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