Issue



One leg at a time


10/01/2004







I've been on the road a lot recently, both attending industry conferences and trade shows and meeting with individual companies. At just about all of my meetings I've inevitably found myself discussing the unique importance of contamination control expertise and the equally important requirement for contamination control professionals to know how their counterparts are applying the discipline and technology in the multiple user industries and applications that contamination control science serves.

For example, already, the bio/pharmaceutical and medical device industries are beginning to see the benefits their contamination control professionals can bring to their efforts at meeting the FDA's new emphasis on "risk-based" compliance and validation. They recognize that this group is uniquely prepared to see beyond the otherwise largely insular view of their own industry and point them to proven, cost-effective systems, technologies and solutions already in place elsewhere. Certainly, contamination control experts in the semiconductor industry have already paved much of the way in terms of implementing real-time process monitoring technology and integration with MES and ERP systems.

There's also no question that the food processing and packaging industry has historically looked more within itself than to other industries in establishing practices and procedures for its operations. Yet, this industry and the pharmaceutical industry clearly share more than a few common concerns, not the least of which is government regulation.

As such, it is certainly not unreasonable to expect that the manpower shortages driving the FDA to push the pharmaceutical industry toward more automated and integrated process monitoring and reporting systems will also be felt by the food industry (whether through FDA, FSIS or both). Already through HAACP, cGMP practices, and 21 CFR Part 11 requirements, the industries must address many common requirements–that can benefit from common solutions.

Now, more than ever before, it just makes sense for the entire community of contamination control professionals to begin working more closely together as one cohesive discipline aimed at improving the quality, safety and efficiency of all manufacturing operations impacted by contamination concerns. It's also an unprecedented opportunity for contamination control technology suppliers to reach out beyond their historic customer comfort zones and pursue cooperative activities with different industries to develop creative solutions to their individual requirements. Certainly, CleanRooms magazine will continue to not only play its part in helping with this "cross-fertilization" activity, but in actively driving the initiative by reporting on the benefits available to, and achieved by, all of the industries served.

John Haystead
Editor in Chief