Method of preventing lamellar silica formation in glass container

A method of screening a glass container for storing a pharmaceutical formulation for susceptibility to lamellar silica formation when filled with the pharmaceutical formulation, comprising:

• filling a washed and depyrogenized glass container with a buffer for the pharmaceutical formulation, wherein the glass container comprises ions selected from the group comprising sodium, calcium, hydroxide, silicate, and combinations thereof;
• storing the filled glass containers at a temperature of 40° C. for at least 14 days;
• optically analyzing the buffer after storage for formation of one or more particles in the buffer;
• when particle formation is observed, isolating the one or more particles from the buffer for structural and elemental analysis;
• analyzing the isolated one or more particles using one or more of optical microscopy, scanning electron microscopy/energy dispersive X-ray spectroscopy (SEM/EDS), Fourier-transform infrared spectroscopy (FTIR), x-ray photoelectron spectroscopy (XPS), differential interference contrast microscopy (DIC), microflow imaging (MFI), and combinations thereof to determine a morphology of the particles and chemical composition;
• and
• analyzing an interior surface of the glass container, once emptied and after isolating the one or more particles, for delamination-type deformation of the interior surface, wherein the presence of particles having a chemical composition comprising silicon, oxygen, and carbon, and the absence of delamination-type deformation of the interior surface of the glass container indicates susceptible to lamellar silica formation.