Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach

Visible particulate matter contamination is responsible for the rejection or recall of numerous batches of injectable product each year. The result is wasted time, effort, money, product and the limited availability of medically necessary drug and biologic products. Recently published compendial standards have alleviated some of the confusion surrounding suitable test methods and acceptance criteria for visible particulates; however, the complexities of visual inspection methods across a wide range of injectable product types packaged in diverse and sometimes complex container systems has complicated the approach to visible particulate control in injectable products. The solution is a life-cycle approach to visible particulate contamination control that addresses the prevention, inspection, identification, and remediation of visible particulate contamination. More importantly, the life-cycle approach to visible particulate control is aligned with current United States Food and Drug Administration's good manufacturing practices and can serve as an effective tool for demonstrating regulatory compliance for inspections, audits, and regulatory submissions.