What Your Biological Indicator Strategy Might Be Missing

By Lloyd Rowe, Senior Technical Manager, Protak Scientific Source: Protak Scientific

Successful bio-decontamination in sterile drug manufacturing is critical for product and patient protection as well as regulatory compliance. Biological indicators (BIs) have long been considered the gold standard for evaluating a bio-decontamination cycle’s effectiveness. In practice, BIs are placed throughout an isolator to determine whether the cycle effectively deactivated BI spores at different locations. However, hydrogen peroxide (H₂O₂) distribution during decontamination is not uniform, and BIs are often placed according to perception of risk or ease of physical access rather than based on systemic data. BIs also provide only pass/fail data, making it more difficult to determine the cause of failures.

EU GMP Annex 1, ISO 14644-5, and EN 17141 all encourage a risk-based, data-informed approach to BI location selection and contamination control strategy (CCS). And though these guidances require the use of BIs, periodic BI testing alone is not sufficient to build a low risk, data-informed approach. Enzyme indicators (EIs) have emerged as a compelling supplemental technology that provide rapid, quantitative data to inform BI placement and establish a robust validation package. Download the full article to explore the limitations of the traditional BI strategy and how to establish a more effective hybrid approach.