Issue

FDA hones initiative focus to get it right the first time

The invention controls contamination on product surfaces, machine tools and work areas within semiconductor, data storage, fluid filter, display, aerospace and medical industry cleanrooms.

Pharmaceutical manufacturing organizations face the challenge of balancing resources to meet and maintain current good manufacturing practices (cGMPs) compliance expectations with their need to continually improve the efficiency of operations. With proper planning and attention to core business objectives, information technology (IT) solutions can help organizations achieve a proactive and sustainable approach to:

At every turn, we seem to be hit with information that's throwing us off the scent of recovery, putting our nation in a suspended sense of uncertainty that we've never quite experienced before.

Chartered Closure

Much has been written recently regarding cleanroom airflow and airflow velocities. This interest is prompted by the desire to balance the contamination-control requirements of facilities with the energy consumption associated with moving the large quantities of air required.

The margin for error in selecting and implementing contamination control solutions that provide adequate levels of protection is getting smaller and smaller.

You say potato...

In my very first column published in CleanRooms four years ago this month, I wrote: "The instrumentation, software and knowledge required for verification of cleanroom classifications are well known to specialists who provide verification services to the industry.

The teleconference was sloppily scripted, and the players were as awkward as kids in a school play.

Present methods for high-level disinfectants in the pharmaceutical industry leave a chemical residue that can alter the effectiveness of the drugs being produced.

Manufacturing flooring never commanded much respect since the dawning of the Industrial Revolution. Even in plants that took great pride in keeping their factory floors gleaming, floors could never compete with the status accorded the more exotic components of high-tech manufacturing.

The design was complete, and 25 percent of the work on a start-up company's research and development facility was finished when desperate times called for desperate measures.

I frequently visit pharmaceutical and biotechnology facilities to provide assistance in troubleshooting of microbial excursions—environmental data that is at or above established action limits for the regulated area—as well as training on cleanroom contamination control.

Disappointment was the general industry reaction last fall when the U.S. Food and Drug Administration (FDA) released a preliminary follow-up to its 1987 aseptic processing guidance.

If you overlook mops and buckets, you might trip over them. However, it is much more disastrous to trip over soil load and bioburden in your cleanroom, a result of overlooking the use of mops and buckets.

Electro-Safe, a durable, transparent vinyl curtain, is equipped with carbon scrim, which grounds out all electric charges and brings the curtain down to zero voltage.