PFS filling machine
This integrated line automates nest-style RTU packaging with automated/manual outer bag removal and manual inner liner handling, paired with a filling-stoppering machine.
The PFS filling machine is designed for high-precision aseptic filling applications, operating efficiently within ORABS/CRABS environments to ensure ISO Class 5 compliance and minimize cross-contamination risks. The system supports scalable production requirements, making it suitable for both small-batch manufacturing and mid-scale commercial production.
Key Features
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Aseptic Compliance: Operates within ORABS/CRABS systems to meet ISO Class 5 cleanroom standards.
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Scalable Throughput: Adjustable production capacity ranging from 25–100 units per minute, supporting flexible manufacturing needs.
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cGMP & FDA-Aligned Design: Equipped with CIP/SIP-ready components for efficient cleaning and sterilization processes.
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Endotoxin Control: Validated system ensuring endotoxin levels below 0.25 EU/mL.
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Rapid Changeover: Optimized for RTU nest trays, allowing quick transitions between different container formats and product viscosities.
Advanced Options
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PAT (Process Analytical Technology) integration for enhanced process monitoring
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Track-and-trace systems to improve data integrity and regulatory compliance
Applications
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Injectable pharmaceuticals
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Gene therapy products
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Antibody-drug conjugates (ADC) manufacturing
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Sterile pharmaceutical filling operations
The PFS filling machine provides a reliable and compliant solution for pharmaceutical manufacturers seeking efficient, flexible, and contamination-controlled aseptic filling systems.
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