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
Applying metrology–the science of measurement–to the art of medical device design. The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 1.
All businesses and market segments embrace continuous improvement, some at faster rates than others. Rapid prototyping has made significant advances over the past 10 years by embracing three-dimensional models, high-speed machining, modular tooling, new steel alloys, and many more innovations. These innovations have reduced lead times while keeping costs in check. While the healthcare industry has made use of these technologies, demands on component and assembly validation have increased as well, resulting in an increase in the timeframe for validating molds that often exceeds the time needed to build the mold. There are, however, new technologies and processes that original equipment manufacturers can adopt to help streamline the validation cycle. One area of focus should be metrology.
Metrology is the science of measurement. Metrology includes all theoretical and practical aspects of measurement.
There are three aspects of metrology that I will address in this series of articles: product characterization, gauge development and repeatability, and metrology equipment and standardization. Each of these aspects must be considered individually and holistically in order to streamline the validation process, avoid schedule delays or redo loops, and lower developmental costs.
Read the full blog here: http://medicaldesign.com/design-engineering/smart-metrology-next-step-speeding-development-cycles-part-1
United States Pharmacopeia (USP) held a two-day workshop, <em>Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics</em>, June 26 & 27 at their Rockville (MD) site. This was the first USP particle workshop in several years; the robust attendance demonstrated that control of particles continues to be a major focus of the pharmaceutical industry.
Because differences exist between regulatory agencies from region to region, West regulatory affairs continually stays informed of new developments and changes in order to provide customers with accurate regulatory support regarding packaging requirements.
West has recently converted its Elastomer Formulation Drug Master Files (DMFs) to an electronic (eCTD) format.
Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.
Patient safety is defined by the Institute of Medicine as: the prevention of harm to patients.<sup>1</sup> The extension of this principle to general safety in healthcare is: the freedom from accidental injury, and it applies not only to patients, but to all professionals and workers in the healthcare field.<sup>2</sup>
English
Chinese
