CST-IS

Compact Sterility Testing Isolator System

The Compact Sterility Testing Isolator System (CST-IS)  is a modular cGMP Class A/ISO 5 isolator system specifically designed for QC Laboratories.

Available downloads:
  • Barrier Isolation Technology Brochure

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GUARANTEED ASEPSIS

The CST-IS assures the highest air quality of the isolated environment thanks to:
– an engineered filtration system composed by 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;

MODULAR BASED CONFIGURATION

The system is based on a versatile modular concept: the base isolator configuration is composed of a single 2 to 4-gloves working chamber which can be easily expanded with additional modules. This makes CST-IS perfectly suitable to every need and process. A select number of available options may be added at a future date.

EASE OF MAINTENANCE

A Virtual Private Network connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere.

GLOVE INTEGRITY TESTING

The CST-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 CST-IS.

AUTOMATIC LEAK TEST

The CST-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).

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
  • Modular configuration concept of the system
  • Integrated VPHP generator (HYPER) and distribution circuit
  • VPN connection for a secure and private communication via Internet network–remote access and assistance, updates, maintenance and training
  • High Efficiency Particulate Air (HEPA H14) filtration
  • Unidirectional Air Flow
  • Positive/negative pressure gradient achievable
  • View/Access panel latches with integrated safety switches
  • LED lighting system
  • Increased operator safety with better ergonomics

OPTIONAL INTEGRATED EQUIPMENT

  • VPHP sensor for TLV environment (safety sensor)
  • Integrated Non-viable (Particle) monitoring system
  • Integrated Viable (Microbial) monitoring system
  • Integrated Automatic Glove Leak Testing System (AGLTS)
  • Integrated 21 CFR part 11 compliant paperless graphic recorder
  • Integrated Sterility Testing Pump
© 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