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Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
Our Integrated Solutions program brings together West’s primary packaging, device, analytical, regulatory and contract manufacturing expertise in a single-source solution. West can help you Simplify the Journey™ at any stage of drug development. Learn more by visiting our Integrated Solutions Program page or contact a technical representative today for additional support and guidance.
Last week, West once again exhibited at CPhI/Innopack—Europe’s premier trade show that brings together approximately 36,000 senior pharmaceutical professionals from more than 150 countries. West was among the show exhibitors that included providers of packaging, finished doses, machinery, ingredients, contract services, and other related services.
In a product’s development lifecycle, the importance of packaging can sometimes be overlooked until a packaging specialist becomes involved and can elucidate whether the packaging design is suitable and meets the tests for form, fit and function. Some companies that may not understand or emphasize the critical elements of a good package in the design phase may find out too late that the package is unsuitable after sustaining one or more failures during validation testing.
While medications can provide life-saving solutions to patients, they can also result in harm to medical personnel who might suffer unintended exposure to potent drugs. The seemingly simple act of placing a syringe needle into a septum-sealed vial can result in inadvertent needle-sticks, with potential drug exposure. Additionally, the transfer of potent chemotherapeutic drugs can result in fugitive droplets or volatilization of the drugs and therefore personnel exposure.
Vial adapters are easy to use and pose less risk of needlestick injury than traditional syringe and needle manipulation. They not only provide needle-free transfer of liquid for reconstitution, but also enable consistent withdrawal of drug product from a vial. By providing such consistent withdrawal, the use of vial adapters can aid in reducing the amount of required overfill (extra drug product in a vial to address the fact that not all drug product can be removed), which may result in cost savings.
West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma<sup>®</sup> 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec<sup>®</sup> film, RB2 Coating, RSV<sup>®</sup> and RUV<sup>®</sup> processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.