NU-PR797 Compounding Aseptic Isolator Restricted Access Barrier System
NU-PR797 Compounding Aseptic Isolator Restricted Access Barrier System
USP 797 COMPLIANT | STERILE NON-HAZARDOUS COMPOUNDING | POSITIVE PRESSURE RECIRCULATING | ISO CLASS 5 ENVIRONMENT
The PharmaGard NU-PR797 is a USP <797> Compliant Primary Engineering Control (PEC). Defined as a Compounding Aseptic Isolator (CAI), model NU-PR797 is composed of a stainless-steel enclosure and polycarbonate front window with gloves that provide 20 air changes minute of ISO Class 5 HEPA filtered air for the preparation of sterile, non-hazardous drugs. The isolator is sub-divided into a work chamber that is kept at a more substantial positive pressure than the adjoining interchange chamber, which is positively pressured to the room. This cascade of pressure prevents contamination in the interior. A sliding door and work tray allow the passage of items within the isolator before compounding, while the hinged front window allows easy access for maintenance. Standard minihelic gauges display the pressure in both the work and interchange chambers. However, the optional PharmaGard™ digital monitor alerts the operator when the work chamber positive pressure declines below acceptable parameters.
Features
CHECK INSIDE PRESSURE DIFFERENTIALS AT A GLANCE.
FLOWGARD CONTROL SYSTEM
The FlowGard control panel features one minihelic gauge for each chamber. This allows the user to quickly monitor and compare the positive pressures in each one and ensure that the correct differential is being maintained between the work and interchange chambers and between the entire unit and the room. Membrane buttons are used to activate the blower and lights.
PRESSURE DIFFERENTIALS FOR A PURPOSE.
INSIDE PRESSURE DIFFERENTIALS
The entire compounding aseptic isolator is maintained at positive pressure compared to the room in which it is installed in order to protect against the entrance of contaminants. Inside, a downflow of 45-55 fpm (0.23-0.28 m/s) of HEPA filtered air creates 20 air changes per minute and an ISO class 5 environment. The interior is sub-divided into a work area that is kept at a stronger positive pressure than the adjoining interchange chamber in order to protect the sterile drugs handled inside it from contamination floating in. Downflow air is re-filtered and recirculated while additional air drawn from the room ensures the compounding isolator maintains its positive pressure.
A WORKZONE CONFIGURED FOR YOUR WORKFLOW.
INTERNAL SLIDING TRAY & DOOR
The internal sliding door in the wall that separates the interchange chamber from the work area allows a tray to slide through when introducing items into the unit prior to compounding. A standard electrical outlet and optional IV bar further optimize the work area for your compounding procedures.
THE FINAL TOUCH.
WASTE DISPOSAL SYSTEM OPTION
The optional waste disposal system allows the technician to pass their waste through an opening in the work surface and down into a receptacle attached to the underside of the compounding aseptic isolator. The receptacles can be conveniently replaced when necessary following pharmacy procedures.
