Description

Uncompromising Aseptic Processing for Pharmaceutical Excellence

The LR-200 Piston Monoblock is a cornerstone of modern sterile pharmaceutical manufacturing. Designed from the ground up for Grade A/B cleanroom integration, this machine provides a complete, validated solution for filling and sealing sensitive parenteral products. Its four-piston dosing system with check valves guarantees exceptional accuracy and repeatability for liquids, viscous solutions, and suspensions, making it indispensable for producing ophthalmic solutions, vaccines, monoclonal antibodies, and other sterile injectables where product integrity and patient safety are paramount.

Technical Specifications & Validation-Ready Design

• Machine Type: Fully Automatic, GMP-Validated Rotary (Carousel) Monoblock.

• Filling Principle: Volumetric piston dosing cylinders (4 cylinders) with sanitary check valves. Ensures precise, drip-free filling independent of product viscosity or density.

• Filling Nozzles: 2 filling nozzles (spouts) supplied by the 4-piston system for continuous, high-speed operation.

• Capping Heads: Equipped with plugging heads for dropper inserts (for eye drops) and screw capping heads for lyophilization stoppers or screw-thread vials.

• Construction & Hygiene: Fully 316L Stainless Steel construction with electropolished contact surfaces. Designed for validated Clean-in-Place (CIP) and Sterilize-in-Place (SIP) processes. Can be equipped with an ISO 5 laminar airflow hood.

• Control & Documentation: Advanced PLC with audit trail, electronic batch records, and multi-language HMI. Supports full IQ/OQ/PQ validation protocols.

Target Products & Applications

• Products: Formulated for sterile liquids, suspensions, ophthalmic solutions, vaccines, biologics, and other injectable pharmaceuticals.

• Containers & Closures: Handles sterile vials, bottles, and ampoules. Applies elastomeric dropper inserts, screw caps, and flip-top closures suitable for lyophilized and liquid products.

Your Assurance of Compliance and Product Integrity

• Built-in GMP Compliance: Every aspect, from material traceability to surface finishes, adheres to cGMP, EMA, and FDA guidelines for aseptic processing. The machine is supplied with a comprehensive documentation package to streamline your validation.

• Maximum Product Protection: The closed piston dosing system and hygienic design minimize contamination risks. CIP/SIP capabilities ensure sterilization between batches without disassembly.

• Precision that Reduces Waste: High-accuracy filling (±0.25% or better) minimizes costly overfills of high-value pharmaceuticals, maximizing yield and profitability.

• Global Pharmaceutical Support: Backed by validation support (IQ/OQ/PQ) and a dedicated team experienced in pharmaceutical audits. Our global hubs ensure access to sterile-grade spare parts and technical support 24/7.

Validate Your Sterile Filling Process

Implementing a new aseptic line is a critical decision. Schedule a virtual Factory Acceptance Test (FAT) with our pharmaceutical engineering team to review validation documentation, discuss your specific product requirements, and simulate throughput for your sterile injectables or ophthalmic products.

📜 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.

🔍Ready to Eliminate Production Bottlenecks?

💎Need Industrial Production Automation?

📥Free line configuration for your products, throughput validation testing!