Standard Sterility Test Isolator

Standard Sterility Test Isolator

Standard Sterility Test Isolator

Sterility test isolator Sterility testing consists of verifying the absence of microbial contamination in sterile pharmaceutical products. The isolator consists of :

  • The main chamber,
  • The SAS,
  • The VPHP H2O2 generator,
  • The peristaltic pump,

Sterility tests are carried out in accordance with GMP regulatory requirements. They are carried out using a peristaltic pump and appropriate filtration units.


Customized Technical Solution

Static and Dynamic protection

Quick installation and Implementation

Easy Surface Cleaning

A modular range

Some modular elements:

  • Technical enclosure, Bio-decontamination
  • SAS Work chamber 2 gloves, 4 gloves, 6 gloves,
  • Exit via SAS entrance or front panel, SAS exit or RTP Continuous liner

We can study any specific request for customised equipment. Contact us

Technical specifications

  • Camfil H14 filter;
  • Class 2 sealing;
  • Manufactured exclusively in 316L stainless steel;
  • Optimised filter-to-filter cleaning;
  • Short bio-decontamination times;
  • Unidirectional flow (laminar and non-turbulent) to guarantee Grade A;
  • Bio-decontamination by SOLIDFOG nebulisation
  • Integration of peristaltic pump.


  • Option 1: Double H14 filtration at intake;
  • Option 2: Double H14 filtration at exhaust;
  • Option 3: Integrated MAS-100 aerobiocollector;
  • Option 4: Integrated PMS IsoAir Pro-E particle counter;
  • Option 5: Wi-Fi MK glove tester.

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A sterility test isolator is essential equipment in the pharmaceutical industry for testing the sterility of products, particularly injectable products. Key features include

  • Controlled environment: creates a hermetically sealed environment to prevent contamination.
  • HEPA filtration: uses HEPA filters to ensure ultra-clean air.
  • Physical barrier: provides separation between operator and product.
  • Aseptic handling: equipped with gloves and transfer locks for safe handling.
  • Automated control: incorporates automated systems to regulate temperature and humidity.
  • Applications: used for sterility testing in the pharmaceutical industry.
  • Regulatory compliance: designed to meet pharmaceutical quality standards.

In short, sterility test isolators play an essential role in the quality control of pharmaceutical products, ensuring that products are free from microbial contamination.

Need a Specific Configuration? Customized Dimensions?

Discover our custom-made insulators designed to meet your requirements

EREA is a globally recognized leader in providing state-of-the-art isolator and cleanroom air flow solutions tailored to the specific needs of pharmaceutical, biotech, as well as cosmetic industries, all compliant with Annex 1 of GMP.

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