MGA AseptiSeal VS Sartorius Biosealer TC

Criteria MGA AseptiSeal - Aseptic Tube Sealer Biosealer® TC – Sartorius
Introduction

The Aseptic Tube Sealer developed by MGA Technologies is a dedicated device designed to ensure sterile disconnection of thermoplastic elastomer (TPE) tubing, such as C-Flex®, in cleanroom environments. It provides a secure and aseptic separation solution for single-use fluid circuits, in compliance with pharmaceutical and biotech standards.

The Biosealer® TC by Sartorius is an automated device designed for aseptic disconnection of thermoplastic elastomer (TPE) tubing in biopharmaceutical manufacturing environments. It enables sterile sealing of dry, wet, or liquid-filled tubing without the need for additional accessories.​

Applications
  • Sterile Bioproduction: Used to disconnect fluid pathways during manufacturing without compromising the sterility of the system.
  • Cleanroom Pharmaceutical Processes: Ideal for flexible single-use system configurations, ensuring safe and contamination-free disconnections in pharma-grade environments.
  • Single-Use Equipment Lines: Perfectly integrated into modular single-use setups, where secure, traceable, and validated disconnections are required.

The Aseptic Tube Sealer by MGA Technologies provides reliability, process safety, and regulatory compliance. Its compatibility with multiple tubing types and seamless integration in cleanrooms makes it a key solution for modern aseptic fluid management.

  • Aseptic Disconnections: Ideal for performing sterile disconnections of fluid circuits in biopharmaceutical manufacturing processes, maintaining total product sterility even in non-classified environments.
  • Comprehensive Production Processes: Used across various critical steps, including media preparation, drug substance purification, drug product formulation, cell harvest, and downstream processing.
  • Versatile Fluid Management: Seamlessly integrated into modular single-use setups where secure and validated disconnections of liquid-filled tubes are required.

The Biosealer® TC by Sartorius offers a reliable, versatile, and user-friendly solution for the aseptic disconnection of TPE tubing. Its compatibility with a wide range of tubing sizes and materials, combined with its intuitive user interface and portability, makes it an essential tool for modern bioprocessing.

Technical characteristics
  • Broad Diameter Compatibility: Supports TPE tubing with outer diameters ranging from 4 mm (1/43) to 19.1 mm (3/43), covering a broad spectrum of pharmaceutical applications.
  • Qualified for Multiple Tubing Types: Tested and validated for use with C-Flex®, AdvantaFlex®, and Tuflux®, ensuring flexibility in your consumable sourcing.
  • Automated Sealing Process: Performs automated sealing and cutting of the tube in a single sterile operation, removing the need for manual intervention during the disconnection phase.
  • GMP-Compliant & Cleanroom-Ready: Fully designed for GMP-compliant operations, featuring a hygienic, easy-to-clean design and a user-friendly interface for cleanroom environments.
  • Wide Compatibility: Capable of sealing TPE tubing with dimensions ranging from 1/83 × 1/43 to 3/43 × 13 (ID × OD). It handles dry, wet, and liquid-filled tubes without the need for additional accessories.
  • Material Versatility: Fully compatible with the most industry-standard TPE tubing types, including Tuflux® TPE, C-Flex® 374, AdvantaFlex®, SaniPure™ BDF™, and PharMed® BPT.
  • Robust Sealing: Creates a 20 mm wide sealing area for maximum stability. It includes an integrated cutting guideline to ensure a clean and precise separation with scissors.
  • Intuitive User Interface: Features an LCD touchscreen that provides step-by-step guidance. The system comes with pre-installed parameters optimized for various tubing materials and sizes to ensure process consistency.
  • Portability & Ergonomics: Weighing only 3 kg, the device is highly portable. It can be operated on a tabletop or in a hanging position, allowing for easy use directly at the disconnection site.
  • Optimized Process Time: Offers efficient performance with sealing cycles ranging from 2 to 4 minutes, depending on the specific tubing material and dimensions.