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.
Discover the modular configuration (ST-IS Modular).
COMPATIBLE WITH NEW AGLTS 2
“I am pleased to report that the CST-IS is running well, and we have successfully completed the qualification phase. The efficiency and reliability of the equipment have exceeded our expectations, and I am confident that it will significantly contribute to our processes control.
I would like to commend TEMA Sinergie’ s team for their professionalism and responsiveness. The level of service we have received from your company has been exemplary and hope this to continue in the upcoming services.”
Oncology and Hormones Engineering Supervisor
ADCAN Pharma
"The experience of working with an exceptional, scientific, and proficient Tema Sinergie team was remarkable.
The installation and qualification of the isolator were precise, fast, and in line with the requirements of good manufacturing practices GMP."
Oncology and Hormones Quality Control Manager
ADCAN Pharma
The CST-IS assures the highest air quality in the isolated environment.
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).
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.
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.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.
The ST-IS series is equipped with an integrated Automatic Glove Leak Testing System (AGLTS 2) in compliance with the international standard ISO 14644-7 Annex E.5 and Annex 1, EU Guidelines.
Main features
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ST-IS is controlled by a Siemens PLC of the S7-1500 series and a Siemens 12″ SIMATIC HMI, characterized by touch technology, with widescreen TFT color display and user-friendly graphics.
The operator interface, developed by Tema Sinergie, allows simple and intuitive use, thanks also to the “one-touch” function and the possibility of recovering stored work programs.
The management software complies with the requirements of GAMP5 and FDA 21 CFR Part 11.
