Description

The Flexible Aseptic Core for Modern Pharmaceutical Manufacturing

The LR-500 Universal Aseptic Rotary Monoblock represents a strategic investment for pharmaceutical facilities prioritizing flexibility, quality, and compliance. Designed to serve as the protected heart of a filling line, it is equally capable of handling terminally sterilized non-sterile products requiring ultra-clean conditions and sterile injectables demanding full aseptic processing. This versatility makes it ideal for contract manufacturers and drug companies producing a diverse portfolio, allowing for efficient batch changeovers and maximized asset utilization under one controlled environment.

Integrated Laminar Flow Technology: Creating an ISO 5 Critical Zone

The cornerstone of this machine is its integrated laminar flow box. This system generates a continuous, unidirectional flow of HEPA-filtered air (ISO Class 5 / Grade A) over the critical filling and stoppering/capping stations.

• Contamination Control: This air curtain acts as a physical barrier, drastically reducing the risk of airborne particles and microbial contamination from the surrounding environment settling on open containers or product surfaces.

• Process Protection: It enables the machine to operate effectively in a lower-grade cleanroom (e.g., ISO 7 or 8), as the critical zone is locally protected, offering a significant advantage in facility design and operational cost.

Universal Design for Sterile & Non-Sterile Liquid & Viscous Products

Built on a robust rotary platform, the LR-500 Universal handles a wide viscosity range. It incorporates a precision rotary dosing system (configurable with piston or peristaltic pumps) for accurate volumetric filling. An automatic rotary capping or stoppering station, synchronized within the laminar flow zone, ensures secure container closure. This design is «universal» by accommodating everything from oral solutions and topical creams to parenteral drugs, all while maintaining the appropriate environmental control for each product classification.

Technical Specifications & cGMP Design Features

• Machine Type: Fully Automatic, Universal Rotary Monoblock with Integrated Laminar Flow Box (LAF).

• Process Standard: Designed for Aseptic and Ultra-Clean (ISO 5) filling processes.

• Filling Technology: Configurable rotary precision dosing system (piston/peristaltic).

• Containment: Laminar Flow Booth with H14 HEPA filtration.

• Container Compatibility: Glass and plastic vials/bottles of various pharmaceutical sizes.

• Output Speed: High-speed rotary output suitable for medium to large batch production.

• Construction: Full cGMP-compliant design. All product contact parts are AISI 316L Stainless Steel, electropolished. Features cleanroom-compatible materials and finishes.

• Sterilization & Cleaning: Designed for CIP (Clean-in-Place) and SIP (Sterilize-in-Place) of product contact paths.

• Control & Data: Advanced PLC with validated Touchscreen HMI supporting electronic batch records, recipe management, and full audit trail capabilities.

Target Applications: Versatility Across Drug Product Types

This monoblock is the definitive solution for a comprehensive range of pharmaceutical applications:

• Sterile Products: Parenteral injectables (vials), ophthalmics, vaccines.

• Non-Sterile Products (requiring low bioburden): Oral solutions and suspensions, topical creams/ointments, nasal sprays.

• Biologics & Advanced Therapies: Liquid formulations requiring precise, protected handling.

Engineered for Regulatory Compliance & Global Pharmaceutical Support

This machine is built not just for performance but for successful regulatory audits. Its design aligns with cGMP, FDA, EU GMP Annex 1, and PIC/S guidelines. We support this with a comprehensive validation package (IQ/OQ/PQ documentation assistance) and a global service network offering 24/7 pharma-grade technical support, validation-spare parts, and expertise to ensure your production of critical medicines remains compliant and uninterrupted in any region.

📜 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!