Tema Sinergie ST-IS Series provides a comprehensive range of aseptic isolators, fully compliant with the strictest cGMP and international regulations, specifically designed for Sterility Testing. The high level of aseptic conditions achievable (cGMP Class A/ISO 5) and the integrated sterility testing pump guarantees the safest working conditions during Quality Control Operations.
Modular based configurations or custom-designed to fit specific user requirements.
Applications
Typical applications: Sterility Testing, Quality Control operations.
Compliances
Annex 1, EU Guidelines, cGMP, GAMP 5, FDA CFR 21 Part 11
