Chinese style enlarged freeze dryer

L * a series

A reliable choice

The new requirements of the R&D center for freeze-drying machines are the feasibility and reliability of scaling up the freeze-drying process. FDA investigators believe that there is a lack of strict documentation guidance for the process of developing process formulas, clinical trials, and commercial production. Therefore, they emphasize that cGMP should be used as a quality control measure and implemented as a standard specification throughout the process from research and development to production.

The new L * A series freeze dryer is an experimental freeze dryer designed specifically for the R&D center of *. We must always remember that the development of new drugs is one of the most critical steps in achieving success in commercial production.

At the same time, the L * a series products use GMP standards as quality supervision standards, and all products comply with laboratory cGMP standards.

Design features

The L * a series products have a compact design structure, with all components integrated into the box and equipped with casters for easy movement. The vacuum, refrigeration system, and other necessary components are fully configured and connected to the public facilities before use.


*The design concept

This series of products provides a solution for the R&D center to explore the freeze-drying process. L*aVarious appropriate components, devices, and sensors are configured to control temperature, pressure, and time, providing sufficient control for various processes and ensuring process repeatability.

This equipment includes a plate heat exchanger and other high-quality components to ensure the quality of our freeze-drying machineHeating and cooling rate reached1℃/minute(Same as industrial freeze dryers.)

throughThe valve between the sample chamber and the condenser can easily achieve process optimization,This valve is used for pressure rise testing and thermodynamic control, making it easy to optimize the freeze-drying process. This valve can also load and unload products directly without defrosting when the condenser is not fully loaded.

The refrigeration system can achieve a condenser temperature of -85 ℃ and a laminate temperature of -60 ℃. Only suitable for HFC environmentally friendly refrigerants, ensuring that the environment is not polluted and can be used for a long time.

flexible application

By using a capping device, the spacing between the layers can be easily adjusted,Suitable for bottles of various capacities, sizes, and types.In addition, there is an interface left on the side of the freeze-drying machine for connecting 6-port multi manifold, which can freeze open freeze-drying bottles of CN29/32.
forAdvanced R&D Centerprovided
solution

The sample chamber and layer board use the same structure and materials as the industrial freeze dryer.The manufacturing material is 316L stainless steel and all internal components are designed to be easy to clean. The condenser is also made of 316L stainless steel and equipped with an electric heating rapid defrosting device.
The sample chamber and condenser are both equipped with transparent acrylic doors for easy observation of the entire freeze-drying process.

Sandwich style laminated board with thermal conductive silicone oil circulation channels inside. This structure enables the product to achieve temperature control during in-situ pre freezing and sublimation stage heating.The top layer of heat radiation board is used to ensure that all samples on the board are uniformly heated.

Usually, the vacuum sensor of the freeze-drying machine used in research and development is installed on the vacuum channel to reflect the vacuum degree inside the chamber. The L * a device has a vacuum sensor located inside the chamber, which directly reflects the actual vacuum level of the environment in which the sample is located.This enables pilot studies to achieve amplification effects.
control system

based onPLCcontrol
A user-friendly interface
touch screencontrol system

L*aseriesThe main feature of the freeze-drying machine is the use of PLC instead of the microprocessor used in traditional models of this type. All industrial freeze dryers use PLC systems. So using the same system in the pilot freeze-drying machine canEnsure the reliability and repeatability of the process,Simultaneously ensuring that the device complies with cGLP standards.

The control of freeze-drying process through human-machine interface (HMI) mainly includes:
Information display of main components of the system (valves, motors, indicators, etc.)
Alarm information reception
Display of parameters in freeze-drying cycle process
Eliminate the possibility of misoperation
Protecting the system through authorization of the operator
Development of freeze-drying process
Download information through USB interface

The user interface is a very prominent and easy to understand 6.5-inch color touch screen display. Through this touch screen, various parameters of the freeze-drying process can be quickly inputted.
Alternatively, as an option, the device can also be connected to different peripherals such as a chart recorder, printer, or PC. With the PC connected, you can use both the original operating interface and the Windows interface for direct control.

Lyologger
Data collection software that collects charts, events, alarms, and historical records (ASCII code files) through serial ports

LyoStar/Lab
Specially designed SCADA program software for research and development. It can design, load and store process programs to record the freeze-drying process in real time, draw freeze-drying curves, generate reports, historical records, alarms, etc.
Compliant with 21 CFR 11 standards.