Pharmaceutical isolator mat

for productionaseptictransfer

Product overview
The MAT material transfer isolator is a compact, standalone isolator designed for safe, fast material transfers and efficient surface decontamination in isolator-based filling lines. Transfer type: Material. Customization level: Modular configuration.

Key benefits

• Maximum safety: Fully automated processes reduce manual interventions and associated risks.
• Regulatory compliance: Complies with Annex 1 and relevant GMP requirements enabling GMP-compliant transfers (EU GMP Grade A / ISO 5).
• Efficient transfers: Short transfer paths and times due to close proximity to the filling line.
• Compact design: Approx. 1.5 m² footprint for easy integration, even in confined production areas.
• Independent operation: Standalone solution without external HVAC connection thanks to the SKAN nanox catalyst.
• Flexible integration: Compatible with a wide range of materials, container sizes, and production layouts.
• Easy handling: Floor-level loading solutions and a large glass door for simple operation.
• Individual configuration: Modular design with numerous shelving solutions and options.

Application

• Preparation of filling processes: Decontamination and transfer of tools, consumables, and other items required for aseptic or aseptic-toxic filling operations.
• Decontamination of heat-sensitive materials: Uses hydrogen peroxide (H₂O₂) to decontaminate materials that cannot be autoclaved without compromising product quality.

Process (typical workflow)

• 1. Loading: Materials are loaded into the MAT isolator, typically positioned close to a filling line in a Grade C or D cleanroom.
• 2. Decontamination: Fully automated H₂O₂ cycle using skanfog micro-nebulization technology. Efficient cycle within 30–45 minutes (for empty chambers, without RTPs), includes leak testing.
• 3. Transfer out: After validated decontamination, transfer via Rapid Transfer Port (RTP) containers into the filling line.
• 4. H₂O₂ neutralization: The nanox catalyst fully decomposes H₂O₂ after decontamination; exhaust air can be returned directly to the room.

Product highlights

• Automated safety and standardized processes reduce risks and simplify risk assessment.
• Time efficiency: Cycle times of 30–45 minutes accelerate material flow and reduce filling line downtime.
• Operational flexibility: Process adaptable to different transfer types, materials, and monitoring requirements.
• Decontamination performance: Designed for >6-log reduction via skanfog H₂O₂ micro-nebulization.

Regulatory & validation features

• Annex 1 support: Facilitates microbiological and particulate monitoring consistent with Annex 1 requirements.
• GMP standards: Enables transfers compliant with EU GMP Grade A (ISO 5).
• Validation-friendly: Automated cycles and SOP-based operation reduce validation effort.

Included/available transfer and options

• RTP for solids: Up to size 350.
• AT-Port: For aseptic liquid transfers.
• Glove test device: With position control.
• Shelving installation: Available on request.
• Various shelving and modular accessories available on request to tailor configuration.

Environmental / airflow and exhaust
Unidirectional airflow without recirculation. Exhaust air can be released directly into the room thanks to the SKAN nanox catalyst which ensures rapid decomposition of hydrogen peroxide to single-pass reduction levels (< 0.1 ppm).

Operation & control

• Control: PLC-based system; Siemens or Allen Bradley.
• User interface: 18.5” HMI (customizable).
• SCADA: System for monitoring and control, GMP-compliant and 21 CFR Part 11-ready.

FAQs (summary)

• How does MAT support Annex 1? — Provides validated decontamination and standardized cycles, minimizing manual interventions and supporting Contamination Control Strategy (CCS) and aseptic material transfer requirements.
• Advantages vs conventional airlocks? — Fully isolated with automated H₂O₂ cycles; reproducible, faster, and safer decontamination with fewer manual interventions.
• Impact on equipment efficiency? — Reduces transfer paths and times; often shortens material preparation from several hours to less than one hour.

Technical specifications

• Footprint: Approx. 1.5 m² (approx. 16 ft²).
• Weight: Approx. 800 kg.
• Working chamber: EU-GMP Grade A (ISO 5).
• Decontamination: > 6-log via skanfog H₂O₂ micro-nebulization.
• Cycle time: 30–45 minutes (empty chamber, without RTPs).
• Airflow: Unidirectional, without recirculation.
• Exhaust air: Direct to room via nanox catalyst; single-pass H₂O₂ reduction to < 0.1 ppm.
• RTP for solids: Up to size 350.
• AT-Port: Available for aseptic liquid transfers.
• Room monitoring (optional): H₂O₂ TLV sensor.
• Chamber monitoring (optional): H₂O₂ sensors.
• Microbial and particulate monitoring: In accordance with Annex 1.
• Control system: PLC (Siemens or Allen Bradley).
• HMI: 18.5" (customizable).
• SCADA: GMP-compliant and 21 CFR Part 11-ready.