According to existing regulations and Good Manufacturing Practices recommendations, isolator technology in the pharmaceutical industry and cell culture-based medicine provides a physical barrier between a process that may require sterility and pressurization, whether positive or negative against the external environment, guaranteeing the necessary protection, reducing potential contamination and the risks of cross-contamination.
The physical barrier is a fully welded chamber within which a specific ventilation and filtration strategy allows a controlled atmosphere. This camera also has glasses to allow the vision of the completely hermetic process.
This new generation of isolators designed for the application of cell and gene therapies enables biotechnology centers and cell culture-focused laboratories to continue advancing while operating within the increasingly restrictive boundaries of various regulatory bodies and the guidelines for proper manufacturing. National and international (FDA, GMP and ISO 14644-7).
These equipment have a connection to a decontamination system by Hydrogen Peroxide, integrated VHP or with connections to an external equipment, this biodecontamination system in dry phase has a reduction of up to 6 log and provides optimized application time, allowing to have tight cycle times.