Improvements to a drug delivery system (DDS) can control the consistency and increase the quality of drug delivery. Parker’s self-sealing polyisoprene is designed to improve on existing systems available in the market. Parker’s USP <381> self-sealing polyisoprene elastomers demonstrate exceptional self-sealing capabilities, even with needles as large as 16-gauge. Due to the minimal force required for piercing, our material is ideal for seals and septa used in infusion systems and insulin pumps. Using our USP <381> polyisoprene material may improve septum performance and user safety for doctors, nurses, and patients.
A needle, as large as 16-gauge, can pierce the polyisoprene septa as many as 20 times with no trace of leaks. Good self-sealing properties ensure that when the needle comes out, the drug stays in. Our self-sealing polyisoprene is non-coring. After piercing, there is no visible fragmentation and therefore no tiny pieces to clog the system or contaminate the fluid. This is important to maintaining the purity of the drug throughout the delivery process and ensuring a safe transfer to the patient.
Parker’s self-sealing polyisoprene meets USP <381> standards for the functional testing of closures intended to be pierced by a needle. It also meets biological testing as defined by USP <88> and USP <87> for in vitro and in vivo testing, respectively. Our self-sealing polyisoprene passed the biological reactivity and systemic injection tests. The material is biocompatible and has shown no harmful reactions or toxic effects.
Using Parker’s self-sealing polyisoprene for seals and septa in insulin pumps and infusion systems provides improved performance, ease of use, and increased safety due to elimination of leaks and reduction of blockages. This pioneering material allows medical staff to have seals and septa that can be pierced multiple times during use with no leaks. The development of this new product is an exciting prospect for the drug delivery market.
Our facilities are located near major cities to enable easy distribution. Contact us for more information on how we can improve reliability with your drug delivery system.
This article was contributed by Saman Nanayakkara, engineering manager, Parker Hannifin Composite Sealing Systems Division.
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