Sterility Testing Isolator System
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.
IT’S TIME TO UPGRADE YOUR PROCESSES!
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
The ST-IS 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.
The system is based on a versatile modular concept: the base isolator configuration is composed of a single 4-gloves working chamber which can be easily expanded with additional chambers/airlocks.
This makes ST-IS perfectly suitable to every need and process.
A select number of available options may be added at a future date.
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).
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.
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.
The ST-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.
The ST-IS can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital.
DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.
