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Laboratory model system and method for development and characterization of preparation product filling process

A model system, laboratory technology, applied in teaching models, simulators, educational appliances, etc., can solve problems such as inspection and evaluation of shear stress that are not mentioned

Pending Publication Date: 2021-07-16
SHANGHAI WUXI BIOLOGIC TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The simulation software does not mention the investigation and evaluation of the shear stress in liquid filling, and it is only a theoretical simulation. There is no corresponding test model for evaluating the impact of the process on product stability

Method used

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  • Laboratory model system and method for development and characterization of preparation product filling process
  • Laboratory model system and method for development and characterization of preparation product filling process
  • Laboratory model system and method for development and characterization of preparation product filling process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The PF6 peristaltic pump of Watson-Marlow Company was used as the metering filling pump 1, and a silicone tube with a length of 50 cm at both ends, an inner diameter of 4.8 mm, and a wall thickness of 1.6 mm was taken as the figure 1 In the pipe section 4 and pipe section 8, two silicone tubes with a length of 25cm, an inner diameter of 3.2mm, and a wall thickness of 1.6mm are figure 1 In the pipe section 2, select the appropriate Y-type interface 3 and 3' for connection. Fix the connected pipeline on the pump head of the peristaltic pump, connect a Bosch filling needle with an inner diameter of 3.5 mm on the solution outlet side, and place a polystyrene plastic bottle under the filling needle as a receiving container 5 . Bovine serum albumin (BSA) solution (viscosity about 1cp, histidine buffer, pH=6.0, sodium chloride 150mM, BSA concentration 15mg / mL) was selected as the simulated solution.

[0038] Set the filling volume of the peristaltic pump to 2.00mL, the pump s...

Embodiment 2

[0040] The PF6 peristaltic pump of Watson-Marlow Company was used as the metering filling pump 1, and a silicone tube with a length of 45 cm at both ends, an inner diameter of 4.8 mm, and a wall thickness of 1.6 mm was taken as the figure 1 In the pipe section 4 and pipe section 8, two silicone tubes with a length of 10cm, an inner diameter of 3.2mm and a wall thickness of 1.6mm are figure 1 In the pipe section 2, select the appropriate Y-type interface 3 and 3' for connection. Fix the connected pipeline on the pump head of the peristaltic pump, connect a Bosch filling needle with an inner diameter of 3.5 mm on the solution outlet side, and place a polystyrene plastic bottle under the filling needle as a receiving container 5 . Bovine serum albumin (BSA) solution (viscosity about 1cp, histidine buffer, pH=6.0, sodium chloride 150mM, BSA concentration 15mg / mL) was selected as the simulated solution.

[0041] Set the filling volume of the peristaltic pump to 20.00mL, the pump s...

Embodiment 3

[0043] The PF6 peristaltic pump of Watson-Marlow Company was used as the metering filling pump 1, and a silicone tube with a length of 150 cm at both ends, an inner diameter of 4.8 mm, and a wall thickness of 1.6 mm was taken as the figure 1 In the pipe section 4 and pipe section 8, two silicone tubes with a length of 20cm, an inner diameter of 3.2mm, and a wall thickness of 1.6mm are figure 1 In the pipe section 2, select the appropriate Y-type interface 3 and 3' for connection. Fix the connected pipeline on the pump head of the peristaltic pump, connect a Bosch filling needle with an inner diameter of 3.5 mm on the solution outlet side, and place a polystyrene plastic bottle under the filling needle as a receiving container 5 . Bovine serum albumin (BSA) solution (viscosity about 1cp, histidine buffer, pH=6.0, sodium chloride 150mM, BSA concentration 15mg / mL) was selected as the simulated solution.

[0044] Set the filling volume of the peristaltic pump to 2.00mL, the pump ...

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Abstract

The invention discloses a laboratory model system and method for development and characterization of a preparation product filling process. The model system comprises a filling liquid supply device, a metering filling pump, a filling device, a pipeline and a timing device, wherein the filling liquid supply device, the metering filling pump and the filling device are in fluid communication with one another, and the pipeline is connected with the filling liquid supply device, the metering filling pump and the filling device in a fluid communication mode.

Description

technical field [0001] This application relates to laboratory model systems and methods for the development and characterization of the filling process for formulated products. The model and method of the present application improve the accuracy of process research, realize the simulation of production process conditions, and reduce the research and development costs of enterprises. Background technique [0002] During the filling process of the drug solution, the components in the solution will be exposed to various physical stress conditions, such as high temperature and high shear stress (Elias, C.B., Joshi, J.B., 1998.Role of hydrodynamic shear onactivity and structure of proteins.Adv.Biochem.Eng.59, 47-71.), the gas-liquid interface produced by the foam is accompanied by high shear stress, etc. (Maa, Y.-F., Hsu, C.C., 1997.Protein denaturation by combined effect of shear and air-liquid interface. Biotechnol. Bioeng. 54, 503-512.). The above physical stress will affect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G09B9/00G09B25/02
CPCG09B9/00G09B25/02
Inventor 黑明阳舒乐姜晓龙王玉习晓博韩建峰
Owner SHANGHAI WUXI BIOLOGIC TECH CO LTD