ISOVAX provides isolators for the product formulation and aseptic filling conditions, to reduce the contamination risk and ensure environmental control.
Isolators reduce the cost of maintaining the area under aseptic conditions as the class maintained in the area is limited to the Isolator; the surrounding area can be of the lower class.
The establishment of a validation discussion group aided the fundamental risk assessment by emphasizing the importance of human contamination in safe, effective aseptic processing. When evaluating the findings of the process simulations, it was clear that personnel was the sole significant source of microbiological contamination in aseptic processing/filling.
Combining an isolator with highly automated aseptic processing lines and/or filling lines has the potential to allow for operation in a microbe-free environment.
Aseptic Processing, Aseptic Filling, Sterility Testing, Aseptic Testing & Sampling, and Aseptic Transfer.
All the isolators can be provided with Half suites/Full suites/air fed helmets, dust masks.