USP <790> & <1790>

Elevate your visual inspection capabilities with Gateway Analytical. We provide the expertise and tools to turn regulatory challenges into opportunities for quality assurance. We understand that building a successful visual inspection program takes years of effort, including hiring and training the right personnel, qualifying your inspection program, and establishing a workflow that can be followed for years.

Gateway Analytical: Your Partner in Precision

Our mission at Gateway Analytical goes beyond analytical testing, we strive to help companies like yours develop a comprehensive visual inspection program to identify, track, and trend visible defects as regulatory agencies require on your journey to market. Contact us today to start laying your foundation of success for visual inspection.

Gateway Analytical - Analysis Solutions

Navigate the Complexities of USP 790 & 1790 with Gateway Analytical

Adherence to the stringent requirements of USP 790 and 1790, mandated for all injectable and parenteral products, can be challenging. These crucial regulations often present interpretative and procedural difficulties, particularly in managing foreign particulate matter. Our expertise transforms the demanding standards of USP 790 and 1790 into opportunities for quality assurance, tackling the complexities of foreign particulate matter, and recognizing visual inspection as a dynamic, ongoing process.

Early-Phase Development

Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.

Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

Particulate
Analysis

Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

Medical Device
Analysis

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.

For comprehensive visible testing services, turn to Gateway Analytical. Our advanced testing capabilities and expertise ensure that your pharmaceutical products meet the highest standards of safety and quality.