Description

High-Capacity Fill-Finish for Lyophilized Injectable Production

This LR-100 configuration addresses the need for speed and precision in one of pharmaceutical manufacturing’s most sensitive processes. It is specifically engineered for the aseptic filling and partial sealing (stoppering) of liquid drug formulations into vials that will undergo lyophilization. The system’s defining feature is its eight high-precision peristaltic pump heads, which provide industrial-scale filling capacity while maintaining the closed, contamination-free fluid path essential for sterility. The integrated rubber stopper insertion head automatically places sterile stoppers onto the filled vials, a crucial «pre-stoppering» step that allows for controlled sublimation during subsequent freeze-drying.

Technical Specifications: Eight-Head Efficiency with Integrated Stoppering

• Machine Type: High-speed, automatic rotary filling and stoppering monoblock for aseptic processing.

• Core Productivity Feature: Eight high-precision peristaltic pump dosing heads.

• Core Aseptic Function: Liquid filling and rubber stopper insertion (pre-stoppering) for lyophilization.

• Material Handling: Input accumulation table for efficient vial feeding and workflow.

• Automation: One vibratory stopper orienter for feeding rubber closures.

• Container Compatibility: Glass or plastic vials suitable for lyophilization.

• Primary Application: Sterile lyophilized pharmaceuticals (vaccines, biologics, antibiotics).

Purpose-Built for Lyophilized & Sterile Pharmaceuticals

This high-capacity monoblock is the production engine for advanced sterile drug manufacturing:

• Lyophilized (Freeze-Dried) Injectables: Vaccines, monoclonal antibodies, peptides, antibiotics, and other unstable biologics requiring freeze-drying.

• Sterile Pharmaceuticals: Parenteral drugs, ophthalmic solutions, and other sterile liquids in vial form.

• Biotechnology: Cell and gene therapy products, diagnostic imaging agents, and other sensitive biopharmaceuticals.

• Contract Sterile Manufacturing: Ideal for large-scale contract development and manufacturing organizations (CDMOs).

Validated for Global GMP & Aseptic Standards

We provide the technological foundation for compliant, high-volume sterile manufacturing worldwide.

• Aseptic & GMP by Design: Constructed with 316L stainless steel, designed for full CIP/SIP, and engineered to support validation per GMP, FDA, and EU Annex 1 guidelines for sterile products.

• Complete Compliance: Complies with CE, EAC, and ISO 9001 standards. ATEX options available.

• Global High-Volume Support: Includes comprehensive IQ/OQ/PQ validation packages, 24/7 remote monitoring, and a 24-month performance guarantee. Supported by specialized pharmaceutical teams from our global hubs.

📜 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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