Scanning Electron Microscopes

Putting all of the “Naming of Samples” and crazy specimens aside, Scanning Electron Microscopes are used for a wide array of important and sometimes life-saving situations. ASPEX was recently confronted with a situation in which a reader sent in skin which was thought to have fibers within it.

After having months of discomfort, the reader [...]

The United States Pharmacopoeia (USP) defines the allowable limits of particulate matter in injections and parenterals in Test Section 788. This section classifies particulate matter in injections and parenteral infusions as any unintentional presence of mobile undissovled particles, with the exclusion of gas bubbles. The USP sets forth two methods in which to [...]

Particle size distribution, or PSD, according to size, list of values of a relative amount of particles present in a given sample. Since pharmaceutical products are required by the FDA to strive for products free of foreign particles, it is essential to be able to quantify and classify particles to maintain the quality of [...]

Quality by Design (QbD) in the pharmaceutical industry is a push from the United States Food and Drug Administration (FDA) towards a level of process understanding that would result in assured product quality while the product is being manufactured, rather than Quality by Inspection (QbI) which takes place after the product is completed. [...]

The International Organization for Standardization (ISO) set the standard for the number of particle inclusions allowed in hydraulic or lubrication systems. The ISO 4406 Code for cleanliness in machinery is based upon the number of particles in a lubricant greater than 4, 6, and 14 micron, in that order. These numbers give machinists [...]

Particle characterization evaluates particle size and shape, along with the physical and chemical properties of the sample, to identify the particular particles of the sample in such a way that allows for comparisons between several samples. This gives manufacturers the data necessary to evaluate the quality of one batch of material to another, allowing [...]

Particle detection and characterization methods have changed the way manufacturers think about quality control. In the automobile industry, understanding the particles that enter into the production line, even the most minute, can be the difference between product failure and product success. Particle contamination in any form allows for the possibility of mechanical wear, [...]