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For many pharmaceutical manufacturers, commercial filling lines are simply a part of the manufacturing process. But when a drug is still in development or requires prescreen stability testing for new primary container selection , small-quantity filling can be difficult. To send such quantities to a contract manufacturer or commercial lines, such as isolator or RABs, can be expensive and time consuming.
As the concept of flexible filling evolves, components in sterile bulk and nest configurations will become more common for small-batch campaigns. Bench-top fillers, which can sit on lab tables and be filled either by hand or through limited automation, can help with small-quantity filling requirements. Many manufacturers are also turning to smaller, automated fill-finish units that have interchangeable modules that can accept different primary containers and components for filling, including prefillable syringes, vials and cartridges.
West currently offers several component options including stoppers, seals and syringe plungers in packaging suitable for small-quantity filling. As the market evolves, we’re developing options for more of our products, including Daikyo Crystal Zenith® vials and syringes.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
<em>Welcome to Tech Talk, our latest feature from blogger Beverly Prohaska, Vice President, Global Information Systems. These features will discuss how West uses information technology internally and externally to help ensure customer satisfaction. Look for Tech Talk to appear regularly on the West blog.</em>
When it comes to filing time, the last thing you need is a surprise. The pharmaceutical industry focus on issues of extractables and leachables (E&L) from packaging/delivery systems began during the mid-1990s. Since then, regulatory agency awareness of these issues has increased, while drug product formulations and other drug product contact materials have become more complex. When agency questions on extractables and leachables do arise, the process to evaluate them can seem overwhelming. As a result, many customers are asking: “Do I really need to complete all of the testing requested?”; “What does West already know about the elastomer formulation I am using?” or “Where do I start?”
The supply of sterile pharmaceutical closures into a filling line is an essential element of the production of parenteral drug products. In addition to sterilizable bags, West offers closures in aseptic transfer bags – referred to as “port bags” or “ported bags.” Port bags contain a “beta” port that is attached to the actual bag <strong>(Figure 1).</strong>
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
<p><em>Dr. Heike Kofler, Amy Miller, Jennifer Riter<br /></em><em>West Pharmaceutical Services, Inc.</em></p><p>One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, a process known as moisture transmission.</p>
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