Safemate Cyto
CLASS II MICROBIOLOGICAL SAFETY CABINET FOR CYTOTOXICS MANIPULATION
BioAir cytotoxic drugs preparation Cabinet Safemate Cyto has been designed and built according to DIN12980 and EN12469:2000 standards and provides the laboratory technician with the maximum level of safety against inhalation of aerosols generated during the reconstitution protocols.
Description
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 certified 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.
These last generation Cytostatic drug handling Cabinets have been manufactured according to the most stringent safety standards for this category of Safety Cabinets. The internal design, the air flow aerodynamics and monitoring, the built-in safety devices, the exclusive patented “bag-in, bagout” filter changing protocol and the very accurate manufacturing guarantees the highest performances at the most stringent safety levels, as specifi ed by DIN 12980 and EN12469 standard. Certified intrinsic safety, combined with impressively competitive prices, gives the end user a state of the art cabinet accessible to every budget, that only experienced European design and accurate quality manufacturing, can provide.
FEATURES
- Triple HEPA H14 filtration system
- V-shaped anti obstruction front grill
- Electrically operated front glass
- Thight seal closure system
- Full stainless-steel working area
Safety for the operator and the environment
(Three HEPA H14 fi lters, Certifi ed intrinsic safety) Operator protection is obtained thanks to the excellent containment efficiency of the front air barrier and the double filtration of the air discharged in the environment.
Safety for the product and the patient
(ISO5 = Class 100 inside, the cabinet work area) The sterility of the drugs is essential for the safety of the patient.
Safety for the engineers
(Patented Bag-in/bag-out fi lter replacement system) An important safety element is the third HEPA H14 fi lters stage placed underneath the work surface. Aerosols generated inside the work area are captured by the third stage fi lters preventing cytotoxic compounds to contaminate the interior of the cabinet. Replacement of the third stage filters thanks to the patented “bag-in/bag-out” system is obtained without any risk of exposure to dangerous compounds both for the workers and the environment. The downflow and exhaust filters further process the air coming from the third stage filters.
This filtration system exceeds the required ISO5 = Class 100 air cleanliness for the preparation of paranteral drugs and also the safety of the environment thanks to the three levels filtration of the recirculated air.
Safe and easy to use
• Solid work surface divided in sectors.
• Comfortable 195 mm front opening and special designed front grill ensures a constant front air
barrier (air speed ≥ 0.5mt/sec).
• Retention effi ciency: (Apf) ≥ 1.5 x 105
(Aperture protection Factor EN 12469)
• Sloped front design for the highest operational comfort and maximum work area visibility.
• Light intensity > 1200 lux.
• Work surface displacement (vibration) <0.005mm RMS between 20Hz and 20,000Hz (ISO 5349 tested ).
• Noise level ≤ 55dB(A) (ISO 11201, ISO 4871 and ISO EN 3744 tested).
• Back wall installed IP65 PC monitor (option).
Safe and efficient filtration and ventilation system
• Three stages HEPA H14 High Efficiency Particulate
Air filters with 99.995% effi ciency on 0,1-0,3 µm
particles (Most Penetrating Particle Size) (EN1822-
1 and EN 13091:1999 tested) ensures ISO 5 air
cleanliness (according to ISO 14644-1) or Class
100 (according to FED STD 209E) mandatory to
guarantee product sterility and patient health.
• Sloped back side of the working chamber for
the best down flow distribution.
• Exhaust and recirculating flow rates ensure
25 air changes/min in the working area (30%
exhaust, 70% recirculation split).
• Exhaust transitions easily installable.
In case of power failure, the cabinet is reset to
original working conditions.
Easy and safe maintenance
• The patented Bag-in, Bag-out filter changing technique with continuously hermetic separation between contaminated areas and the external environment using third stage of fi ltration (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].
• The engineer is always working from external, not contaminated environment, and he is never in physical contact with contaminated materials or areas with potential high risk of contamination.
The Internationally Patented Bag-in/Bag-out filter changing technique (Patent IT N° 1.387.496 dated 13.4.2011; EU N° 09156281.9-1253 dated 26.3.2009) avoids rupture of isolation continuity of the work chamber during fi lter changing procedure ensuring hermetic separation between contaminated areas and the external environment.
References
[2] M. Ohlmeyer, W. Strolz: Schwebstoff-Filteranlagen für die Abluft aus
kerntechnischen Einrichtungen. Kernetchnik 15 (1973) Nr. 9, 416 – 423
Continuous monitoring
The cabinet performance is constantly monitored through a sophisticated microprocessor.
Any malfunctions are promptly signalled to the operator through audible and visual alarms.
• State of the art Microprocessor control system offering:
– LCD monitor
– Automatic control of preset airfl ow volumes
– Sliding sash window with smart control and “yzy” air/aerosol-tight movement
– Permanent monitoring of HEPA fi lters life span
– Permanent display of working conditions
– Continuous monitoring of front barrier air fl ow for the highest operator safety
– Low barrier alarm
– Power failure alarm
• Volt-free contact for remote monitoring of exhaust fan or other functions related to cabinet status
(on/off).
• Automatic reset of initial conditions in case of power failure.
• Visual display of SAFE conditions. Pre-warning before actual alarm conditions are reached (visual and
acoustic alarms).
• Soft touch control with keys for standard service utilities.
• Multilevel alarms, with redundancy functions.
Mechanical and functional specifications
Sturdy and reliable construction.
The robust metal work and the quality of the material ensure reliability and a long work life.
• Shipped in two separated boxes (base and cabinet) for the easiest and safest transportation and
on-site installation.
• AISI 304 Stainless Steel internal surfaces with 2B fi nishing (including spillage tray).
• Solid worksurface and special designed front grill. Electrically operated vertical sliding sash (multilayer
6 mm safety glass) with “yzy” movement that ensures maximum air tightness when in working position,
by pressing the glass against the sealing gasket. The sliding sash is also hinged to allow easy cleaning
procedures of the internal glass surface (swing-out feature).
• Cleanability Index ”C” grade. (EN 12296 tested and certifi ed).
• Utilities inlets from the top of the cabinet.
• 230V-50Hz or 220-230V-60Hz.
CE certifi cation according to Machinery Directive 89/392/ EEC, 91/368/EEC, 93/44/EEC 93/68/EEC.
S@feMate Cyto specifications:
S@femate Cyto 0.9 | S@femate Cyto 1.2 | S@femate Cyto 1.8 | |
| Dimensions of Work Chamber: (W x D x H) mm | 924 x 600 x 700 | 1230 x 600 x 700 | 1830 x 600 x 700 |
| Overall Dimensions: (W x D x H) mm | 1074 x 840 x 2220 | 1380 x 840 x 2220 | 1990 x 840 x 2220 |
| Height on Stand: (mm) | 2235 | 2235 | 2235 |
| Front Opening Height: (mm) | 200 | 200 | 200 |
| Air Filter Grade: | H14 class HEPA filters with 99.999% efficiency at 0.3 micron particle size | ||
| Weight: | 310 kgs | 340 kgs | 450 kgs |
| Electrical Supply: | 220/240V-50Hz | 220/240V-50Hz | 220/240V-50Hz |
| Noise Level: | < 55 dB (A) | < 55 dB (A) | < 55 dB (A) |
| Lighting Level: | > 1200 lux | > 1200 lux | > 1200 lux |
