Difficult-to-Inspect Parenteral (DIP) Products
Visual inspection of pharmaceuticals, especially for ‘difficult-to-inspect’ products like opaque solutions, powders, or emulsions, can be less effective due to limitations in detecting small or specific-shaped particulates. This challenge is heightened in clear solutions within clear containers and varies further with non-standard product-package configurations. Despite these hurdles, the pharmaceutical industry mandates 100% inspection to comply with USP 790.
Our advanced secondary destructive screening and testing methods are designed to overcome environmental contamination risks, offering a reliable pathway to market for your clinical and commercial products.
Advanced Inspection for Clear Solutions
The problem with difficult-to-inspect products is that they limit or diminish the ability to detect visible particles that may be present. As a result, additional analysis through destructive inspection or testing is required to ensure compliance with USP 790. However, many companies struggle to perform secondary destructive screening and testing methods due to difficulties limiting environmental or foreign particulate matter in the sample, which can cause the lot or batch to fail inspection.
Your Trusted Partner in DIP Inspection
Gateway Analytical stands out as a reliable partner for testing difficult-to-inspect parenteral products. Our extensive experience in secondary destructive screening and testing, combined with our proficiency in isolating foreign particulates and minimizing laboratory contamination, positions us as a trusted choice for lot release. Companies can rely on our expertise to confidently bring their products to the clinical or commercial market.
