Are you still using laminar flow hoods in your sterility testing?

sterility testing isolators

Technology for Sterility Testing is rapidly moving forward and laminar flow hoods are being replaced with better, specifically designed isolators.

Here are just a few reasons for this change:

  • Isolators are suggested and preferred by the regulatory bodies.
  • Isolators reduce the risk of contamination from operators and the external environment.
  • The contained volume in isolators is suitable for toxic products.
  • Isolators allow for decontamination through an automated and validated cycle.
  • Isolators are installed in a class D environment so no gowning is necessary for operators.

Ultimately a cost benefit for the company and less headache for microbiologists!

Comecer’s Modular Sterility Testing Isolator is designed for use by lab professionals where aseptic conditions for sterility testing of pharmaceutical products are necessary.

MSTI Modular Syerility Testing Isolator

A real modular approach to sterility testing

Available modules  include different sizes of working chambers as well as two kinds of pre-chambers (one larger with laminar airflow, one smaller with turbulent airflow). Desired configurations based on the specific customer need is reached combining the different modules.

Modular sterility testing isolator solutions

Customized solutions for internal chambers

The MSTI can be equipped with customized racks, accessories and other tools for your specific needs. Dedicated load studies are carried out to correctly host and position all samples, such as vials, ampoules, bags, syringes as well as consumables like saline solutions, culturing media, petri dishes.

Details Sterility Testing Isolator

The heart of MSTI: integrated VPHP decontamination system

An integrated VPHP generator assures the 6-log decontamination of all the internal volumes in the shortest possible time. Full cycle reporting is provided through the main isolator HMI. The Cycle Development and PQ at the customer’s premises are performed by Comecer’s experienced personnel using reference calibrated instruments and following optimized protocols.

The system includes on board:

  • dehumidifier
  • HEPA filter
  • vaporizer
  • double stage catalytic converter.

State of the art features

  • Stainless steel AISI 316L enclosure and Stainless steel AISI 304 cover sheathings
  • Laminar airflow on working area with highest recirculation rate
  • Integrated VPHP generator
  • Security sensor for VPHP in the Lab environment
  • Peristaltic pump
  • Liquid waste container (circuit internally sanitizable)
  • Viable and non viable monitoring system (circuit internally sanitizable)
  • Anemometer
  • Humidity and temperature sensor
  • HEPA H14 filters on inlet
  • Glove extenders
  • 7” widescreen HMI with user-friendly interface including USB and ethernet port

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