Selecting the Cleaning
24 CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM
our boss announces that you are in charge of
selecting and implementing a new cleaning system.
Recently, we described steps to take1 in terms of ana-
lytical tests that you or prospective equipment/chem-
ical vendors can run to determine which systems can perform
effectively. Now it is time to actually make a selection.
Kick the tires
When it comes to the outlay of a large sum of money, go
beyond the flashy brochures, published case studies, and the
performance claims made by sales associates. Ask for a list of
references, people who have purchased the same system. And
then, actually call them.
Is the type of cleaning equipment pertinent to what you
need? It is unlikely that you will find an exact process match.
More often than we would like to see, we have called references only to find that the cleaning equipment was of a very
different type than what we were concerned with on the current project. A good evaluation of a vapor degreaser is not
necessarily useful if you want to purchase an in-line aqueous
Ask them about their total experience. Not just, “Does the
system do the job?” but inquire about the purchasing, installation, and follow-up customer support. Were there issues of
cost creep, delivery delays, or installation glitches? Was the
vendor prompt and thorough at answering questions? Is the
vendor still there for support or did they disappear into the
woodwork once the equipment was purchased?
If possible, arrange for a site visit, so you can view the
cleaning process in its native habitat. Does the equipment
hold up with continued use? Is it corroded? Are the technicians muttering curse words under their breath every time
they come near the cleaning system? If you can, ask the techs
how they like the system.
It’s a selection, not an election
Hopefully, you will have a number of equipment vendors to
select from. However, look rationally at your reasons. It is
more than looking at which one has the most items in the
“pro” column and fewest in the “con” column. Are you selecting purely on capital cost? Are you considering total cost of
ownership? Have you factored in the value of vendor support? If you or your boss tends to add up the pros and cons,
try the approach of listing the selection factors and then
assign a number related to importance of each factor.
It might be O.K. to go with your gut, but figure out why
your gut is saying that. Are you most attracted to the one that
matches the color of your facility? Yes, we have actually seen
upper management purchase the second or third equipment
choice because it matched the décor. Ask the equipment ven-
dors about color choices before you talk to your boss.
Bidding is not a global contest. Speaking of cost, be selective in
the number of bids you request. It takes the bidder time and
money to put together a bid and it takes you time and money
to analyze it. We have frequently found it most productive to
start with a large list of “possibles,” but down-select to a few
“probables” to request full quotes from. Among the criteria for
down select are ROMs for cost and delivery, degree of vendor
support during the pre-selection process, and, of course, performance of the system for your application.
When it comes time to request meaningful quotes, be as
detailed as possible in the request specification. The more
detailed you are, the less guessing you will need to do to
interpret the bids. For example, if you do not specify stainless
steel tanks, a vendor may base a bid on a carbon steel tank
to save on capital cost and keep the bid price down, but that
tank may not last as long and wind up costing you more
money in the long run. Equipment suppliers are running
a business, so keep the door open for future projects. For
example, our policy is to not share bids among competitors.
When the final selection is not final
Medical device manufacturers talk of IQ-OQ-PQ validation
for equipment. 2 Installation qualification (IQ) says that the
equipment is properly installed (e.g. plugged into the correct
socket). Operational qualification (OQ) means that it operates as described in the manual. Performance qualification
(PQ) means that not only is it hooked up right and operates,
but successfully performs the task that is needed. It is not
enough that your product was successfully cleaned in equipment at the vendor’s test lab; it needs to perform in your
plant. It is a good idea to put a “PQ provision” into the contract for a system; make sure that the system is successfully
cleaning your product in your plant before final payment is
made. Think of it as “lemon” insurance. It is more than just a
warranty that the equipment works—it works for the application for which it was chosen.
It might cost extra to have the vendor’s technical people come
out to help with the installation and employee training. However,
frequently that can be a good investment and relatively inexpensive
insurance. The experienced technician who has installed this equipment before can be a lot more effective than reading a user manual.
BFK Solutions LLC