Analytics and testing
Q PTE: Various analytics and testing are involved in aseptic processing, including sampling, validation, and identification.
Can you talk about some of the major considerations manufacturers need to keep in mind for this part of aseptic processing?
O'Connor: Sampling is an important part that involves testing to determine whether your process is in control throughout manufacturing.
Before approving a process, it must be validated, which requires an extensive battery of tests on the product, including characterisation,
identification, and contamination minimisation. One key factor for taking samples of biologics is to ensure that the product
is not contaminated while samples are taken, which could lead to false positives.
Samples are also taken after the product has been sterile-filtered for sterility testing. If the product does not pass sterility
test, it will be a failed batch and will be rejected.