Is Manual RTP Integrity Verification Introducing Unnecessary Variability?

Two operators can run the same rapid transfer port integrity check and reach different conclusions. When verification depends on manual procedures, operator technique and interpretation can become part of the result, which is a problem for contamination control in aseptic manufacturing. The case for automating the check is consistency, not speed: a repeatable process produces results that are easier to evaluate and compare over time. For established facilities, the practical questions are fit with installed RTP configurations and how results enter the quality record, particularly when an unexpected result needs investigation. One automated approach is examined, along with the qualification points that still need confirming.

Read the full article to check your own verification steps for operator-dependent judgment calls.