Aseptic isolator
GloveFAST Aseptic
The aseptic isolator for the highest requirements in cleanroom processes
The GloveFAST Aseptic is a modern, GMP-compliant positive pressure isolator with vertical laminar airflow that has been specially developed for work processes where maximum product safety, sterility and operator protection are essential. Thanks to its modular design, the isolator can be flexibly adapted to customer-specific requirements and is suitable for both routine use and demanding pharmaceutical applications.
Typical areas of application:
- Production and mixing of TPE/TPN solutions
- Aseptic IV preparations
- Production of sterile eye drops
- Working with stem cells and umbilical cord blood
- CIV-AS applications (centralised production of medicinal products)
- Carrying out microbiological sterility tests
Optionally with integrated FASTER NHP system
For maximum microbiological safety, the GloveFAST Aseptic can optionally be equipped with the FASTER NHP system (Nebulised Hydrogen Peroxide) - a fully validated, TÜV SÜD GMP-certified system for H₂O₂ decontamination. This system enables automated, reproducible and documented bio-decontamination of the chamber and airlocks in the shortest possible time. It fulfils all requirements according to Annex 1 of the EU GMP guidelines.
Features
- Cleanroom class A in the working area (in accordance with EU GMP guidelines and ISO 14644-1 class 3)
- Closed design for complete separation of operator and process
- Overpressure operation with actively controlled air flow (+75 Pa)
- Automatic pressure holding test with storage in the control system (audit trail)
- HMI touch display (8 inch) with user-friendly menu navigation
- IQ/OQ documentation, optional PQ and DEHS test ports
- Remote diagnostics function for service and maintenance efficiency
- Hinged windscreen with gas struts for easy cleaning and access
- Ergonomic design for standing or seated operation
Transfer locks
- Integrated airlocks on both sides with hygienic transfer tables
- Mutually lockable inner and outer doors (electromagnetic)
- Airlock ventilation via G4 pre-filter + two H14 HEPA filters
- Optionally with vertically opening doors with safety sensors
- Rinsing phase with time delay for particle-free airlock process
Air ducting & filter technology
- Air velocity in the usable space: approx. 0.45 m/s
- With accidentally opened glove ports: ≥ 0.7 m/s according to ISO specification
- 70 % recirculated air, recirculated via HEPA filter H14
- 30 % exhaust air for pressure control and air quality assurance
- HEPA H14 filter (in accordance with EN 1822) with 99.995 % MPPS efficiency
- Integrated DEHS test connections for all filter units (including airlocks)
Optional accessories & special equipment
- FASTER NHP H₂O₂ gas flushing system
- Particle monitoring with the PZG series (incl. ISO-, GMP-, FDA-compliant report output)
- 19" touchscreen monitor (integrated flush into the rear panel)
- Camera for process monitoring, data logger, humidity/temperature sensors
- Electrically height-adjustable base frame
- Air sampler connection, RJ45, RS232, USB interfaces
- Airlock pressure display, signalling device, redundant alarm systems
- Scale connection or integrated prepared scale
- Activated carbon filter to supplement chemical adsorption
Glove system & port equipment
Biogel Eclipse™ Indicator double glove system:
- Colour-coded indicator function for perforation
- 97 % detection rate for micro-damage
- Excellent wearing comfort and protection
Easy-Change Push/Push cuff ring system
- Tool-free change under sterile conditions
- Optional: various glove materials (neoprene, CSM, EPDM)
- Individually configurable port sizes (e.g. Ø 250, 300 or 350 mm)
Why GloveFAST Aseptic from FASTER?
- Maximum product safety thanks to closed system architecture
- Future-proof technology thanks to optional integration of the NHP system
- Validated process reliability thanks to IQ/OQ/PQ and DEHS test connections
- Ergonomic design for comfortable and safe working conditions
- Complete documentation & GMP conformity for pharmaceutical applications
- Versatile configuration options - from standard models to customised solutions
| Model Type | GloveFAST Aseptic 1.2 m | GloveFAST Aseptic 1.5 m | GloveFAST Aseptic 1.8 m |
|---|---|---|---|
| Standards | EN 1822, EN12469, EN61010-1, ISO 14644.1 | EN 1822, EN12469, EN61010-1, ISO 14644.1 | EN 1822, EN12469, EN61010-1, ISO 14644.1 |
| General dimensions (W×H×D, mm) | 2510 × 2450 × 868 | 2815 × 2450 × 868 | 3120 × 2450 × 868 |
| Usable dimensions (W×H×D, mm) | 1192 × 740 × 580 | 1497 × 740 × 580 | 1802 × 740 × 580 |
| Air flow (m/s) | 0.45 | 0.45 | 0.45 |
| Electr. Connection | 230V, 50Hz, 1-phase ≤ 240 Watt | 230V, 50Hz, 1-phase ≤ 240 Watt | 230V, 50Hz, 1-phase ≤ 240 Watt |
