Steriline – cRAB & Isolator

100 %

Italy Design & Made

With Integration of H2O2 Vapour Generator

Compliance with cGMP and 21CFR part 11 requirement

Isolators

STERILINE isolators can be installed in Class C or D rooms. They can be either stand alone equipment (quality control, research and development, sampling,
compounding, sterility test, etc.) or specially designed for fully integrated aseptic production line, in compliance with cGMP regulations.

The Isolators are designed for production of sterile products, either toxic or non toxic, maintaining uncompromised, continuous isolation of its interior from the external environment.

ISO 5 environment is achieved by HEPA filtered, unidirectional air that vertically flows over the process area.

Pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is HEPA filtered by BIBO filters.

cRAB

STERILINE closed Restricted Access Barrier Systems (cRABS) are designed for the production of sterile products, either toxic or non-toxic.

These systems provide protection for operator from product and for product from operator and they prevent contamination by keeping the production process enclosed in a confined area.

The cRABS enclose a space where HEPA filtered, unidirectional air vertically flows over the process area. Pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is HEPA filtered by “Bag-in Bag-out” (BIBO) filters.

cRABS must be installed in Class B rooms.