Screening Strategy for Drug Products and Glass Vials
USP 1660 outlines crucial guidelines for understanding and detecting glass delamination in primary glass containers, yet its complex nature often leads to challenges in interpretation and application. At Gateway Analytical, we transform the complexities of USP 1660 into actionable insights. Let our expertise guide your journey through glass delamination screening, ensuring the integrity of every product.
The screening strategy for drug products and glass vials is a systematic approach designed to evaluate the compatibility and safety of glass packaging for pharmaceutical use. This strategy involves a series of tests that assess the chemical and physical interactions between the drug formulations and the glass vials. The aim is to identify any potential issues, such as glass delamination or leaching of harmful substances, that could compromise the quality and efficacy of the drug product.
Accelerating Access to Life-Saving Medicines
At Gateway Analytical, we have decades of experience in conducting glass delamination studies. Our team of scientists are experts in designing personalized glass delamination screening studies that cater to your specific needs. We consider the primary container you are using and your formulation and develop a robust analysis that provides you with conclusive results.
Comprehensive Screening for Uncompromised Quality
Reach out to Gateway Analytical for expert guidance in navigating USP 1660 and designing effective glass delamination studies
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.