‍ Hot Melt  Extruder

Purpose:       

      This device is an exclusive solid dispersion one-step granulator developed by our company for

 pharmaceutical formulations. It can achieve one-step granulation of various types of solid dispersions 

 such as taste masking, solubilization assistance, and targeted release, and can also directly prepare  

 slow-release granules.

Principle:

       The raw materials are fed into the feeding hopper through a quantitative feeding device and then

 evenly conveyed by a twin-screw. The screw is heated in sections, gradually increased in temperature,

 and the material is melted step by step. In the middle section, it achieves fusion, and then gradually 

decreases in temperature. Finally, it is extruded by the screw through the orifice plate to form a dense 

and hard strip. The target particle size product is obtained by conveying and shearing the strip material

through a conveying and shearing device.

Characteristic:

1. Feeding system: vibration feeder, twin-screw feeder, to meet the feeding needs of customers for 

    materials of different properties.2. Heating method: Design to perform segmented electric heating 

    on both upper and lower cylinders simultaneously, ensuring uniform heating.

3. Multi stage precise temperature control system (within the set value range of ± 0.5 ℃): adopting a

   precise temperature control feedback system, the temperature of each section is stable without

   interference, ensuring the stability and reproducibility of the hot melt process.

4. Current monitoring feedback system: online monitoring of extrusion current value, determination of

    extrusion torque, feedback protection of twin-screw, and increase screw service life.

5. Dual cooling system: integrating water cooling and air cooling, better ensuring the stability heating 

    temperature.

6. Combination twin-screw: The twin-screw adopts a multi-stage splicing form, integrating mixing, 

    pressurization, melting, extrusion, and cooling to ensure complete fusion of the main drug and 

    auxiliary materials.

7. Orifice plate selection: Different shapes and apertures of extrusion orifice plates can be selected to

    adapt to the extrusion of materials with different properties.

8. Multi stage exhaust: Design multi-stage exhaust holes to effectively discharge air, moisture, etc. 

    from the molten material, reduce extrusion pressure, and improve product quality.

9. Conveyor shearing device: Different structures of shearing devices can be equipped according to the

    characteristics of different materials to obtain uniform particles.

10. Compliant with GMP standards, easy to disassemble and clean, with three-level password permissions. 

     Process parameters are automatically controlled by PLC, and all data is automatically stored online and 

     can be exported via USB flash drive.

11. Function extension: Continuous wet granulation.

    Specifications-models-main technical parameters:

                                                          DS-BIOAT Reciprocating Cylinder

Product Introduction:

       The DS-BIOAT automatic reciprocating cylinder dissolution system consists of a reciprocating cylinder dissolution device

and an automatic sampling workstation. Meet the relevant requirements of the US Pharmacopoeia, Chinese Pharmacopoeia

and European Pharmacopoeia. The device adopts a transparent hollow cylinder equipped with screens at both ends. The 

sample to be tested is placed in the cylinder and the screens at both ends are tightened before being placed in a dissolution  cup

containing dissolution medium and gently reciprocating up and down. The dissolution medium flows through a reciprocating

cylinder through a sieve, providing shear force at the liquid-solid interface during the dissolution process of the drug. Suitable for 

the dissolution study of new drug formulations such as sustained-release, targeted release, and enteric coated delayed release formulations.‍

Main Features:

1. 300ml glass dissolution cup, 7-position, 6-row, in accordance with pharmacopoeia requirements.

2. The connecting rod type reciprocating structure ensures that the reciprocating stroke is fixed and unchanged.

3. Better leakage conditions have better dissolution effects for low solubility drugs.

4. The standard design meets the requirement of fully automatic switching between multiple media, better simulating changes in human 

    pH environment.

5. Less media required, easy to change pH and good correlation with bioavailability data.

6. Online filtration function: two-stage filtration, columnar filtration, and 0.45um membrane circulation filtration. The 0.45um membrane

    is installed in the circulation pipeline to fully solve the problem of sample adsorption. During the experiment, no air is allowed to pass

    through the membrane, ensuring stable system pressure.

7. software system
① 8.4 inch touch screen control, Wahyong diffusion workstation, human-computer interaction, simple operation.
② Can configure 1000 accounts and 1000 experimental methods.
③ Paperless report management, capable of connecting to network printers, data can be stored locally and backed up to USB flash drives 

     or enterprise servers.
④ Data audit tracking function, three-level permission management, in compliance with FDA 21 CFR Part 11 requirements.