AP-IS series by Tema Sinergie provides a comprehensive range of totally aseptic isolators, fully compliant with the strictest cGMP and international regulations.
The high level of aseptic conditions achievable (cGMP Class A/ISO 5) makes these isolators the perfect solution for pharmaceutical and biological industries. Modular based configurations or custom design to fit specific user requirements.
Applications
Typical applications are: R&D, Batch Scale Aseptic Filling, Sterility Testing, Aseptic Dispensing & Sampling of APIs, Aseptic Transfer.
Compliances
Annex 1, EU Guidelines, cGMP, Gamp5, FDA CFR 21 part 11.
