Description

Aseptic Fill-Finish Precision for Critical Parenteral Drugs

This advanced LR-100 configuration is built for one of the most regulated processes in pharma: the aseptic fill-finish of injectable drugs. It is optimized for small glass vials, specifically penicillin and insulin-type vials, which are standard for many biologics, vaccines, and sensitive formulations. The system’s core is its triple peristaltic pump dosing system, which provides superior throughput while maintaining the closed, contamination-free fluid path essential for sterility assurance. It performs the critical «pre-stoppering» step—placing rubber stoppers on filled vials—which is necessary for subsequent lyophilization (freeze-drying) or to create a stable closure before final aluminum cap sealing.

Technical Specifications: High-Throughput Sterile Processing

• Machine Type: Automatic, rotary filling and stoppering monoblock for aseptic processing.

• Core Function: Liquid filling, rubber stopper insertion (pre-stoppering), and Flip-Off cap placement.

• Filling Technology: Three independent peristaltic pump dosing heads for high-speed, accurate filling.

• Closure System: Stopper insertion head for rubber stoppers and a crimping/roll-on head for smooth aluminum Flip-Off caps.

• Material Handling: Input and output accumulation trays for efficient vial handling.

• Container & Closure: Small glass vials (penicillin/insulin) with lyophilization rubber stoppers and aluminum Flip-Off caps.

• Environment: Designed for integration into Grade A/B cleanrooms or isolators.

Designed for Vial-Based Injectable Therapeutics

This monoblock is the production workhorse for a range of critical drug products:

• Lyophilized (Freeze-Dried) Injectables: Vaccines, antibiotics, peptides, biopharmaceuticals requiring freeze-drying for stability.

• Insulin and Hormone Therapies: Various types of insulin and other hormone solutions packaged in small vials.

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

• Biotechnology: High-value cell therapies, monoclonal antibodies, and other sterile biologics.

Validation-Ready for Global Pharmaceutical Standards

We provide the technological foundation for compliance in the most demanding markets.

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

• Complete Compliance: Compliant with CE, EAC, and ISO 9001 frameworks.

• Global Pharmaceutical Support: Includes comprehensive IQ/OQ/PQ documentation, 24/7 remote monitoring, and a 24-month performance guarantee. Supported by our specialized pharmaceutical teams 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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