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.
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
"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
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;
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.
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.
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.
Maximizing operators’ effectiveness is essential to minimize the risk 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.
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).
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.