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LyoBeta

LyoBeta

LyoBeta

Product catalog summary
Introduction
The document discusses the new demands in R&D centers, focusing on the scale-up feasibility and quality of procedures. It highlights the FDA's concerns about the lack of strictness and documentation in technology transfer from R&D to clinical trials and production, emphasizing the importance of cGMP as a quality oversight.

LyoBeta Series Lyophilizers
The LyoBeta Series lyophilizers are designed for advanced research centers, crucial for the initial development of new drugs. These units can connect to peripherals like chart recorders, printers, or PCs, offering data logging and SCADA software for scientific R&D studies.

Control System
The LyoBeta Series features a non-proprietary PLC control system, ensuring reliability and reproducibility. The graphic HMI user interface allows for easy operation, displaying system information, receiving alarms, and developing recipes.

Design Features
The LyoBeta is equipped with components to control temperature, pressure, and time, ensuring process control and reproducibility. It includes brazed plate heat exchangers for efficient cooling and heating, and a refrigeration system reaching -83°C in the condenser and -65°C on the shelves.

Flexibility and Efficiency
The unit is adaptable to different product fill volumes and vial sizes, with a stoppering device and a lateral inlet port for freeze-drying open flasks. The thermal fluid system ensures uniform heat transfer across shelves.

Technical Specifications
The document provides detailed technical data, including shelf dimensions, temperature range, condenser capacity, power requirements, and vacuum pump flow for different LyoBeta models.

Conclusion
The LyoBeta Series offers high-quality, precise control, and temperature uniformity, making it an ideal choice for advanced research centers focused on drug development.
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Catalog excerpts

LyoBeta-2

LyoBeta series A Responsible Choice New demands in R+D centers are related to scale-up feasibility and quality of procedures and research methods. FDA investigators consider that transfer of technology from R+D departments to clinical trials and later commercial production is carried out with lack of strictness and poor documentation practices. Therefore, they are emphasizing on the concept of cGMP as a quality oversight, comprising all practices in R+D and production processes. The new LyoBeta Series lyophilizers are laboratory units that have been designed specifically for advanced research...

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LyoBeta-3

Control system Based on PLC and user Friendly TOUCH-SCREEN One of the main new features of the LyoBeta Series freeze-dryers is the incorporation of a non-proprietary PLC, instead of the classic microprocessor, more commonly used in this type of equipment. This system, fully proven in the industrial models, guarantees maximum reliability and reproducibility in the process, totally adapting the equipment to cGLP. The system allows control of the freeze-dryer functions via a graphic HMI (Human Machine Interface) user interface, which offers the following possibilities: • Displaying of information...

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LyoBeta-4

Design features The LyoBeta is a compact unit with castors, constructed in a steel stove-enamelled cabinet. The equipment is supplied fully assembled, including the vacuum and refrigerating system and all necessary elements, ready for operation after connecting to the utility services. Efficient Design THE DESIGN OF THIS UNIT OFFERS THE BEST CAPABILITIES FOR R+D ACTIVITIES. LyoBeta has been equipped with the appropriate components, devices and sensors to control processing conditions: temperature, pressure and time. This allows defining the process variables to achieve adequate control and reproducibility....

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LyoBeta-5

The best Solutions for Advanced Research Center High Quality and Superior Craftsmanship THE CHAMBER AND SHELVES HAVE BEEN CONSTRUCTED WITH THE SAME PHILOSOPHY AS PRODUCTION UNITS. They are made entirely from stainless steel AISI 316 L and they are fully accessible inside for cleaning purposes. The condenser, which is also made of AISI 316 L, has a rapid ice-defrosting device, which works by means of a group of external electrical resistors. Both the chamber and the condenser have transparent acrylic doors to facilitate viewing of the process. Drying chamber Precise Control and Temperature Uniformity...

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LyoBeta-6

Freeze-Drying Equipment LyoBeta Technical data FEATURE Unit LyoBeta 15 LyoBeta 20 LyoBeta 25 LyoBeta 35 Number of shelves ud 3+1 4+1 4+1 6+1 Shelves dimensions mm 338 x 450 338 x 450 380 x 450 380 x 450 inches 13.3 x 17.7 13.3 x 17.7 14.9 x 17.7 14.9 x 17.7 m2 0.46 0.61 0.68 1.03 sq. ft. 4.94 6.56 7.31 11.08 mm 93 66 100 60 inches 3.7 2.6 3.9 2.4 Shelf temperature range °C –65 a +80 –65 a +80 –65 a +80 –65 a +80 Condenser capacity kg 30 30 40 40 lb 66 66 88 88 kg 12 12 18 24 lb 26 26 39 52.8 °C <–83 <–83 <–83 <–83 wxd Useable shelf area Clearance Condenser capacity in 24 h Final condenser temperature...

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