Lamellae and Visible and Subvisible Glass Particles
Lamellae, along with visible and subvisible glass particles, refer to thin flakes or layers that can detach from the inner surface of glass containers used for storing pharmaceutical products. This phenomenon, often a result of glass delamination, can introduce contamination into the medication, posing risks to product integrity and patient safety. Identifying and analyzing these particles is crucial in maintaining the quality and efficacy of pharmaceuticals, ensuring that treatments remain safe for patient use. Gateway Analytical specializes in detecting and understanding the implications of such particles, utilizing advanced techniques to safeguard against potential contamination.
Ensuring Integrity, One Particle at a Time
The ‘lamellae and visible and subvisible glass particles’ test assesses the presence of lamellae and visible and subvisible glass particles in the solution. The analytical techniques to evaluate this parameter include visual inspection, stereomicroscopy, or scanning electron microscopy – energy-dispersive X-ray spectroscopy (SEM-EDS).
Gain Insight into Glass Lamellae and Particles in Solutions
At Gateway Analytical, we employ advanced techniques like SEM-EDS to identify any glass particulates, ensuring your packaging meets the highest scientific standards. Reach out to our experts for expert testing support.
Gateway Analytical: Your Partner in Precision
Early data collection is key to identifying potential delamination incidents before they impact product integrity. For guidance on setting up baseline screenings or any inquiries about glass delamination, Gateway Analytical is here to assist. Contact us today for expert support in safeguarding 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.