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Coring and fragmentation are two typical events that can occur when a needle is pierced through a vial closure to withdraw drugs from the vial or expel drugs into the vial.
Despite being used interchangeably, coring and fragmentation are two different mechanisms. Coring happens when a needle shears out cores (or slivers) from a rubber closure as it pierces the closure. Cores are, at times, longitudinal in shape. On the other hand, fragmentation is the formation of characteristically small, irregular particles when a needle pierces through a rubber closure and abrades the rubber material.
The two major factors causing coring and fragmentation are, of course, the rubber closure and the needle. Despite seeming simple to control, each comes with a number of variables that need to be addressed and regulated. Regarding the closure, the main concerns are the hardness of the rubber formulation and the thickness of the stopper diaphragm where the needle pierces through.
However, with regard to the needle, there are varying quality parameters (sharpness, consistency, etc.), designs (bevel angle, needle gauge, heel type, etc.) and textures (smoothness, siliconization, etc.). Also, there are different piercing techniques (speed, angle of puncture, number of times needle is reused, etc.) practiced by the many healthcare providers around the world and patients who are self-administering drugs at home.
To effectively prevent coring and fragmentation, it is critical that there is good communication between drug manufacturers and healthcare providers and/or at-home patients/caregivers. A drug manufacturer needs to understand the puncturing technique most commonly used by the intended healthcare providers. Similarly, healthcare providers should reach out to drug manufacturers to communicate their needs.
For more in-depth discussion about coring and fragmentation, please contact your Technical Customer Support representative.
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.
The coring and fragmentation of elastomer components used in containment of parenteral drug products continues to be a challenge. Many factors influence these phenomena, so it is critical that a pharmaceutical manufacturer understands how a vial system will be used, for example: what is the recommended needle gauge, is it single- or multi-dose, could spikes, vial adapters or closed system transfer devices be used. Cores and fragments can be generated by needle penetration of the elastomer components. Cores are formed by the needle cannula cutting the elastomer – ordinarily they are cylindrical. Fragments are formed via an abrasion phenomenon of the needle penetration – shapes are irregular. <br />
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
For injectable drug products, coring and fragmentation of elastomer stoppers is a critical concern. This is caused by tearing or shearing a fragment of the stopper in a vial during insertion of a needle or a spike. The cores/fragments that enter the drug product may lead to harmful patient outcomes. Testing of stoppers is a must for many pharmacopeias. Coring and fragmentation is complex and influenced by many factors, in particular the stopper and the needle.
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure. For the purposes of this discussion, the focus will be on the functional performance of the stopper and what key aspects should be considered during the assessment and selection process. Coring and fragmentation, container closure integrity, and machinability of the stoppers will be briefly reviewed.
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