Using Thermoplastic Elastomers for Stoppers and Septums
A new thermoplastic elastomer (TPE) in the Versaflex HC line from PolyOne GLS Thermoplastic Elastomers is suitable for insert-molding infusion therapy stoppers and septums. Versaflex HC products have been available for different stopper and septum products for a few years, and the new TPE is one of several formulations the company has developed in an effort to provide a faster and cleaner production process compared with traditional vulcanized elastomers used for pharmaceutical packaging and delivery devices, a company spokesperson tells PMP News. “These developments have helped our customers cut operational costs and free up production capacity,” reports John Voyce, marketing manager, PolyOne GLS Thermoplastic Elastomers. Injection molding is typically a one-step process, whereas multiple steps are needed to process vulcanized rubber.
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The Versaflex product line includes several technologies such as soft gels, oxygen barrier solutions, overmolding grades, high-clarity products, and plasticizer-free, low-migration formulations.
|Finetool Saudi Arabia Company Limited of Jeddah selected PolyOne GLS Versaflex HC TPE for the resealing septum in its insert-molded IV bottle. The TPE material replaces multiple operations with one injection molding step.
Versaflex HC 2110-35N is the specific material for infusion stoppers and septums for bags and bottles that must reseal after multiple penetrations. “This complements our portfolio of materials for gaskets and seals, which includes Versaflex HC 2110-57B (low stiction for plungers), Versaflex HC 2110-43N (for gaskets and stoppers) and the Versaflex HC 9220 series of products,” Voyce explains.
Finetool Saudi Arabia Company Limited of Jeddah recently chose the new Versaflex HC TPE for the resealing septum in its new insert-molded IV bottle. Finetool was able to improve the resealing and coring performance of the septum compared with that of designs that featured other materials. The company was also able to reduce processing steps for a significant economic advantage. “We designed our new cap to meet the stringent performance, compliance and cost requirements of our OEM, a leading producer of sterile IV solutions,” explained Ahmed Noah, general manager of Finetool S.A., in a statement. “The new Polyone Versaflex HC material delivers better processability than rubber for cost advantages, plus excellent resealing capability and cleanliness. We are very pleased with the results obtained with this TPE.”
Voyce tells PMP News that PolyOne GLS has already obtained independent approval for Versaflex HC 2110-35N to ISO 10993-4 and -5, USP VI and USP <381> elastomeric closures for injection. Versaflex HC 2110-35N also meets the requirements of ISO 15759 (Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers manufactured by the blow–fill–seal process) in a septum, which includes criteria of low coring when penetrated with a gauge 11 spike after autoclaving (121°C for 30 minutes or 106° C for 50 minutes), Voyce explains.
To tackle some challenges, PolyOne GLS’s healthcare marketing team has combined technologies for a specialty solution. “For example, resealable stoppers have traditionally been manufactured from polyisoprene rubber that must be molded as a discreet component, but overmolding technology typically used for Versaflex OM solutions can be employed with Versaflex HC 2110-35N for medical septums, meaning that parts can be co-molded directly onto a PP or PE substrate,” explains Voyce. “This innovation removes the need for assembly, ensures security and connection of the parts, and can be used to improve identification of end products.”
Versaflex HC 2110-35N can also be directly bonded to polyethylene and polypropylene during molding, eliminating the need for additional assembly and providing a secure bond.
PolyOne Global Color & Additives can provide color technology support so that Versaflex HC 2110-35N can provide visual confirmation of a drug group or branding for the pharmaceutical company.
And because thermoplastic elastomers do not employ any curing agents such as sulphur or zinc, there are no reactive residuals left after manufacturing, so finished stoppers do not require washing.
For more details, visit www.polyone.com/news.
---By Daphne Allen, Editor