IDAC 700 glove-box is designed to provide a containment system suitable for the manipulation of oncological powders/liquids and is fitted to be connected to a reactor with a capacity of 50l. The system is designed and built in accordance with the ATEX directive.
The system is composed of a pre-chamber for materials in/out and a product weighing/handling chamber. The weighing/dispense sample comes in bags, enters the pre-chamber and is transferred to the chamber for manipulation. The material weighed/dispensed is discharged into a bin connected to the bottom of the weighing chamber through an automatic throttle valve.
The system works with nitrogen (inertisation of the entire system). In case of accident (pressure loss from the isolator, ie rupture of a glove) the system is able to maintain the correct Dp, so as to avoid any possible leakage of toxic product (powder, liquid or gaseous).
The machine, operating in a negative pressure environment is designed for stand-alone operation. A precision pressure control guarantees chamber internal pressure of -100Pa and pre-chamber internal pressure of -50Pa from the external environment.
The structure of the chamber and the pre-chamber is manufactured of 2mm thick polished AISI 316L stainless steel with rounded corners, 20mm radius angles for easy cleaning and drying operations. Components have been assembled with a continuous welding method using argon fluxing.
The chamber front side is inclined by 5 degrees in order to improve the ergonomics for the operator.
The chamber door can be opened and is equipped with shock absorbers. The structure of the door is made of stainless steel and acts as a frame for the glazing.
The door is fitted with three oval-shaped flanges, sized at 10 “, forming the glove housing.
On the outer elevation above the chamber can be found the housing for filtration, blowing and washing circuit valves, inertisation system valves and the O2 analyzer plant.
On the outside of the chamber the operation panel display and the display control differential pressures are installed for easy viewing.
Inside the chamber a scale to measure weight of the ingredients and a glass vessel with mixing system (shaker) of liquid and solid active and excipients are housed. The shaker is equipped with an air inlet motor directly connected to the entry hatch of the reactor.
Inside the chamber a spray wash hose gun is also housed for cleaning.
The connection between the chamber and the pre-chamber is through a hinged and interlocked door.
The rectangular shaped pre-chamber allows the passage of the bags of stored materials necessary to the process.
The fixed vision-panel on the pre-chamber is fitted with one oval-shaped flanges , size 10 “, for gloves housing
The bottom of the chamber is equipped with an automatic ball valve that is linked to the collection tank of sanitizing liquid used in the cleaning operations.
The filtration etc is as per the main chamber installation.
The system blows the chambers with nitrogen N2 in “normal” and in “suspended” mode.
Door opening and closing, lighting system, nitrogen flow, pressure and filter clogging visual alarms as well as washing cycles programming and management are all controlled through the operator Siemens Touch Panel externally.
The isolator washing system is connected to the PW circuit and is all linked with sanitary piping and valves. The washing circuit is drained and dried after use for maximum cleanliness.
The system is also equipped with an automatic washing system working by means of rotating cleaning nozzles (spray balls). The PLC manages the washing program cycle and timing.
Outside each chamber a lighting system, controlled from the operator panel, provides light with average intensity of 500 lux.