Aggressive Screening Conditions Studies

At Gateway Analytical, we understand the critical importance of selecting the right glass packaging for your pharmaceutical products. Our Aggressive Screening Conditions Studies offer a robust evaluation of your product-package containers, simulating extreme conditions to test their durability and resistance to glass delamination. This not only ensures the packaging you choose is up to the task but also monitors the consistency and quality of glass from your suppliers. With our expertise, you can have peace of mind knowing your products are protected by packaging that’s been rigorously tested for the long haul. Let us help you maintain the highest standards of product integrity and safety.

Empowering Precision, Ensuring Safety

In the pursuit of pharmaceutical perfection, every detail counts. Our aggressive screening test involves three suggested formulations and conditions to accelerate a delamination event. Indicators of degradation in the container include pitting, fractured inner glass wall surfaces, changes in the concentration of SiO2, or the number of glass lamellae and particles in solution.

Gateway Analytical - Analysis Solutions

At Gateway Analytical, we specialize in conducting these aggressive screening tests, guiding companies in choosing the most suitable primary glass containers for their formulations. Our expertise ensures a thorough evaluation, aligning with USP 1660 standards. For detailed assistance in executing aggressive screening tests and selecting optimal primary containers, please reach out to Gateway Analytical.

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.

Gateway provides comprehensive USP 1660 testing framework to help companies prevent glass delamination events or detect their presence before drug products are recalled.