Is it possible to handle potent compounds under sterile conditions?

Containment is the separation of hazardous areas from sensitive areas by means of physical or aerodynamic barriers. It can have two applications: sterile containment and potent containment. In the first case, a positive pressure regime ensures the protection of the working environment from external contamination, while in the second case a negative pressure regime keeps the API confined within the working environment to protect the operators.

In some cases it becomes necessary to handle potent compounds under sterile conditions to protect the personnel and, at the same time, prevent product contamination. The most suitable technology for this application is a rigid wall isolator.

Isolators ensure the physical separation between the working chambers and the installation rooms. Decontamination cycles (vaporized hydrogen peroxide within the isolator and SIP in the process equipment) are executed before starting the operations to create an aseptic environment where drugs can be safely handled. During this phase and during the working phases the isolator works under positive pressure to prevent any potential product contamination.

At the end of the operations, after the whole batch is processed, it is possible to breach the sterility of the isolator. The control system switches the ventilation to a negative pressure regime at the beginning of the washing and cleaning phase, when the working chambers and the integrated process equipment are decontaminated.