Compliant with GMP, class 2, the compounding production isolator is designed to ensure operator protection during the handling of high activity active ingredients (HPAPI) aimed at producing mixed compounds.
MAXIMUM SAFETY
The system is equipped with inflatable and/or static seals made of FDA-approved EPDM to ensure a Class II seal.
AUTOMATIC LEAK TEST
GLOVE INTEGRITY TESTING
It can be equipped with an Automatic Glove Leak Test System (AGLTS).
INTEGRATED WASH-IN-PLACE (WIP)
INERT GAS DISTRUBUTION SYSTEM
Equipped with an integrated inert gas distribution system.
PROCESS IN CONTAINMENT
Two continuous bag liners are integrated into the isolator.
INTEGRATED PROCESSES
Lined vessel for preparation of mixed products integrated into the isolator for total containment of the production process. Mechanical integration, via EPDM membrane, to enable weighing procedures using integrated load cells. Integrated WFI and nitrogen circuits managed by the isolator's PLC, which preloads recipes for fully automated process management.
KEY FEATURES.
Isolator system fully controlled by PLC
Handles with integrated safety sensors
Sustainable low-voltage fans
Integrated sliding control module
Virtual Private Network (VPN)
Integrated high-precision scale and operator terminal
50lts lined container for preparation of mixed compounds
Rapid Transfer Port (DPTE 190-XS)