6 FROM THE EDITOR March 2014 • www.cemag.us
Managing Cleanroom Operations for
Today and Tomorrow
Putting out the fires and handling immediate, pressing issues are the mainstay of most management and oper- ations roles. There are always responsibilities—both unexpected and routine—that can eat up time, energy,
and keep you focused on the here and now.
With so many demands on the day-to-day workload, it’s hard
to make time to assess processes and create short and long term
plans that will move your operations forward. Many managers
liken their role to a juggling act. While it takes relatively little time
to master traditional juggling with three similar balls in the air,
the tasks are rarely that consistent in weight (importance) and size (value). In this issue,
we attempt to draw attention to some items that often can be put on the back burner.
Looking to the future: Barbara and Ed Kanegsberg asked industry experts about
the future of cleaning and validation. Their responses remind us all to consider where
you want to be and how you plan on getting there. As one expert put it, thoughtful
consideration is more than “doing whatever is necessary to get the job done.”
Staying current with USP guidance: The recent revision to USP <1116> moves
away from the alert and action level concept for bacterial detection in aseptic environments. In “Practical Application of Rapid Microbiological Methods to the USP
<1116> Contamination Recovery Rate Approach,” Peter Noverini discusses a monitoring method which places focus on trends as opposed to CFUs.
Meeting the requirements of the cleanroom classification: Just because the cleanroom classification has lots of identification (e.g. Class 100/ISO 5/Grade A) doesn’t
mean you’ve got all the bases covered. To gain an understanding of how these linked
classifications do and don’t work well together, Jeanne Moldenhauer offers documented information on “Understanding Cleanroom Classifications.”
On-going facility operation review: Keeping your facility “tuned up” is the focus of
Facilities Guy, Richard Bilodeau’s article “Through the Building Commissioning Maze”
In this two-part series, he talks about the role of on-going commissioning and how it can
help optimize building operations and solve building issues before they become critical.
Documenting procedures: Jan Eudy’s “Document Management” column discusses documentation specific to medical device manufacturing but the overall process
for documentation holds true for almost all processes. This includes going beyond
just recording the words but starts with establishing the procedure, documenting
it, implementing it, and maintaining it.
Sourcing the latest products, equipment and technology: The annual Buyer’s Guide
is included with this issue of Controlled Environments. It continues to be the most
comprehensive listing of cleanroom-specific products and vendors. It covers from
the walls in and is a shortcut to online searching and unrelated results.
A manager’s job is one of continuous evaluation and improvement. We welcome
your suggestions on how to make the most of your resources and time.
Vol. 17 • No. 3
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Charles W. Berndt, C. W. Berndt Associates Ltd.
Ahmed A. Busnaina, PhD, NSF Center for
Microcontamination Control - Northeastern University
Scott Mackler, Cleanroom Consulting LLC
Gregg A. Mosley, Biotest Laboratories Inc.
Bipin Parekh, PhD, Entegris Inc.
Morgan Polen, Lighthouse Worldwide Solutions
Michael Rataj, Aramark Cleanroom Services
Raymond K. Schneider, PE
Consultant and Faculty Member, Clemson University
Howard Siegerman, Ph.D.
Siegerman and Associates LLC
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Scott Sutton, PhD, Microbiology Network Inc.
Art Vellutato, Jr. , Veltek Associates Inc.
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