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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.
The first factor is the stopper; formulation, design, siliconization, and sterilization have an effect. Generally, the softer the stopper and the thinner the diaphragm, the lower the level of cores/fragments. Also, siliconization may lower the level of cores/fragments. Regarding sterilization, steam processed stoppers have lower levels as compared to those gamma processed. Compression force may also have an effect; high compression forces should be avoided. As expected, stoppers intended for multi-dose application will see higher levels.
The second factor is the needle; type, gauge, needle lubricity, and penetration force have an effect. Very importantly, also having an effect on the level of cores/fragments are the angle of puncturing, speed of puncturing, location of puncture, and reuse of needle. These points are the focus of a new Technical Report by West: Impact of Piercing Techniques on Stopper Coring & Fragmentation. Studies showed that different piercing techniques and practices could result in stopper coring and fragmentation issues. Hence, to reduce levels of cores/fragments, it is recommended that healthcare professionals and end users follow best practices such as piercing within the target ring to avoid hitting stopper legs, piercing at appropriate speeds, and limiting reuse of needles.
West’s commitment to patient safety involves developing and supplying components that can meet not only the requirements of pharmacopeias, but comply with even stricter standards. For more on how West can help in stopper selection, contact a Technical Customer Service (TCS) representative or Account Manager.
Our vision for the West Knowledge Center has always been to deliver a digital platform full of the most cutting-edge science and product information to further support our customers and potential customers in their search for packaging and device solutions and services. But what about individuals who are new to the industry? Where do they go to gain a strong foundation in these areas to figure out exactly what they need?
The complexity of bringing a combination product, such as an on-body delivery system (OBDS), to market cannot be overstated. Changing or unclear regulations are often cited by the industry as a major source of confusion which contributes to that complexity. However, continuous incorporation of updated standards and newly issued guidance documents during the development process can reduce risk, improve patient safety, save time and headaches when the submission date ultimately approaches.
Responsible business practices are essential to fulfilling West’s mission of helping people live healthier lives. Our corporate values are at the foundation of our culture, and we hold ourselves accountable to the highest standards of quality, integrity and respect – for our team members, customers and the patients we serve.
This week, West is delighted to be at the Parenteral Drug Association (PDA) Europe Annual Meeting in Berlin, Germany. During the show, we will provide more information on our <a href="/zh-cn/products/prefillable-systems/syringe-components/rigid-needle-shields-and-tip-caps">Rigid Needle Shield </a>(RNS). Designed to provide added safety for prefilled syringes with a staked needle, the West RNS helps assure the integrity of injectable drug products. The West RNS will be showcased along with West’s comprehensive product portfolio and technical insights.
<p>By William and Suzette Rishel</p><p><em>Bill and Suzette Rishel are team members at West’s Jersey Shore, Pa., facility. Bill serves as Value Stream Lead and Suzette as a Quality Assurance Inspector.</em></p>
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