Introduction
The CDP cabinet is a containment solution for the weighing, the handling and the dosing of chemical and pharmaceutical active products with the operator outside the LAF (laminar airflow) area.
This CDP cabinet is a vertical laminar flow of Class M 3.5 (Fed. Std. 209 E) air, with a vertical return grid on the frontal side supplied with absolute filter on recovery and recirculation air. The cabinet is designed with part of the air reticulate and quote of air exhausted outside, after absolute filtration.
To ensure the quality of the sample, the MINICAPT PS1 monitors in real time the following values:
· Possible obstarction Of the BIOCAPT sampling head used frot the collection;
· The value of the flow.
· The front panel is fitted with a series of LEDs which display the status of the system,
· Connection to the 220VAC (or 115VAC on request);
· Charge level of the battery; · Battery in charging phase
· Alarm of flow blockage · TX/RX on the serial line (RS 232 and RS 485)
· Receipt of the signal from the remote control (optional) · Status of the pump (on/off).
Operating principle
The CDP cabinet is a containment solution for the handling and dosing of non-sterile products (including medium/low active ingredients and eccipients) with the operator outside the LAF (laminar airflow).
The identified and carefully estimated factors considered as essential, with particular reference to process and safety requirements, are:
protection of the product;
protection and safety of the operator;
containment of handled product;
cleanness of working area;
ergonomic factors.
Main design features
The operator and product protection by cross contamination between environmental/product and vice versa will be obtained with a physical containment into handling area powder, with a slight negative pressure inside the cabinet and a airflow barrier at level of front working aperture.
The air front barrier is designed to permit an aspiration equal to 30% of the total air with a minimum air frontal velocity of 0.40 m/s and recirculation of the remaining 70% of the air on the working area in laminar air flow condition equal to a velocity of 0.45 m/s +/-20%.
The sterility -cleanness of working area is guaranteed by a filtration of the air by absolute HEPA filter H14 and velocity of 0.45 m/s +/-20%.
As far as product protection from the operator is concerned, it also relies on the down-flow of the HEPA filtered air, as well as on the appropriate personal protection devices like individual garments including mask, headgear, white coat, gloves and compliance with all the sanitary and safety regulations recommended in the Operating Manual of the CDP cabinet and in the user safety procedures (like cGMP).
