The cleanliness of enclosures or parts is critical to avoid the presence of particulate contamination which can be bad for quality or performance. A good method to establish cleanliness is the ...

Subvisible particulate testing is critical to assess the safety of medical devices, and particulate contamination should be minimized to avoid possible negative health consequences to the patient. A ...

Particulate contamination of injectable drugs isn’t just a hindrance for manufacturers and customers: it can pose serious health risks, too. And when those drugs are intended for cancer patients, the ...

A streamlined workflow using Six Sigma's DMAIC methodology was developed to identify and mitigate visible particles in biologics, reducing time and resources while maintaining quality. Visual ...

An update to USP<1788> Methods for Determination of Subvisible Particulate Matter was released in May 2021. Its goal is to assist in the support and clarification of the information provided in ...

Particle contamination has proved a stumbling block for many drug manufacturers in recent years. Now, Japan's Toyobo is learning that lesson the hard way. The FDA has taken out its red pen to chide ...

The pharmaceutical and biopharmaceutical industries continue to embrace the utilization of single-use systems (SUS). With the ever-growing adoption of SUS products, increasing scrutiny has been placed ...

Cleviprex injection recalled due to presence of particulate matter The FDA and The Medicines Company have notified healthcare professionals of a voluntary nationwide recall of 11 lots of Cleviprex ...

Investigation of sub-visible and visible particles is often challenging, in large part, due to the limited amount of available samples. Many of these analytical challenges arise during composition ...

As semiconductor devices become more complex and the critical particle size for today’s cutting-edge technology nodes falls into the sub-10 nm size range, controlling and mitigating potentially ...