Modular Sterility Testing Isolator
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. A compact configuration (CST-IS) is available.
Compatible with new Glove Integrity Testing System, AGLTS 2.
ITELPHARMA has acquired a Sterility Testing Isolator designed and manufactured by Tema Sinergie. The isolator is composed of a Transfer Chamber and Testing Chamber, equipped with an integrated Open Loop / Single Pass VPHP Generator (HYPER). The isolator will support us with the considerable amount of tests weekly provided by Itelpharma, using rapid bio-decontamination cycles. The isolator has been installed in our radiopharmaceutical facility based in Ruvo di Puglia, Bari, Italy and it's currently full operational serving our sterility testing activities. Firmly believing in the positive value of technological and commercial partnerships, ITELPHARMA appreciated the collaboration demonstrated by Tema Sinergie during the project.
Site Manager & Qualified Person (QP)
ITELPHARMA
ST-IS is an aseptic isolation system designed to provide the best environmental and working conditions for conducting sterility tests according to Pharmacopeia.
ST-IS consists of two chambers with different characteristics and functionalities. The first step of the workflow involves placing the material for sterility testing into the Transfer Chamber, followed by the execution of the decontamination process using the integrated VPHP system. Once the process is complete, the material can be transferred to the Processing Chamber without compromising the aseptic level of the Processing Chamber, which has been previously subjected to the decontamination process.
The Working Chamber is equipped with a state-of-the-art integrated peristaltic pump, allowing for simple and reliable execution of the test.
The ST-IS assures the highest air quality in the isolated environment.
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).
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 ST-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.
