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No routine trending of: Individual defect types (e.g., hair, glass, atypical particulate) This approach limited: Early detection of contamination signals Data-driven escalation and intervention Aseptic Process and Environmental Monitoring Weaknesses Environmental monitoring failures linked to: Occluded equipment surfaces Surfaces not reliably exposed to (b)(4) decontamination High-risk interventions: Involved stopper handling and equipment manipulation Occurred within ISO 5 environments Were already identified as risky in internal assessments, yet remained permitted Sampling methodology: Use of contact plates with sweeping motion Inability to attribute contamination to specific surfaces Reduced sensitivity compared to swab sampling for irregular or critical surfaces SEE ALSO: Types of Sampling Methods in Environmental Monitoring Stopper Control as a Contamination Risk Reliance on pre-shipment (tailgate) samples supplied by stopper vendors

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That selectivity likely explains the favorable safety profile observed across decades of research