Modular Sterility Testing Isolator

This new Modular Isolator System has been conceived for Lab professionals who require aseptic conditions for sterility testing of pharmaceutical products.
Given the level of aseptic conditions achievable within the system, other processes such as Aseptic Dispensing/Sampling, and Aseptic Product Transfer may be conducted.
The base isolator system is composed of one class A, 4 glove Chamber and one class B Pre-chamber (before sterilization, class A after sterilization). The pre-chamber may be used as a rapid gassing port. Available upgrades include additional chamber(s), rapid transfer port(s), sterility testing system(s), viable & non-viable counting and an assortment of sensors (which may also be installed at a later date).

The isolator system is equipped with an unidirectional air flow for both chambers with positive pressure with respect to the lab environment. The system is designed to take air from a Class D laboratory or from a HVAC system.
HEPA (H14) unidirectional down flow filters and return filters.
Inlet pre-filtration available upon request.
Pressure chamber and inlet/outlet filters are constantly monitored.
All the inflatable and static seals are made of FDA approved White Silicon Bio-Guardian®. This elastomer contains anti bacteria inhibitors that prevent surface growth of micro organisms.
All the view panels are made of 12 mm tempered glass and may be externally laminated with a safety film.
The operator works seated on a predisposed adjustable ergonomic stool supplied with the isolator.

This model has been conceived with advanced technological highlights:

MODULAR SYSTEM ready for future upgrades: composed in the standard version by a testing chamber (grade A) and a rapid gassing chamber (grade B before sterilization; A after sterlilization);
AVAILABLE UPGRADES include additional chamber(s), Rapid Transfer Port(s); Sterility Testing System(s), viable & non-viable counting systems, assortments of sensors (which may also be installed at a leater date;
INFLATABLE & STATIC SEALS made of approved white silicon with bacteria inhibitors to prevent surface growth of micro organism;
ADJUSTABLE OPERATOR STOOL to work in perfect ergonomy and comfort even for an extended period of time.
FULLY PLC CONTROLLED with friendly operator touchpanel (GAMP 5 compliant software);
INTEGRATED VHP CIRCUIT adaptable to any VHP Generator
UNIDIRECTIONAL AIR FLOW for both chambers (positive pressure with respect to the lab environment): designed to take air from a Class D lab or from HVAC system.

Other key features:

• Fully PLC controlled
• Software GAMP 5 compliant
• Friendly operator interface
• Integrated VHP circuit adaptable to any VHP Generator
• High grade stainless steel 316L internally and 304 externally
• Sliding tray and internal storage systems made of SS 316L