyoStar II runs the cycle programmed by the operator.
2. Increased product safeties for amorphous, low collapse temperature products and for products with higher fill volumes and solids concentrations. In order to assist scientists in ensuring product safety for products that fall outside SMART's preferred boundaries the following adjustments to the SMART algorithm were made:
• The upper shelf temperature boundary during primary drying for amorphous products will be 5°C.
• SMART will not permit shelf temperature increases after the completion of half of primary drying.
3. Automatic Backfill and Stoppering functionality added. The operator can now choose to automatically backfill and stopper the vials as part of the recipe. This eliminates the need for personnel to be present during this step.
4. The FTS SMART system can now display vacuum units in mTorr or mBar.
5. The underlying Intellution brand software has been upgraded from Version 3.0 to the latest Version 4.0.
SMART Freeze-Dryer Technology is the result of a development partnership and an exclusive licensing agreement with the University of Connecticut (UConn) and Purdue University.