AC-IS series by Tema Sinergie is a complete range of Aseptic Containment Isolator Systems designed for sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs), including cytotoxics. The systems can be configured and used in both R&D laboratories and production suites.
Aseptic Containment Isolators are specifically engineered to ensure the highest level of asepsis and to maximize the operator protection, in compliance with the strictest cGMP and international regulations. By combining the experience gained through years in design and production of aseptic and containment systems, AC-IS series can grant a GMP Class A/ISO 5 environment and an OEL5 (≤20 ng /m3) level operator protection.
Cost-effective upgradable standard systems are available, as well as process specific, fully customized solutions.
Applications
Typical applications are: Synthesis & Final Formulation, Aseptic Product Transfer, Manual Sampling, Weighing and Dispensing operations of Highly Potent Active Pharmaceutical Ingredients (HPAPIs).
Compliances
Annex 1, EU Guidelines, cGMP, OEL5 (≤50 ng / m3), GMP Class 2, ATEX compliant solutions also available, Containment Test according to SMEPAC, Gamp5, FDA CFR 21 part 11.
Aseptic Containment Isolator SystemAC-IS Series | Aseptic Containment Isolator System
Compact laminar flow isolator system.AC-IS Series | Aseptic Containment Isolator System
