MSTI Modular Sterility Testing Isolator

MSTI is a Modular Sterility Testing Isolator System conceived for Lab professionals who require aseptic conditions for sterility testing of pharmaceutical products.

QA-MICROBIOLOGY_Modular-Sterility-Testing-Isolator

Highlights of modular sterility testing isolator:

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

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 sterility testing isolator 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.

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