Early Predictive Screening Studies
Early predictive screening studies are a proactive measure to address the issue of glass delamination, a significant concern in the pharmaceutical industry due to its potential impact on product safety and efficacy. These studies are designed to evaluate the compatibility of various pharmaceutical formulations with glass containers well before the product reaches the market.
Formulations containing acetate, citrate, phosphate buffers, or sodium salts of organic acids like gluconate, malate, succinate, and tartrate can be incompatible with glass containers and cause delamination in medical & pharmaceutical products. Similarly, formulations with high ionic strength, complexing agents such as EDTA, and high pH levels can also be aggressive when filled into glass containers.
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Predictive Screening
To avoid future stability problems and potential market recalls, it’s vital for companies to conduct early predictive screening studies of their primary glass containers in combination with their formulations. These studies help identify potential issues and ensure the selected containers suit the formulations. Gateway Analytical has extensive experience performing glass delamination studies, which have helped companies make market recall decisions and select primary containers for their complex formulations.
Reach out to Gateway Analytical to explore how our tailored predictive screening studies can safeguard your products
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.