mat – Material Transfer Isolator

Efficient and safe material transfers are essential in aseptic production – especially after the implementation of Annex 1. They not only impact safety but also the of the overall efficiency of the manufacturing processes.

The mat material transfer isolator has been specifically designed for this critical step. It enables safe, fast, and flexible transfers of tools, consumables, and other items into filling isolators. Through fully automated processes, mat offers one of the most efficient solutions for validated transfer processes with a minimal footprint.

• Areas of Application

  The mat is placed in Grade C or D cleanrooms to efficiently transfer materials into Grade A chambers. Its compact design allows for a seamless integration into existing production workflows. mat is particularly used alongside aseptic filing lines, minimizing transfer distances and times while maintaining the highest safety standards. Transferred materials undergo decontamination through a validated hydrogen peroxide (H2O2) process. The transfer is then performed using Rapid Transfer Port (RTP) containers, ensuring a safe infeed into the filling isolator.

• Advantages of mat

  – Maximum safety: High degree of automation minimizes transfer process risks and simplifies risk assessments.
  – Regulatory compliance: Fully adheres to Annex 1 and other Good Manufacturing Practice (GMP) regulations.
  – Fastest cycle times: Efficient decontamination in only 30-45 minutes with skanfog® technology.
  – High flexibility: Supports various material types and container sizes.
  – Standalone solution: Operation without HVAC connection due to integrated nanox® catalyst.
  – Compact design: Requires only 1.5 m² (≈16 ft²) of floor space.

• Proven technologies

  – skanfog® decontamination system: Fully automated cycle with leak testing.
  – nanox® catalyst: Neutralizes hydrogen peroxide for maximum operator safety.
  – Innovative ventilation: Unidirectional airflow without recirculation.

• Regulatory compliance & validation

  mat supports GMP-compliant transfers according to EU-GMP Grade A (ISO Class 5) standards. Standardized operating procedures (SOPs) and a fully automated transfer process minimizes manual interventions while facilitating validation.

• Flexible adaptation to your processes

  Thanks to its compact, modular design, mat can be customized to meet specific requirements. A large glass door, floor-level loading solutions, and flexible shelves ensure optimal handling.

• Available Options:

  – RTP (up to size 350) for solids
  – AT-Port™ for aseptic liquid transfers
  – H2O2 MAK sensor for room monitoring
  – H2O2 sensors for chamber monitoring
  – Microbial and particulate monitoring according to Annex 1
  – Glove test devices with position control
  – Shelf mounting upon request