PFS filling 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.