CTH3





 

 


CYTOTOXIC DRUG CABINET



Introduction
Designed for the situation where is requested the operator, product and environmental protection from dangerous effects due to uncontrolled diffusion of air-transported contaminants and, in the same time, to avoid any biological interference from the environmental to the product during its handling.

Applications
Normally used in hospital pharmacies, oncology department, day-hospital and pharmaceutical industries. For a correct use and application of the cabinet here described, it is necessary to refer to the appropriate standard norm and rules in force in the country where the cabinet is used. The main standard for product in Europe is a German Standard DIN 12980.


Definition
CTH 3 produced by Steril S.p.A. is a triple absolute filter cabinet and it is defined: Class II as designed with a frontal working opening for the aspiration of 30% of the total air involved, at a minimum velocity of 0,51 m/sec., and the remaining 70% is recirculated through a HEPA filter in the working chamber with a laminar flow velocity of 0,39 m/sec. +/- 20% (as defined by German standard DIN 12950/10).

Certifications

CTH3 cabinet produced by Steril S.p.A. is certified by CAMR of Porton Down (UK) as it satisfies the German standards DIN 12980 for cytotoxic cabinet type "H" for operator (containment test), environmental and product protection. Furthermore it is designed to fulfil international standard for biohazard cabinet DIN 12950/10, NFX 44201 and NSF 49


Main Technical Specification
Work chamber, spillage tray and chassis for protection of HEPA filter in stainless steel AISI 304L "2B" finishing. Working surface in stainless steel AISI 304L "2B" finishing, removable longitudinal sectors perforated version. Front window, safety glass with camlock to provide an easier access for large items. Construction structure in steel epoxy-polyester powder painted, resistant to the most common industrial disinfectants. Ventilation system by means of n°2 motor blowers, one dedicated to the one-way airflow in the working chamber, equal to 70% of the total involved air, the other dedicated to exhaust the remaining 30%. The motor blowers are centrifugal types, direct driven motor with double aspiration and protection factor, respectively, of IP44 and IP20. In case of failure of the exhaust fan, the main recirculate fan is able to guarantee, for the period of emergency, the efficiency of the protection of the front barrier. Air filtration by double stage of recirculation and exhaust air, through HEPA filter type H13 with efficiency 99,99% on 0.3 micron particle size (as per European Standard EN1822) and through HEPA filter type H14 with efficiency 99,999% on 0.3 micron particle size (as per European Standard EN1822). The 3rd stage of absolute filtration, under the working surface, treats the whole 100% of the air to prevent contamination of Cytotoxic product from the inside of the cabinet to parts like construction structure, motor-blower and other components. It is important to point out that sealing of recirculated and exhaust filters are guaranteed by sealing and negative pressure designed plenum. Sealing of the 3rd HEPA filter under working surface is guaranteed by sealing and by overpressure sterile air area around it.


Command and Controls
Air ventilation control by means of automatic regulation of the revolution velocity of the motor-blower. High-resolution flow rate volumetric devices, directly interfaced to microprocessor, achieve the automatic regulation. The microprocessor guarantees the activity of the motor-blower and controls the optimal function even in presence of effects caused by progressive clogging of the HEPA filters. Alarm device optical (led) and acoustic (buzzer) type, activated, at real time, by the microprocessor.

Standard features
· Fluorescent lights (n°2 - 36W each)
· Power socket 4 A UNEL IP 44 (right internal side)
· Vacuum line with manual tap (right internal side) manufactured in compliance with UNI/CIG regulations, piping made of copper and hose-bard 10 mm. diameter (external) for the connection to the main line.
· Gas line with manual tap (right internal side) manufactured in compliance with UNI/CIG regulations, piping made of copper and hose-bard 10 mm. diameter (external) for the connection to the main line. The gas line is provided with automatic safety valve for interruption in case of electric blackout and/or low gas feed pressure.
· Front closure panel in anodised aluminium with 30W germicidal UV lamp, wave length 253,7 nm (UV-C).
· DOP/DOS test inlet hose-barb port

Available size 140 cm


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