When you need to meet the highest quality standards

Daikyo D Sigma® offers high-quality elastomeric components for injectable pharmaceuticals designed to reduce particulates, lower patient safety risks, and decrease variability. Daikyo D Sigma® components combine advanced technologies and a long history of industry expertise.

Particle contamination has become a hotly debated quality issue. As a result, the regulatory burden for particle-free manufacturing (freedom from visible particle contamination) and the absence of foreign particles and chemical or physical contaminants has become a challenge for the industry. To meet these ever-increasing quality demands, West and Daikyo are pleased to introduce Daikyo D Sigma® - a superior quality of elastomer components.

Daikyo D Sigma® components combine several critical quality attributes, starting with the tightest particle specification in the Daikyo portfolio. Daikyo D Sigma® elastomer components combine advanced technology and expertise to deliver the tightest particle specifications in the Daikyo portfolio and 100% dimensional verification. This helps reduce variability and mitigates potential risks to patient safety.

Daikyo D Sigma® components are available in ready-to-use validated(DAIKYO RUV®) and ready-to-sterilize validated(DAIKYO RSV®) grades. The variety of packaging configurations ranges from DAIKYO RUV® Small Packs (500 / 1,000 pieces) to standard commercial configurations in STERILizableBAG ™ or portion bag packaging, as required.

  • Vision inspected at 0.01 mm² particle sizes, Tighter AQL, Particle Testing performed to ISO 8871-3 - Minimize drug safety risk and improve patient protection

  • Components are washed and sterilizable(RSV®) or sterile and ready-to-use(RUV®) - Reduce your manufacturing footprint, streamline processes and outsource risk

  • Automated 100% verification - Reduced risk of variability

  • State-of-the-art, clean rubber formulation - Low extractables and volatiles

  • Flurotec® film- Forms a protective barrier between the drug and its closure, reducing stopper sticking and clumping

  • RB2 coating technology- An alternative to silicone that reduces subtractive particle reduction associated with silicone, improved machinability

 

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