Pur Q® Fused
Quartz Vials
Your breakthrough belongs in ours
Active pharmaceutical ingredients are becoming more complex, fragile and sensitive. At the same time, expectations for consistent product quality and purity are higher than ever.
Pur Q® fused quartz vials, at 99.995% SiO2, have unparalleled purity, owing to the methodical removal and deliberate avoidance of additives and impurities of all types. Control at the single-digit part-per-million level represents a leap forward in expectations for pharmaceutical glass packaging quality. By removing the sources of potential leaching ions and problematic chemical degradation routes, Pur Q® vials greatly reduce risk to formulation stability and efficacy throughout the product lifetime.
Key Features
Unrivaled chemical durability assures liquid stability and reliable long-term storage of even the most aggressive and sensitive formulations
Ultra-high purity (>99.995% SiO2) eliminates risks associated with glass inhomogeneities (including delamination), as well as problematic metal ion leachables
State-of-the-art tubing and vial manufacturing avoids glass-to-glass contact and delivers exceptional mechanical durability and cosmetic quality
Industry-standard sizes (2ml–50ml) and tolerances guarantee no unwelcome manufacturing surprises as a drop-in material replacement
As a proud FDA Emerging Technology Program participant Momentive Technologies has direct engagement with regulatory bodies
Potential Applications
Pharmaceutical primary packaging
What’s Missing Makes It Remarkable
Unlike conventional Type I multicomponent glass vials, quartz vials are 99.995% pure silicon dioxide (SiO2). This level of purity means Pur Q® vials have an exceptionally inert, nonreactive surface that virtually eliminates any risk of interaction with your packaged drug formulation. Control at the single–part-per-million level is unparalleled and represents a leap forward in expectations for pharmaceutical glass packaging quality.
Conventional Type I vials in use today are typically only 75% to 80% SiO2, with the remaining components comprised of both intentional and inadvertent additives, particularly from the boron, alkali and alkaline earth groups. These additives are prone to leaching ions into packaged drugs, leading to possible changes in pH, contamination and shelf life.
Chemical Durability That’s in a Class of Its Own
Momentive Pur Q® fused quartz vials are simply 99.995% SiO2. In the bulk, at the surface, at the top, on the bottom, everywhere, every batch, every vial, before heat, after heat, all the time.
For multicomponent glasses such as borosilicate, the local composition, well, varies. Varies by manufacturer, by batch, by thermal history, by geometry, by fill volume, from inside to outside. The multiple elements within the glass can, and frequently, rearrange themselves, creating enriched and depleted areas.
How can I tell if this is happening to my vials? Look for signs of heterogeneous chemical attack like surface pitting, blisters or pits on the inner vial surfaces after exposure to almost any formulation.
See pictures after exposure to water for one hour at 121°F. These are so common that they have unfortunately become expected in Type I vials. Micrographs of the inner vial surfaces following <USP660> hydrolytic stability testing reveal that the Pur Q® vial exhibits none of the features typically observed on conventional Type I vials.
Surface Comparison @ 5000x SEM (after USP 660 Surface Glass Testing)
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