The ST-IS (Sterility Testing Isolator) is a cGMP Class A/ISO 5 modular isolator system specifically designed for Sterility Testing, which guarantees the safest working conditions during Quality Control Operations.

It’s a flexible equipment that guarantees the best working conditions for different applications, such as Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Product Transfer.

Guaranteed Asepsis: The ST-IS assures the highest air quality of the isolated environment due to:
– an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional down flow, return, and exhaust filters;
– Our integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle;
– inflatable seals made of FDA-approved White Silicon Bio-Guardian, with anti bacteria inhibitors.

Data Management: The ST-IS can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital. DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.

Modular Based Configuration:The system is based on a versatile modular concept: the base isolator configuration is composed of a single 4-gloves working chamber which can be easily expanded with additional chambers/airlocks. This makes ST-IS perfectly suitable to every need and process. A select number of available options may be added at a future date.

Automatic Leak Test: The ST-IS is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).

Glove Integrity Testing: The ST-IS can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 100μm diameter.

Ergonomic Design:Maximizing operators’ effectiveness is essential to minimize the risks of accidents, eliminate unscheduled downtime and boost production quality. Operators are assured the most comfortable working conditions by the outstanding ergonomics of the isolator.

Ease of Maintenance: An integrated sliding control module made of AISI 316L stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations. A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance anytime, everywhere.

  • Fully PLC controlled isolator system
  • Modular configuration concept of the system
  • Integrated VPHP generator and distribution circuit
  • VPHP resistant anemometer
  • VPHP resistant relative humidity and temperature (rH%+T) sensor
  • External monolithic Control Cabinet made of AISI 304 stainless steel
  • View/Access panel latches with integrated safety switches
  • LED lighting system
  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

 

 

 

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Picture of our Automatic Glove Leak Tester