We design and manufacture our range of isolators for the transfer and handling of sterile products, guaranteeing total protection for both the product and the worker when carrying out contained operations.
We have a range of sterility test isolators designed to protect against contamination risks, generated by the process itself or by external factors, both to the quality of the product and to that of the operator himself.
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.
Turnkey project executed in several phases with excellent coordination and compliance with deadlines.
Complete project adapted to the security and containment needs of the client.
"La Paz" Hospital in Madrid received on June from the Spanish Agency for Medicines and Health...
The OEL (Occupational Exposure Limit) is an indicator that is used to prevent risks to the health...