Note: Descriptions are shown in the official language in which they were submitted.
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SYSTEM AND METHOD FOR HAZARDOUS DRUG SURFACE CLEANING
This application claims priority of US provisional application number
61/788,426 filed
on March 15, 2013. All applications are incorporated in their entirety by
reference.
COPYRIGHT NOTICE
A portion of the disclosure of this patent contains material that is subject
to
copyright protection. The copyright owner has no objection to the reproduction
by
anyone of the patent document or the patent disclosure as it appears in the
Patent
and Trademark Office patent files or records, but otherwise reserves all
copyright
rights whatsoever.
BACKGROUND OF THE INVENTION
Field of the Invention
[001] The present invention relates to a method and system for cleaning
surfaces.
More particularly the present invention relates to a method and system for the
removal of hazardous drug products from surfaces.
Description of Related Art
[002] The ability to clean environmental surfaces of contamination is an
important
job in many situations from food preparation to hazardous situations. Each
situation
has various particular issues for contamination removal and the systems for
cleaning
vary with the contamination to be removed.
[003] Most surface cleaning in work and other environments is to sanitize the
area
to remove viral and bacterial contamination under conditions where the
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contamination will harm the person using the environment or something prepared
or
worked on in the environment like food preparation or the like. Sanitization
concentrates on killing the virus or bacteria and not on cleaning, though
removal of
the contamination is a form of cleaning. Dead bacterial left behind do not
usually
pose much, if any, of a threat. One of the most difficult areas of
contamination is in
areas where drugs and related hazardous drug products are utilized. In these
situations the issue is not bacteria or virus killing, it is the complete
removal of
products that even minute quantities might cause severe toxicities, injury or
even
death to the subject or person exposed to the contamination.
[004] Since hazardous drugs are toxic, direct bodily contact thereto, or
exposure to
even micro-quantities of the drug, considerably increases the risk of
developing
health fatalities such as skin cancer, leukemia, liver damage, malformation,
miscarriage and premature birth. Such exposure can take place when a drug
containing receptacle, such as a vial, bottle, syringe, and intravenous bag,
is
subjected to overpressure, resulting in the leakage of fluid or air
contaminated by the
hazardous drug to the surroundings. Exposure to a hazardous drug also results
from
a drug solution remaining on a needle tip, on a vial or intravenous bag seal,
or by the
accidental puncturing of the skin by the needle tip. In addition, surface
contamination
can result from the synthesis, production, packaging, weighing, compounding of
hazardous drugs, and the like. This is especially true for those working in
healthcare
situations or laboratories.
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BRIEF SUMMARY OF THE INVENTION
[005] The present invention relates to the discovery that a two part cleaning
system
cleans up hazardous drug surface contamination better than existing cleaning
systems and methods. By cleaning first with a quaternary ammonium solution
followed in successive order by a isopropyl alcohol and water solution
hazardous
drug products are cleaned up without leaving detectable residues form the
surfaces.
[006] In one embodiment, the present invention relates to a method of cleaning
a
surface contaminated with a hazardous drug product comprising:
a) wiping the surface a first time with a first solution of an quaternary
ammonium solution having a concentration of from about 0.5% to
about 5.0%; and
b) wiping the surface a second time in succession with a second solution
of water and isopropyl alcohol; the isopropyl alcohol comprising at least
about 50% of the solution.
[007] In another embodiment, it relates to a system for cleaning a surface
contaminated with a hazardous drug product comprising a first towelette
impregnated with a solution of a quaternary ammonium solution having a
concentration of from about 0.5% to about 5.0% and a second towelette
impregnated
with a water and isopropyl alcohol solution the isopropyl alcohol comprising
at least
about 50% of the solution.
[008] In yet another embodiment, it relates to a kit of parts for cleaning a
surface
contaminated with a hazardous drug product comprising:
a) a first solution of an quaternary ammonium solution having a
concentration of from about 0.5% to about 5.0%;
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b) a second solution of water and isopropyl alcohol, the isopropyl alcohol
comprising at least about 50% of the solution; and
c) instructions for cleaning the contaminated surface with each of the
solutions in succession.
DETAILED DESCRIPTION OF THE INVENTION
[009] While this invention is susceptible to embodiment in many different
forms,
there is shown in the drawings and will herein be described in detail specific
embodiments, with the understanding that the present disclosure of such
embodiments is to be considered as an example of the principles and not
intended to
limit the invention to the specific embodiments shown and described. In the
description below, like reference numerals are used to describe the same,
similar or
corresponding parts in the several views of the drawings. This detailed
description
defines the meaning of the terms used herein and specifically describes
embodiments in order for those skilled in the art to practice the invention.
DEFINITIONS
[010] The terms "about" and "essentially" mean 10 percent.
[011] The terms "a" or "an", as used herein, are defined as one or as more
than
one. The term "plurality", as used herein, is defined as two or as more than
two. The
term "another", as used herein, is defined as at least a second or more. The
terms
"including" and/or "having", as used herein, are defined as comprising (i.e.,
open
language). The term "coupled", as used herein, is defined as connected,
although
not necessarily directly, and not necessarily mechanically.
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[012] The term "comprising" is not intended to limit inventions to only
claiming the
present invention with such comprising language. Any invention using the term
comprising could be separated into one or more claims using "consisting" or
"consisting of' claim language and is so intended.
[013] Reference throughout this document to "one embodiment" "certain
embodiments" and "an embodiment" or similar terms means that a particular
feature,
structure, or characteristic described in connection with the embodiment is
included
in at least one embodiment of the present invention. Thus, the appearances of
such
phrases or in various places throughout this specification are not necessarily
all
referring to the same embodiment. Furthermore, the particular features,
structures,
or characteristics may be combined in any suitable manner in one or more
embodiments without limitation.
[014] The term "or" as used herein is to be interpreted as an inclusive or
meaning
any one or any combination. Therefore, "A, B or C" means any of the following:
"A;
B; C; A and B; A and C; B and C; A, B and C". An exception to this definition
will
occur only when a combination of elements, functions, steps or acts are in
some way
inherently mutually exclusive.
[015] The drawings featured in the figures are for the purpose of illustrating
certain
convenient embodiments of the present invention, and are not to be considered
as
limitation thereto. Term "means" preceding a present participle of an
operation
indicates a desired function for which there is one or more embodiments, i.e.,
one or
more methods, devices, or apparatuses for achieving the desired function and
that
one skilled in the art could select from these or their equivalent in view of
the
disclosure herein and use of the term "means" is not intended to be limiting.
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[016] As used herein the term "cleaning" refers to the removal of
contamination on a
selected surface. In particular, it relates to removal of hazardous drugs, and
hazardously related products (e.g. breakdown products and products used to
make
the hazardous decay) from the surface. In general, removal relates to removal
of
such contaminants to a degree that all detectable residues of a hazardous drug
product are removed. Surfaces include but are not limited to countertops,
equipment,
walls, floors, and essentially any solid surface that is compatible with the
ingredients
being used to clean the surface.
[017] As used herein the term "surface" refers to any solid surface that one
would
encounter hazardous drug contamination. For example, in drug manufacture, drug
discovery and drug dispensing, counters, walls, equipment, cabinets and the
like in
the environment may need to be cleaned of drug contamination. This is
especially
true where Federal regulation dictates certain levels of cleanliness to
operate a
business.
[018] The term "towelette" as used herein, generally includes any napkin,
paper
towel, tissue, fabric, cloth, or similar rnaterial, or any other object
suitable for
applying the solutions of the present invention to the surface to be cleaned.
The
towelette can be reusable or disposable as desired. A disposable towelette
usually
refers to low cost materials designed for a single use, such as made with
paper or
very inexpensive cloth or other materials since all materials can be disposed
of. The
material must be absorbent enough to impregnate the towelette with each of the
solutions. Therefore, the material for each solution can be the same or can be
different depending on the characteristics desired. Since it is intended for
dean-up of
a hazardous drug product, it will need to be capable of having the product
stuck or
be absorbed in slurry or solution onto the surface of the towelette before
disposal.
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The size of the towelette is, by choice, the size of the area to be cleaned
in, and
therefore is within the skill in the art if the towelette is small or large in
view of the
disclosure herein.
[019] Medical, nursing, pharmacy and laboratory personnel that are involved in
the
preparation, use and administration of hazardous drugs suffer the risk of
being
exposed to the drugs or the compositions used in the manufacture and delivery
of
drugs, which may escape to the surrounding surfaces and thus come into contact
with personnel utilizing the surfaces or coming in contact with them. As used
herein,
a "hazardous drug product" is any material the contact with which may
constitute a
health hazard. This includes the drugs themselves the precursors, side
products,
solvents utilized therewith and the like connected with the drugs themselves.
Illustrative and non-lirnitative examples of such drugs include, inter alia,
cytotoxins,
antiviral drugs, chemotherapy drugs, antibiotics, and radiopharmaceuticals,
such as
herceptin, cisplatinum, fluorouracil, leucovorin, taxol, metatroxat, gemzar,
cyclophosphamide, Cytoxan, and neosar, or a combination thereof, in a liquid
or
solid state. Other examples of hazardous drug products include docetaxel,
paclitaxel,
5-fluorouracil, cyclophosphamide, ifosfamide and cisplatin. Contaminated then
refers
to the hazardous drug product being on a surface where someone can come into
contact with the drug product.
[020] The system comprises a first cleaning and a second cleaning. In this
system,
a process whereby the surface is first cleaned with a solution of a quaternary
ammonium solution having a concentration of from about 0.5% to about 5.0%. The
solution, in other embodiments, can be 1 to 3% or the like. In other
embodiments the
solution can be impregnated on a reusable or disposable towelette. Next, after
the
first cleaning, a second cleaning in succession is performed. In succession
refers to
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a time period right after the first cleaning such that there is little or no
time for the
surface to be recontaminated such as mere seconds but within a reasonable time
period. The second cleaning is performed with a second solution of water and
isopropyl alcohol, the isopropyl alcohol comprising at least about 50% of the
solution.
The towelettes or whatever is utilized to apply the solutions can be disposed
of in
hazardous waste containers or the like or reutilized after appropriate
cleaning. The
solutions can be delivered for application by a user to a towelette or can be
impregnated onto a towelette for use.
[021] In one embodiment, there is a kit of parts wherein the first and second
solution are packaged or otherwise delivered, along with instructions for use
in
cleaning a hazardous drug product from a surface by utzing a first wiping and
a
second wiping with each of the solutions in succession. In one embodiment the
quaternary ammonium solution is utzed to wipe the surface first.
[022] Those skilled in the art to which the present invention pertains may
make
modifications resulting in other embodiments employing principles of the
present
invention without departing from its spirit or characteristics, particularly
upon
considering the foregoing teachings. Accordingly, the described embodiments
are to
be considered in all respects only as illustrative, and not restrictive, and
the scope of
the present invention is, therefore, indicated by the appended claims rather
than by
the foregoing description or drawings. Consequently, while the present
invention has
been described with reference to particular embodiments, modifications of
structure,
sequence, materials, and the like, apparent to those skilled in the art still
fall within
the scope of the invention as claimed by the applicant.
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