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When selecting parenteral packaging components, the vial and stopper are typically discussed, but the seal is often an afterthought. Seals do not have direct product contact and are considered secondary packaging. However, the selection of an appropriate seal is critical to assure proper container closure integrity as well as determine how the product will function for the end user.
When selecting a seal to complete a container closure system, there are three critical dimensions to consider:
One helpful activity when making recommendations to customers is a theoretical calculation referred to as the “stack-up assessment.” This calculation allows West to determine the amount of excess skirt length available for completing the crimp under the vial crown by using the nominal or mean values for the glass vial crown height, stopper flange thickness and proposed aluminum skirt lengths. We make an assumption of approximately 20 to 40 percent rubber stopper flange compression (Check with your equipment vendor for specific recommendations for your specific system.) To determine the excess skirt length achieved, the below calculation is performed:
excess skirt length = [mean skirt length – aluminum thickness] –[vial crown height + ((flange thickness) x [(100 - % compression)/100])]
An aluminum thickness of 0.008 inches is assumed. An excess seal skirt length of approximately 0.030 inches or slightly greater is required for an acceptable crimp on a vial.
This theoretical calculation is a helpful guideline, but it is not a substitute for component testing. Each dimension mentioned has a tolerance, so there is some variation in the parts. Therefore, it’s important to ensure that the components in their final state are compatible via appropriate container closure integrity testing.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
The need for <a href="/sitecore/service/notfound.aspx?item=web%3a%7b8E02CCA4-F229-4EDC-93A4-6A837E7FA55E%7d%40zh-CN">advanced containment solutions</a>, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.
Glucose monitoring, or measuring the amount of sugar in the blood, is a vital part of everyday care for those suffering from diabetes. Traditional tests require patients to prick their fingers and place a drop of blood on a test strip. The strip is then placed in a glucose meter that reports the results to the patient. While this test is very accurate, it offers a reading for only a single point in time. For patients to get a range of their blood glucose levels, more frequent data is needed at a variety of different times.
Diane Paskiet, Director, Scientific Affairs, serves as co-chair for the 2014 PDA Packaging Conference: Pharmaceutical Packaging Systems – <em>Current and Emerging Practices, Technologies and Materials</em>, which will be held at the Washington Marriott Wardman Park, Washington, D.C. on May 20-21, 2014.
West works by the side of our health care partners to understand patient needs and provide integrated delivery systems that optimize the effectiveness of drug delivery while enhancing the patient experience. Creative business models will ensure effective collaboration, either by leveraging West’s proprietary technologies or partnering with individual customers through the development process to apply West’s design, engineering and manufacturing skills to create customer-specific solutions.
We recently announced our partnership with <a rel="noopener noreferrer" href="https://techin-iitpkd.org/" target="_blank">TECHIN – a Technology Innovation Foundation of IIT Palakkad</a> which focuses on assisting innovation and incubation for growing entrepreneurs, to build a Medtech Research Center of Excellence.