This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems. By David Ladoski and Dan Klees
Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.
The new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs.
Aging facilities have become a concern in the pharmaceutical and biopharmaceutical manufacturing industry, so much that task forces are formed by trade organizations to address the topic. Too often, examples of aging or obsolete equipment, unit operations, processes, or entire facilities have been encountered.
Unconfined yield strength (bulk strength) is the major principle stress that will cause material in an unconfined state to fail in shear. It is the primary flow property that governs the development of hang-ups in process equipment. It is used to compute critical arching and rathole dimensions for a given material in a hopper or bin.
As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”1 Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”2 that includes ideas such as Quality by Design (QbD) in the development process. This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.