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

Aseptic Compliance: Operates within ORABS/CRABS systems to meet ISO Class 5 cleanroom standards.
Scalable Throughput: Adjustable production capacity ranging from 25–100 units per minute, supporting flexible manufacturing needs.
cGMP & FDA-Aligned Design: Equipped with CIP/SIP-ready components for efficient cleaning and sterilization processes.
Endotoxin Control: Validated system ensuring endotoxin levels below 0.25 EU/mL.
Rapid Changeover: Optimized for RTU nest trays, allowing quick transitions between different container formats and product viscosities.

Advanced Options

PAT (Process Analytical Technology) integration for enhanced process monitoring
Track-and-trace systems to improve data integrity and regulatory compliance

Applications

Injectable pharmaceuticals
Gene therapy products
Antibody-drug conjugates (ADC) manufacturing
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.