The innovative and very flexible FlexPro 50 production system for biotechnological products and pharmaceuticals essentially consists of three components: an isolator system from Ziel and precisely filling and sealing machine modules from Groninger with the option to add a Martin Christ freeze dryer including the innovative LyoShuttle loading and unloading system. The FlexPro 50 is designed so that the production of pharma-ceuticals can be made extremely flexible by exchanging the predesigned modules. The machine modules are simply inserted and connected using the "lock-and-key" principle.
All FDA requirements for pharmaceutical production are fulfilled.
The new LyoCube acrylic glass made of acrylic glass (PMMA) offers a large, effective area of up to 0.6 m2 and particularly comfortable operation thanks to rectangular shelves and its front swing door. The LyoCube acrylic glass can be combined with an extensive range of accessories. The LyoCube acrylic glass is particularly suitable for the use of unheated shelves or racks for up to 90 microwell plates. The LyoCube is also available in a stainless steel version – LyoCube stainless steel. Especially for the use of heated shelves.
For routine applications, a high degree of process reliability is expected in addition to application-specific flexibility. The Alpha or Beta device series with the new LSCbasic control system fulfils these requirements.
Useful functions, such as the schematic system diagram providing information about the system status at a glance, the indication of the product temperature based on the ice pressure curve or the use of multiple languages are highly convincing.
It is common practice to use freeze-drying not only for aqueous solutions. Typical examples are HPLC fractions with solvents, such as acetonitrile, TFA and other alcohols or products with tert-Butyl alcohol, DMSO etc.
The new Alpha 3-4 LSCbasic solvent package enables safe working with these often flammable solvents and offers improved deposition (ice condenser approx. –105°C) and a very high level of chemical resistance.
An innovative PAT tool: The wireless product temperature measurement system WTMplus 2.0 for comfortable handling without annoying cable tangles. Improved sensor geometry and optimised response times ensure precise measurement results during all freeze drying phases. The new generation of sensors has an RFID chip to enable automatic identification during the process. The measurement system, which is integrated into the control system, can be used in all pilot and production freeze dryers made by Christ.
The product range of the Martin Christ Company has been expanded to include the new, patent-pending LyoShuttle automated loading and unloading system. The freeze-dryer is loaded by a loading robot that uses timing belts to move horizontally. All of the components have been selected based on cGMP considerations.
Thanks to its flexible and space-saving construction, the LyoShuttle option is particularly suitable for production freeze dryers in the pharmaceutical field, including under insulated conditions, and requires significantly less space.
The LyoShuttle system from Martin Christ has outstanding advantages to ensure product quality and production reliability.
Because process times can be many hours long, it is seldom practical to observe the drying process.
This is where Martin Christ turns to LyoCam: a high-quality, full HD industrial camera continuously photographs the product, at intervals varying from seconds to minutes, depending on the process stage. Event-controlled high-frequency recording or freezing is also possible with controlled nucleation. The behavior of the ice condenser (build-up) can also be documented.
The key feature, however, is coupling images using our LPCplus SCADA system on the freeze dryer.
Regarding the freezedrying of products in vials, it should be avoided, that all samples freeze at different times. It is the aim to gain more process control and more homogenous end product properties.
The introduction of the new accessorie LyoCoN by Martin Christ is the answer to this challenge: The vials are initially cooled down and subsequently charged with a fine ice fog. The ice crystals move into the vials and work as freezing nuclei. All vials crystallize within seconds – without the stochastic time lag by suprercooling.
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The LyoCube with useable shelf area of up to 0.6 m2 provides user-friendly operation with front door and rectangular shelves. Flask drying in up to 2 x 3 glasflasks is available as an option. The LyoCube is available for the latest LSCplus laboratory freeze dryer product line or as a retrofit of existing freeze dryers with LSC controller.
The user-friendly process control system LPCplus SCADA software brings together the operation of all freeze-drying functions and the associated administrative tasks under a single user interface – of course, 21 CFR Part 11 compliant. LPCplus supports in conjunction with online process data the self-optimizing of lyophilization recipes.
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With the Epsilon 2-4 LSCplus, we proudly present the last remaining pilot unit at Christ upgraded with the innovative LSCplus controller. The freeze dryer is specially dedicated to sensitive, low freezing products. Ice condenser and shelf temperatures of -85 °C resp. -70 °C enable solvent freeze drying at its best.