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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.

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 (2mlC50ml) and tolerances guarantee no unwelcome manufacturing surprises as a drop-in material replacement
  • As a proud FDA Emerging Technology Program participant ԰ has direct engagement with regulatory bodies

Potential Applications

  • Pharmaceutical primary packaging

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.

Quartz Vials

Whats 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 singleCpart-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.

Soda Lime Silicate

(Type III Vials)
~75% SiO2

Borosilicate

(Type I Vials)
~80% SiO2

Fused Quartz

(Pur Q Vials)
~99.995% SiO2

vials_legend

Chemical Durability Thats 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 121F. 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)
Vial Surface Comparison

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Pur Q Fused Quartz Vials

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No. 6, 10th Floor, No. 65, Gaotie 7th Road, Zhubei City, Hsinchu, Taiwan

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No. 1088 Yuanshen road, Suite 1101 Pingan Fortune Building, Shanghai 200122, China

+86 21 5848 1388

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԰ Korea Ltd.

7F of WONIK Building, 20, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do,
Republic of Korea

+82 31 8038 9069

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԰ Japan KK

Park West 10th floor, 6-12-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo 1600023,
Japan

+81 3 6721 1910