Description

Integrated Aseptic Processing Environment for Critical Sterile Filling

This advanced LR-100 configuration represents a significant leap in contained aseptic technology. It is engineered not just as a filler, but as a complete micro-environment that provides an ISO 5 (Class 100) zone of unidirectional airflow over the critical filling area. The integrated HEPA (High-Efficiency Particulate Air) filtration system ensures the air supplied is free from viable and non-viable particles. The key differentiator is the built-in laser particle counter, which provides continuous, real-time monitoring of airborne particles within the enclosure, delivering documented proof of environmental control—a cornerstone of modern Quality by Design (QbD) and EU Annex 1 compliance for sterile products.

Technical Specifications: Built-in Sterility Assurance

• Machine Type: Integrated sterile filling installation with a contained aseptic environment.

• Core Sterility Feature: ISO 5 / Class A laminar airflow canopy with integrated HEPA filtration system.

• Critical Monitoring: Built-in laser particle counter for real-time environmental monitoring and data logging.

• Filling Technology: High-precision peristaltic pump dosing (configuration as per specific needs).

• Primary Application: Sterile filling of pharmaceutical liquids, vaccines, and sensitive biologics.

• Container Compatibility: Plastic vials/bottles (can be adapted for other formats).

• Key Benefit: Provides a validated, monitored aseptic zone, reducing reliance on full cleanroom classification for the filling operation.

Applications for Sterile Liquids & Sensitive Biologics

This installation is the definitive solution for manufacturing where environmental control is non-negotiable:

• Sterile Pharmaceuticals: Small-batch injectables, ophthalmics, vaccines, and antibiotic solutions.

• Advanced Therapies & Biologics: Cell therapies, gene therapies, monoclonal antibodies, and other ATMPs (Advanced Therapy Medicinal Products).

• Clinical Trial Materials: Sterile filling of investigational drugs where batch size is small but quality requirements are extreme.

• Contract Sterile Manufacturing: Ideal for CDMOs requiring flexible, high-assurance filling capabilities for multiple client products.

Annex 1/GMP Compliance & Global Validation Support

We provide the technology and documentation to meet the evolving global standards for aseptic processing.

• Annex 1 / FDA Compliance by Design: The integrated particle monitoring and HEPA system directly address EU GMP Annex 1 requirements for continuous monitoring and controlled environments in aseptic processing.

• Complete Data Integrity: The particle counter provides auditable data logs, supporting GMP data integrity requirements for sterile production.

• Global Validation & Support: Includes full DQ/IQ/OQ/PQ validation packages for the isolator and filler, 24/7 remote monitoring, and a 24-month performance guarantee. Supported by specialized aseptic processing experts 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.

🔍Ready to Eliminate Production Bottlenecks?

💎Need Industrial Production Automation?

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