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Product Overview
TCM Compound Injection Sterilization Filtration Equipment
The TCM Compound Injection Sterilization Filtration Equipment is a high-precision, sterile-guaranteed integrated solution independently developed by Henan Zhengzhou Chlory Technology Co., Ltd.—a National High-tech Enterprise with over 20 years of membrane separation and biopharmaceutical processing expertise. Tailored specifically for the terminal sterile purification of TCM compound injections (with complex multi-component systems), this equipment addresses the core pain points of traditional TCM compound injection processing: incomplete microbial removal, pyrogen residue risks, loss of heat-sensitive active ingredients due to harsh conditions, membrane fouling caused by complex components, and particle contamination affecting medication safety.
Integrating advanced membrane separation technologies (ultrafiltration pretreatment + 0.22 μm sterile microfiltration), low-temperature sterile processing, and intelligent control systems, the equipment covers the entire process chain from raw TCM compound injection liquid pretreatment, colloidal impurity removal, pyrogen elimination to terminal sterilization filtration. It realizes molecular-level physical separation, effectively removing bacteria, molds, yeasts, pyrogens (endotoxins), colloidal proteins, polysaccharides, and fine particles while retaining bioactive components such as alkaloids, flavonoids, and saponins. Fully compliant with GMP, FDA, and Chinese Pharmacopoeia standards (sterility test qualified, no pyrogen detected), the equipment offers multiple series models (MZ/TC/GS/UF) with processing capacities ranging from 10 Kg/h to 8000 Kg/h, adapting to small-batch R&D, pilot production, and large-scale industrial production of various TCM compound injections.
Core Advantages
1. Sterile & Pyrogen-Free Compliance for Complex Formulations
2. High Retention of Multi-Component Active Ingredients
Adopts a "ultrafiltration (10–50 kDa) pretreatment + 0.22 μm sterile microfiltration" combined process. Ultrafiltration efficiently removes pyrogens (molecular weight >100 kDa) and colloidal impurities from complex compound systems, while the 0.22 μm high-precision PVDF/PES/ceramic membrane achieves 100% interception of microorganisms. The final product meets the sterile requirement (no microbial growth in culture) and pyrogen standard (qualified by rabbit test or limulus test), fully complying with the strict quality requirements of TCM compound injections.
Operates at a low temperature of 20–25℃ throughout the entire process, avoiding thermal denaturation of heat-sensitive active ingredients (e.g., volatile oils, polyphenols) in TCM compound formulations. The multi-component active ingredient retention rate reaches ≥98%, far exceeding traditional high-temperature sterilization, and fully preserves the synergistic clinical efficacy of TCM compound injections.
3. Anti-Fouling & Deep Purification
4. Green Safety & No Cross-Contamination
5. Intelligent Operation & Stable Batch Consistency
Targeting the high viscosity and complex colloidal composition of TCM compound injection liquids, the cross-flow operation design of the membrane module enhances anti-pollution performance. The multi-stage filtration process achieves an impurity removal rate of ≥99.5%, reducing the turbidity of the treated injection to ≤0.3 NTU. It effectively removes fine particles and incompatible macromolecular impurities that cause adverse reactions, ensuring the injection is clear and transparent with no visible foreign matters.
Pure physical separation process without adding chemical bactericides or clarifiers, avoiding chemical residues and component interactions. All wetted parts are made of pharmaceutical-grade 316L stainless steel and FDA-compliant membrane materials. The closed-loop system and CIP cleaning design prevent cross-contamination, meeting the strict sterile production requirements of the pharmaceutical industry.
Equipped with a PLC automatic control system, real-time monitoring of key parameters such as filtration pressure, flow rate, and turbidity. The online membrane integrity tester (bubble point test) verifies filtration effectiveness before and after each batch. The anti-fouling membrane design and CIP cleaning system extend the service life of core components to 2–3 years, ensuring consistent product quality across batches.
Main Features
Integrated Process Design:
Targeted Membrane Configuration:
Integrates pretreatment, ultrafiltration pyrogen removal, sterile microfiltration, and CIP cleaning into one system. Reduces floor space by 30% compared to split equipment and seamlessly connects with subsequent sterile filling processes (C-grade clean area).
Customizes membrane materials (PVDF/PES/ceramic membrane) and pore sizes based on the complex multi-component characteristics of TCM compound injections. The ultrafiltration pretreatment module effectively mitigates membrane fouling caused by complex systems.
Compliance & Safety Assurance:
Flexible Capacity Scalability:
Turnkey Service Capability:
Meets GMP, FDA, and Chinese Pharmacopoeia standards. Supports full-process parameter recording and traceability, facilitating regulatory inspection. All materials in contact with products pass biocompatibility tests to ensure injection safety.
Covers a wide range of processing capacities from 10 Kg/h (pilot scale, e.g., XH-SMZ4015-1X) to 8000 Kg/h (large-scale industrial production), adapting to diverse production needs from laboratory R&D to mass production.
Provides one-stop services from on-site raw material testing, process optimization, equipment manufacturing, installation, and commissioning to operator training and after-sales maintenance, including whole-line turnkey project support.
Technical Parameters
Item |
Specification |
Filtration precision |
Pre-filter:1~5μm; Terminal sterile filter:0.22μm |
Molecular weight cut-off |
1000-300000Da customizable |
Working pressure |
|
Material in contact with liquid |
316L stainless steel |
Filter membrane material |
PES/PTFE sterile grade |
Processing capacity |
50kg/h - 8000kg/h customized |
Bacteria retention rate |
≥99.99% |
Universal Performance Indicators
Key Treatment Efficiency: Vitamin recovery rate ≥98%; Impurity removal rate ≥99%; Turbidity ≤0.5 NTU
Product Quality: Clear and transparent filtrate; No secondary precipitation; Complies with GMP/FDA and national pharmaceutical standards
Membrane Service Life: 2–3 years (under normal operation and maintenance)
Control System: PLC automatic control + touchscreen; Real-time monitoring of pressure, flux, temperature
Core Configuration
System Module |
Core Equipment/Technology |
Function Description |
Pretreatment Unit |
High-speed centrifuge, precision filter (5 μm) |
Remove large-particle impurities and suspended solids; reduce membrane load |
Ultrafiltration Pyrogen Removal Unit |
UF membrane module (10–50 kDa) |
Remove pyrogens, colloidal proteins, and polysaccharides from complex systems; prevent membrane clogging |
Terminal Sterilization Filtration Unit |
0.22 μm sterile microfiltration (MF) module (PVDF/PES/ceramic) |
Intercept microorganisms and fine particles; achieve sterile filtration |
Auxiliary Unit |
CIP cleaning system, buffer tank, turbidity detector, membrane integrity tester |
Prevent membrane fouling; stabilize process parameters; verify filtration effectiveness in real time |
Matching Filling System |
Sterile filling machine, capping machine, leak detector (optional) |
Realize seamless connection between sterilization filtration and filling; maintain sterile environment in C-grade clean area |
Application Scenarios
-
Small-Batch R&D & Pilot Production
2. Medium-Scale Industrial Production
3. Large-Scale Industrial Production
Application: R&D of new TCM compound injection products in pharmaceutical enterprises, universities, and research institutions; small-batch production of high-value compound injections.
Recommended Models: XH-SMZ4015-1X (10–30 Kg/h), XH-MZ40-1X (30–50 Kg/h).
Value: Flexible process parameters, compact design, and strict sterile control, supporting rapid verification of new compound formulations and processes.
Application: Mass production of TCM compound injections for regional market supply.
Recommended Models: XH-MZ80-4X (500–1000 Kg/h), XH-TC3019-4X (500–1000 Kg/h).
Value: High production efficiency, stable anti-fouling performance, and easy compliance with GMP requirements, meeting medium-volume supply demands.
Application: Large-scale production of well-known brand TCM compound injections for national distribution.
Recommended Models: XH-TC3091-8X (5000–7000 Kg/h), XH-UF8040-24X (6000–8000 Kg/h).
Value: High flux, continuous operation, and strong scalability, supporting large-scale supply and consistent product quality across batches.
Application Cases
1: Large-Scale TCM Compound Injection Sterilization Project
2: Pilot Production of New TCM Compound Injection
Customer Profile: A leading domestic TCM enterprise specializing in compound injections, with a daily output of 15 tons of compound anti-inflammatory injections.
Project Requirements: Achieve sterile and pyrogen-free standards, retain multi-component active ingredients, and solve membrane fouling issues. The original process had frequent pyrogen test failures and low active ingredient retention.
Recommended Equipment: XH-TC3091-8X (5000–7000 Kg/h) + XH-UF8040-24X (6000–8000 Kg/h) combined system.
Application Effect: Sterility test pass rate reached 100%, pyrogen test all qualified, and multi-component active ingredient retention rate was 98.2%. The number of visible particles (≥10 μm) was ≤2 per mL, fully meeting Chinese Pharmacopoeia requirements. Membrane cleaning cycles extended by 50% compared to traditional systems, and the project passed GMP re-certification smoothly.
Customer Profile: A biopharmaceutical R&D institution engaged in new TCM compound research, with a pilot production capacity of 30 Kg/h.
Project Requirements: Ensure sterile filtration effect, eliminate pyrogens, retain synergistic active ingredients, and support flexible process adjustment.
Recommended Equipment: XH-UF4040-1X (50–100 Kg/h) + XH-MZ40-1X (30–50 Kg/h) combined system.
Application Effect: Sterility and pyrogen tests were qualified, active ingredient retention rate was 98.5%, and the injection had good clarity and stability. The equipment supported the R&D of 2 new TCM compound injections, shortening the R&D cycle by 35%.
Company Profile
Zhuolineng Technology Company
With 20+ years of experience in chlorination system manufacturing, Zhuolineng is a certified (ISO 9001, ISO 14001, ISO 18001) original equipment manufacturer (OEM) specializing in water treatment solutions. We offer:
1. Customized package design (AutoCAD, SolidWorks-supported engineering).
2. After-sales services: On-site inspection, electrolyzer refurbishment, and capacity upgrades.
3. Membership in China's Chlorine Committee, ensuring compliance with global industry standards.
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