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By Mary Tan

January 25, 2021

One of the main risks associated with drug delivery via vial containment systems is particles that can result from fragmentation and coring of rubber stoppers subjected to needle or spike punctures. This risk can be mitigated by using prefilled syringe systems, whereby the drug dosage has been filled into the syringe by the drug manufacturer. The drug dosage is then administered by subcutaneous or intramuscular injection. A prefilled syringe system generates fewer particles during drug administration, as compared to a vial containment system. Furthermore, this form of drug delivery system ensures efficiency and greater convenience.

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By Gabrielle Gehron

March 13, 2020

Historically, finding suitable containers for complex protein drug products has been difficult, since interaction with elastomeric closures can result in particle formation. These particles indicate an underlying change within the drug product, undermining integrity and risking patient safety. The correlation of silicone coatings with protein aggregation has made some wary of their use; however, an elastomeric closure with no coating or film can be difficult to process. Another concern is that leachables originating from the elastomeric closure can induce particle formation.