Aseptic isolator PSI-L

for sterility testingfor productionfor the pharmaceutical industry

Product overview
PSI-L is a modular isolator platform for aseptic and aseptic–toxic processes, described as "The Swiss Army Knife among isolators". It provides reproducible Grade A conditions, highest product and operator protection, and is adaptable to formulation, compounding, sterility testing, handling of toxic substances and ATMP processes.

Key features

• Maximum process reliability: reproducible Grade A conditions for aseptic and aseptic–toxic processes.
• Highest product and operator protection: closed or open isolator technology for sensitive and highly potent applications.
• Wide range of applications: formulation, compounding, sterility testing, handling of toxic substances, ATMP processes.
• High flexibility: adaptable to different processes, media and automation levels.
• Interchangeable process units: rapid module changeover via the standardized L-flange.
• Short decontamination cycles: integrated skanfog system for efficient H₂O₂ decontamination.
• Compact platform design: small footprint with high process integration.
• Fast implementation: standardized, pre-production reduces delivery and project timelines.

Applications

• For pharmaceutical manufacturers: suitable for aseptic upstream and downstream processes (formulation, compounding, sterility testing, handling of highly potent substances).
• For biotech and ATMP applications: handling of sensitive products such as cell and gene therapies (formulation, sample handling, preparation, product-close transfers).
• For C(D)MOs: modular setups for development, clinical phases and small-scale production.

Process (integrated aseptic end-to-end)

• 1. H₂O₂ decontamination: automated decontamination with integrated skanfog system achieving >6-log reduction prior to process start.
• 2. Material transfer and preparation: introduction via H₂O₂ airlocks, RTP ports or AT port for liquids; preparation inside isolator.
• 3. Core aseptic processes: open or closed steps such as formulation, compounding, sieving, sterility testing, ATMP-specific applications; manual, semi-automated or robot-supported operations.
• 4. Toxic containment: closed systems with safe-change filters, WIP spray guns and drain systems for safe handling of highly potent substances.
• 5. Product removal and further processing: controlled discharge of intermediates or final products for inspection, packaging or storage.

Product highlights

• Rapid process change without modifying the isolator via standardized L-flange for exchanging entire process units.
• One platform for diverse aseptic applications: each chamber can function as an independent isolator with its own air handling, monitoring and reporting.
• Standardized platform reduces capital investment and shortens time to operation.

Regulatory readiness

• Designed for compliance with EU GMP Annex 1 and FDA requirements; aseptic processes and decontamination are reproducible, validated and auditable.
• Data integrity and qualification: qualifiable to GAMP 5; supports 21 CFR Part 11 with secure, audit-traceable batch and process data storage.
• Integrated monitoring: sensors for H₂O₂, pressure, airflow, temperature and other environmental parameters; integrated viable and non-viable monitoring solutions.

Transfer options

• H₂O₂ airlock with automatic leak test and independent airflow.
• RTP (Rapid Transfer Port) integrable into side wall or L-flange.
• AT-Port for aseptic liquid transfer between room and isolator.

Monitoring & sensors

• Viable monitoring: integration of active air samplers at critical locations.
• Particle monitoring: integrated particle counter with isokinetic probe.
• Pressure and filter monitoring: differential pressure monitoring to cleanroom and for individual HEPA filters.
• H₂O₂ and occupational safety: H₂O₂ sensors and TLV monitoring.
• Environmental sensors: airflow, temperature and relative humidity sensors.

Technical specifications

• Standard working chamber (W × D × H): 2000 × 1417 × 3000 mm.
• H₂O₂ transfer airlock (W × D × H): 1000 × 1417 × 3000 mm.
• Working chamber weight: approx. 1950 kg.
• Airlock weight: approx. 800 kg.
• Room height: minimum 3 m.
• Working chamber classification: EU‑GMP Grade A (ISO 5).
• Decontamination: >6‑log reduction via skanfog H₂O₂ micro‑nebulization.
• HEPA filtration: double HEPA filtration for supply and exhaust air.
• Airflow: unidirectional airflow.
• Operating modes: over‑ or underpressure operation possible with pressure cascades between modules.
• Containment: integrated safe‑change filters for potentially contaminated return air.
• Washdown option: spray nozzles with WFI connection and drains for aseptic–toxic applications.
• Exhaust air: direct to room using SKAN nanox catalyst for rapid decomposition of hydrogen peroxide or alternatively via technical floor to outside.