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Xingdeke Taishida Pharmaceutical Technology (Shanghai) Co., Ltd
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Xingdeke Taishida Pharmaceutical Technology (Shanghai) Co., Ltd

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    Building A15, Sany Zhushengyuan, Zhengbo Road, Fengxian District, Shanghai

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Imported pilot process exploration type freeze-drying machine

NegotiableUpdate on 05/06
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Overview

The investigators of the $r $n $r $nFDA import small-scale freeze-drying machine believe that there is a lack of strict document guidance in the process of process formulation from research and development to clinical trials and commercial production. Therefore, they emphasized that cGMP should be used as a quality control measure, and this equipment should be executed according to this standard specification from research and development to production.

Product Details

Exploration of imported small-scale pilot process for freeze-drying machine*The design concept


This series of products provides a better solution for the R&D center's exploration of freeze-drying technology.

The pilot process exploration type freeze-drying machine is equipped with various appropriate components, devices, and sensors to control temperature, pressure, and time, providing sufficient control for various processes and ensuring their repeatability.



Exploration of imported small-scale pilot process for freeze-drying machineFeatures of the equipment


This pilot process explores the freeze-drying machine equipment, which includes plate heat exchangers and other high-quality components, to ensure that our freeze-drying machine can achieve a heating and cooling rate of 1 ℃/minute (the same as industrial freeze-drying machines)


Process optimization can be easily achieved through the valve between the sample chamber and the condenser. 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.


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 upper 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. This 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 allows for the amplification effect that can be obtained in pilot studies.


The main feature of this series of pilot process exploration freeze-drying machines 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 can greatly ensure the reliability and repeatability of the process, while making the equipment comply with cGMP standards.