Containment isolator

for APIfor HPAPIsampling

Dual-chamber weighing isolator Airlock with one glove allowing for loading of material and instruments Working chamber with three gloves intended for work with hazardous materials Possible to ensure inert atmosphere inside chambers (N2, Ar) Leak tightness class 3 according to ISO 10648-2 “C” Class cleanliness according to EU GMP standard “Audit Trail” compliant Electronic control system for automatic adjustment of basic operating modes managed by Siemens PLC Color touchscreen controls Jacket material: stainless steel AISI 304 Isolator working chamber material – AISI 316L with a thickness of 3.00 mm Polished surface finish, Ra < 0.6 µm Inlet filtration HEPA H14 - “C” Class cleanliness Safe filtration of exhaust air with double HEPA H14 filters Easy-to-clean inner and outer surfaces Sliding trays between chambers for easy material transfer Oval holes with gloves for improved material handling Turbulent flow Negative pressure mode Turbulent Flow Commonly used for “C” and “D” classes of cleanliness where the direction of airflow is not clearly defined. The air flows in an irregular direction from the air supply inlet to the air outlet through cylindrical HEPA filters H14 at a filtering efficiency of 99.995%. The rate of air exchanges of clean air into the chamber usually ranges from 5 to 40 exchanges per hour. Negative Pressure The HVAC system allows for the formation of negative pressure in the interior of the isolator. This function is mostly used in case of a failure – compromised leak-proofness - and helps to protect personnel.