The Role of a Robust Environmental Monitoring Program in Sterility Test Failure Investigations

[Article Title]

A sterility test failure should never be viewed as an isolated laboratory result. Sterility testing is destructive and limited to a small subset of units, so a passing test cannot prove a batch is sterile and a failed test cannot show when or where contamination was introduced. This article explains how a risk-based, qualified, and well-trended environmental monitoring program becomes the primary source of evidence in aseptic sterility test failure investigations.

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