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Cytostatic
drugs are therapeutic agents intended for, but not
limited to, the treatment of cancer. These drugs are
known to be highly toxic to cells, mainly through their
action on cell reproduction. Many have proved to be
carcinogens, mutagens or teratogens.
Cytostatic drugs are increasingly being used in a variety
of healthcare settings, laboratories and veterinary
clinics for the treatment of cancer and other medical
conditions such as rheumatoid arthritis, multiple sclerosis
and auto-immune disorders.
Health effects attributed to exposure to occupational
cytostatic drugs can be very serious.
Research shows that where a high standard of risk control
is in place, threats to healthcare are reduced.
However, no exposure limits are set for cytotoxic drugs.
Medical opinion is such that even low-level exposure
to cytostatic drugs should be avoided as much as possible.
Research has shown that the implementation of suitable
safety precautions reduces the incidence of adverse
health effects [1].
BioAir cytostatic drugs preparation Cabinet s@femate
cyto is manufactured and tested in accordance with
DIN12980: 2005 and EN 12469:2000 standards and provides
the laboratory technician with the maximum level of
safety against inhalation of aerosols generated during
the reconstitution protocols.
MAIN SPECIFICATIONS
Other than the two classic HEPA H14 filters needed
for the filtration of exhausted air and downflow recirculating
unidirectional airflow, a tertiary filtration stage
HEPA H14 (with bag-in, bag-out filter changing protocol
ensuring a safety level in excess of the one obtained
with the Ohlmeyer procedure [2] ) is located underneath
the work surface in order to provide, by filtering
100% of the recirculated airflow, the required safety
for the maintenance personnel when removing this stage
of filtration for substitution.
Four levels of safety are therefore provided:
1. Safety for the operator, (extremely high retention
factor) identical to the one provided by a Biological
Safety Cabinet.
2. Safety for the environment (double HEPA H14 filtration
stage in the exhaust flow).
3. Safety for the product and between products (much
better than class 100 in the work area thanks to the
double HEPAH14 filtration stage in
the recirculated flow).
4. Safety for the engineers when changing the tertiary
filter stage (patented bag-in bag-out procedure).
Technical specifications
ㆍ Microprocessor controlled motor blower, with volumetric
sensor for exhausted air flow monitoring
ㆍ State of the art Microprocessor control system offering:
- Large screen monitor.
- Automatic control of preset airflow volumes.
- Sliding sash window with smart control and “yzy”
air-tight movement.
- ermanent monitoring of HEPA filters life span.
- Permanent display of working conditions.
- Highest air flow stability both in case of transitional
disturbances or progressive filter clogging.
- Semi-automatic fumigation cycle (EN12297 tested and
certified).
- Continuous monitoring of front barrier air flow for
the highest operator safety.
- Low barrier alarm.
- Power failure alarm.
ㆍ Volt-free contact for remote monitoring of exhaust
fan or other functions related to cabinet status (on/off).
ㆍ Automatic reset of initial conditions in case of
power failure.
ㆍ Shipped in two separated boxes (base and cabinet)
for the easiest transportation and on-site installation.
ㆍ Prepared for installation of internal IP65 PC monitor
(optional). |
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Mechanical and functional specifications
ㆍ Sloped front design for the highest operational comfort.
Sloped back side of the working chamber for the
best down flow distribution (cabinet carcass EN12298 tested and
certified for air tightness).
ㆍ Utilities inlets from the top of the cabinet.
ㆍ AISI 304 Stainless Steel internal surfaces with 2B finishing
(including spillage tray). Solid work surface (2 sections)
and special designed front grill.
ㆍ Electrically operated sliding multilayer
6 mm safety glass window with “yzy” air tight movement (the
front window is also hinged for the easiest cleaning
procedures of internal glass surface).
ㆍ Comfortable 200 mm front opening.
ㆍ Easy to install retrofit options through lateral sides.
ㆍ Three stages H14 High Efficiency Particulate Air filters
with 99.999% efficiency on 0,3 μ particles (most penetrating
particle size) (EN1822-1 and EN 13091:1999 tested and certified).
ㆍ Filter change and maintenance from the front of the cabinet
for all stage of filters.
ㆍ Bag-in bag-out tertiary filter stage changing technology
(avoiding rupture of isolation continuity of the
work
area during filter changing; safety level in excess of the
one obtained with the Ohlmeyer procedure [2].
ㆍ Exhaust transitions easily installable.
ㆍ Key operated. The key can be removed when the unit is
in SAFE mode, in order to avoid unwanted operation.
In case of power failure, the cabinet is re-set to original
working conditions.
ㆍ Self calibration cycle performed at cabinet warm-up.
ㆍ Visual display of SAFE conditions. Pre-warning before
actual alarm
conditions are reached (visual and acoustic
alarms).
ㆍ Soft touch control with keys for standard service utilities.
ㆍ Interconnected UV and fluorescent lights.
ㆍ Exhaust and recirculating flow rates ensure 25 air
changes/min in the working area (30%, 70% split).
ㆍ Front barrier air speed ≥ 0.5mt/sec.
ㆍ Aperture protection Factor (Apf) ≥ 1.5 x 105 (retention
efficiency).
ㆍ Cleanability Index “C” grade. (EN 12296 tested and certified).
ㆍ Light intensity on work surface > 1200 lux.
ㆍ Noise level ≤ 55dB(A) (ISO 11201, ISO 4871 and ISO EN
3744
tested and certified).
ㆍ Work surface displacement (vibration) <0.005mm RMS
between 20Hz and 20,000Hz (ISO 5349 tested and certified).
ㆍ 220/240V, 50Hz power supply.
ㆍ Max power (for each power point) 3Amps.
ㆍ CE certification according to Machinery Directive 89/392/
EEC,
91/368/EEC, 93/44/EEC 93/68/EEC. |
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ㆍ The
patented Bag-in, Bag-out filter changing technique with
continuously hermetic separation between contaminated
areas and the external environment using third stage
of filtration (with no need to be removed from the inside
of the work chamber of the cabinet) ensures a safety
level in excess of the one obtained
with the Ohlmeyer
procedure [2].
ㆍ The engineer is always working from external, not
contaminated environment, and he will never be in physical
contact with contaminated materials or areas with potential
high risk of contamination. |
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ㆍ High resolution
large digital display.
ㆍ Permanent monitoring of HEPA filters life span.
ㆍ Alarms. Multilevel alarms, with redundancy functions.
ㆍ Permanent display of working conditions.
ㆍ Continuous monitoring of front barrier air flow
for the highest operator
safety. |
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ㆍ AISI 304 Stainless
Steel internal surfaces with 2B finishing (including
spillage
tray). Solid work surface and special designed
front grill.
ㆍ Cleanability Index ”C” grade. (EN 12296 tested
and certified).
ㆍ Light intensity on work surface ≥ 1200 lux. |
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| Model |
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s@femate
cyto 0.9* |
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s@femate
cyto 1.2* |
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s@femate
cyto 1.8* |
| Work
chamber (wxdxh) mm |
924 x
600 x 700 |
1230 x
600 x 700 |
1840 x
600 x 700 |
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| Overall
(wxdxh) mm (*) |
1074 x
840 x 2220 |
1380 x
840 x 2220 |
1990 x
840 x 2220 |
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| Front
opening height mm |
195 |
195 |
195 |
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| Weight
Kg |
280 |
340 |
450 |
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| Power
supply |
220/240
V - 50 Hz |
220/240
V - 50 Hz |
220/240
V - 50 Hz |
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| Power
W |
350 |
400 |
750 |
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| Noise
Level dB(A) |
< 55 |
< 55 |
< 57 |
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| Lighting
lux |
> 1200 |
> 1200 |
> 1200 |
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| * Shipped in
two boxes (base and cabinet) |
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| How to order |
| Cytotoxic
Drug Handling Cabinets |
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| LY10000 |
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S@femate
Cyto 0.9 floor standing |
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| LY20000 |
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S@femate
Cyto 1.2 floor standing |
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| LY20800 |
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S@femate
Cyto 1.2 ABC floor standing |
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| LY40000 |
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S@femate
Cyto 1.8 floor standing |
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| LY40800 |
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S@femate
Cyto 1.8 ABC floor standing |
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| UV |
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| AKC0001 |
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Mobile
UV light kit |
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| Please
enquire about the many option and accessories
available. |
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Installed standard utilities:
⊙ 1 Vacuum tap.
⊙ 2 Electrical socket (Schuko).
⊙ Power failure alarm.
⊙ Automatic recovery of initial conditions
when mains return. |
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References
[1] Handling Cytotoxic drugs in the workplaceVictorian
Workcover Authority Melbourne Vic Australia
(2003)
[2] M. Ohlmeyer, W. Strolz: Schwebstoff-Filteranlagen
fur die Abluft aus kerntechnischen Einrichtungen.
Kernetchnik 15 (1973) Nr. 9, 416 - 423 |
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