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
Research has been expanding understanding of biological systems at an exciting pace. In parallel, the biotechnology industry has been rapidly evolving as different biological entities (e.g., cellular and gene-based products) are increasingly harnessed as resources and therapeutics. To maximize the global utilization of biotechnology advances and drive further advancement of the industry, standards are needed.
The International Organization for Standardization (ISO) has convened a technical committee (TC 276) that will address this need by identifying and filling gaps in standardization for biotechnology applications. West has been invited to join TC 276 to contribute its expertise regarding packaging and delivery systems. TC 276 is organized into five working groups that are creating normative and informative standards in the following areas:
The initial standards developed will be broad and horizontal in nature, but will provide the basis for more specific, vertical standards that address the goal of world-wide consistency. One committee expert cleverly compares the suite of standards to a well-known fast food chain, in that both seek to ensure consistent quality independent of location. The first standards are expected to issue in 2018. Additional standards will issue continually as needs are identified and participation from concerned industry, governmental and academic parties increases.
West’s commitment to support ISO TC 276, as well as other industry groups (e.g., PQRI, PDA), is an example of its long-standing commitment to products that enable the safest delivery of drug products to patients.
More information about the international ISO TC 276 Committee can be found here.
The US Mirror Committee is administered by the National Institute of Standards and Technology (NIST), click here to learn how to get involved.
In order to ensure the best quality drug product and optimal patient outcomes, it’s important for drug manufacturers to foster a collaborative effort with their packaging suppliers from the beginning – and that means starting with the patient in mind. Understanding patient needs and how that drug will be delivered, whether through one of West’s delivery devices or some other device, will help determine the needs within the West manufacturing process.
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.
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.
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
