Description

Precision Aseptic Filling for Cosmetic & Pharmaceutical Injectables

Integrated Aseptic Barrier Technology: Laminar Flow & Monitoring.

Automated Syringe Handling & Precision Filling Process.

Target Applications: From Dermal Fillers to Parenteral Drugs.

Engineered for Global Regulatory Standards & Support.

LR-50 Automatic Syringe Filling and Stoppering Monoblock is engineered for the most critical packaging application: parenteral and intracutaneous products. In markets across Southeast Asia, the Middle East, Latin America, and Eastern Europe, where the cosmetic injectables and biosimilar sectors are expanding rapidly, this machine provides a turnkey solution to achieve international quality standards. It integrates the entire post-wash syringe process—orientation, filling, stoppering—within a protected, monitored environment, drastically reducing contamination risk and human intervention for high-value, sterile products.

Integrated Aseptic Barrier Technology: Laminar Flow & Monitoring

The cornerstone of the LR-50 is its built-in laminar airflow (LAF) booth. This system generates a unidirectional, vertical ISO Class 5 (Class 100) air curtain over the critical filling and stoppering zone.

• HEPA Filtration: Equipped with H14-grade HEPA filters, it removes 99.995% of airborne particles ≥0.3 μm, protecting the product from environmental contaminants.

• Particle Monitoring: An integrated laser particle counter provides continuous environmental monitoring, offering data for batch records and quality assurance, a vital feature for audit compliance.

• Containment: The enclosure acts as a physical barrier for operator protection and product protection.

Automated Syringe Handling & Precision Filling Process

1. Automatic Loading: Glass syringes are automatically fed and oriented onto a rotary indexing table.

2. Vacuum-Assisted Precision Filling: Each syringe is positioned under a piston filler with a vacuum-assisted nozzle. This technology is crucial for high-viscosity products (like gels) and prevents dripping or aerosolization. The vacuum helps draw the precise dose into the syringe barrel, ensuring exceptional volumetric accuracy and minimizing product loss.

3. Automatic Plunger (Stopper) Insertion: After filling, the machine automatically places and inserts a rubber plunger (elastomeric stopper) into the syringe barrel. This is a critical step in forming the primary container closure system.

4. Discharge: The finished, filled, and stoppered syringe is discharged for subsequent processes like cap placement, labeling, or inspection.

Technical Specifications & Compliance Features

• Machine Type: Fully Automatic Rotary Monoblock with Integrated Aseptic Barrier.

• Filling Technology: Precision Piston Pump with Vacuum-Assist Nozzle.

• Filling Accuracy: Typically ±0.5% or better, critical for costly active ingredients.

• Stoppering: Automatic rubber plunger (stopper) placement and insertion station.

• Aseptic Environment: Integrated Laminar Airflow (LAF) Booth with HEPA H14 filtration (ISO 5/Class 100).

• Monitoring: Built-in real-time particle counter.

• Speed: Configurable, suitable for small to medium batch production (hundreds to several thousand syringes per hour).

• Syringe Compatibility: Glass syringes of various standard sizes (1ml, 2.5ml, 5ml).

• Construction: Fully GMP-compliant design. All product contact surfaces are AISI 316L Stainless Steel or higher-grade material. Features electropolished surfaces, rounded corners, and easy cleanability.

• Control System: Advanced PLC with validated touchscreen HMI. Supports recipe management, parameter control (fill volume, vacuum level), and comprehensive data logging for audit trails.

Target Applications: From Dermal Fillers to Parenteral Drugs

• Cosmetic Dermatology & Aesthetics: Hyaluronic acid (HA) dermal fillers, Botulinum Toxin (Botulinum Toxin Type A) solutions, mesotherapy cocktails, biostimulators.

• Pharmaceutical & Biotech: Subcutaneous and intramuscular injections, vaccines, biologics, hormones, low-volume parenteral drugs.

• Medical Device: Pre-filled syringes with medical gels or lubricants.

Engineered for Global Regulatory Standards & Support

This machine is built not just for performance but for compliance. Its design philosophy aligns with GMP, FDA, and EU Annex 1 guidelines for sterile manufacturing. We understand that entering regulated markets requires reliable partners; thus, the LR-50 is supported by our global network offering validation support (IQ/OQ/PQ documentation templates), technical service trained in aseptic processes, and regionally stocked critical spare parts. This ensures manufacturers in growth regions can produce to global standards and scale their operations with confidence.

📜 Schedule virtual airflow visualization test.

💡 Mention your: Target market (EU/US/Global South), Active ingredient, Required throughput.

🔬 Schedule virtual factory acceptance test with our engineers.

🏷️ Request Compliance Audit: Free gap analysis with throughput simulation.

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