When a product is classified as a Difficult-to-Inspect Product (DIP) such as a suspension, a cell therapy, or a formulation in amber glass, the primary challenge is not simply detecting a particle, but scientifically justifying the adequacy of the inspection process itself. Standard visual inspection reaches a technical ceiling when the product matrix or container obscures the path of light. To maintain a defensible particulate control strategy for DIP, the focus must shift from routine AQL counts to Secondary Destructive Visible Particulate Screening:
Quantifying Detection Limits: Destructive screening provides the quantitative data required to verify AQL performance where visual sensitivity is challenged.
Demonstrating Compliance: This secondary verification is essential to ensure adherence to USP <790> and <1790> expectations for non-standard modalities.
Regulatory Confidence: When visual inspection alone cannot demonstrate patient safety, destructive screening provides the data that survives regulatory review.
Gateway Analytical operates where in-house labs and CDMOs stop, providing the specialized testing necessary to ensure your particulate governance is scientifically defensible. Ready to fast-track your DIP investigations? Reach out today for a priority consultation: 📞 (724) 443-1900 | ✉️ in**@***************al.com
