Cytostatic isolator
GloveFAST Cyto Pharma

Illustrations may contain additional options subject to a charge
Illustrations may contain additional options subject to a charge
Illustrations may contain additional options subject to a charge

GloveFAST Cyto Pharma - Cytostatic isolator for safe handling of toxic substances, TÜV Nord GS-certified

Validated personal safety, cleanroom class A, TÜV-certified - now also with optional H₂O₂-NHP system from FASTER

The GloveFAST Cyto Pharma is a high-performance negative pressure isolator with vertical laminar airflow, specially developed for the safe preparation and filling of cytotoxic, CMR and other highly potent substances. Thanks to its fully enclosed design with laminar airflow, the isolator ensures strict physical separation between the operator and the process while complying with cleanroom class A in accordance with the EU GMP Guide and DIN EN ISO 14644-1 (ISO 5).

For maximum process safety, the GloveFAST Cyto Pharma can be equipped with the tried-and-tested FASTER H₂O₂ NHP decontamination system on request. This system enables fast, validated bio-decontamination of the entire working chamber - safe, documented and TÜV SÜD-certified.

  • Features
    • Air quality cleanroom class A (unidirectional displacement flow laminar flow) according to EU GMP guide in the entire work area
    • Easy cleaning of the interior and exterior surfaces as well as the multifunctional control unit
    • Automatic pressure retention test with data storage in the control unit
    • Remote control function: external dialling-in to the device via network for possible fault detection (cost savings for service)
    • Safe, consistent separation of operator and process thanks to closed system
    • Negative pressure operation (-75 Pa) with laminar air flow behaviour and actively controlled fans
    • Sterile glove changing system
    • Simple monitoring, testing and maintenance
    • Ergonomically designed for easy operation, good visibility and high operator comfort
    • Selectable display of internal pressure with delayed antivalence time, automatic pressure drop test and pressure drop indicator
    • Electropolished, easy-to-clean stainless steel work surface.
    • High air exchange rate in the work area and material airlocks for rapid clean-up of contaminated air and rapid removal of disinfectants
    • Airlocks with transfer trays, foot switches for doors and interlocking doors
    • SIEMENS HMI touch panel (display size 8")
    • Software with audit trail and FDA 21 CFR Part 11 compliant
    • Stand-by switch/night mode
    • Tested and documented quality (IQ/OQ)
    • Favourable price-performance ratio compared to custom-made isolators
    • Standards-compliant with DIN 12980:2017, EN ISO 14644-7, EN 61010 (electrical installation), VDE / DIN 57789 (testing), VDI 2083-1 and VDI 2083-3 (qualification)
    • Air quality cleanroom class A according to EU-GMP Guide and DIN EN ISO 14644-1 class 5
  • Airflow
    • Ambient air (A) is sucked in via H14 HEPA filter, which is located on the transfer chambers, and pressed into the working area of the transfer chambers
    • Air is drawn in through the main fan and second HEPA filter (E)
    • Compressed air is forced into the plenum, directed via vertical flow HEPA filter and as laminar flow into the working area (B) to protect the product to be treated in the working area
    • From here, the air is drawn through perforations in the work surface into the main H14 HEPA filter below the work surface and channelled through the exhaust duct (C) located on the rear wall
    • Part of the air is discharged through the H14 exhaust HEPA filter (D)
    • This process creates the negative pressure conditions in the work area (B) and thus protects the operator and the environment
  • Optional equipment for all isolator models
    • Connections for compressed air, vacuum, nitrogen
    • H2O2 fumigation, H2O2 airlock
    • Electrically height-adjustable base frame
    • 2 isolators (double version) with central 3-way airlock
    • Isolator with 1 airlock
    • Internal vertical airlock doors (electric)
    • Activated charcoal filter
    • Hanging rod in the working chamber
    • Isokinetic probe for particle monitoring
    • Water-protected sockets IP 44
    • Connection for air sampler
    • Airlock pressure indicator
    • Camera for process documentation
    • Test disc with manometer for glove tightness
    • 19" clean room monitor with touch screen
    • Work surface for operation with scales
    • RJ 45 / RS 232 / USB connections
    • Monitoring of temperature and humidity
    • Completely made of stainless steel 1.4301 / < 0.8 µm
    • 3-way airlock with connected cytostatic safety cabinet
    • Potential-free contacts
    • Further options on request

State of the art for safe working

The isolator is made of powder-coated sheet steel as standard, but can also be manufactured entirely from 1.4301 stainless steel on request. Stainless steel 1.4404 is used in the usable space and the work surface is removable. The system is filtered with unidirectional displacement flow (laminar flow) via HEPA filters (High Efficiency Particulate Air Filter H14). The front screen offers several practical and proven features. It is equipped with either 2 or 4 integrated glove ports with a diameter of 300 mm for comfortable working. It can be opened for cleaning work and is held in the open position by gas struts. During operation, the seal of the disc is pressed against the isolator with 3 ratchet screws and the isolator is connected to the airlocks in a gas-tight manner via a static seal.

There is an optional 19" touchscreen monitor on the rear, which is flush-mounted. In order to avoid restrictions in operation due to light reflections, we have dispensed with an additional glass panel above the monitor.

The isolator is suitable for both sitting and standing workstations. One hundred per cent legroom is structurally guaranteed by the main filter being offset to the rear.

The isolator is equipped with transfer airlocks on both sides for inserting and removing the materials to be treated. Each transfer lock has an inner and outer door as well as a pull-out transfer table from the lock into the working chamber. Each airlock is ventilated via a G4 pre-filter and 2 H14 HEPA filters.

The air flowing into the working chamber is always filtered by an H14 HEPA filter, regardless of whether one of the airlock doors is opened.

For safety reasons, the inner and outer doors on the airlocks are each electromagnetically interlocked. This means that only one airlock door can be opened at any one time.

If the airlock door is closed, an adjustable time delay elapses until one of the other doors can be opened. This ensures that no particles enter the working chamber or escape from the working chamber into the open air (flushing phase). Each airlock has a foot switch for opening the inner airlock doors.

  • Transfer airlock doors (swing doors)
    • Outer and inner transfer airlock doors are hinged doors
    • Outer doors can be opened from bottom to top - optionally also from left to right or right to left using the side stop
    • Mechanism is operated via a button on the interlock and a second switch on the display
    • Inner transfer lock doors can be opened from front to back using a foot switch or a second switch on the display. Note: No loss of space in the working area due to swing doors
  • Optional vertical airlock doors
    • Automatic opening/closing via foot switch
    • Door moves vertically upwards
    • Counter-pressure sensors ensure safety
    • No carry-over of contamination via the doors
  • Control / monitoring
    • Multifunctional touch display
    • Optional free contacts for on-site exhaust air system and alarms
  • Password protection on the control unit

    Changes to the interlock locking time or alarm limit values are only possible by entering a password

  • Power failure
    • Triggers an audible alarm (powered by its own battery)
    • A UPS system is optionally available, with which you can continue working for 10-20 minutes
  • Separate switches
    • Foot switch on the left to open the inner airlock door on the left
    • Foot switch on the right to open the right-hand inner airlock door
  • Frame
    • Metal base frame, fixed, height 800 mm
    • Optional: completely in stainless steel 1.4301
  • HMI Touch Panel
    • Digital Siemens HMI touch panel that displays all measured values and has a scroll-down function
    • No analogue differential pressure displays
  • Menu with various features
    • Operating hours counter (hours, minutes)
    • Last service (date, time, password protected)
    • Last pressure maintenance test (date, time, passed or failed)
    • Measured values of the pressure maintenance test (measured value 1, measured value 2, etc.)
    • Remaining filter running times
    • Fan performance exhaust air or recirculated air in per cent
    • Indoor and outdoor temperature
  • Alarms via the PLC control visible on the display (freely adjustable)
    • Air exchange rate
    • Useful room pressure
    • Main filter differential pressure monitoring
  • Automatic pressure drop test

    The isolator automatically performs a pressure test to ensure that the isolator and the airlocks are completely sealed.

    • Automatic negative pressure build-up of approx. -250 Pa, then holding time
    • Automatic start of measurement when the negative pressure reaches -150 Pa
    • Measurement every 90 seconds, values saved in PLC, 3 measurements in total
    • All values can be read off the display afterwards

    Criterion: maximum 25 Pa pressure drop/min

    • Pressure drop higher than 25 Pa/min: Display shows "Pressure test failed"
    • Pressure drop less than 25 Pa/min: Display shows "Pressure test passed"

    Criterion 25 Pa in 90 sec. measuring time.

  • Gloves/sleeves
    • Separately interchangeable glove-sleeve combination - interchangeable while maintaining the cleanroom atmosphere
    • Advantage: Large sleeve opening for better manoeuvrability - complication-free operation by employees of different heights
  • Double glove system

    Biogel Eclipse™ Indicator - the benchmark in protection and safety

    • Consists of two gloves: green inner glove and straw-coloured outer glove
    • Thinner and softer as well as highly tactile and comfortable to wear
    • Easy to remove thanks to special inner coating
    • If the outer glove is perforated, the liquid from the surgical field is distributed between the two gloves. Green dot to indicate perforation
    • Patented double glove system detects 97 % of perforations
  • Easy-Change cuff ring system (push / push)
    • Specially developed for sterile glove changes
    • Quick and easy changing without breaking the integrity of your environment
    • Guarantees personal and product protection when changing

details

  • Display
    Home screen (display size 8")
    Parameter display
    Pressure drop test
    Exhaust air fan power display
  • Sluice
    Airlock cover
    Airlock door - Signal display Door control monitoring in the rear panel
    Vertical airlock door
    Sluice disc
    Airlock disc - CPC clutch
  • Isokinetic measuring probe and touch monitor
    Isokinetic measuring probe
    Touch monitor
    Smooth surfaces without gaps in accordance with GMP
  • Easy-Change filter system
    Easy-Change filter system suitable for all 60 litre disposal bins
  • Transfer tray
    Transfer tray in the airlock
  • Miscellaneous
    DEHS measuring port - CPC coupling
    CPC connections
    Exhaust air shut-off valve
Model type GloveFAST Cyto Pharma 1.2 m GloveFAST Cyto Pharma 1.5 m GloveFAST Cyto Pharma 1.8 m
Standards DIN 12980:2017, EN 1822, EN61010-1, ISO 14644.1 DIN 12980:2017, EN 1822, EN61010-1, ISO 14644.1 DIN 12980:2017, EN 1822, 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
Downflow (m/s) 0.45 0.45 0.45
Electr. Connection 230V, 50Hz, 1-phase ≤ 240 Watt 230V, 50Hz, 1-phase ≤ 280 Watt 230V, 50Hz, 1-phase ≤ 320 Watt