Sterility isolators: a complete range of solutions for microbiological quality control in the pharmaceutical field

ST-IS Series by Tema Sinergie offers a complete range of Sterility Isolators, fully compliant with the most stringent cGMP regulations and international laws, specifically designed for carrying out sterility tests and quality control activities.

Sterility Isolator is an aseptic isolator system specifically designed for microbiological control activities in the pharmaceutical field, in particular for the execution of GMP required sterility tests for the release of production batches.

Over the years, this kind of isolator has established itself as a technological benchmark for the implementation of quality control activities, thanks to higher versatility, safety and reliability standards compared to other available solutions.

On the one hand, hence, we can well say that the sterility test isolator today represents a technological standard for the industry, while on the other hand, choosing the system which best suits your needs can be proven to be not that easy. There are several variables to take into consideration: from the most suitable configuration for the development of the process which is to be implemented, to the transfer systems, the integration of the work tools, up to the sizing of the chambers which must be adequate for the amount of tests to be performed, as well as the space available for the installation.

That’s why Tema Sinergie has come up with a complete range of Sterility Isolators for quality control activities (ST-IS Series) to respond to the different production needs of the pharmaceutical field.

A team of skilled engineers is available to guide you in choosing the different accessories available and create the best suited solutions for the needs of the department, up to the design of a completely tailor-made line.

ST-IS Series: the best technology serving your process

The ST-IS Series range has been developed in view of some engineering choices aimed at assuring the best conditions (cGMP Class A/ISO 5) for quality control activities to be handled.

The process environments for the sterility tests to be carried out are characterized by the use of AISI 316L stainless steel, with internal Mirror Brite finish (< 0.3 μm) and external Scotch Brite finish (< 0.8 μm), inflatable gaskets made of silicone compound containing silver ions, which allow a Class 2 sealing level, in accordance with ISO 10648-2, while preventing microbial growth, engineered filtration system which includes High-Efficiency Particulate Air filters (HEPA H14) or Ultra Low Penetration Air (ULPA U15) in a unidirectional ventilation system, with 0.45 m/sec speed in accordance with GMP.

All of the ST-IS Series systems have an integrated single pass Vaporized Hydrogen Peroxide bio-decontamination system for rapid bio-decontamination cycles, as well as environmental monitoring sensors, both of a non-viable type (particle) and viable (microbiological).

Furthermore, the ST-IS Series isolators are entirely controlled and monitored by PLC interfaced with a touch HMI system, and can automatically double-check both the integrity of the whole system and that of the gloves installed via the AGLTS 2, the new generation of Glove Integrity Testing System for isolators and RABS in the pharmaceutical industry.