GloveFAST Cyto Pharma
Safety First. FASTER Cytotoxic Isolators (GloveFAST Cyto Pharma) offer safe and consequent separation between operator and process at latest state-of-the-art technology. No matter if connected in series or as single unit: You always work absolutely safely with all CMR agents.
The GloveFAST Cyto Pharma is a negative pressure isolator with vertical laminar air flow. Due to a closed system, there is a safe separation between operator and process. To meet the individual applications in cytostatics manufacturing, the GloveFAST Cyto Pharma isolator can be customized with numerous options. Optional accessories such as an analytical balance in combination with a low-vibration work surface, a 19" touch monitor, an isokinetic measuring probe, the coupling of the isolator to a 3-way airlock, the installation of a camera for process documentation or a monitoring system allow the cytostatic isolator to be equipped for any process in the pharmacy.
- Cytotoxic (CMR)
- Hazmat, under TRGS 525
- Any other toxic active agents
- Air quality of cleanroom class A (unidirectional displacementcurrent Laminar Flow) as per EU-GMP Guide within the completework zone
- Easy cleaning of inner and outer surface
- Easy to clean multi-functional control
- Automatic pressure decay test, data are stored by the control
- Remote control function. ENVAIR service is enabled to log in the unit in case of failure messages via network, therefore cost-savings in service.
- Safe and consequent separation of operator and process due to a closed system
- Negative pressure operation (-75Pa) with laminar airflow and actively regulated blowers
- Sterile glove-changing system
- Easy surveillance, test and maintenance
- Ergonomically designed for easy operation, good visibility and high operators’ comfort
- Eligible display of internal pressure with delayed ambivalence time, automatic pressure decay test and pressure decay display
- Electro-polished stainless steel work surface, easy to clean.
- High air-change rate within the work zone and the transfer hatches for rapid clean-up of contaminated air and rapid disposal of disinfection agents
- Hatches with transfer tablets, foot switches for doors and door interlock system
- Multi-functional touch-display (size 8")
- Stand-by circuit / night-operation mode
- Tested and documented quality (IQ/OQ)
- Reasonable price/performance ratio compared to custommade Isolators
- Standard-conformity to DIN 12980:2017, EN ISO 14644-7, EN
- 61010 (electric installation), VDE / DIN 57789 (test), VDI
- 2083-1 and VDI 2083-3 (qualification)
- Air quality of cleanroom class A as per EU-GMP guide and DIN EN ISO 14644-1 class 5
The Isolator basically consists of powder-coated sheet steel but can be constructed entirely of stainless steel 1.4301. The work chamber is made of stainless steel 1.4404 and the work surface is removable. The unit features unidirectional displacement flow (Laminar Flow), filtered by HEPA filters (High Efficiency Particulate Air Filter H14). The front visor offers a number of practical and tested features. It is equipped with either 2 or 4 integrated glove ports of 300 mm diameter which allow most comfortable work. For easy cleaning purposes it can be turned up, held in open position by gas pressure springs. During operation the gasket of the visor is pressed against the Isolator by 3 knurled screws. The Isolator is connected gas-tight to the hatches with a static gasket.
The rear wall optionally holds a flush-mounted 19" touchscreen monitor. In order to avoid limitations in operation due to reflections there is no additional glass screen in front of the monitor.
The Isolator can be operated in sitting or in standing position. The 100% leg/knee clearance is granted by the main filter being placed backwards.
The Isolator is fitted with transfer hatches at both sides for loading and unloading the material to be treated. Each hatch is fitted with inner and outer doors as well as with a sliding transfer tray from the hatch into the work chamber. Each hatch is ventilated via a prefilter G4 and 2 HEPA filters H14.
The air entering the work chamber is filtered by a H14 HEPA filter in any case, no matter if one hatch door is open or not.
For safety reasons the inner and outer hatch doors are electromagnetically interlocked so that only one door can be opened. All other doors are locked and can not be opened at that time.
When the hatch door is closed again, a pre-settable delay program becomes active until one of the other doors can be opened. Therefore it is granted that no particles can enter the work chamber or escape to the ambient during the rinsing phase. Each hatch is fitted with a foot switch to open the inner hatch doors.
Transfer hatch doors (hinged doors):
Inner and outer doors of the transfer hatches are of hinged type. The outer doors open upwards. Optionally they can be opened from left to right or vice versa. The mechanism is operated by a key at the hatch and a second key at the display. The inner hatch doors open from front to back, operated by a foot switch or a second key at the display. Advice: You do not loose space in the work zone by the hinged doors. As soon as you use the transfer tablet there is still enough space.
Optional vertical hatch doors:
The inner vertical hatch doors are operated by a foot swith, by pressing the relevant foot switch the relevant inner hatch door will open automatically. The door slides vertically up. When the door is to be closed again, the foot switch must be pressed again. The door will automatically slide down. The doors are fitted with a pressure sensor to avoid that fingers can be caught. Due to this new function the inner doors must no longer be opened manually, avoiding cross contamination via the doors. Even the complete work flow will be more economic.
Regulation / Control:
- Multi-function Touch-Display
- Optional free contacts for on-site exhaust system and alarms
Password protection of the control:
Changes of hatch-lock time or alarm limits are only possible after entering a password.
In the event of a power breakdown an acoustic alarm is released. This alarm is powered by a separate battery. Optionally a UPS is available which holds the work conditions for 10 – 20 mins.
- Left foot switch to open the left inner hatch door
- Right foot switch to open the right inner hatch door
- Fixed metal support, 800 mm high
- Option: entirely of stainless steel 1.4301
HMI Touch Panel:
The Isolator is fitted with a digital Siemens HMI-Touch-Panel with scroll-down function, which indicates all measuring values. The Isolator has no analogue differential pressure indications.
The menu has various features:
- Operation hours counter (hours, minutes)
- Last service (date, time, password-protected)
- Last pressure test (date, time, pass or fail)
- Measured values of pressure test (value 1, value 2, etc.)
- Remaining filter lifetime
- Exhaust air blower capacity (percent)
- Circulating air blower capacity (percent)
- Inner temperature
- Outer temperature
Alarms of the PLC-control, visible at the display:
- Air change rate
- Work zone pressure
- Main filter differential pressure monitoring
All alarms are free adjustable.
Automatic Pressure Decay Test:
The Isolator independently performs a pressure test to make sure that Isolator and hatches are completely tight.
- Automatic negative pressure build-up of approx. -250 Pa, then holding time.
- Automatic start of measuring when the negative pressure reaches -150 Pa.
- Measuring is performed every 90 seconds, the values are stored from the PLC. 3 measurings in total, all values can be read from the display after the test is finished.
Criteria: maximum 25 Pa pressure decay/min
- In case the pressure decay is more than 25 Pa per minute the display will show „Pressure Test Fail”.
- In case the pressure decay is less than 25 Pa per minute the display will show „Pressure Test Pass”.
Criteria: 25 Pa in 90 sec. measuring time.
Gloves / Sleeves:
Separately changeable glove/sleeve combination. The gloves can be exchanged without breaking the clean atmosphere inside the work chamber.
The advantage of a large sleeve opening is a better mobility. The unit can be operated by persons of different body size without problems.
Biogel Eclipse Indicator – the ultimative solution in protection and safety.
The innovative Biogel Eclipse™ Indicator consists of two gloves: one green inner glove and one outer glove.
The inner glove is half a number bigger than the outer glove. The advantage is that the pressure to the hand is reduced so that less fatigue can occur.
In case the outer glove will be erforated, the liquid from the operation field distributes between the two gloves. A green spot on the outer glove indicates the perforation. Beside this quick perforation indication the Biogel Eclipse™ convinces of its optimal fit and the clearly better wearing comfort and the excellent sense of touch. Biogel Eclipse™ gloves are thinner and clearly smoother than other gloves. The special Biogel inner lining allows to put it on easy even with moist hands.
Why double-glove system?
Perforation of normal gloves remain undetected during handling but perforations are detected with the patented Biogel Eclipse Indicator system.
- 97% of the perforation will be detected with the patent Biogel Eclipse Indicator System
- Double-glove systems reduce the perforation risks from 34,7% to 3,8%.
- Double-glove systems reduce the contamination of hands from 13% to 2%.
Easy-Change Cuff Ring System (push/push)
The easy to exchange ENVAIR Easy-Change cuff ring system was especially designed for sterile change of gloves. In case of changing a glove Easy-Change guarantees person and product protection. If you need to do a routine glove change, change a defective glove or just put on another glove size, the system allows easy and quick change without breaking the integrity of the surrounding area. The cuff ring has a double lip seal system which ensures that the containment never will be broken.
You can change a glove by putting a new sterile glove onto one inner blue cuff ring, inside the Isolator, and then push the old glove together with the other inner cuff ring into the sleeve or a bag.
|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|
|Overall Dimensions (W×H×D, mm)||2510 × 2450 × 868||2815 × 2450 × 868||3120 × 2450 × 868|
|Useful Dimensions (W×H×D, mm)||1192 × 740 × 580||1497 × 740 × 580||1802 × 740 × 580|
|Electrical Data||230V, 50Hz, single phase ≤ 240 Watt||230V, 50Hz, single phase ≤ 280 Watt||230V, 50Hz, single phase ≤ 320 Watt|
- Compressed air, vacuum and nitrogen connections
- H2O2-gassing, H2O2-hatch
- Electrically adjustable support
- 2 Isolators (double version) with central 3-way-hatch
- Isolator with 1 hatch
- Vertical inner hatch doors (electric)
- Active charcoal filter
- Suspension rod in the work chamber
- Isokinetic probe for particle monitoring
- Water-protected sockets IP 44
- Connection for air sampler
- Display of hatch pressure
- Camera for documenting the process
- Test disc with manometer for glove integrity
- 19" cleanroom monitor with touch screen
- Work surface with provision for balance operation
- Interface RJ 45 / RS 232 / USB
- Monitoring of temperatur and humidity
- Entirely made of stainless steel 1.4301 / < 0,8 μm
- 3-way hatch with connected Cytostatic Safety Cabinet/Workbench
- Potential-free contacts
- Further options upon request
Ambient air (A) is drawn in through an H14 HEPA filter located on top of the transfer chambers and forced into the working area of the transfer chambers. Then the air is drawn through the main blower and a second HEPA filter (E). The compressed air is forced into the plenum, passed over the vertical flow HEPA filter and directed as a 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 the perforations in the work surface into the main H14 HEPA filter below the work surface and directed through the exhaust duct (C) located on the rear wall. A portion of the air is discharged through the H14 exhaust HEPA filter (D). This process creates the negative pressure conditions in the work area (B), protecting the operator and the environment.