Production isolator spectra

for pharmaceutical laboratoriesfor cellular therapyfor quality control

Overview
Compact, modular aseptic isolator designed for sterility testing and other aseptic laboratory processes in regulated pharmaceutical and biotech environments. Provides a GMP-compliant Grade A working zone with integrated decontamination and monitoring features suited for high-reliability batch release workflows.

Key benefits

• Optimized for sterility testing and aseptic manual/semiautomated operations
• Minimizes false positives through controlled process conditions
• Reproducible workflows with reduced operator error
• Short decontamination cycles and fast system readiness to increase throughput
• Continuous process control with automated monitoring and reporting
• Space-efficient design for integration into existing labs and cleanrooms
• Ergonomic access and intuitive operation for laboratory staff
• Lower operating costs due to reduced H2O2 consumption

Applications

• Quality control laboratories and pharmaceutical manufacturers: standardized sterility testing for batch release and audit-ready documentation
• Formulation and aseptic process steps: manual and semi-automated handling in formulation and filling support
• Biotech and ATMP workflows: suitable for sensitive non-standardized processes such as cell and gene therapies

Process (reproducible workflow)

• 1. Loading and preparation: materials and test units prepared, disinfected and transferred into the isolator for structured campaigns
• 2. H2O2 decontamination: automated skanfog micro‑nebulization ensures rapid, uniform H2O2 distribution and validated aseptic conditions
• 3. Aeration and release: controlled aeration to safe residual levels before aseptic operation
• 4. Sterility test or aseptic operation: execution of direct inoculation, membrane filtration or other manual steps under controlled conditions
• 5. Monitoring and documentation: continuous particle and viable monitoring with automated data logging for audits

Product highlights

• Modular system design: predefined chambers combinable and adaptable to process needs
• Efficient decontamination: skanfog H2O2 micro‑nebulization enables rapid, reproducible decontamination (working chamber cycle including aeration ≈ 1 hour; airlock ≈ 20 minutes)
• Safe handling of active substances: negative‑pressure operation and integrated safe‑change filters for containment

Regulatory / Compliance

• GMP‑compliant design for hygienic and controllable aseptic processing
• Cleanroom classification: working chamber meets EU‑GMP Grade A (ISO 5); operation designed for Grade D or CNC depending on national rules
• Data integrity: software compliant with CFR 21 Part 11 and GAMP 5; electronic records, audit trails and electronic signatures supported

Automation & Integration

• PLC control: Siemens or Allen Bradley
• SCADA: audit trail, alarm management and data export (e.g. AVEVA PI)
• IT integration: configurable for connection to existing laboratory IT/automation environments

Monitoring

• Viable monitoring: option to integrate an active air sampler near the process
• Particle monitoring: integrated particle counter for continuous control

Downloads & Multimedia
Product brochure and video materials available in product resources.

Technical specifications

• Total dimensions (W × D × H): 2460 × 2413 × 1034 mm
• Working chamber size (W × D × H): 1894 × 898 × 740 mm
• Working chamber classification: EU‑GMP Grade A (ISO 5)
• Decontamination: >6‑log reduction via skanfog H2O2 micro‑nebulization
• HEPA filtration: double HEPA filtration on supply and exhaust
• Containment: integrated safe‑change filters for potentially contaminated return air
• Exhaust air: direct to room with SKAN nanox catalyst for rapid H2O2 decomposition after decontamination
• Automation: Siemens or Allen Bradley PLC; SCADA with audit trail and data export
• Monitoring: active air sampler integration; integrated particle counter
• Decontamination / cycle times: working chamber cycle incl. aeration ≈ 1 hour; airlock ≈ 20 minutes