Aseptic Processing Risk Assessment

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

See: JVT

Posted by Dr. Tim Sandle