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QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
A Quality Target Product Profile (QTPP) is used to establish CQAs. When West decided to create a new syringe plunger it created a QTPP with a CQA for control of breakloose and glide forces. Development of the NovaPure® plunger included risk-based design inputs, Finite Element Analysis (FEA) modeling, data generation on multiple concepts, and final product performance verification with glass barrels from multiple suppliers of a 1mL long staked needle syringe. Throughout the development process QTPP served as a guideline to assure that targeted specification values for breakloose and glide force were met. Using QBD philosophy and principles can help to optimize breakloose and glide forces and significantly reduce plunger variation from part-to-part
Use of QbD principles ensures that components are developed based on science and data-driven decisions, and meet critical specification for defects, visible and sub-visible particulate and extractables consistently. In order to achieve a high-quality product, QbD components are washed and steam sterilized for optimized material compatibility and the knowledge gained throughout the process is used to maintain continuous improvement by the manufacturer. Selecting a manufacturing partner like West early in the development process can help pharmaceutical companies choose a high-quality component for use in prefillable syringe systems that will meet demands for high quality, improved total cost, and increased safety and security for the drug product.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Final packaging is often the last process step before a product leaves a factory. Any failure in the process at this point puts the cost of the finished and filled drug at risk, as well as the capacity of the process.<br />
The revision to the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals standard becomes official on December 1, 2013. The revision will limit printing to <span style="text-decoration: underline;">only</span> cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product sold within the United States. Seals with the embossed “Flip-Off” or printed with other non-cautionary labeling will not be compliant with this new standard.
Let’s face it – we humans love our pets. World pet markets are growing at a dramatic rate, with several countries witnessing higher-than-ever pet ownership and spending. Industry insiders attribute this growth to the humanization of pets. This means that more and more cultures now regard companion animals as beloved family members. Hence, there is a push to increase the standard of living for pets – including higher quality veterinary care products.
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.
Experimental characterization of an elastomer plunger in a particular pre-filled syringe system is essential to help pharmaceutical manufacturers determine whether that plunger is suitable for intended use. The strategy for a characterization study must consider relevant factors, in particular, compatibility with drug product and the ability to enable consistent delivery of drug product (dosage and time), by a clinician or by an autoinjector.
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