equipment cleaning processes.
ical). For automated processes, design and cleaning of the
tooling can be more challenging than that for the product.
Therefore, consideration of the 4Ds4 and taking a life-cycle
approach5 to design and critical cleaning of tooling can
make the difference in success and failure of product assem-
Certainly, in pharmaceutical production where containers,
transfer lines, and other items come in contact with the
product, there are well-defined protocols for CIP and monitoring. In manufacture of product, many surfaces may come
into close contact with the product. It is a good idea to set
up procedures to avoid inadvertent product contamination.
Unfortunately, we regularly observe assembly and coating
failures that could have been avoided by planning and
validating cleaning and maintenance processes for tooling,
fixturing, and even ovens.
Other cleanroom surfaces, such as floors, walls, and bench
tops, can cause problems with the product. Contaminants
can be particle, thin film, or vapor. They can be organic,
inorganic, biological, or a complex mixture. Repeated cleaning and polishing can lead to biofilms.
Having a cleaning and maintenance program in place is
essential. We often hear something to the effect that “we hire
people” who “take care of” the floors and walls after the first
and second shift leave. The vision that comes to mind is that
of a cadre of earnest elves who, every night, quietly enter
the cleanroom, scrub it down with toothbrushes, and then
steal away before the break of dawn, leaving the cleanroom
spotless and meeting all specifications. There are wonderful
cleanroom cleaning services. However, the same provisos
apply to using cleanroom cleaning services as to using contract cleaners for the product. That is, you are responsible
for the process; you are responsible for cleaning. Find out
what cleaning protocol is used; make sure it is what you
need for production. Pin down the specifics, make modifications if necessary, and get the protocol in writing. Every
now and then, you might consider a friendly visit to those
1. ISO/TC 209 WG 12: “Cleaning of surfaces to achieve
defined levels of cleanliness in terms of particle and chemi-
2. B. Kanegsberg, E. Kanegsberg and K. O’Donoghue, “Keeping
Product Clean In and Out of the Cleanroom,” Controlled
Environments Magazine, Jan. 2009 and Feb. 2009.
3. J. Broad and B. Kanegsberg, “Putting Cleaning Protocols to
the Test,” Controlled Environments Magazine, July 2012.
4. B. Kanegsberg and E. Kanegsberg, “4D Processes,” Controlled
Environments Magazine, Jan. 2014.
5. B. Kanegsberg and E. Kanegsberg, “Medical Device
Manufacturing Shifts to Lifecycle,” Controlled Environments
Magazine, Apr. 2014.
Barbara Kanegsberg and Ed Kanegsberg (the Cleaning Lady
and the Rocket Scientist) are experienced consultants and educators in critical and precision cleaning, surface preparation, and
contamination control. Their diverse projects include medical
device manufacturing, microelectronics, optics, and aerospace.
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