Best Freeze Drying Solutions The ultimate plus Pilot Freeze Dryers Epsilon 2-6D LSCplus Epsilon 2-10D LSCplus
2 Best Drying Results
Advanced System Technology for Best Drying Results The freeze dryer EPSILON 2-6D/2-10D LSCplus is a high performance universal laboratory and pilot unit for freeze drying of solid or liquid products in ampoules, vials, glass flasks, plasma bottles or dishes. All operations are possible inside the unit: Pre-freezing of products on liquid-controlled shelves down to a shelf temperature of approx. 50 C to +60 C according to preselected desired time and temperature limits Freeze drying (sublimation) of products according to preselected desired time, temperature and pressure limits. Shelf temperature at the initial phase of the sublimation process is approx. 40 C Final drying of products with preselected desired time and temperature limits and high final vacuum to remove the capillary and molecular bounded water. Final vacuum is approx. 0.005 mbar (depending on pump performance) Double-chamber system: Ice condenser directly behind the drying chamber Internal condenser coils for best vapor trapping Large cross-section between drying- and ice condenser chamber Nearly no drop of pressure between both chambers. Excellent drying rates for sensitive materials and products with low-eutectic points or low collapse temperatures High efficiency and economic operation of the freeze dryer Application-oriented process-control-system LSCplus ( Lyo-Screen-Control ), microprocessor-based Minimized space requirements The freeze dryers EPSILON 2-6D/2-10D LSCplus are suitable for freeze drying of materials such as bacteria and virus cultures, blood plasma, serum fractions, antibodies, sera, vaccines, biopharmaceutical complex proteins, plant extracts, diagnostic test kits. 3
Design Features Vial stoppering Easy and safe Powerful shelf temperature control Liquid cooled and heated shelves, control range -50 to +60 C (freezing and main drying), shelf temperature accuracy +/-1K. Defrosting without water Via reverse operation of compressor system the ice condenser coils can be defrosted very efficient ( hot gas defrosting ). No production of additional waste. Optimal vapour transport 120 mm diameter valve, ice condenser directly behind drying chamber (no pipe connection which results in a pressure drop). Uncompromising Process Control Via intuitive, simple to control interface LSCplus (Lyo-Screen-Control). Can be combined with process visualization LPCplus, complying with the most current GMP/CFR-guidelines. Epsilon 2-6D LSCplus Compact design with powerful compressor- and vacuum system Most efficient condenser design Flexible shelf area eco-version Available as an option, uses environmentally friendly, natural refrigerants. 100% engineered and manufactured in Germany. LSCplus-Controller Epsilon 2-10D LSCplus Shelf dimensions 350 x 400 mm 4
Most Comprehensive Range of Customized Solutions With the Epsilon-Pilot-Range Martin Christ have set the standard for high quality and productive pilot systems. These freeze dryers look and function in a very similar way to the large production freeze dryers. They provide the highest level of functions for successful research and process development. Pilot systems with customized configurations have been supplied to global acting pharmaceutical companies and Biotech start-ups. Modifications include: Clean Room Integration Isolator / Glove Box Integration Process Optimization Tools (PAT - Process Analytical Technology) - Lyocontrol - LyoBalance - Weighing System - Sample Thief / Manipulator - Comparative pressure measurement (Pirani-MKS) - Wireless T-Probes (see page 8) H 2 O 2 -Decontamination LN 2 -Booster Special Systems for Solvents Example: sample thief/manipulator with camera monitoring Example: glove box integration Example: system for Clean-Room-integration, control via Touch-Screen 5
LSCplus colour touchscreen and intuitive operation To aid in designing your process run we have integrated our highly regarded production optimised interface the LSCplus control system into every model. All of the accessories are also integrated. Automatic process sequences ensure reproducible results. Picture driven touchscreen control Automatic or manual sequence of freezedrying processes Intuitive input of programs based on different freezedrying sequences/recipes Graphical diagram of the freezedrying process Selection of different switching conditions, depending on the system configuration Overview of the language selection Storage memory for up to 32 user-defined programs Detailed messages Wide selection of languages already integrated Definable measure for the temperature ( C/ F) and pressure (mbar/hpa/torr) Password protection possible (up to 3 levels) Process data acquisition and convenient data exchange via USB or Ethernet Graphical diagram of a freeze drying process Actual value display with functional diagram 6
Process monitoring and documentation We understand process monitoring and documentation is crucial to the validation of many applications regardless of the run and the run size. Therefore process data collected during a run on our system can be documented and archived with the aid of the LyoLogplus software available for installation on an external PC. Complete run data and settings can be transferred from the freeze dryer via USB or Ethernet. LyoLogplus enables the subsequent analysis of the processes by way of an intuitive user interface. For further versatility it is also possible to use LPCplus to develop your freeze drying process. LPCplus delivers an online view of the processes data in a graphical format. Need to scale up? Enjoy easy platform migration from pilot through to production scale with uniform interface and software solutions. LyoLogplus Data storage on a USB memory stick Easy process documentation with LyoLogplus LPCplus (Lyophilisation Process Control) for process control and documentation Avoid unwanted thawing thanks to our reliable process monitoring and innovative LyoRx sensor Automatic determination of the freezing point with LyoControl for secure process control LPCplus LyoLogplus and LPCplus with a multilingual user surface We design and craft our freeze dryer to follows the published cgmp/glp guidelines. The optional LPCplus software complies with the current GAMP standard guidelines. System qualification (IQ/OQ) is therefore possible upon request. 57
Process optimisation With the aid of pre-defined FD-programs/recipes and intelligent interactions of product relevant parameters such as Product temperature LyoRx (electrical resistance) Pressure data (pressure increase test, comparison between Pirani- and capacitive sensor) and in combination with the FD-control System LSCplus, a self-optimizing cycle mode can be defined. As a result, time and costs for cycle development and transfer to production can be reduced by at least factor 3 compared to conventional freeze dryers. WTMplus in Pilot units Optional is a wireless temperature measurement WTMplus for up to 8 samples sensor available. Special features are Fully integrated system within controller LSCplus No separate tool-box required for monitoring and visualization Antenna inside drying chamber for maximum coverage of all vial positions Improved sensor technology, small and robust design High accuracy +/ 0.5K (max. +/ 1K) No heat input to samples as with wired probe, therefore measurement of real values 8
Process optimisation in detail The LSCplus series offers a variety of options to optimise your freeze drying processes. In addition to documentation and key parameter analysis, the automatic determination of critical product data is also available. Our intelligent systems even offer the option of automatic tuning for set values based on current process conditions. As a result, these laboratory freeze dryers offer numerous options for supporting process development and optimisation, which can provide important findings designed to enable confidence in scale-up conditions. Freezing point Our LyoRx sensor monitors electrical resistance as well as the product temperature. The resulting profile data can be utilised by our LyoControl software for the automatic determination of your product freezing point. The benefit to your process is a reliable estimation of the critical product temperature tolerances during the main drying phase to prevent product melting. Product resistance The LyoRx sensor enables the automatic control of the energy supply of the individual shelves during the main drying phase, which makes it possible to limit the thawing effects of the product, for example. LyoControl Product temperature In order to measure the product temperature, every shelf can be equipped with a PT-100 sensor. The product temperatures on the various shelves can be viewed in the LSCplus control system. Pressure increase test The transition from the main drying phase to the secondary drying phase can be initiated with our automatic pressure increase test. Christ solutions include an integrated valve between the product chamber and the ice condenser. This valve is briefly oscillated during the main drying phase. If the pressure increase in the product chamber remains below set limits whilst the valve is closed our system can determine, no further sublimation water left in the product and the secondary drying phase can be initiated. Comparative pressure measurement The use of two different vacuum sensors (Pirani and capacitive principle of measurement) enables conclusions to be made concerning the end of the main drying phase. When the difference of the pressure measurement falls below a predefined limit, the secondary drying phase will be started automatically. LyoBalance exact determination of drying speed The microbalance LyoBalance provides the ultimate direct measurement of the drying advancement. As innovation, the operation is integrated in LSCplus with data monitoring via the LyoLogplus or LPCplus-software of the pilot unit. No need for a second software for logging of the weight loss. Furthermore, the speed of drying is documented. Comparative trials can be assessed instantaneously. 59
Technical Specification Ice condenser Max. capacity Performance Temperature Chamber volume Shelf system dimensions (W x D) temperature range temperature accuracy Number of shelves and capacities see table on next page Refigeration system Refrigerant Dimensions (W x H x D) of the basic unit Weight Power supply (other voltages on request) Nominal power of the basic unit Communication interface Noise level as per DIN 45635 Defrosting function Vial stoppering manual hydraulic automatic function aeration-stoppering-storage LyoControl (freezing point determination, measurement of product ressistance) End point determination product temperature measurement WTMplus Wireless Temperature Measurement pressure increase test capacitive pressure measurement comparative pressure measurement LyoBalance weighing system Programmer module for up to 32 recipes with 64 sections each Additional functions safety pressure LyoRx resistance safety value T product and shelf USB LyoLogplus Epsilon 2-6D 6 kg 3,5 kg/24 h approx. 85 C approx. 23 l 225 x 300 mm approx. 50 to +60 C < +_ 1K 2x0,6 kw + 1x0.6 kw CFC-free 860 x 1.267 x 650 mm approx. 330 kg 3 x 400 V/50 Hz 3.45 kva Ethernet 61 db(a) Hot gas = option = standard Epsilon 2-10D 10 kg 8 kg/24 h approx. 85 C approx. 50 I 350 x 400 mm approx. 55 to +60 C < +_ 1K 2x1.2 kw + 1x0.9 kw CFC-free 1.190x1.295x850 mm approx. 750 kg 3 x 400 V/50 Hz 6,8 kva Ethernet 64 db(a) Hot gas Subject to technical changes 10
Shelf Capacities Epsilon 2-6D Shelf width : 225 R-Vials 2R 4R 6R 8R 10R 15R 20R 25R 30R Shelf length: 300 mm 35 45 40 45 45 60 55 65 75 Shelf 15 Ø mm 16 16 22 22 24 24 30 30 30 Qty of shelves Area Spacing Numbers are max loading, subtract 10 % when using frames! 1 + 1 0,07 250 280 280 130 130 115 115 72 72 72 2 + 1 0,14 117 560 560 260 260 230 230 144 144 144 3 + 1 0,21 73 Standard 840 840 390 390 345 345 216 216 H-Vials 5H 7H 8H 10H 15H 20H 25H 30H 50H 100H mm 41 41 47 54 59 58 58 63 73 95 Ø mm 21 22 23 25,5 27 32 36 36 43 52 Qty of shelves Area Spacing Numbers are max loading, subtract 10 % when using frames! 1 + 1 0,07 250 160 143 135 111 90 65 50 50 36 21 2 + 1 0,14 117 320 286 270 222 180 130 100 100 72 42 3 + 1 0,21 73 Standard 480 429 405 333 270 195 150 150 without sealing device 4 + 1 0,27 51 Tray only 5 + 1 0,34 40 Tray only 6 + 1 0,40 31 Tray only Epsilon 2-10D Shelf width : 350 R-Vials 2R 4R 6R 8R 10R 15R 20R 25R 30R Shelf length: 400 mm 35 45 40 45 45 60 55 65 75 Shelf 15 Ø mm 16 16 22 22 24 24 30 30 30 Qty of shelves Area Spacing Numbers are max loading, subtract 10 % when using frames! 1 + 1 0,14 354 613 613 326 326 266 266 165 165 165 2 + 1 0,28 170 1226 1226 652 652 532 532 330 330 330 3 + 1 0,42 108 1839 1839 978 978 798 798 495 495 495 4 + 1 0,56 77 2452 2452 1304 1304 1064 660 5 + 1 0,70 59 Standard 3065 6 + 1 0,84 47 Tray only 7 + 1 0,98 38 Shallow Tray only H-Vials 5H 7H 8H 10H 15H 20H 25H 30H 50H 100H mm 41 41 47 54 59 58 58 63 73 95 Ø mm 21 22 23 25,5 27 32 36 36 43 52 Qty of shelves Area Spacing Numbers are max loading, subtract 10 % when using frames! 1 + 1 0,14 354 363 326 290 243 218 147 117 117 83 54 2 + 1 0,28 170 726 652 580 486 436 294 234 234 166 108 3 + 1 0,42 108 1089 978 870 729 654 441 351 351 249 4 + 1 0,56 77 1452 1304 1160 972 872 588 468 5 + 1 0,70 59 Standard 6 + 1 0,84 47 Tray only 7 + 1 0,98 38 Shallow Tray only 11
Martin Christ Gefriertrocknungsanlagen GmbH An der Unteren Söse 50 D-37520 Osterode am Harz Germany Tel. +49 (0) 55 22/50 07-0 Fax +49 (0) 55 22/50 07-12 www.martinchrist.de info@martinchrist.de 02/2014 N