Cytotoxic Safety Cabinets

This Cytotoxic Drugs Handling Cabinet (Chemioterapic Antitumoral Reconstitution) are used for the preparation of Chemioterapic Antitumoral drugs. They are manufactured to meet stringent safety standards (DIN12980, EN12469 and Australian standard AS2567).

SAFEMATE Cyto Cytotoxic Safety Cabinet Features:

• State of the art microprocessor control system.
• Large digital display, high resolution
• Air and aerosol-tight sliding sash, electrically operated by finger touch
• Alarms for low air flow and wrong front window position
• Sloped front and back wall for the most comfortable access
• Front access for tertiary filter stage maintenance and service
• Bag-in bag-out tertiary filter stage changing technology (avoiding rupture of isolation continuity of the work area during filter changing according to KTA 3601 Lüftungstechnische Anlagen in Kernkraftwerken)
• Easy retrofit options

Cytotoxic 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. Cytotoxic 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 rheumatoidarthritis, multiple sclerosis and auto-immune disorders.

Health effects attributed to exposure to occupational cytotoxic drugs can be very serious. Research shows that where a high standard of risk control is in place, threats to healthcare are reduced.

No exposure limits are set for cytotoxic drugs. Medical opinion is such that even low-level exposure to cytotoxic 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].

Safemate Cyto cytotoxic drugs preparation Cabinets are manufactured in accordance with DIN12980 standard and provides the laboratory technician with the maximum level of safety against inhalation of aerosols generated during the reconstitution protocols.

SAFEMATE Cyto Cytotoxic Safety Cabinet Image Gallery:

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SAFEMATE Cyto Main Specifications:

These lastest generation Cytotoxic drug handling Cabinets have been manufactured according to meet 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 and the very accurate manufacturing, guarantees the highest performances at the most stringent safety levels, as specified by DIN 12980 and EN12469 standard and have been certified by the most prestigious European certification bodies for Safety Cabinets.

Other than the two classic H14 filters needed for the filtration of exhausted air and downflow recirculating unidirectional airflow, a tertiary filtration stage (with bag-in bag-out filter changing protocol according to KTA 3601 Lüftungstechnische Anlagen in Kernkraftwerken) 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 Aperture protection factor) identical to the one provided by a Biological Safety Cabinet
2. Safety for the environment (double H14 filtration stage in the exhaust)
3. Safety for the product and between products (class 100 in the work area)
4. Safety for the engineers when changing the tertiary filter stage (bag-in bag-out procedure)

Technical Specifications

• Microprocessor controlled motor blower, with volumetric sensor for exhausted air flow monitoring
• State of the art Microprocessor control system offering:
  - Large screen monitor.
  - Automatic control of preset airflow volumes.
  - Sliding sash window with smart control.
  - Permanent monitoring of HEPA filters life span.
  - Alarms. Multilevel alarms, with redundancy functions.
  - Permanent display of working conditions.
  - Highest air fl ow stability both in case of transitional disturbances or to 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
• Volt-free contact for remote monitoring of exhaust fan.
• Automatic reset of initial conditions in case of power failure Mechanical and functional specifications
• Prepared for installation of internal IP65 PC monitor (optional).

Mechanical and Functional Specifications

• 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 certifi ed for air tightness)
• Utilities inlets from the top of the cabinet.
• Stainless Steel internal surfaces with 2B finishing (including spillage tray). Solid work surface (2 sections) and special designed front grill.
• Electrically operated sliding multilayer safety glass window (max opening at 120°)
• Comfortable 200mm front opening
• Easy to install retrofit options through lateral sides.
• Exposed exhaust Hepa filter for easy visual integrity check.
• Three stages of H14 class High Efficiency Particulate Air fi lters with 99.999% efficiency on .3micron particles (most penetrating particle diameter) (EN1822-1 and EN 13091:1999 tested and certified)
• Filter change and maintenance from the front of the cabinet for all stage of filters.
• 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]
  
• Exhaust transitions easily installable.
• 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.
• Self calibration cycle performed when cabinet is switched on.
• High speed rinse and set up cycle performed, before reaching the SAFE operating mode.
• 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. Interconnected UV and fluorescent lights.
• Exhaust and recirculating flow rates ensure 25 air changes/min in the working area (30% 70% split)
• Front barrier air speed ≥ 0.5mt/sec
• Aperture protection Factor (Apf) ≥ 1.5 x 10 exp 5
• Light intensity on work surface > 900 lux.
• Noise level ≤ 55dB(A) (ISO 11201, ISO 4871 and ISO EN 3744 tested and certified)
• Work surface displacement (vibration) <0.005mm RMS between 20Hz and 20,000Hz (ISO 5349 tested and certified)
• 230V, 50Hz
• Max power (for each power point) 3Amps.
• Microprocessor equipped with analogical watch dog.
• CE certification according to Machinery Directive 89/392/EEC, 91/368/EEC, 93/44/EEC 93/68/ EEC.

All Bio-Cabinets products conform to strict International Standards and are installed by NATA accredited laboratory technicians from LAF Technologies.

SAFEMATE Cyto Overall Dimensions.

Cytotoxic Drugs Handling Cabinet	Safemate Cyto. 1.2	Safemate Cyto. 1.8
Overall Dimensions (wxdxh) mm	1380 x 800 x 2130	1990 x 800 x 2130
Weight (kg)	350 kg	540 kg
Internal Dimensions (wxdxh) mm	1230 x 600 x 720	1830 x 600 x 720
Front Opening Height mm	200	200
AERODINAMICS DATA	-	-
Recirculated Airflow	circa 900 mc/h	circa 1360 mc/h
Exhausted Airflow	circa 450 mc/h	circa 680 mc/h

• Service power point
• Vacuum taps
• Semi-automatic fumigation procedure.
• Power failure alarm
• Automatic recovery of initial conditions when mains return.
• Hepa filter life span monitoring
• Stand-by mode
• Ready for optional IP 65 internal PC monitor installation