ST-IS Series

Sterility Testing Isolator

The Sterility Testing Isolator is a cGMP Class A/ISO 5 custom-designed isolator system specifically designed for Sterility Testing, according to customer’s requirements.

These parameters were pinned out to bestow the safest and most ergonomic working conditions during Quality Control Operations.

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  • ST-IS Series

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GUARANTEED ASEPSIS

The ST-IS series assures the highest air quality of the isolated environment thanks to:
– an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional down flow, return, and exhaust filters;
– HYPER, Tema Sinergie’s 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.

AUTOMATIC LEAK TEST

The ST-IS series 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).

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.

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 ST-IS series.

GLOVE INTEGRITY
TESTING

The ST-IS series is 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.

DATA
MANAGEMENT

The ST-IS series has been upgraded with DataWall, a software application developed by Tema Sinergie for data management.

ENERGY
SAVING

Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.

KEY FEATURES

  • Fully PLC controlled isolator system (Siemens S7-1500)
  • Integrated VPHP generator (HYPER) and distribution circuit
  • Integrated VPHP sensor for TLV monitoring (safety sensor)
  • Integrated VPHP sensors for chambers’ concentration monitoring (High / Low values)
  • Integrated Non-viable (Particle) monitoring
  • Integrated Viable (Microbial) monitoring

• Rapid Transfer Ports (mod. DPTE 190-XS)
• VPHP resistant anemometer
• VPHP resistant relative humidity and temperature (rH%+T) sensors
• Integrated Sliding Control Cabinet made of AISI 316L stainless steel
• View/Access panel latches with integrated safety switches
• LED lighting system

Available downloads:
  • ST-IS Series

Are you interested in this product?

© 2021 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up