One solution to getting the opporator further away from the potent compound, providing a safer work environment, is to use isolator technology. These are leak tight, negative pressure barrier isolator that allows for the handling of hazardous pharmaceutical compounds. This containment chamber creates a unidirectional HEPA-filtered airflow of better than ISO Class 5 (Class 100) air cleanliness conditions within the negative pressure chamber to prevent migration of hazardous contaminants to the outside and to minimize cross contamination across the direct compounding area.
This technology holds the promise of freeing the building envelope and its occupants from the many protocols that are found in a regulated manufacturing environment. Fundamentally changing design, energy consumption and gowning protocols in a cGMP spaces.