Drug Delivery Septum
Solutions That Improve Safety for Patients and Providers
The use of suboptimal elastomeric closures in pharmaceutical packaging can lead to issues such as contamination, drug degradation, and patient safety concerns. When considering USP <381> compliant polyisoprene elastomers for seals and enclosures on drug vials, it's important to understand how they address these challenges and enhance septum performance and user safety.
Key things to know about USP <381> polyisoprene elastomers
Puncture Resistance and Resealing
These elastomers offer excellent puncture resistance and resealing properties, allowing for multiple needle insertions without compromising the seal's integrity and preventing contamination.
Low Extractables and Leachables
Formulated to minimize extractables and leachables, these elastomers reduce the risk of chemicals migrating into the drug product, ensuring patient safety and maintaining drug efficacy.
Chemical Compatibility
Polyisoprene elastomers are compatible with a wide range of pharmaceutical products, preventing potential degradation or reactions between the elastomer and the drug.
Reduced Fragmentation
USP <381> compliant elastomers are less prone to fragmentation or coring, lowering the risk of particulate contamination entering the drug product.
Sterilization Compatibility
These elastomers can withstand various sterilization methods, ensuring that the closures maintain their properties and contribute to the overall safety and quality of the pharmaceutical product.
Consistent Performance
By adhering to the strict quality control and performance standards set by USP <381>, polyisoprene elastomers deliver consistent performance, effectively protecting the drug product and providing a reliable barrier against contamination.
USP <381> Compliant Polyisoprene Compounds
Learn more about Parker's USP <381> compliant polyisoprene formulations that address critical aspects and improve septum performance and user safety for both providers and patients
Additional Resources
USP <381> compliant polyisoprene compounds for pierceable elastomeric enclosures.
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