Description

Aseptic Fill-Finish Solution for Lyophilized & Sterile Injectables

This LR-100 configuration addresses one of the most sensitive stages in pharmaceutical manufacturing: the aseptic transfer of liquid drug product into sterile vials prior to lyophilization. The machine performs precise liquid filling via twin peristaltic pumps, ensuring no product contamination. Its defining feature is the integrated vibratory rubber stopper orienter and insertion head, which automatically places sterile rubber stoppers onto the filled vials. This «pre-stoppering» is crucial, as it allows for controlled sublimation during freeze-drying while maintaining sterility. The entire process is designed for integration into isolator or cleanroom (Grade A/B) environments.

Technical Specifications for Critical Processes

• Machine Type: Universal, rotary filling and pre-stoppering monoblock for aseptic processing.

• Primary Function: Liquid filling and partial rubber stopper placement (pre-stoppering) for vials destined for lyophilization.

• Filling Technology: Two independent peristaltic pump dosing heads with calibrated silicone tubing.

• Stoppering Technology: Vibratory bowl feeder for stopper orientation and a dedicated insertion head for placing rubber stoppers.

• Container & Closure: Glass penicillin vials or insulin vials with lyophilization rubber stoppers.

• Key Benefit: Enables a critical, automated step in the fill-finish process for lyophilized injectable drugs.

• Environment: Designed for sterile (aseptic) processing in controlled environments.

Designed for Pharmaceutical Lyophilization

This monoblock is purpose-built for advanced pharmaceutical manufacturing:

• Lyophilized (Freeze-Dried) Injectables: Antibiotics, vaccines, biologics, peptides, and other unstable drugs requiring freeze-drying for stability.

• Sterile Injectables: Small-volume parenteral (SVP) drugs, diagnostic imaging agents, ophthalmic solutions in vials.

• Biotechnology: Cell and gene therapy products, monoclonal antibodies, and other sensitive biopharmaceuticals.

Validation-Ready for Global GMP Production

We provide the technological foundation and documentation for regulated markets worldwide.

• Aseptic & GMP by Design: Constructed with 316L stainless steel, full CIP/SIP capabilities, and a design that supports stringent GMP and Annex 1 requirements for sterile products.

• Full Compliance: Compliant with CE, EAC, and ISO 9001. ATEX option available.

• Global Support for Validation: Includes complete IQ/OQ/PQ documentation packages, 24/7 remote monitoring, and a 24-month performance guarantee. Supported from our pharmaceutical hubs in Dubai, Hanoi, and Lagos.

📜 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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