Description

The Precision Core for Sterile Injectable Manufacturing

The LR-500 Automatic Rotary Aseptic Monoblock is engineered as the reliable, high-speed heart of a sterile filling line for the global pharmaceutical industry. It transforms the separate, high-risk processes of filling, stoppering, and seal application into one synchronized, enclosed operation. For manufacturers and CMOs in key growth regions supplying critical medicines, this machine provides the technology to achieve the required sterility assurance level (SAL) while maximizing output and operational efficiency. Its design minimizes particulate generation and operator intervention, directly supporting compliance with modern regulatory expectations for aseptic processing.

Integrated Aseptic Process: Filling, Stoppering & Seal Crimping

1. Vial Handling & Precision Filling: Vials (penicillin, insulin, or other formats) are automatically fed and oriented onto a sterile-grade rotary indexing table. Each vial is positioned under an ultra-precise rotary piston filler with anti-drip nozzles. Fill volumes are meticulously controlled, critical for potent and high-value drug substances.

2. Automatic Stoppering: Immediately after filling, the machine automatically places a sterilized elastomeric rubber stopper into the vial neck. This step is performed within the protected zone to maintain sterility.

3. Flip-Off Seal Crimping: The final step is the precise application and crimping of a smooth aluminum seal with a plastic flip-off cap. The rotary crimping head applies consistent force to secure the seal over the stopper and vial neck, ensuring a tamper-evident and hermetic primary container closure system.

Technical Specifications & cGMP Design Features

• Machine Type: Fully Automatic, Aseptic-Grade Rotary Monoblock (Filling + Stoppering + Aluminum Seal Crimping).

• Process: Designed for aseptic filling within ISO 5/Grade A environments.

• Filling Technology: High-accuracy rotary piston pump system. Accuracy typically ±0.5% or better.

• Containers: Glass vials (penicillin vials, insulin vials) of standard sizes (2R, 3R, 4R, 6R, 8R, etc.).

• Closures: Rubber stoppers and aluminum flip-off seals (flip-off caps).

• Output Speed: Configurable for medium to high-speed production, suitable for batch sizes from thousands to hundreds of thousands of units.

• Construction: Fully cGMP-compliant, pharmaceutical-grade design. All product contact surfaces are AISI 316L Stainless Steel, electropolished. Features rounded corners, easy access for cleaning, and minimal particle-shedding surfaces.

• Cleanability: Designed for CIP (Clean-in-Place) and SIP (Sterilize-in-Place). Compatible with clean steam sterilization of product pathways.

• Control & Data Integrity: Advanced PLC with validated Touchscreen HMI. Supports electronic batch records, recipe management with password protection, alarm logging, and provides comprehensive data for process validation (IQ/OQ/PQ).

Target Applications: Parenteral Drugs, Biologics & More

This monoblock is the definitive solution for packaging a wide spectrum of sterile injectables:

• Antibiotics: Penicillin-based drugs, cephalosporins.

• Hormones & Peptides: Insulin, human growth hormone.

• Vaccines: Liquid vaccine formulations.

• Biologics: Monoclonal antibodies, recombinant proteins.

• Other Parenterals: Small-volume liquid drugs, diagnostics, contrast media.

Engineered for Pharmaceutical Validation & Global Support

• Reduced Contamination Risk: The integrated, enclosed process significantly reduces interventions and manipulation points compared to separate machines, enhancing sterility assurance.

• Regulatory Compliance: The machine’s design philosophy and documentation support align with cGMP, FDA, EU GMP Annex 1, and PIC/S guidelines.

• Validation Support: We provide essential documentation templates and support to facilitate your Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

• Global Pharmaceutical Network: We offer specialized support for pharmaceutical clients, including 24/7 technical support from engineers trained in GMP, regionally available validation-grade spare parts, and service teams experienced in aseptic processing environments. This ensures regulatory compliance and production continuity for vital drug manufacturing worldwide.

📜 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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