USP <1660> Glass Delamination Screening and Testing
USP <1660> addresses the critical issue of glass delamination, which refers to the deterioration of the inner surface of glass containers holding medical and pharmaceutical products. This phenomenon presents a considerable obstacle within the pharmaceutical sector, as the flaking or peeling of the glass can contaminate the product, potentially compromising its safety and efficacy.
Understanding the root causes of glass delamination is critical given its history of prompting extensive product recalls across the industry. Factors such as the chemical composition of the glass, the pH levels of the stored medicines, and the storage conditions can all play a role in triggering this undesirable reaction. By thoroughly investigating these contributing elements, Gateway Analytical helps to develop more resilient packaging solutions and preventive strategies, ultimately safeguarding patient health and maintaining the integrity of pharmaceutical products.
Navigate Glass Delamination with Confidence
To help understand the mechanisms behind glass delamination and prevent such events, USP 1660 provides information on the topic and a series of tests companies can use to detect its presence before a product is recalled. The chapter outlines a screening study of three specific parameters, which can help companies predict the surface durability of the glass containers they select for their product-package configuration. However, it does not provide instructions on screening testing or the number of samples required for a robust study.
Our USP 1660 Glass Delamination Screening and Testing services are designed to provide you with precise insights, enabling you to predict and prevent potential risks.
If you have any questions or concerns about glass delamination testing, please get in touch with Gateway Analytical today. Let us help you navigate these regulatory requirements with confidence and precision.
Empowering Pharma with Clear Insights
Regulatory agencies have become increasingly aware of the prevalence of glass delamination and have raised concerns about it. As a result, pharmaceutical companies must now provide glass delamination data as part of their filings. Companies that do not plan to provide this data often struggle to find a laboratory with the expertise to perform the analysis and provide the necessary testing samples. Gateway Analytical understands USP 1660 in the context of regulatory expectations. We pioneered glass delamination testing over ten years ago. Our data and conclusions have been crucial in providing evidence to recall commercial drug products from the market or refuting the necessity. We have analyzed thousands of samples and can determine with precision how close companies are to having a glass delamination event or the need to recall their products.
Extractables
& Leachables
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Early-Phase Development
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.