Issue

During this election season, we’ve all heard a lot of talk about “change.”

IEST sets goals for new nanotechnology Recommended Practice Working Group activities.

Since human-generated contamination plays a large role in critical environments, special care must be taken to provide appropriate garments to minimize the human impact on the cleanroom.

Compiled by Carrie Meadows

A National Research Council (NRC) committee of experts provided a boost to neighbors opposing construction of a biocontainment research lab at the Boston University Medical Center by declaring in late November that a draft environmental impact report concerning the facility is “not sound and credible.

For the second year in a row, a survey of safety professionals has found that non-compliance with personal protective equipment (PPE) protocols continues to be an issue in the workplace.

According to a subcommittee of the U.S. Food and Drug Administration’s Science Board, the nation’s food supply is at risk, as are the regulatory systems that oversee the nation’s drug and device supplies. In a report presented in December, the subcommittee attributed the deficiencies to increased demands on FDA and resources that have not increased in proportion to those demands.

The best combination medical device makers select product materials, process steps, and monitoring strategies in the early stages of product development to ensure biocompatibility and product stability throughout the manufacturing process.

Barrier technology is designed to replace the use of conventional ISO 5 cleanrooms in pharmaceutical filling and packaging (i.e., ampoules, vials, cartridges, and pre-filled syringes).

NASA planetary protection programs charged with keeping biocontamination out of space.

The latest regulations call for a shift in particle monitoring strategies.