Sterility Test Isolators

Sterility Test Isolators
Sterility Test Isolators
Sterility Test Isolators
Sterility Test Isolators
Sterility Test Isolators
Sterility Test Isolators
Sterility Test Isolators
Sterility Test Isolators

Sterility Test Isolators

Pharmacopoeias (the official publication containing a list of medicinal drugs with their effects and directions for their use), require the Sterility testing of sterile pharmaceutical products to determine acceptability of a production batch. Sterility Testing is therefore an essential element of sterilization validation and barrier isolators are employed to help eliminate risk and protect the product from both the process and externally generated factors.

Schematic design and manufacture a range of rigid Sterility Test Barrier Isolators that can be configured to suit customer specific requirements.

All of Schematic Barrier Isolators are designed in-house in both our UK and Indian facilities with specific attention to ergonomic design to provide a reliable aseptic environment for sterility testing and other aseptic processes.

Schematic's range of Sterility Test Isolators are suitable for performing both Direct Inoculation and Filter Membrane sterility tests with flexibility to be bio-decontaminated by different types of bio-decontamination systems available and fully comply with ISO 14644-7:2004 producing an EU GMP "Grade A" environment throughout the chamber.

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Design Features

  • Conforms to cGMP
  • Material of Construction 316 Stainless Steel
  • Unidirectional laminar airflow
  • Auto leak test cycle
  • Conditioning cycle
  • VHP cycle
  • Operation Cycle
  • Transfer and Main chambers
  • Mousehole between chambers
  • Integrated with Air Velocity sensors
  • Integrated with Temperature and RH (Relative Humidity) sensors
  • Chambers with different coloured lights

Technical Specification

  • ISO 5 Environment
  • Electro magnetic door locking systems
  • Size to suit client requirements
  • Integrated with AHU and BIBO
  • Integrated with WIP (cleaning)
  • Integrated with VHP generator
  • Integrated with Catalyst Filter

Operational Benefit

  • Ergonomic design helps to reduce operator fatigue/over reaching
  • Mousehole incorporates auto lifting door to control transfer
  • Chambers coloured lights eliminate light sensitivity product issues


  • Injectable areas of plant
  • Sterile Product Testing
  • Clean Rooms (Grade A)

Supply Options

  • Temperature and RH control air intake
  • Percentage of air recirculation can be customised to suit the client requirements
  • Integrated with SART ports
  • Integrated with RTP (Rapid Transfer) ports
  • Can be integrated with online non-viable particular counter

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