Know what you need, get what you need
12/01/2002
We simply can't take for granted that we understand all there is to know about our particular businesses.
However, we're all guilty of this at one point in our careers—usually right around the time we start believing that things couldn't be better. We become locked into a "business as usual" mentality where we deflect the forces of change and become mired in a stagnant state without even realizing we are.
Once we're hit with a cold splash of reality, our first turn is understandably back to the basics. This "splash," and subsequent desire for the fundamentals, is the continued inspiration for the CleanRooms Basics supplement, probably our most-requested section over our 15 years of publishing CleanRooms.
In a time when every expense is being dissected under a microscope, we decided the time was right to focus on how end users can get a clean environment that meets a particular need, fits an available space and, most importantly, meets a down-sized budget. When you know what you need, you get what you need without falling into the trap of preconception or paying for unnecessary space.
I can't tell you how many times I've heard cleanroom designers, builders and contractors tell me stories about potential clients who open a meeting with the line: "I know exactly what I need." Nine times out of ten their preconceived vision is grossly overestimated.
It's the goal of this year's Basics to help put a stop to this syndrome. If you're ready to start a new-build or retrofit project, jot down what you think you need then read this month's Basics. Pick up a phone, call a contractor, ask a few questions—that extra effort just might save you a few headaches, as well as some money.
CleanRooms East 2003: A good thing gets better
One of the most satisfying duties my job offers is the ongoing reinvention of the CleanRooms Conferences. This is a process of weighing and measuring what works, listening to attendee feedback and then launching forth on an odyssey that finds me in contact with some of the top contamination control minds in the business.
For CleanRooms East 2003 we've come up with our most interactive group of sessions to date. We've given our life sciences readers sessions that cut to the heart of their U.S. Food and Drug Administration (FDA) concerns, while our microelectronics readers will benefit from freshly-developed airborne molecular contamination (AMC), advanced mechanical design and automation sessions.
As is the case on the East Coast, there's a slant toward our readers operating in regulated markets. Pharma/biotech attendees will learn how to design a cleaning and disinfection program, share insights into the new FDA aseptic guidelines and get the inside story on the agency's new current good manufacturing practices (cGMP) reassessment initiative from former FDA inspectors.
Look to www.cleanrooms.com for a complete look at all the sessions we're offering March 17-19 in Boston. We look forward to seeing you there.
Michael A. Levans
Chief Editor
You know what you have to do
The philosophies are simple: Legislation not regulation, if nothing else, product and patient, not protocol and procedures.
Experts and observers of the biotechnology and pharmaceutical industries say this should be the mission statement for the U.S. Food and Drug Administration (FDA) initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," a topic that CleanRooms is tracking in more ways than one.
But it's rather difficult to comprehend just what the plan is, especially when the FDA says the effort will preserve public safety and foster innovation, but tells the public at the same time not to expect it to enforce a law that requires biannual inspections of drug making facilities.
Back peddling a bit, news of this initiative came to CleanRooms rather strangely.
In late August, the FDA sent an e-mail blast, inviting a host of journalists to dial into a teleconference. The e-mail provided the number to call and the time of the press conference, but it did not even remotely mention what the topic would be about. And the FDA wasn't about to give any hints either.
The initiative came out of the blue, and at the time this column was being penned, two months after the announcement, the FDA told Cleanrooms there was nothing new to report.
A revamp is needed and the FDA's action is encouraging to many, but it clearly scares pharmaceutical and biotechnology companies, many of which believe the initiative is a wrench in the works of drug discovery and development technology that could change the world for the better forever.
Medical industries need to be policed, plain and simple. There are cheaters out there. Yet, the FDA clearly has a lot to learn about the technologies that have most certainly outpaced its current good manufacturing practices (cGMPs) and put us in reach of touching the face of a higher power.
Our roles are clear. Let's get to work. All creatures great and small deserve it.
Mark A. Desorbo
Associate Editor
Letters
A reason to become a vegetarian
I read Mark DeSorbo's Viewpoint entitled "Comparing Cadavers to Ground Beef" in the September issue, and I would like to add more to the story.
If you visit a beef slaughterhouse, you will see an air-driven gun that pushes a plunger into the animal's brain. The plunger is used on animal after animal, with no thought of cleaning. That is the way surgeons worked in 1850, spreading diseases from one subject to the next.
After seeing this, I came up with a kind of aluminum condom that could be used over the plunger and discarded after one use. I tried it at the University of Arizona meat lab and it worked fine. I thought that the industry and U.S. Department of Agriculture (USDA) would leap at this idea, especially in view of mad cow disease.
Well, I was wrong.
The industry and USDA said the present system was fine, there was no need to change it. And that is where things stand. Keep this in mind when you eat beef.
Prof. Stuart A. Hoenig, P.E., Ph.D.