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One of the challenges a drug manufacturer faces is controlling the drug product at the point-of-use in a hospital or clinical environment. Often the method of vial access is variable, leading to an increased risk of harmful patient outcomes such as stopper cores or fragments entering into the drug product, which can contribute to cardiovascular events. There are a number of causes that contribute to stopper coring and fragmentation in the field that depend primarily on the technique of the practitioner and the properties of the elastomeric closure.
Causes of Coring or Fragmentation (Technique):
Causes of Coring or Fragmentation (Closure Properties):
To reduce the possibility of coring, West recommends increased field education on proper needle/spike usage and selection. Additionally, the drug manufacturer can help prevent coring through the proper selection of elastomer formulation and design for end use. For known multidose applications, synthetic isoprenes and specific low-coring stopper designs are available. Vial adapters are another way for the drug manufacture to ensure normalized vial access in the field and multiple dose withdrawal with a single stopper puncture. Finally, understanding the impact of processing on the physical properties of the elastomeric formulation is an essential aspect for reduced coring. Please contact your West Technical Account Specialist to discuss some low-coring stopper options.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.