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Isolation Technology

Modular Sterility Testing Isolator (MSTI)

| PRODUCT MANUFACTURER: COMECER

Product Description

The Modular Sterility Testing Isolator (MSTI) is a system created for lab professionals who require aseptic conditions for sterility testing of pharmaceutical products.

Thanks to the level of aseptic conditions achievable within the MSTI, additional applications such as aseptic dispensing/sampling and aseptic product transfer may also be conducted.




A base isolator system and sterility testing isolator

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 an 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 an HVAC system.

Main Features and Benefits

  • Sterility testing isolator
  • Used in R&D, laboratory, and hospital pharmacy environments
  • Used for testing and asepsis applications
  • Fully PLC controlled
  • GAMP 5 compliant software
  • 7” widescreen HMI with a user-friendly interface including USB and Ethernet port
  • High grade 316L stainless steel (internally) and 304 externally
  • Sliding tray and internal storage systems made of SS 316L
  • Equipped with unidirectional airflow for both chambers with positive pressure with respect to the lab environment
  • Designed to take air from a Class D laboratory or HVAC system
  • HEPA (H14) unidirectional downflow filters and return filters
  • Integrated VPHP generator
  • Anemometer
  • Humidity and temperature sensor
  • Glove extenders
  • Constant monitoring of pressure chamber and inlet/outlet filters
  • All inflatable and static seals made of FDA approved White Silicon Bio-Guardian® (elastomer contains anti bacteria inhibitors that prevent the surface growth of microorganisms)
  • View panels made of 12mm tempered glass and may be externally laminated with safety film
  • Includes predisposed adjustable ergonomic stool for operator comfortability

Options

  • Ability to upgrade to additional chambers, rapid transfer ports, sterility testing systems, viable and non-viable counting and assortment sensors (may also be installed at a later date)
  • Inlet pre-filtration available upon request
  • AGT onboard
  • Paperless graphic recorder

Accessories

  • Customized racks and tools

Video

Additional Product Model Imagery

Working chamber sterility isolator

Tray in sterility isolator

Inside the sterility isolator

Product details and downloads

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