Sterility Test Isolator

Sterility Test Isolator

The Envair Technology sterility test isolator is designed for sterile processing and sterility testing routines that require an internal sterile environment with EU GMP Grade A air over the workspace with a degree of operator protection. This type of system is widely used by manufacturers of liquid medicinal products and independent sterility test companies.

The sterility test isolator is monitored, controlled and alarmed to provide and maintain strict internal environmental conditions within the isolator workspace; this ensures the integrity of the system to achieve the required cleanliness levels. The equipment has been designed and manufactured following cGMP and GAMP 5 guidelines, in addition to industrial equipment directives.

Key Features

  • Unidirectional HEPA filtered supply airflow at 0.45m/s
  • Integrated sterility test pump, flush with chamber base
  • Siemens S7-PLC control system with HMI touchscreen display
  • Automatic inflating silicone seals on main chamber and hatch doors
  • Integrated Vaporised Hydrogen Peroxide (VHP) decontamination system capable of providing a 6-log reduction of microbiological spores
  • Rapid decontamination cycle times
  • Independent chamber decontamination cycles
  • Integrated viable and non-viable air sampling controlled via the HMI touchscreen display
  • CFR 21 Part 11 compliant
  • Flexible design and chamber layouts

Ask us a question

Get in touch to ask about our product

Ask us a question

Get in touch to ask about our product

Download the data sheet

Get the full product specification in pdf format

Request a quote

Get in touch to ask about pricing

Request a quote

Get in touch to ask about pricing

Envair Technology is the unified brand of Envair and Total Containment Solutions (TCS). From our earliest roots in 1972, we have grown to become a global single-source provider of next generation clean air and containment systems, including dispensing isolators, processing isolators, ducted fume cupboards, recirculating fume cupboards, biological safety cabinets, laminar airflow cabinets, ventilated enclosures and more.

Related Products

expand_less