Last modified: 2025-06-07
Abstract
Environmental Monitoring (EM) of both viable and non-viable particulates plays a critical role in maintaining the sterility of Injectable Pharmaceutical Products manufactured under aseptic conditions. This study sought to find, assess, and manage environmental contamination risks within PT. XYZ Farma's Beta-Lactam Injection Ready-to- Fill Manufacturing Facility. As described in BioPhorum 2019, a structured risk-based approach was used combining a grid-based assessment with Failure Mode and Effect Analysis (FMEA). Key risk factors covered were cleanliness, personnel movement, material flow, proximity to exposed products, operational complexity, and frequency of hand intervention. The assessment was conducted in two stages: initial scoring based on cleanroom zoning, followed by advanced scoring to refine monitoring strategies in high-risk areas. Results showed that zones near the filling and capping machine, and Laminar Airflow units, presented the highest risk due to frequent human interaction and open product exposure. These areas were prioritized for enhanced viable and non-viable monitoring and personnel gowning assessments. Although the current EM program showed no major non-conformities, the absence of a documented risk-based rationale was noted. This study highlights the importance of adopting a scientifically justified, risk-based EM strategy aligned with ICH Q9 (R1), EU GMP Annex 1, and current best practices.