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Fast and easy

SKANFOG® STI – Safe sterility testing, easy to install and fast in operation

 

Your needs:

  • Aseptic environment for sterility testing
  • Avoiding false results
  • Low running cost compared to clean room installations
  • Fast and easy: installation in the factory, test performance and qualification

 

Our solution:

Sterility tests for pharmaceutical products should be performed in an isolator free of microbial contamination to avoid false test results caused by a non-sterile environment. The Sterility Test Isolator SKANFOG® STI is the technically most advanced isolator with:

  • a fully automated SKANFOG® H2O2 decontamination
  • an automated leak test of the working chamber
  • a well documented SKANFOG® fogging technology
  • an integrated catalytic converter in the exhaust air to break down H2O2 to water vapor and oxygen
  • exhaust air double HEPA H13 filter
  • a 6 log reduction of G. stearothermophilus

Beyond that, the basic isolator working chamber is also equipped with:

  • two shelves to hold necessary materials for sterility testing
  • one bar across the chamber to hang test material
  • a drain with a hose olive and a Triclamp DN 10 on the outside
  • two Triclamps to install: an isokinetic probe for particle counting and a sampling head for airborne viable sampling

 

Features:

  • Short decontamination time (< 30 minutes)
  • Catalytic converter: no exhaust duct required
  • Material airlock not required thanks to fast decontamination time
  • The isolator is also suitable for testing hazardous products

 

Options:

  • Sterility test pump from different suppliers
  • Wireless glove testing device
  • A H2O2 Threshold Limit Value sensor (TLV) in the surrounding room
  • Glove stretchers to hold the gloves in a fixed position during the decontamination cycle

 

A broad range of services:

  • Comprehensive documentation package to fulfill the requirements of the authorities
  • FAT in Europe - based on the strictest international standards for pharmaceutical equipment
  • Installation, commissioning, IQ/OQ, cycle development and microbiological qualification according to well accepted SKAN AG standards
  • Service, spare parts and requalification support during equipment life cycle
  • Documented operators training on site and at SKAN Academy in Switzerland

 

Please note: STI is only available in certain countries within Latin America and Asia.

For more information, please contact our sales department.

 

pdfDownload the SKANFOG® STI Brochure

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