Contamination control in biomedical devices impacts soils regardless of status of viability.1-3 There is an ASTM working group and associated standard under development for overall assessment of extractable residue.

After a full month of on/off travel in April, which included Sarasota and Baltimore, I ended up in Las Vegas-not to gamble my life away, but to attend the 50th consecutive annual 2004 Estech meeting given by IEST.

The last several years have seen a ground swell trend among large manufacturers toward flowing down cleanliness requirements on parts and assemblies to their sub-tier suppliers.

Effective cleanroom microbial control requires an understanding of the risk factors associated with microbial contamination, an understanding of effective prevention and remediation steps, and an understanding of the regulatory requirements associated with the use of products and procedures designed to achieve microbial control.

Last month we wrote about electropolishing (EP) —the science and some problems. We also introduced the idea that removing a surface metal layer, and everything attached to it, is actually a step of final cleaning. In this column we’ll solve those problems, consider costs, and examine some cleaning applications.

I’m getting soiled bunnysuits returned by my commercial launderer. He says he can’t get them any cleaner with the solution he uses. My question is, are nonionic surfactants as effective in cleaning my polyester cleanroom bunnysuits as anionic surfactants would be?

The United States Food and Drug Administration (FDA) is the government agency responsible for the approval of new drugs and the controls for manufacturing of pharmaceuticals that are consumed in the United States.

Electropolishing (EP) is normally used to produce a shiny finish to complex metal parts. That’s probably why you know of it. Industries use EP for finishing of metal used in pharmaceutical, dental, semiconductor and medical applications.

It is always interesting to share strategies in packaging development with others in the clean room industry. A common theme in discussions I have had over the years is the challenge packaging engineers face developing the best product for a particular application.

When people think of corrosion they typically have visions of rusted-out cars that have seen too many miles of salted pavement in a Midwest environment. The sheet metal of car panels made from steel alloys are 31,750,000 angstroms (0.125”) thick and can be converted to dust in a matter of three years or so.

The requirement to manufacture drug products is at an all time high. With the forecast for increased demand, pharmaceutical and bio-tech companies continue to set goals for finding ways to increase product yield and to reduce overall construction schedules.

Immersion cleaning with liquid or supercritical CO2, can be advantageous. CO2, raises no concern about health issues and is non-flammable, virtually inert, and not an ozone-depleting compound.