Glass Delamination in Pharmaceutical Containers - USP 1660

Glass delamination using USP 1660 guided testing to evaluate the inner surface durability of glass containers and their interactions with drug products.

Delamination is characterized by the formation of glass flakes (lamellae), which are shed from the internal surface of the glass container. These lamellae cause contamination and have the potential to release harmful compounds that could negatively impact the drug products and consumers. Bottles and vials manufactured by molding and ampules, cartridges, vials, and prefilled syringes manufactured from tubing glass are most commonly used as container systems for parenteral and nonparenteral drugs in the pharmaceutical industry.

It is important to remain FDA compliant using USP 1660 guided testing that verifies no inner surface glass delamination of the container system. Our team at Intertek developed a custom comprehensive testing program to meet the needs of USP 1660. We have the capability to test glass surface chemistry and evaluate the inner surface durability of the chosen glass container through various specialized instrumentation and unsurpassed testing expertise. Microscopy and high-resolution SEM-EDS can be used to identify the presence of lamellae and degree of surface pitting.

Our in-house ICP-MS and pH/conductivity testing round out the guidelines of USP 1660 by providing SiO₂ concentration in your drug product. All our glass delamination testing is done within our facility, providing convenience and superior service.

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GLASS DELAMINATION TESTING PROGRAM
PARAMETER	TEST PARAMETER	INSTRUMENTATION
Glass inner surface	Degree of surface pitting Chemical composition as a function of depth	SEM-EDS XPS with depth profiling
Extracted elements in solution	Conductivity/pH SiO₂concentration	Conductivity/pH meter ICP-MS or ICP-OES
Lamellae and visible and subvisible glass particles	Presence of particles Number Size Morphology Composition	SEM-EDS FTIR Microscopy Image Analysis

Intertek supports the broad needs of various industries, including chemical, through a global network of expertise delivering custom services such as assurance, testing, inspection, certification, outsourcing, advisory and training to help manage your risk, reach new markets, improve your performance and advance your business. Total Quality. Assured.

Intertek Pharmaceutical Services

P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA

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