TEMA HC-IS

High containment isolator system

The HC-IS is a modular high containment isolator designed for the safe handling of highly potent active pharmaceutical ingredients (HPAPIs) in R&D, production, and quality control environments. Developed for GMP-regulated operations, the system supports stringent containment levels while maintaining operator protection and process control.

The modular design starts from a single working chamber and can be expanded with additional chambers or airlocks to fit specific applications such as weighing, dispensing, sampling, or product transfer.

For controlled performance verification, HC-IS includes routine automatic chamber leak testing based on ISO 10648-2 pressure decay principles. The system can be equipped with the integrated AGLTS 2 automatic glove leak testing system, supporting structured glove integrity testing in line with ISO 14644-7 Annex E.5.

Optional configurations include integrated manual or automatic wash-in-place (WIP), secure remote access via VPN, and advanced data management solutions such as SCADA integration. Energy-efficient ventilation technology supports reduced power consumption throughout operation.

HC-IS provides a flexible containment solution for processes requiring high safety standards, modular scalability, and regulatory alignment.

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