Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs. The testing of a product contact component is driven by the risk that the component ...

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

With the growth of automation and increase of workers engaging with machines, I felt there would be some benefit to sharing an example of the safety risk assessments that we do in order to reduce or ...

Mold is an insidious material that at its very early stages is quite natural and unassuming. It is a naturally occurring biological contaminant with some positive characteristics, including the ...

A majority of safety practitioners accept the premise that absolute safety is not attainable. Still, some safety practitioners profess that only a risk-free environment is acceptable. These two ...

This article is part of PharmTech's supplement "Injectable Drug Delivery." Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Because of the nature ...