2D/ 3D Single Use Storage Bags

Auto 21CFR Multistaged DZMF Filtration Systems

Product Description

Bioneau® FilSTEMS™ Clarification Harvest System is a high-performance, skid-mounted unit designed for efficient removal of biomass, cell debris, and particulates from fermentation or cell culture media. Engineered for biopharma and API processes, it uses depth micron filtration for consistent, high-throughput clarification with product integrity. GMP-compliant and modular, it integrates seamlessly into upstream operations like mAbs production, enzyme clarification, and vaccine harvest, FMC Impurities, Color Improvement etc.

Flow Range: system custom design from 20L volumes to 20KL batch sizes
Filtration: Absolute stepdown filtration from reaction mass 10 µm to final 0.2/ 0.1 µm filtration
Compliance: 21 CFR Part 11 ready with secure data handling.
Smart Interface: Touchscreen HMI/IPC with live pressure, flow, and dashboards.
Automation: Recipe-based stepwise or batch processing.
Control System: PLC/SCADA with alarms and interlocks.
Compact Skid: Minimal footprint, easy to install and clean.
FilSTEMS^TM: Patented tech (under examination*) for optimal performance.
Depth Filtration: 0.2–10 µm multi-layer filters for high dirt-holding & clarity.
Low Shear: Gentle processing for sensitive biologics.
CIP/SIP: Clean/sterilize-in-place compatible.
Modular Design: Single/multi-filter options for custom needs.

Biopharma:

Cell Culture/ Microbial/ Bio-Enzymes
mAbs/ Biotherapeutics Plasma, Cell & Gene Therapy
Injection, Implants and Blood Plasma, Biosimilar, Nutraceuticals, Pro-biotics/ mRNA Therapeutics

Vaccines