HC-IS series by Tema Sinergie is a complete Pharmaceutical primary production range Pharmaceutical primary production of High Containment Isolator Systems designed to maximize the operator protection during manipulations of high potent Pharmaceutical Ingredients pharma APIs, HAPIs, and PAP These systems are specifically made for pharmaceutical industries that require the highest containment levels during R&D, production and QC operations. HC-IS series thanks to a perfect combination of design and manufacturing strategies assure a 100% OEL5 (≤20 ng /m3).
Applications
Typical applications are: Product Transfer, Manual Sampling, Weighing and Dispensing operations of Highly Potent Active Pharmaceutical Ingredients (HPAPIs).
Compliances
OEL5 (≤50 ng /m3), GMP Class 2, FDA CFR 21 part 11, Gamp 5, ATEX compliant solutions also available, Containment Test according to SMEPAC.
Pharmaceutical primary production
Containment Isolators are available in standard configuration, or can be customized to cover a wide range of processes, from HPAPIs synthesis to the final formulation. Customized solutions for chemical synthesis and manufacturing processes that comply with user requirements, such as standard or custom-designed Multi-stages Containment Isolator Systems that guarantee the lowest Operator Exposure Levels (OEL).
Containment Dispensing Isolator (QC Lab)HC-IS Series | High Containment Isolator System
Containment Dispensing IsolatorHC-IS Series | High Containment Isolator System
