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Unanticipated incompatibilities between the drug product and a closed system transfer device (CSTD) delay therapeutic delivery to the patient. Considering the CSTD with the drug product and even co-packaging the drug product with an optimal FDA-approved CSTD will positively impact drug product therapeutic performance and ultimately patient care.
Healthcare providers, medical device, component and pharmaceutical manufacturers, as well as, leading governmental and regulatory agencies have long recognized the issues healthcare workers face with compounding and administering hazardous drugs. These industry leaders have convened to establish policy, increase awareness, and develop specific devices to protect healthcare personnel during occupational handling of hazardous drugs. In December 2019, USP <800> was enacted specifying that CSTDs “should be used when compounding hazardous drugs” and “must be used when administering antineoplastic” drugs when the dosage form allows.1 The development of the aforementioned regulations and the emphasis on using the appropriate safety devices, such as CSTDs, establish a perspective that the safety of both patients and healthcare workers is significant.
Typically, CSTDs utilize either air-cleaning or physical barrier functional technologies, which are designed to inhibit the escape of the hazardous drug substance.2 Effectively designed and used CSTDs should be utilized in combination with other safety measures (personal protective equipment and engineering controls) to mitigate the exposure risk to the healthcare worker who may compound or administer hazardous drugs to patients.1, 3-4 However, various users have revealed a range of potential problems between CSTDs and container closure systems that include device-related issues, such as fluid leakage and broken components to chemical incompatibilities with the devices on the market.5 These issues elucidate the importance of choosing the most appropriate CSTD to provide physicochemical compatibility with a drug product and ultimately the best protection to the healthcare worker. Additionally, the lack of standard and harmonized performance requirements to demonstrate compatibility between a CSTD and a drug container closure system further complicates the issue. In response, working groups like Product Quality Research Institute (PQRI) are developing test standards and guidance for evaluating the inter-connectability between the vial and transfer device.6
Our expert team of dedicated scientists in West’s Analytical Services and Scientific Insights Labs have partnered with several organizations to establish multiple CSTD test capabilities and methods to investigate the issues with the container closure component or interfaces with the CSTD. Capabilities include the following:
West is “By Your Side” as you navigate the challenges of assessing a CSTD with your drug product container closure system. Please visit our page to learn more about our expertise and testing capabilities
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.
Coring, fragmentation, and stopper push-in are some of the common issues associated with rubber stoppers used with transfer devices (e.g., vial adapters). This is because they are punctured with spikes, which are significantly larger in diameter than needles, and are made from plastic materials.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.<sup>1</sup>
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the second of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
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