We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
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.
According to standards published by International Organization for Standardization (ISO) and China National Medical Products Administration (NMPA), the key functional properties of a stopper for a spike-type application are:
Tests are performed with spikes with specific dimensions/properties, as described in the respective standards. However, these tests may not be indicative of vial transfer devices if they are infusion spikes. Thus far there is no standard for vial transfer devices. Further issues may result from differences in use, namely variations in use by healthcare workers and improper angle of spike insertion (which can result in need for excessive force and stopper push-in). USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings seeks to address some of these issues. In their recent article Five Challenges of Closed System Transfer Devices, PDA Letter (January 7, 2020), West experts C. Zhao, Ph.D. and A. Radwick, Ph.D. discuss the following five issues:
West continuously monitors industry issues and standards to understand their impact and works with customers to develop solutions. For more on how West can help, contact an Account Manager or Technical Customer Support (TCS) representative.
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.
<p style="text-align: justify;">Most cancer drugs are hazardous. OSHA, NIOSH and USP regulations, enacted to protect healthcare workers from exposure, stipulate the need for safe delivery. Needle-free devices, such as spikes, can help to meet this need. However, traditional spikes used in infusion systems have posed a concern with small drug vials — stopper push-in by spike incidents can occur.</p>
United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems. This addressed characterizing for biological reactivity, physicochemical testing and functionality testing and compliance was typically a supplier responsibility. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025. This will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. Under the new chapter, it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system.
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.
A good elastomer stopper for a vial container system needs to have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is crucial, as they determine performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. West understands these issues, and therefore is able to develop formulations to offer maximum performance. An example is the formulation 4040/40, which was designed according to quality-by-design (QbD) principles.
English
Chinese
