Compliance, Protection, Reliability........ And more.
Gelaire CytoFast cytotoxic drug safety cabinets ~ overview
CytoFast cytotoxic drug safety cabinets
Protection for products, operators and service personnel
Pharmaceuticals Cytotoxic drug safety cabinets (CDSCs) are defined in Australian standards AS 2567 and AS 2639 as the primary barrier against exposure to aerosols produced in the preparation, manipulation and dispensing of cytotoxic drugs.
Many of these drugs were shown to be mutagens and some to be carcinogens in cell DNA and chromosomal studies. Additionally, a causal relationship has been shown between occupational exposure of unprotected pregnant women to these drugs and increased incidence of teratogenesis. Effects of exposure to these drugs are insidious and may not manifest themselves for some years.
Class II biological safety cabinets are unsuitable for use with cytotoxic drugs because aerosols recirculated within the cabinet contaminate fans and internal plenums, thereby exposing service personnel to contaminated surfaces.
An increasing number of animal-based studies involve the use of cytotoxic drugs, and some of this work has been carried out in Class II cabinets. Hazards posed to service personnel from this inappropriate use are now more widely understood, with the result that CDSCs are now specified more frequently for these applications.
These cabinets are also suitable for use with agents likely to cause genetic alterations or synergetic activities with other materials.
AIRFLOWS AND PROTECTION
Personnel and environment protection is provided by an air barrier at the work opening and H14 HEPA filtration of exhaust air. Inflow of ambient air into a full-width grille in the work opening creates the air barrier.
A quantity of air equal to the barrier inflow is exhausted to the room through the exhaust filter. Vertical laminar airflow recirculated within the work zone through a second H14 HEPA filter maintains a sterile environment for product protection.
Location of the exhaust filter system directly under the work tray prevents recirculation of aerosols of drug products to fans and internal plenums, thus protecting service personnel.
CytoFast cabinets embody the latest European control and filtration technology, together with class-leading ergonomics and functionality. Cabinets are free-standing are available in widths of 900 mm, 1200 mm and 1800 mm; all with exhaust discharge at the top. Cabinets comply fully with Australian standard AS 2567, DIN 12980 and the EU standard EN 12469.
An electric sash front window with smooth, silent operation can be raised to a maximum opening of 420 mm for cleaning or movement of materials; or completely closed, obviating the need for a work zone closure panel. Glass side panels are fitted in the work zone.
Cabinets are available in isolator configuration with glove ports and H14 HEPA-filtered transfer hatches. This version conforms to Class III in ISO 14644-7.
ECSÂ® control and energy management
The new ECSÂ® (Eco Control System) microprocessor employs the latest technology for integrated management of airflows and filtration. Self-regulation of airflows compensates for gradual loading of filters, while restoring power balance. Combining AC fans and certified low pressure-drop filters, the ECSÂ® system optimises power consumption, thereby reducing CO2emissions into the environment
Gelaire CytoFast cytotoxic drug safety cabinets ~ features
Knee space of 300 mm optimises comfort for seated operators
Flat air barrier grille integrated into the work tray without ledge or joint
Window and all switched function operated by touch controls
Noise level in situ typically < 60 dB(A) with ultra-low vibration
Safety and operational features
EcoÂ®Control System optimises energy consumption
Fans automatically adjust to maintain safe airflows
Constant monitoring and reporting of all operating functions in an illuminated LCD
Display of laminar flow and air barrier velocities, operated by
Selectable display of:
Internal and external temperature - Hours of operation
Fan power factor - Scheduled filter lifetime
Speed-reduction â€˜standbyâ€™ mode allows continuous operation with power saving
â€˜Blackoutâ€™ reporting if power supply to the cabinet fails while the user is absent
Audible and visible alarms indicate window malposition, out-of-range airflows or any other malfunction
Robust, gastight housing with Dupontâ„¢ AlestaÂ® antimicrobial powder-coat paint finish
using environmentally-sustainable silver ions to resist growth and spread of microbes.
304 stainless steel (SS) work zone
316 SS work tray for increased corrosion resistance
H14 minipleat HEPA filters with protective hydrophobic membrane on work zone filter.
High-capacity multidihedral exhaust filters for increased life
Activated carbon exhaust filter
Work zone power outlet
Accessories and options
Isolator configuration with glove ports and transfer hatches
Additional work zone power outlet
Infusion rail in work zone
Independent testing and certification
Gelaire safety cabinets are independently tested and certified, pre-delivery and on-site, to current Australian Standards by an
independent NATA-registered testing laboratory.
In pharmacy applications, these cabinets should be installed in the special cleanroom specified in AS 2639, with HEPA filters on supply and exhaust air and a pressure regime for aerosol containment.
Gelaire CytoFast cytotoxic drug safety cabinets ~ technical
CytoFast cytotoxic drug safety cabinets
Overall dimensions mm
Work zone dimensions mm
Work opening height
and air barrier test method
Gelaire CytoFast cytotoxic drug safety cabinets ~ downloads
Gelaire Cytosafe bulletin
Gelaire Installations manual BH Series
Gelaire bulletin BSCs with cytotoxic drugs
Gelaire bulletin BSC alarm operation
These are PDF files, to obtain a free Adobe PDF reader: