Sterility Testing Isolator

Extract Technology’s Sterility Test Isolators are designed to allow operators to perform sterility testing in an aseptic environment providing assurance of process integrity. Sterility testing isolator is composed of sterilized experiment chamber, a transfer chamber and integrated Hydrogen Peroxide Decontamination.

Features

  • 304 stainless steel isolator shell and plenum.
  • Two-glove pass box with VHP generator connections; has a differential pressure of 20±5Pa when operation.
  • Four-glove main chamber with VHP generator connection; has a differential pressure of 30±5Pa; integrated with isokinetic sampling head of particle counter; equipped with microbe sampler; air flow velocity sensors is installed to control the recirculation fans speed.
  • Ergonomically designed for operation comfort.
  • Unidirectional airflow at the speed of 0.45±20% m/s.
  • H14 (filtration efficiency of 99.995%) HEPA filters are used for inlet, outlet and recirculation.
  • Working station for one or two operators working through gloves.
  • Tempered glass windows are used for safe operation and clear views.
  • Surfaces are polished to facilitate cleaning.
  • Inflatable gaskets are used for windows sealing.
  • Air volume control valves are used for adjust the pressure in the isolator.
  • Touch screen and friendly HIM are designedd for easy operation of the isolator.
 

Options

  • RTP for material in and out
  • Bag out system for waste
  • Integrated Sterility Testing System for aseptic product testing and microbial limit testing