The ST-IS (Sterility Testing Isolator) Beta 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 a flexible equipment that guarantees the best working conditions for different applications, such as Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Product Transfer. Specific applications for Beta emitters available.
GUARANTEED ASEPSIS
The ST-IS Beta 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.
EASE OF MAINTENANCE
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.
ERGONOMIC DESIGN
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 ST-IS Beta.