Visible Particulate Contamination Control for Injectable Products: A Lifecycle 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 lifecycle approach to visible particulate contamination control which addresses the prevention, inspection, identification, and remediation of visible particulate contamination. More importantly, the lifecycle approach to visible particulate control is aligned with current FDA CGMPs and can serve as an effective tool for demonstrating regulatory compliance for inspections, audits, and regulatory submissions.