Aseptic Microsphere Dispensing & Formulation System (Explosion-Proof Type)

The Aseptic Microsphere Dispensing System (Explosion-Proof) is a precision formulation and production equipment specifically engineered for the biopharmaceutical sector. Built upon high-performance vacuum homogenizing emulsification technology, it is deeply optimized for the preparation of micro-particles such as microspheres, microcapsules, and liposomes. This integrated system combines classification, filtration, washing, de-watering, drying, and aseptic dispensing, ensuring precise encapsulation of active substances under vacuum to produce high-quality formulations with narrow particle size distribution and superior encapsulation efficiency.

Batch Capacity: 50L – 2000L (Customizable)
Weighting Accuracy: ±0.1%
Temp. Control Range: 5°C – 90°C (Accuracy: ±0.5°C)
Pressure Range: -0.1MPa to 0.3MPa
Materials: 316L Stainless Steel (Wetted parts), mirror polished Ra < 0.4μm
Control System: Siemens/Schneider PLC, compliant with 21 CFR Part 11
EX Grade: Ex d IIB T4 / Customizable per requirements

Describtion

Key Features

1. High-Precision Process Control

Precise regulation of shear force, temperature (5-90°C), vacuum levels, and agitation speed via PLC/HMI automation, eliminating errors caused by manual intervention.

2. Aseptic Assurance Design

Fully closed system design supporting automated CIP (Clean-In-Place) and SIP (Steam-In-Place), compliant with cGMP, GAMP5, and FDA regulations.

3.Explosion-Proof Safety

Engineered for solvent-based processes, the entire unit features an explosion-proof design, equipped with EX-rated motors, control cabinets, and electrostatic grounding monitoring to ensure operational safety

4. Modular & Scalable Design

Modular design facilitates easy integration and maintenance, with capacities ranging from 50L to 2000L, supporting seamless scale-up from R&D to commercial production.

Advantages

Superior Particle Size Uniformity: Unique bidirectional mixing and high-shear emulsification design ensure extremely narrow microsphere particle size distribution, enhancing the stability of drug release.
End-to-End Aseptic Processing: Unidirectional flow protection and aseptic barrier from feeding to finished product packaging, reducing transfer loss and significantly improving encapsulation efficiency.
Optimized Product Recovery: Inclined tank design combined with automatic discharge system minimizes residual loss of expensive raw materials.
Intelligent Recipe Management: The system supports one-click recall of multiple recipes and full-process data recording, ensuring traceability of each batch.

Application Scenarios

This equipment is widely used across various industries requiring high-shear mixing and stable emulsification:

Sustained-Release Formulations: e.g. PLGA microspheres.
Targeted Drug Delivery Systems: Liposome and nanoparticle preparation.
High-end Cosmetics: Microencapsulation of active ingredients.
Biomaterials: Microsphere scaffolds for tissue engineering.

Why Choose Us

Our aseptic microsphere system is more than just an emulsifier; it is a complete turnkey aseptic process solution. Integrating world-leading microsphere processing technology, we focus on addressing industry pain points such as classification difficulties and low recovery rates, helping your biopharmaceutical projects transition rapidly from clinical trials to commercialization.

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