D Sigma Injection Stoppers and Lyophilisation Stoppers

Daikyo D Sigma, Injection Stoppers and Freeze Drying Stoppers

Daikyo D Sigma stoppers feature the tightest particulate specification in the Daikyo portfolio, as well as 100% dimensional verification, improving both patient safety and time to market.

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Product Details

  • Low extractables and volatiles
  • Flurotec® lamination 
  • 100% dimensional verification
  • Visual Inspection to 0.01mm²
  • Particle testing according to ISO 8871-3
  • Injection and Freeze Drying (lyo) designs
  • Ready to sterilise and ready-to-use formats
Daikyo D Sigma logo

View compatible Injection Vials and vial-closures systems including Aluminium Crimp Seals and RayDyLyo Vial Caps

Daikyo D Sigma stoppers are manufactured from a high-tech clean rubber formulation, designed to reduce patient risk and to address the increasing regulatory emphasis on particle-free manufacture.

The Daikyo D Sigma range includes particle testing to ISO 8871-3* and represents Daikyo's tightest particulate specification to date.

In addition to greater patient safety, D Sigma improves time to market and machinabillity. Dimensional consistency is achieved through an automated 100% measurement of critical dimensions, thus reducing variability and ensuring optimal Container Closure Integrity (CCI); whilst Flurotec® lamination not only assists in smoother processing, but also acts as an effective barrier between drug and closure making it ideal for packaging volatile and high-value injectable pharmaceuticals.

D Sigma injection stoppers can be supplied Ready-to-Use-Validated (DAIKYO RUV®) and Ready-to-Sterilise-Validated (DAIKYO RSV®) in a variety of packaging formats ranging from Small Packs of 500-1,000 units (RUV® only) to commercial configurations and port bags.

Click on the tab below for information on the options currently available.

*Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count

Daikyo D Sigma Stopper DescriptionFormulationBarrier Film/CoatingSmall Pack Daikyo RUV® Packaging
Large-Scale Packaging
S2 - 13mm Injection / Serum StopperD21-7SFlurotec® + RB2-401,000 pcsVarious
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S10 - 20mm Injection / Serum StopperD21-7SFlurotec® + RB2-40500 pcsVarious
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Daikyo D Sigma Freeze Dry/Lyo Stopper coming soon

Click below to download and view the full Daikyo D Sigma Brochure

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