Chinese Injection Ultrafiltration Membrane System Project

Project Overview

Location: Xi'an, Shaanxi

Processing Capacity: 800 L/h

Implementation Company: Chengdu Hecheng Filtration Technology Co., Ltd.

Traditional Chinese Medicine (TCM) injections are subject to rigorous standards regarding solution clarity and pyrogen control. Conventional purification processes—such as alcohol precipitation and centrifugal filtration—often suffer from high organic solvent consumption, significant loss of active ingredients, and difficulty in maintaining stable control over endotoxin levels. To enhance product quality and optimize production processes, a local pharmaceutical enterprise in Xi'an introduced an integrated ultrafiltration membrane separation system for the continuous purification of TCM extracts, ensuring compliance with GMP requirements for TCM injections.

The system utilizes an ambient-temperature membrane sieving process, eliminating the need for high-temperature treatment and thereby maximizing the preservation of heat-sensitive active ingredients. The complete production workflow is as follows:

TCM extract filtration and concentrated formulation → Ultrafiltration (impurity removal, purification, and endotoxin removal) → Safety filtration → Dilution and volume adjustment of filtrate → Filling and sterilization → Visual inspection → Final medicinal solution.

System Process Advantages

Efficiently removes colloids, tannins, and macromolecular impurities while consistently eliminating endotoxins, thereby reducing the risk of adverse reactions associated with injections at the source.

Employs an ambient-temperature separation process, eliminating the need for extensive alcohol precipitation steps; this reduces ethanol usage, lowers raw material costs, and alleviates the burden of waste treatment.

Features automated, continuous operation with a stable processing capacity of 800 L/h; minimizes batch-to-batch quality fluctuations and facilitates standardized workshop management.

Modular, integrated design supports Clean-in-Place (CIP) and Sterilize-in-Place (SIP) capabilities, meeting regulatory standards for biopharmaceutical cleanrooms.

Delivers excellent filtrate clarity, reducing the load on downstream filtration stages and simplifying the overall production line workflow.

Project Operational Results

Following the system's implementation, the clarity of the TCM extract improved significantly, and endotoxin levels consistently met compliance standards. Compared to traditional methods, the recovery rate of active pharmaceutical ingredients increased, while organic solvent consumption dropped markedly. The entire system is easy to operate and maintain, reduces comprehensive production costs over the long term, and fully meets the requirements for the large-scale, continuous production of Traditional Chinese Medicine (TCM) injections.

Expanded Process Applications

This ultrafiltration purification solution is highly versatile; beyond TCM injection production, it can be applied to the purification of TCM-based veterinary drug extracts, the refining of various plant extracts, the separation of natural cosmetic raw materials, and impurity removal from aqueous herbal extracts.

Chengdu Hecheng Filtration can customize complete membrane separation equipment based on specific raw material characteristics and production capacity requirements. The company provides hollow fiber, ceramic, spiral-wound, and tubular membrane systems, as well as turnkey services for entire production lines.