Tema Sinergie QA Microbiology Isolators (ST-IS Series) provides a comprehensive range of aseptic isolators, fully compliant with the strictest cGMP and international regulations, specifically designed for Sterility Testing and pharmaceutical quality control activities.
The high level of aseptic conditions achievable (cGMP Class A/ISO 5) and the integrated sterility testing pump guarantee the safest working conditions during quality control operations. QA Microbiology isolators are available in modular-based configurations or custom-designed to fit specific user requirements. A compact configuration (CST-IS) is available.
Typical applications: Sterility Testing, Quality Control operations.
Compliances: Annex 1, EU Guidelines, cGMP, GAMP 5, FDA CFR 21 Part 11.