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

SiO2 concentration

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

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Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
AMER:
+1 800 967 5352
 
 
 
 

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