A
new article of interest:
In
an aseptic process, the drug product and container/closure are subjected to
sterilization methods separately, as appropriate, and then brought together.
This takes place under an aseptic environment, where the aseptic environment is
separated from the general environment by some form of barrier. The aseptic
environment is ISO class 5 (EU GMP Grade A) in operation and the surrounding
environment is ISO class 7 (EU GMP Grade B) in operation.
The
reference is:
Sandle,
T. (2016) Risk Assessment for Intervention Scoring in Relation to Aseptic
Processing, Journal of Validation
Technology, 22 (2): 1-10
Posted by Dr. Tim Sandle