Filling isolator pure² M1

hazardous materialsfor productionfor cellular therapy

Product overview
The pure² M1 — Getting started with isolator technology in the ATMP sector.

• Application type: Aseptic(-to-toxic)
• Customization level: Modular configuration

At a glance

• Containers: AT-Closed Vial®
• Objects per hour: Up to 150
• Filling volume: 0.1–45 ml
• Filling line: AT

Key features

• Automated skanfog H₂O₂ decontamination with validated cycles under 30 minutes
• SKAN nanox catalyst enables direct exhaust to the room without HVAC connection
• Plug-and-play equipment requiring only compressed air and power (low installation requirements)
• Integrated AT-Port for aseptic liquid transfer through the isolator wall
• Peristaltic pump with integrated weighing cell for precise dosing and easy calibration
• Pre-sterilized single-use AT-Assembly components to reduce cleaning validation efforts
• Beginner-friendly, compact, front-accessible, tool-less format change and two HMIs for process tracking
• Delivered with full GMP and FDA 21 CFR Part 11 compliant validation documentation

Application

• For cell and gene therapies — adaptable to workflow needs and supporting rapid transfer steps for cell culture processing
• For pharmaceutical manufacturing — ideal for small-scale aseptic production including aseptic-toxic applications (e.g. CMR substances), ensuring GMP compliance

AT-Closed Vial® ecosystem (Fill Finish)
The AT-Closed Vial® system enables a fully closed aseptic filling process. At its core is the AT-Closed Vial® primary packaging combined with the AT-Cap closure, complemented by suitable filling lines and the single-use AT-Assembly for sterile liquid transfers. All components are aligned to ensure a consistent, contamination-controlled and scalable process.

Process (M1 filling process within the pure² isolator)

• 1. Material introduction — Ready-to-use consumables (AT-Closed Vial®, AT-EasyCap, AT-Assembly) enter through a rapid decontamination airlock
• 2. Liquid transfer — Bulk product introduced via the AT-Port while keeping bulk container outside the isolator for cooling and mixing
• 3. Filling, sealing and capping — Semi-automatic vial filling inside the isolator; laser resealing and capping; peristaltic dosing with calibrated weighing cell
• 4. Batch monitoring — Live batch data displayed on integrated chamber screen for calibration and tracking
• 5. Continuous product exit — Filled vials exit through a mousehole with laminar airflow

Product highlights

• Reduced contamination risk through closed filling: AT-Closed Vial® remains functionally closed throughout the process
• Designed for small batches and scalability to enable smooth transition from R&D to GMP manufacturing
• Efficient decontamination with short cycle times using skanfog H₂O₂ micro-nebulization

Regulatory requirements

• Annex 1-compliant process design supporting minimized interventions and reduced contamination risks
• Container Closure Integrity (CCI) validated by methods such as dye ingress, CT scan, headspace analysis
• Delivered with a validation master plan and a complete test package for the AT-Closed Vial® process

Caractéristiques / Spécifications techniques

• Isolator dimensions (W × H × D): 3300 × 955 × 2277 mm
• Minimum room height: 2400 mm
• Weight: 1250 kg (including airlock and laminar flow)
• Output: Up to 150 AT-Closed Vial® per hour
• Filling volume: 0.1 ml to 45 ml
• Cleanroom requirement for operation: Grade C/D
• Working chamber: Grade A (ISO 5)
• Decontamination: 35% H₂O₂ stored within isolator; automated skanfog H₂O₂ micro-nebulization — validated cycles under ~30 minutes
• Filtration: Double H14 HEPA filtration (99.995% efficiency)
• Airflow: Downflow 0.45 m/s ± 20% (0.25 m/s in standby)
• HMI: HMI for isolator, HMI for M1 filling station, additional screen inside chamber for process tracking
• Glove testing: Optional WirelessGT glove test system
• Chamber material: Stainless steel, AISI 316L (≤ 0.8 µm)
• Housing: ABS
• Window: Double safety glass
• Operating status indicator: Internal lighting (red/white/blue)
• Noise level: ≤ 65 dB(A)
• Power supply: 220–240 V AC, 50–60 Hz, max. 3800 W
• Compressed air: 6–10 bar / 7.5–22 Nm³/h, ISO 8573-1:2010 Class 1.3.1
• Standards & certifications: IEC 61010-1:2010, DIN 12980:2017-05, 2006/42/EC, 2014/30/EU, EN 12469, ISO 14644-3/7, cTUVus-certified
• Key components & process elements: Integrated AT-Port for aseptic liquid transfer, peristaltic pump with integrated weighing cell for high filling accuracy, pre-sterilized single-use AT-Assembly components