Last month I spoke about the relative role of tool manufacturers in the quest for efficient contamination control in the manufacture of ever more sensitive microelectronics. This is indeed an important question but only one among many constantly faced by the entire universe of contamination control user industries. How to achieve efficient contamination control and, specifically, across how large an environment, has been an age old question for everyone with a contamination control requirement. And, of course, the answer has been widely different depending on the specific application. Equally important to note, however, is that it has also been widely different depending on when the question is raised and the current state of the technology and market of the user industry.
Certainly, we’ve seen this in the semiconductor industry, where companies and facilities have shifted emphasis back and forth between minienvironments, large ballroom cleanrooms and hybrid approaches, depending on the level of technology of the product being manufactured and the cost/performance pressures of the marketplace. Likewise, major changes are in the works for the bio/pharmaceutical industry, which is increasingly faced with downward pricing pressures at the same time that it must ramp up production scales for increasingly contamination-sensitive products, particularly biologics.
And, for the bio/pharmaceutical industry, this challenge now expands outward to new users, such as compounding pharmacies, which must balance critical space limitations with exponentially growing demand for aseptically-handled products and stricter contamination control requirements. Some of the terminology is different (safety cabinets, gloveboxes, barrier/isolators, RABS), but the question is the same.
In the food industry, the complexities of implementing very large-scale aseptic processing operations and retrofitting improved contamination control approaches into existing conventional manufacturing lines (and manufacturing mindsets) are just beginning to be openly addressed.
Finally, looking ahead into the not-too-distant future, nanotechnology-scale products will upset the entire universe of existing contamination control solutions-raising all new challenges not only in product protection but in personnel and environmental safety as well.
The point is that the answer to the question of “how-and-how-large” has always been, and always will be-it depends on the time and place. For that reason, we’ll keep calling it the cleanroom question.
John Haystead,
Editor-in-Chief